Express Pharma (Vol. 12, No. 13) May 1-15, 2017

VOL. 12 NO. 13 PAGES 74

www.expresspharmaonline.com

Research

‘India has at least 60 million to 80 million people with chronic respiratory disease’

1-15 MAY 2017, ` 40

CONTENTS The need for a multidisciplinary approach to deliver greater therapeutic results has opened new avenues for growth in the novel drug delivery systems market.

In this issue, Express Pharma profiles two upcoming companies, that have chosen niche formulations to chart their success stories | P22

Vol.12 No.13 May 1-15, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi Prathiba Raju DESIGN

National Design Editor Bivash Barua Asst. Art Director

IT @ PHARMA

40

DIGITIZING DRUG DEVELOPMENT: HOW MUCH CAN IT SAVE?

44

CHOOSING THE RIGHT FDA ESG DIGITAL CERTIFICATES

Pravin Temble Senior Designer Rekha Bisht

PHARMA LIFE

RESEARCH

Graphics Designer Gauri Deorukhkar

63

PHARMA INDUSTRY — WHERE INNOVATION IMPACTS LIVES

64

‘LEADERS TODAY NEED TO LEARN THE ART OF PERSUASION’

Senior Artist Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil MARKETING

34

GANGING UP AGAINST SHIGELLA VIRUS

37

UNEXPLAINED CHEST PAIN MAY SIGNAL HIGHER HEART RISK

39

MERCK AIMS TO ROLE OUT CHILD FORMULA FOR SCHISTOSOMIASIS DRUG

Regional Heads Prabhas Jha - North Harit Mohanty - West Kailash Purohit – South Debnarayan Dutta - East Marketing Team Ajanta Sengupta Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION General Manager BR Tipnis

32

‘INDIA HAS AT LEAST 60 MILLION TO 80 MILLION PEOPLE WITH CHRONIC RESPIRATORY DISEASE’

Manager Bhadresh Valia Scheduling & Coordination Ashish Anchan CIRCULATION Circulation Team Mohan Varadkar

38

BRISTOL-MYERS IMMUNOTHERAPY COMBINATION EXTENDS SURVIVAL IN MELANOMA

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EXPRESS PHARMA

11

May 1-15, 2017

EDITOR’S NOTE

Passing the buck?

P

rime Minister Modi’s announcement that his government would ensure doctors prescribed generic medicines stirred a hornet’s nest. But his visit to his home state was part of the build up to state elections later this year, so the April 17 announcement should not have been a surprise.

This pro-people, pro-poor move to reduce the cost of medicines is in line with the recent price caps on stents and reports indicated that more such moves, like a code of conduct governing marketing activities by pharmaceutical companies, could be part of the amendments to the Drugs and Cosmetics Act. If WhatsApp humour is a mirror of our lives, then the two gems below, are representative of the reactions to the PM’s declaration. When asked by a patient to prescribe some vitamin tablets, this was what the doctor wrote: Tab Thiamine + Riboflavin + Niacin + Pantothenic acid + Pyridoxine + Biotin + Folic acid + Cobalamin and Ascorbic acid + Vit D + Vit E. With the instruction to take once a day after lunch. Leaving the hapless patient to wonder: what do I ask for at the chemist? What will I finally end up with?

Another message doing the rounds makes the point that if people insist on purchasing branded cars, branded clothes, etc, then why do they single out branded medicines (or medical devices) for abuse? Both messages highlight the influence of brands and branding strategies in our lives. For instance, we never photocopy documents, we xerox them even though Xerox is a brand. The government's own initiative to brand its generic medicine outlets under the Jan Aushadhi label is validation enough that brands do matter.

Corporates invest time and resources over many years to build brands, just to gain the trust and loyalty (and wallet) of the consumer. The brand comes with a guarantee of delivering what they promise. In the case of medicines, that's quick relief and no side effects. Which is why pharma companies have invested in creating brands around their generics, giving rise to the category of branded generics.

The government's intention is noble, when price/cost becomes the first benchmark, quality tends to go out of the window. Questionable and inconsistent quality could potentially lead to life threatening situations. Representing the doctors' point of view, the Indian Medical Association (IMA) appreciated the PM's push for generics but pointed out that no new legislation is required to get doctors to prescribe generic drugs since the Indian Medical Council's (MCI) code of ethics already requires them to write the name of the generic on the prescription. Has the IMA been

12 EXPRESS PHARMA May 1-15, 2017

The government’s intention is noble, when price/cost becomes the first benchmark, quality tends to go out of the window.

Questionable and inconsistent quality could potentially lead to life threatening situations

able to ensure this among their members? Not really.

But pharma companies argue that if the aim of the move was to break the pharma company-doctor nexus by taking the choice away from the doctor, prescribing generics only transfers this power to the chemist/pharmacist.

In response, IMA has clarified that the MCI guidelines in fact require doctors to mention both the generic name of the drug as well as the name of the company whose generic the patient should buy and ensure that it was available freely. Another IMA suggestion is that the Central Government Health Scheme (CGHS), PSUs and insurance regulator Insurance Regulatory and Development Authority (IRDA) should mandate reimbursement of only National List of Essential Medicines (NLEM) drugs, unless there is a good reason why this cannot be done.

IMA also hits out at the perceived weak underbelly of the pharma industry in India - qualityalleging that the regulator has been unable to rectify the situation. Hence, IMA has suggested that the Department of Pharmaceuticals be transferred to the Ministry of Health from the current Ministry of Chemicals and Petroleum. This tug of war has been in the works for quite some time.

Just as doctor associations pass the buck to the regulator and the pharma industry, commentators from the latter point to the cost of hospitalisation and consultation fees. Each segment vows to put the 'patient at the centre' but it doesn't seem so.

Are we already seeing the fallout of some of these regulations? The move by pricing watchdog National Pharmaceutical Pricing Authority (NPPA) to cut prices of stents under the Drug Price Control Order (DPCO) in February this year definitely bought down the costs of such surgeries. Two months later, three MNCs, (Abbott, Medtronic India and Boston Scientific) applied to the NPPA to withdraw some of their high end stents from the market. Abbott's statement indicated that the price cuts made it unviable to continue to supply these stents in India. However, one of these stents was anyway being withdrawn from markets after the US FDA raised a safety alert. So are these moves simply posturing?

Indian stent manufacturers have called this a levelling of the playing field and foresee a victory for the Make in India initiative, and we hope this will lead to equal emphasis on 'Innovate in India.' A trade off between availability, accessibility, choice and affordability should not be acceptable. If so, the patient will be the loser ... yet again.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

MARKET GROWTH TRACKER

IPM valued at ` 9,225 crores in March 2017 Domestic companies continued to dominate the market with a 78 per cent share in March 2017 THE INDIAN Pharmaceutical Market (IPM) was valued at ` 9,225 crores in the month of March 2017. After a subdued February, growth revived to double digits for the first time in 2017 and recorded a 10 per cent growth for the month. On a MAT March basis, the industry was valued at ` 114,326 crores and reflected a 9 per cent growth with volumes contributing 28 per cent of this growth and new Introductions playing an important role with 54 per cent contribution to the overall growth.

Number of new launches in Q1 of 2017 (370) have halved as compared to Q1 2016 (721).

However, average value of new brands launched has doubled from ` 0.05 crore to ` 0.1 crore in respective quarters.

The retail channel remained the largest channel in IPM contributing 84 per cent of the overall sales and reflected a 9 per cent growth on MAT Basis. The hospital and doctor channel contributed to 10 per cent and 6 per cent of the overall sales and reflected a 7 per cent and 11 per cent growth respectively. As per QuintilesIMS data, which captures sales from trade stockists, more than 10 therapy areas in the IPM have already

TOP 150 COMPANY SNAPSHOT IPM value – Rs. 9,225 crores (9.7% Growth) Month March 2017 Value (Rs. Crs) 3,958

Rank 1 - 10

510

6

Rank 41 - 60

618

7

Rank 61 - 100

609

7

332

11

8

13

10

6,297

6

7,542

7

7,480

7

6

12

Top 10 companies constitute 43% share of IPM on MAT and Month basis The top 150 companies continue to account for 80% of IPM on MAT and month basis ● For both MAT and month,Top 20 companies contribute to 64% ● For the month,Top 10 companies have reflected stronger performance over the next category of companies while the highest growth is in the companies ranked between 31-40 Source: QuintilesIMS TSA & SSA, March 2017 ● ●

crossed a sale of ` 500 crores in the hospital segment and reflect healthy growth. Lower

growth in the hospital segment was primarily on account of Albumin market which re-

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flected de-growth of -59 per cent.

IPM continued to remain

fragmented with top 10 companies occupying 43 per cent share. Top 10 companies

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MARKET reflected a collective growth of 11 per cent for the month while companies in the 11-20 and 2130 bracket grew slower at 8 per cent and 7 per cent respectively. Five of the top 10 companies grew faster than the market. Lupin with 17 per cent growth was the fastest growing company in the top 10 for the month.

Among the 11-20 companies, DRL (6 per cent), Sanofi (6 per cent) and Emcure (6 per cent) reflected single digit growth while Pfizer reflected de-growth to the tune of -6 per cent for the month on account of discontinuation of Corex.

Domestic companies continued to dominate the market with a 78 per cent share in March 2017 and grew faster than the market with a growth of 10.7per cent while MNCs reflected a 6.5 per cent growth for the month. The largest MNC, Abbott grew slower than the market for the month with 8.59per cent growth while

TABLE 1: PHARMA MARKET SIZE IN MILLION $ BY COUNTRY All values in Million USD

February Month

Month Growth %

MAT February

MAT growth %

Global pharma Mkt

72322

-9.9

1061266

4.3

US

34198

1.9

450721

4.1

Japan

5811

-11.5

79011

6.1

China

4311

-40.52

70148

-3.6

Germany

3134

-5.6

40629

4

Venezuela

2884

129.7

24567

89.3

Brazil

1829

35.6

22540

18.2

UK

1728

-14.9

23304

-9.6

France

1601

-41

32196

-0.8

Canada

1501

2.1

19479

1.8

India

1232

4.9

15456

5.8

Australia

966

15.1

13352

22.8

Italy

946

-60.8

27260

-0.6

Russia

886

4.5

12637

4.9

Spain

814

-54

20057

-2

GSK reflected a growth faster than the market for the first time since July 2016. Pfizer reflected de-growth for the fourth month in a row.

Acute therapies remained the strongest pillar of IPM with a 64 per cent contribution to the total market. However, chronic therapies grew 1.3 times the market at 13.2 per cent vis-à-vis a market growth of 9.7 per cent while acute therapies reflected a low growth of 7.9 per cent for the month.

Cardiac continued to be the largest therapy area for the month, clocking a revenue of ` 1122 crores. Atorvastatin was the largest molecule in the cardiac space. Though it reflected a value de-growth to the tune of -14per cent the molecule witnessed a volume growth of 6 per cent for the month. Telmisartan which was affected by the NLEM last year reflected a value de-growth (-7.6 per cent) however, robust volume growth was recorded for the

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EXPRESS PHARMA

May 1-15, 2017

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MARKET

18

EXPRESS PHARMA

May 1-15, 2017

TOP 40 BRANDS % MS

34

Top 1-10

LANTUS(SANOFI*)

31

JANUMET(MSD*)

0.52

19

48

25

0.37

23

0.33

56

31

NOVOMIX(ABBOTT*)

28

PREVENAR-13(PFIZER*)

27

0.33

12

0.20

PAN-D(ALKEM*)

19

ZINCOVIT(APEX)

18

18

0.19

18

10

0.19

SHELCAL(TORRENT)

17 -2

0.19

0.30

PAN(ALKEM*)

17 -4

0.18

AUGMENTIN(GSK*)

26

8

0.29

SYNFLORIX(GSK*)

16

11

26

5

0.29

ROSUVAS(SUN*)

16

15

SPASMO-PROXYVON +(WOCKHARDT*)

26

0.28

ACILOC(CADILA)

16 -9

0.25

GLIMESTAR-M(MANKIND)

13

23

Value (Rs. Crs)

% Growth

DEXORANGE(FRANCO)

23

14

THYRONORM(ABBOTT*)

22

DUPHASTON(ABBOTT*)

22

FORACORT(CIPLA)

22

MONOCEF(ARISTO*)

21

CLAVAM(ALKEM*)

21

LIV-52(HIMALAYA)

21

PHENSEDYL COUGH(ABBOTT*)

20

VOVERAN(NOVARTIS *)

20

VOLINI(SUN*)

19

% MS

-18 36 14

-3 3

-1 4

17

0.24

BETNOVATE-N(GSK*)

16

0.23

MANFORCE(MANKIND)

16

ZINETAC(GSK*)

16

JALRA-M(U S V)

15

CALPOL(GSK*)

15

BETNOVATE-C(GSK*)

15

0.23

207

%Growth

16

0.23

0.18 0.17

Value (Rs. Crs) LEVIPIL(SUN*)

0.23

0.18

16

0.25

Top 31-40

BETADINE(WIN)

0.20

37

GALVUS MET(NOVARTIS*)

42

% MS

19

ELECTRAL(FDC)

0.30

3

% Growth

6

BECOSULES(PFIZER*)

Top 21-30

MIXTARD(ABBOTT*) GLYCOMET-GP(U S V)

Value (Rs. Crs)

% Growth

Value (Rs. Crs)

Top 11-20

month (12.6 per cent). Rosuvastatin continued to reflect strong value (9.2 per cent) and volume growth (13.9 per cent).

Metoprolol and Amlodipine reflected strong volumes for the month at 10 per cent and 9 per cent growth respectively.

Anti-infectives retained its number two slot for the month with a value of ` 1061 crores, growth, however, was stagnant at 0.7 per cent, making anti-infectives the only therapy area in top 10 to reflect a growth of less than 4 per cent for the month. Ceftriaxine injectables (-10.2per cent) and Cefixime oral solids (-6.7per cent) and Piperacillin + Tazobactam (-0.6per cent) were the large molecules which reflected value degrowth for the month.

Gastrointestinals continued to be the third largest therapy area for the month garnering a revenue of ` 982 crores and continued to impress with 11 per cent growth over SPLY. Ranitidine oral solids were stagnant for the month with a 0.3 per cent volume growth and 1 per cent value growth.

Pantoprazole oral solids and Omeprazole + Domperidone combination reflected low volume growth for the month at 4.9 per cent and 3.4 per cent respectively. Growth was largely driven by top molecules of Pantoprazole + Domperidone and Raneprazole + Domperidone. The Bacillus Clausii market reflected a 47 per cent value growth on account of new launches in this space in the recent past.

Anti-diabetics maintained its fourth position in IPM for the month of March 2017 clocking a growth of 23 per cent over SPLY. DPP4 inhibitors was the largest drug category in the anti-diabetic space with Teneligliptin contributing 20 per cent of the category by value. Vildagliptin reflected a de-growth for the month while its combination with Metformin reflected a de-growth in terms of volumes (-2.6 per cent) and a low value growth (6.4 per cent) for the month.

Dermatology, one of the fastest growing therapy areas in IPM clocked a growth of 21 per cent SPLY with a value of ` 665 crores. Emollients re-

16

0.22

16

0.22

GEMER(SUN*)

15

0.22

GLUCONORM-G(LUPIN)

15

0.20

SEROFLO(CIPLA)

15

0.17

% MS 0.17

16

0.17

33

0.17 0.17

16 12

0.17

-6

0.17 0.16

23 26

0.16

32

0.16

18

0.16

Mixtard continues to be the top brand with a MS of 0.5% Glimestar-M,Janumet and Spasmo Proxyvon + have shown phenomenal growths in March 2017 ● Other brands with remarkable growth are Duphaston, Pan D, Manforce and Gluconorm-G Source: QuintilesIMS TSA & SSA, March 2017 ● ●

THERAPY TRENDS Value (Rs Crs) IPM

MS %

Anti-infectives

1,061

Anti Diabetic

3 23

10

Vitamins / Minerals / Nutrients

718

8

Pain / Analgesics

710

8

Respiratory

709

8

Derma

665

7

Gynaec.

-1 11

11

879

Neuro / CNS

3

1

11

982

2

9

12

1,122

Gastro Intestinal

10

100

9,225

Cardiac

Gwth% (Prev. Month)

Gwth % (SPLY)

460 192

2

Vaccines

170

2

Urology

167

2

Hormones

145

2

Oncology

142

2

2 10

-7 2

21 11

3

7

5

Ophthal / Otologicals

5

10 7

6

576

4

3 15

6 5

4 18

2 0

-2 -1

2

Cardiac therapy and Anti-infective continue to constitute the largest market share in IPM occupying 12% and 11% respectively Anti Diabetics & Derma registered a growth of around 23% and 21% respectively for the same period last year ● Anti-infective & Respiratory have de-grown by 1% & 7%, while rest of the therapies grew over last year Source: QuintilesIMS TSA & SSA, March 2017 Source: ● ●

mained the largest sub category with a 27 per cent growth while Itraconazole reflected 88

per cent growth for the month and continued to be the largest anti-fungal agent.

Neurology reflected a 11 per cent growth for the month over SPLY, Levetiracetam con-

tinued to be the largest molecule in the space clocking a value of ` 42 crore with a 14 per

MARKET cent growth for the month. Escitalopram + Clonazepam reflected a healthy 18 per cent growth with a value of ` 20 crores for the month. Plain Escitalopram was the only molecule in the top 10 to reflect a value de-growth to the tune of 0.3 per cent for the month though it reflected a 9 per cent volume growth.

Global (February 2017) The global pharma market was valued at $1061 billion growing at 4.3 per cent. The US continued to dominate the market with 42 per cent share and growth of 4.1 per cent.

Amongst the top market, India has moved three positions down and is ranked 10th.

Markets which has shown

TABLE 2: INDIAN COMPANY’S MARKET SIZE IN THE GLOBAL MARKET All values in Million USD

February Month

Month Growth %

MAT February

MAT growth %

Indian pharma market globally

1231903

4.9

15455698

5.8

Sun Pharma

102170

8.4

1251162

7.5

Abbott

78297

4.8

989138

5.5

Cipla

67921

7.6

799449

4.4

Mankind Pharma

46193

2.2

586134

7.2

Zydus Cadika

42080

0

532559

1.8

Lupin Laboratories

41072

10.2

507497

9.9

Glaxo Smithkline

40817

4.8

500434

1.1

Macleods Pharma

39215

1.8

497972

9.6

Intas

35746

5.6

435374

6.9

Alkem

35238

3.3

479256

7.7

value growth more than 5 per cent in the month of February 2017 globally are Venezuela, Brazil and Australia; wherein Venezuela has shown more than 100 per cent growth. The Top five EU markets are all degrowing as per February 2017 data. Indian companies hold 1.7 per cent share in the global market and growing faster than the global market as per February 2017 data. Lupin showed double digit growth for February 2017.

(QuintilesIMS is a leading global information and technology services company providing end-to-end solutions to the life sciences and healthcare industry)

EVENT BRIEF MAY TO SEPTEMBER-2017 5

Associate level certification course on cleanroom technology theory and practice

ASSOCIATE LEVEL CERTIFICATION COURSE ON CLEANROOM TECHNOLOGY THEORY AND PRACTICE Date: May 5-6, 2017 Venue: Hotel Marigold by Green Park, Begumpet, Hyderabad Contamination Control Society of India (CCSI) has announced two-day associate level certification course on cleanroom technology theory and practice. The following topics will be covered: airborne particle counting theory and terminology, complying with new revised ISO 14644-1&2:2015, hepa filter testing and standards, cleanroom protocol, gowning and housekeeping, air flow and differential pressure measurement, FAQs on particle counting and hepa filter testing, airflow visualisation studies.

Eminent speakers from industry will take part in the event.

20 EXPRESS PHARMA May 1-15, 2017

Contact Details: Jyoti Gangwani, Executive Secretary CCSI Tel: 022 – 22027982 Email: jyoticcsi@gmail.com

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma

3

PharmaTech Expo 2017

expo and will be concurrently held with ‘Labtec’ & ‘Track & Trace’ Expo 2017. The focus will be on pharma machinery and equipment manufacturing sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event.

Contact details PharmaTechnologyIndex.

21

com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall, Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

INDIA LAB EXPO 2017/ ANALYTICA ANACON INDIA Date: September 21-23, 2017

India Lab Expo 2017/ analytica Anacon India Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific, analytical and biotechnology sector will see international as well as Indian manufacturers and distributors.

Decision makers from sectors like hospitals, diagnostic labs, oil and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Techn-ology, Government of India.

Contact details MMI India INIZIO 507 & 508, 5 th Floor, Cardinal Gracias Road, Opp P&G building, Chakala, Andheri (E), Mumbai - 400099 Tel : +91 22 42554710 Mob: +91 9820668393 Fax: +91 22 42554719 info@mmi-india.in

cover)

+

Bliss GVS Pharma Zim Laboratories

22 EXPRESS PHARMA May 1-15, 2017

The need for a multidisciplinary approach to deliver greater therapeutic results has opened new avenues for growth in the novel drug delivery systems market. In this issue, Express Pharma profiles two upcoming companies, that have chosen niche formulations to chart their success stories

(

THE MAIN FOCUS

Bliss GVS Pharma: Overcoming social bias Bliss GVS Pharma has managed to break through the social bias against suppositories and pessaries in the Sub-Saharan African market. After years of research on these niche dosage forms, the company is trying to create more awareness on the benefits of suppositories and pessaries as dosage forms in the Indian market as well. By Usha Sharma GAGAN HARSH Vice President, Bliss GVS Pharma

W

SR VAIDYA Director, Bliss GVS

hy did Mumbai-based Bliss GVS Pharma choose to excel in a dosage form which has a high social bias? To the extent that this Indian-based manufacturer does not market any of its products in India and is primarily export oriented.

But the choice is turning out to be a smart one and has paid off handsomely. Today, Bliss GVS Pharma has carved a niche for itself in the global pharma market as a manufacturer of suppositories and pessaries. For more than three decades, the company has been addressing unmet healthcare requirements across the world, especially across Sub-Saharan Africa.

Talking about the company's success in African countries, Gagan Harsh, Vice President, Bliss GVS Pharma says, “Brands and products promoted

by Bliss GVS have gained deeper and wider acceptance across hospitals and clinics ranging

from Eastern to Western part of Sub-Saharan Africa. Various products in the therapeutic segments and new dosage forms like suppositories and pessaries stand testimony to this success of Bliss GVS.”

How do they work?

Suppositories are solid dosage form of varying weight and shape, intended for the administration of medicines via the rectum, vagina, or urethra for topical and systemic delivery.

Suppositories are intended for insertion into body orifices where they melt, soften, or dissolve and exert localised or systemic effects. The medicament is incorporated into oleaginous (fatty) bases, which melts at body temperature, or into water soluble or miscible base which further dissolves in the mucous secretions.

A pessary is an intra-vaginal controlled release drug delivery system and is effective in achiev-

ing a continuous delivery of therapeutic agents not only systemically active drugs, such as contraceptive steroids, but also locally active drugs such as metronidazole and other drugs like zidouvidine. This continuous penetration of the drug through vaginal mucosa can prevent the possibility of gastric irritation of drugs and fluctuation of dosaging interval. Suppositories and pessaries dosage forms are primarily used for elderly and children populations but could potentially be used by all age groups.

The benefits The reasons for use of suppositories and pessaries vary according to the target patient group. With children, more traditional formulations like suspensions, syrups, or tablets need to surmount the taste barrier. A ‘bitter’ experience may spoil all possible ‘sweet’ efforts of administration. Secondly, the patient’s

physical condition could make it impossible to swallow any of the above. For instance, a child suffering from nausea/vomiting/ fever etc could result in the medicine being vomited out and repeated administrations could result in an overdose.

Similarly, in the case of elderly patients, administration of oral medications could be difficult in cases of polymedication, meaning the patient needs to be administered a number of medicines at the same interval. Dose clarity is the second barrier, as understanding the correct dosing and its administration could pose a problem considering the physical and mental limitations due to age. And thirdly, there could be compliance issues with medication formulations due to health limitations. For instance, an elderly patient might not have the strength to sit up or needs to be remain in a prone position due to an injury.

Success in Sub-Saharan African

ADVANTAGES OF INTRAVAGINAL DRUG DELIVERY SYSTEM ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗

In case of nausea and vomiting, the act of taking medicine orally may induce emesis, hence the drug is vomited out before it is absorbed. Irritation to the stomach and small intestine associated with certain drugs can be avoided.

Hepatic first pass elimination of high clearance drugs may be avoided partially Contact with digestive fluid is avoided, thereby preventing enzymatic degradation of some drugs The vaginal bioavailability of smaller drug molecules is good.

The bioavailability of the larger drug molecules can be improved by means of absorption enhancer or other approach.

Self -medication is possible.

Convenient access Prolonged retention of formulation.

Great permeation area.

Highly vascular

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With its efforts, Bliss GVS has been able to successfully collaborate and partner with stakeholders of the healthcare industry including doctors, hospitals and policy makers in addressing these gaps in Sub-Saharan Africa. Talking about the growth, Harsh reveals, “We have set up close to about 100 healthcare facilities. This project has now reached a point where around 10,000 patients are treated everyday under various innovative healthcare schemes,

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cover ) which are being run in collaboration with large insurance companies. This initiative, which has been launched in Kenya so far, has its applicability and relevance across the entire Sub-Saharan Africa. Use of technology and leaner supply chain models developed for this initiative can bring down the cost of healthcare substantially thereby making it accessible to the masses. A large proportion of the population in Sub-Saharan Africa are currently without essential primary and secondary healthcare facilities owing to high costs.”

SR Vaidya, Director, Bliss GVS opines, “At present, our products are not available in India as we have realised that In-

R&D initiatives

ADVANTAGES OF SUPPOSITORIES ◗ Free from issues of taste ◗ Do not pose a challenge when a patient is suffering from nausea/vomiting ◗ Are not exposed to gastrointestinal irritation, thereby, avoiding systemic side effects ◗ Unlike, injectables, can easily be administered by patients ◗ Painless option Easy to use suppositories

dian patients are a bit rigid and they prefer conventional formulations, like oral and injectables.

Our medical professionals are also reluctant to use this physiological dosage forms, which offers benefits to the patients.

Awareness needs to be created

in terms of benefits of such methods. However, we saw a similar mind set across Sub-Saharan Africa where the gap in healthcare sector is wide. With our efforts, patients are comfortable in adopting suppositories and pessaries.”

Significant investments have been made by Bliss GVS Pharma to position itself at the forefront of innovation in suppositories and pessaries dosage forms. The company manufactures its products at a recently inaugurated state-of-the-art R&D centre in Mumbai. The company has retained its leadership position across the world in suppositories dosage form in terms of installed manufacturing capacity for suppositions and also the number of formulations developed and commercialised in this dosage form. The newly inaugurated R&D centre will also augment Bliss GVS Pharma's product portfolio in

other novel drug delivery systems (NDDS). The new R&D facility will manufacture new products available for the upcoming manufacturing facility, which will be set up in Maharashtra, the land for which has already been acquired. It will significantly increase the manufacturing capacity for Bliss GVS in other dosage forms like oral solids. Summing up Harsh says, “All in all, exciting new healthcare models, newer and innovative dosage forms and ever increasing manufacturing capabilities ensure that life at Bliss GVS Pharma is always full of challenges and excitement.” usha.sharma@expressindia.com

Zim Laboratories: On the growth path Zim Laboratories' oral disintegrating strips is the latest offering of this Nagpur based company's NDDS portfolio by Usha Sharma

N ANWAR DAUD Managing Director, Zim Laboratories

24 EXPRESS PHARMA May 1-15, 2017

agpur-based pharmaceutical company Zim Laboratories sensed the need to develop novel drug delivery systems (NDDS) at a time when India is seeing a significant rise in its number of children as well as geriatrics.

According to a report released by the Ministry of Statistics in April 2016, the number of citizens in India above the age of 60, saw a rise of 35.5 per cent from 7.6 crore in 2001 to 10.3 crore in 2011 while children make up 39 per cent of the total population of the country, 29 per cent constituting of children in the age between 0-5 years.

Both figures indicate that India requires drug delivery methods which are patient friendly to these age groups. Commenting on the research work and years invested behind developing oral thin films as an NDDS, Anwar Daud, MD, Zim Laboratories says, “We have been working in NDDS since the beginning and started working on oral thin films in 2009. The idea was to

OBJECTIVES OF ZIM LABORATORIES ◗ ◗ ◗

Developing innovative process technology platforms which lend themselves to the development of useful dosage forms that make existing molecules more effective and useful Developing cost-effective techniques for the production of high technology content Pre-Formulation Intermediates (PFI) and finished products.

Developing eco-friendly materials and processes for the production of medicines

combat the issue of swallowing associated with the most prescribed dosage form i.e. tablet.

We have received support (for this work) from the Department of Scientific and Industrial Research (DSIR), Government of India through its Technology Development and Demonstration Programme (TDDP) scheme.”

This independent research and development section recognised by DSIR serves as the originator of several process technology platforms responsible for a huge library of existing and pipelined products. The company's technical team consists of research scientists using state-of-the-art equipment.

Incorporated in 1989, the company has established itself as one of the preferred healthcare solution providers in the field of new drug delivery systems. Zim Laboratories is engaged in research and development, manufacturing, distribution and marketing of pharmaceuticals. Besides orally disintegrating strips, the range of products encompass dosage forms like tablets, capsules, pellets, multi-unit particulate systems, dry syrups, directly compressible granules, taste masked powders, and granules.

Daud elaborates, “We work on the development of multiparticulates, controlled and delayed release systems, nanotechnol-

ogy-based solid dosage forms, oral/sublingual thin films etc. Almost 70 per cent of our R&D expenses are on the development of NDDS. We invest almost 4-6 per cent of our total turnover on R&D.” Daud informs, “We also take part in several developmental projects in collaboration with other academic/research institutes, working on novel process technologies offering new solutions for making unique drug delivery systems more efficiently than ever before. This ensures that our customers perpetually derive the benefits of innovative, cost effective and quality products, which in turn provide them with an unbeatable edge in the

( competitive market place.”

In December 2016, the company bagged the IPA – ACG Scitech Innovation Award for innovative dosage form ‘Oral Thin Films.’

Technology drives the need The strip formation technology requires comprehensive understanding of pharma components and processes as well as basic understanding of strip forming processes used in other industries. In case of low dose drugs, it will be the nature of polymers chosen that will decide the properties of strips but for high dose drugs, the formula and process would need critical studies in order to form strips with predetermined specifications.

Moreover, despite the known use of rapidly dissolving edible strips and their benefits over predecessor technologies for oral ingestion and documented benefits of herbs and pharma active ingredients, these are highly hygroscopic. As a result they stick to each other during storage and they also pose a problem while accurately placing in the mouth. At the same time, these strips do not pose a problem of being rejected / discarded / spit out by non-compliant patients, such as children, after delivery of the strip in their oral cavity.

The company identified the need of an oral rapidly dissolving strip that would not stick to the inner surface of the mouth as soon as it is placed inside, giving sufficient time to manoeuvre inside the oral cavity and to place it at a desired location. But once it is placed in the desired location, the strip needs to stick there so that the patient cannot spit it out.

The company is present in around 30 countries, which has helped it understand healthcare needs across countries. Clients are from across the SAARC countries, the Middle East, African continent, South East Asia, Latin America, CIS etc.

Explaining the passion behind developing NDDS for both the markets, Daud says, “We are committed toward providing our national and international clients an easy and timely access

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to sophisticated process technologies and products, give value for money, and offer our customer innovative and exclusively quality products that differentiate them from their competitors and significantly impact

their bottom-line. That’s why, every day we continue to put our zeal for excellence and spirit of innovation into all our actions.”

He further elaborates, “We are an EU-GMP, WHO-GMP certified and ISO 9001:2008 ac-

THE MAIN FOCUS

credited company supported by an excellent team of professionals and sufficient capacity to meet large requirements for different market segments. We are uniquely positioned to provide expertise novel drug delivery

systems. We support our own and customers’ objectives with specialised formulations to reach the market faster and easier than ever.” usha.sharma@expressindia.com

cover ) INSIGHT

Generating value in generics Utkarsh Palnitkar, Partner and Head, Infrastructure, Government and Healthcare, Life Sciences, KPMG in India, gives an insight on the importance to develop NDDS by Indian pharma companies

W UTKARSH PALNITKAR, Partner and Head, Infrastructure, Government and Healthcare, Life Sciences, KPMG in India

hile active pharmaceutical ingredient (API) is a critical component of any drug formulation, the mechanism by which a drug is delivered plays an important role in the efficacy and safety of a drug. Many large and mediumsized Indian pharma companies are launching and investing in Novel Drug Delivery Systems (NDDS) products, as they have realised that it is a major differentiating factor in the competitive generic indus-

try. Besides, there are various clinical advantages that can drive NDDS, such as, increase in safety, efficacy; a controlled and predictable release; decrease in dosing frequency; minimisation of side effects; and increase in patient compliance. Further, NDDS-based generic product development is more economical and less risky for Indian pharmaceutical companies, as compared with developing a new drug that is far costlier and more time consuming.

Product differentiation, emergence of new complex therapies and increasing NCDs burden driving NDDS Drug delivery technologies can help drug manufacturers differentiate their products from existing ones and enable novel treatments. It can also help tackle the growing non-communicable disease (NCD) burden, which requires a patient to take medicines over a longer term.

NDDS can further help in supporting new therapy areas

based on new age complex molecules, such as proteins, nucleic acid, interferon, and antibodies.

There is a thus a dire need to develop a safe and effective drug delivery system and Indian pharma companies are trying to meet this gap by increasing research and development (R&D) spend towards NDDS development in the last few years.

Scenario in India Slower launch of new innovative drugs and growing

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26 EXPRESS PHARMA May 1-15, 2017

(

THE MAIN FOCUS

STRENGTHENING THE INDUSTRY–ACADEMIA LINKAGE CAN HELP ADVANCE THE UNDERSTANDING OFTHIS NICHE AND EMERGING FIELD. PHARMA COMPANIES CAN FUND OR JOINTLYWORK WITH ACADEMIC RESEARCH TEAMS TO DESIGN AND EVALUATE NEW NDDS PLATFORMS AND DECREASE TIME TO MARKET

competition in generics is driving the growth of niche segments, such as NDDS, in India. Large as well as medium-sized pharma companies are progressing remarkably in NDDS development by focussing on R&D activities and consequently launching various new and controlled drug delivery systems.

Indian pharma companies are riding the tide of advancement and availability of technology in order to deliver conventional drugs using NDDS. The key is to develop formulations that circumvent invasive administration; deliver complex biologics and protein/peptide drugs while minimising side effects and increasing precision.

While market potential is attractive for NDDS, limited clinical data availability to prove its superiority over conventional drugs; lack of specific guidelines and existing patents for new drug delivery systems, collectively, hinder the growth of this niche segment. Despite these challenges, pharma companies are using India’s inherent strengths such as low cost scientific manpower, low cost of clinical trials and low production cost to boost NDDS development.

Way forward The Indian pharma industry could provide value-added offerings with ‘super generics’.

Continuous investment in R&D to innovate and adoption of technology will also play a larger role in drug delivery and help add value, improve margins, extend product lifecycles and, more importantly, allow differentiation in a cluttered generic market. ◗ Harness potential of nanotechnology: While nano-formulations and nano-particles have been used to successfully deliver drugs, the nanotechnology platform has greater potential for many applications, including gene therapy, cancer therapy, delivery of proteins, antibodies, vaccines, and antibiotics. A Mumbai-based pharma company has successfully developed a nan-

otechnology-based platform that targets cancer cells through higher drug localisation with lesser excipient and higher dose ◗ Continuous effort in R&D: Pharma companies need to continuously invest more in R&D for NDDS development. It is crucial to constantly differentiate in a saturated generic market as competitors could potentially launch similar technology-based NDDS products rapidly. A Delhi-based pharma company has designed its entire strategy around NDDS, in order to differentiate itself in the generic market ◗ Embrace innovation and adopt technology: Technology adoption can play an important role in NDDS development as combining drugs with devices and delivery systems is likely to drive success in future.

Moreover, technology and innovation can also help deliver complex biologics (many Indian companies are focussing on biologics (including biosimilars and bio-betters for future growth) ◗ Combine medical devices and chemistry expertise: Pharma companies can combine their expertise in chemistry with the expertise from medical device manufacturers to develop innovative drug delivery device technologies. For example, to manage diabetes, several companies are providing continuous glucose monitoring by integrating the insulin pump and a monitor to provide the right dose of insulin at the right time ◗ Increase industry–academia linkage: Strengthening the industry–academia linkage can help advance the understanding of this niche and emerging field. Pharma companies can fund or jointly work with academic research teams to design and evaluate new NDDS platforms and decrease time to market. For example, a French multinational pharmaceutical company’s India entity has recently collaborated with NIPER Kolkata for their expertise in novel small molecules for anti-diabetics and drug resistant tuberculosis (TB).

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MANAGEMENT

Building on strengths Boehringer Ingelheim is undergoing a comprehensive transformation to derive more growth and value through strategic realignment of its business. By Lakshmipriya Nair

B

ig Pharma is witnessing a transition with significant changes in their operating models as the era of blockbuster drugs comes to an end and a patent cliff looms ahead. Leading pharma companies are amending their strategies, realigning their R&D focus, moving towards specialty drugs and biologics and betting on emerging economies to drive revenue, navigate the changing tides and flourish in this dynamic market.

Boehringer Ingelheim, a German pharma major with global footprint, is a case in point. In a recently held

Constant willingness to change has always been, and remains key success factor of Boehringer Ingelheim

The philosophy of working together with others and partnering for better health around the world is quite central to what we do

Acquiring Merial immediately positions us to be increasingly competitive in a high-growth sector that is in a consolidation phase

Allan Hillgrove

Dr Joachim Hasenmaier

Member of Board of Managing Directors with reponsibilty for Human Pharma Business Unit, Boehringer Ingelheim

Member of the Board of Managing Directors with reponsibility for Animal Health, Boehringer Ingelheim

Hubertus Von Baumbach Chairman of the Board of Managing Directors, Boehringer Ingelheim

annual press conference at its global headquarters in Ingelheim, Germany, to present its financial results for the year 2016, the company declared its intent to become a leaner, focused company with footprint in key clusters. BI has shortlisted three major growth areas for 2017 - human pharma, animal health and biopharma contract manufacturing.

Giving an overview on this year’s priorities for the company, Hubertus Von Baumbach, Chairman of the Board of Managing Directors, BI announced, “We have reduced the number of our businesses. The business on human pharma

28 EXPRESS PHARMA May 1-15, 2017

We placed our innovative products successfully on the market and maintained a good market position for our established medicines Simone Menne Member of the Board of Managing Directors with responsibility for Finance, Boehringer Ingelheim

An investment of one billion euros are done in the innovation unit each year. 11 billion euros has been invested by the company over five years Dr Michel Pairet Head, Innovation Unit, Boehringer Ingelheim

now focusses on the prescription medicines portfolio. With regards to our animal health business, the acquisition of Merial was an important milestone in our comprehensive realignment. And finally, we decided to invest in the expansion of our biopharma production in order to meet future strong demand. All this has strengthened our competitiveness and our customer focus in the individual areas.”

Let’s examine the strategies adopted by the company.

Progressing with partnerships Over the past few years, BI has been increasingly turning towards partnerships to sustain and spur momentum in its growth trajectory. For instance, in a bid to enhance its offerings in human pharma, which continues to be a major growth driver, BI is looking at developing significant innovations in the therapeutic areas of respiratory diseases, cardiometabolic diseases, oncolog, and diseases of the central nervous system as well as immunology. This, in turn, has necessitated the need to ensure better reach of these offerings in the major markets of the world, As a result it has entered into significant tie-ups with other renowned pharma companies. Here are a few instances: ◗ BI markets its diabetes medicine Jardiance, jointly with Eli Lilly and Company. The alliance combines the scientific expertise and business capabilities of the two pharma companies to leverage the growth potential arising out of the global diabetes epidemic. ◗ In March 2016, BI entered into a global collaboration with AbbVie for BI advanced development compounds in immunology. This collaboration helps to ensure effective reach of the promising compounds to needy patients worldwide and enables the companies to strengthen and expand their capabilities in this therapeutic area. ◗ In India, BI is partnering with Lupin, another pharma major to co-market Empagliflozin, a novel sodium glucose co-transporter-2 (SGLT-2) inhibitor in India. A press release informs that

THE YEAR GONE BY IN 2016, Boehringer Ingelheim generated net sales of around 15.9 billion euros, representing an increase of 7.3 per cent in currency-adjusted terms (+7.1 per cent in euro terms). Since operating income improved by 27 per cent to around 2.9 billion euros, the return on net sales came to 18.1 per cent. Boehringer Ingelheim in 2016 employed an average of almost 45,700 people around the world.The acquisition of Sanofi's animal health business, Merial, on January 1, 2017 as part of a business swap increased the workforce to some 50,000.

according to the agreement, Lupin markets and sells the product under a separate brand name Gibtulio while BI sells it under the brand name Jardiance.

In an exclusive interview with Express Pharma, Allan Hilgrove, Head, Human Pharma Business Unit, BI spoke on external collaborations and partnerships as a major strategy towards growth. He said, “The philosophy of working together with others and partnering for better health around the world is quite central to what we do.” He stated that these partnerships helps them create more impact in terms of performance as well as provide them with economic benefits.

This point is validated by Simone Menne, Head of Finance and Member of Board of Managing Directors, BI. Giving a detailed overview of BI’s financial performance in 2016, she highlighted, “We placed our innovative products successfully on the market and maintained a good market position for our established medicines. In addition, we received an extraordinary payment to our net sales agreed within the scope of our cooperation with AbbVie in the field of immune diseases. We also see a sharp increase in operating income to around 2.9 billion euros. The aforementioned payment from AbbVie had a notable impact here too.”

Thus, strategic partnerships has helped the company reap substantial gains and spurred progress.

Merging and divesting for merit Another major realignment has been the decision to merge BI’s animal health business with Merial, Sanofi’s animal health business. A transaction worth $25.5 billion, it has made BI the secondlargest animal health company in the world. Von BaumBach revealed at the press conference that the company has identified animal health as a strategic long-term development priority for the company.

He said, “We have huge plans for animal health in the years ahead. He said, “Net sales in our animal health business will more than double year-on-year in

2017 thanks to the integration of Merial.

We have undertaken to outgrow the market on a sustainable basis in the subsequent years with our solid core business and by taking advantage of new opportunities.”

Reportedly, the company’s animal health sales grew by 8.5 per cent, amounting to $1.55 billion in 2016. The company also foresees that the overall market will touch $56.4 billion by 2030.

Thus, this move is the company’s bid to become the global leader in this segment as it perceives great potential for growth fuelled by increasing demand in the pet market, a swelling demand for meat and mounting threat of infectious diseases. In times to come, the animal health business will comprise over 25 per cent of BI’s total revenue.

At the annual press conference, Joachim Hasenmaier, Head of BI’s Animal Health Business Unit and Member of Board of Managing Directors informed, “Acquiring Merial immediately positions us to be increasingly competitive in a high-growth sector that is in a consolidation phase. By combining two dynamic companies that share the same long-term strategic vision, we are delivering a larger and more innovative portfolio of products and services to prevent disease and improve the health and productivity of animals around the world. ” Hasenmaier also revealed that the company will continue to invest over 10 per cent of its revenue into research and development in animal health, to expand its core businesses of vaccines, antiparasitics and pharma products.

While the company has chosen to expand and fortify its offerings in areas which is likely to see accelerated growth in the coming times, it has also reduced its number of business by combining its prescription business with it human pharma vertical and divesting its holdings in consumer healthcare to Sanofi.

Building capability and capacity The company has also embarked on a venture to bolster its capabilities and enhance its capacity. For instance, BI is set to begin a new production facility in Vienna

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MANAGEMENT to drive growth in its third focus area — biopharma contract manufacturing.

Menne expects a 'considerable boost' to the contract business of the company on the back of the 700 million euros expansion of the biopharma production site in Vienna, with the new plant commencing operations in 2021. She also informed that the biopharma contract manufacturing business net sales grew by 6.4 per cent to 613 million euros in 2016 and contributed to almost four per cent of the total net sales of the company.

At the same time, the company is also looking at expanding its footprints and consolidating its presence in key emerging markets to step up its growth momentum. China is a major market for them, so is India and the Middle East. 2016 saw BI achieve currency-adjusted growth of 20 per cent in China.

see which of these diseases have a large unmet need and look at how we can add value towards addressing the disease. We look at scientific options to address the disease and then look at the commercial feasibility as well.”

He also affirms, “Innovation will continue to drive the pharma industry forward, and advancements in medicine will help the patients and also drive innovation in the industry. More than 20 per cent of our net sales goes into R&D. So, innovation is really at the heart of the company.”

Thus, in line with its mission statement, of value through innovation, BI, besides its own R&D activities, is building a global network comprising academic groups, public research institutions and biotech companies. They are also enhancing their product portfolio with partnership agreements and the systematic inlicensing of technologies and products.

Dr Michel Pairet, Head, Innovation Unit, BI, informs that an investment of one billion euros are done in the innovation unit each year. He also highlights that an investment of 11 billion euros has been made by the company in the innovation unit over five years.

It clearly informs that in-house research and development – supplemented by external cooperation and partnerships – will continue to be a top priority in the future.

Revving up R&D to drive innovation “Our commitment to research and development is an important pillar of our strategy,” von Baumbach stated at the press conference. The company states that it has increased its research and development expenses by four per cent to some 3.1 billion euros. BI’s focus on R&D gets an upward push with the company looking at achieving significant progress in major therapeutic areas through innovative medicines. The key focus of their research work in 2016 were as follows: ◗ Immunology and respiratory disorders ◗ Cardiometabolic diseases ◗ Oncology and immunooncology ◗ Diseases of the central nervous system A few interesting ongoing R&D projects at BI include studies to ascertain whether the diabetes medicine Jardiance can also be used to treat chronic heart failure with and without diabetes. In oncology, the company is also studying the effectiveness of nintedanib for treating mesothelioma, a cancer of caused by asbestos.

Giving an insight on how the company looks at training its focus when it comes to therapeutic areas for R&D, Hillgrove

30 EXPRESS PHARMA May 1-15, 2017

Far-reaching impact Thus, the company has clearly identified its future avenues for progress and already embarked on its journey. It has begun a comprehensive transformation with a mix of big and small steps to create a more enhanced value chain. Von baumbach asserts, “Constant willingness to change has always been, and remains key success factor of Boehringer Ingelheim.” However, the ripples of this change is likely to be felt in all markets where BI has an established presence.

It would be interesting to witness the effects of these changes in India and track them as they lay the foundations for further growth.

Source: BI Annual Report 2016

explained, “We choose a number of therapeutic areas to focus on.

Every five years or so we look at what is called a disease map, we

look at all the diseases that mankind is suffering from. We

lakshmipriya.nair@expressindia.com

MANAGEMENT REPORTS

Pipeline drug offers promise in treatment of platinum-resistant ovarian cancer: GlobalData ImmunoGen announced that the first patient was dosed in its pivotal Phase III study that investigates mirvetuximab soravtansine as a single agent treatment in platinum-resistant ovarian cancer MIRVETUXIMAB soravtansine, a drug currently being trialled by ImmunoGen, has the potential to solve a major unmet medical need for patients with platinum-resistant ovarian cancer, according to research and consulting firm GlobalData.

As explored in the company’s latest ovarian cancer report, once a patient becomes resistant to platinum-based chemotherapy regimens, the efficacy and duration of response with current treatment options are highly limited and demonstrate modest activity at best. Earlier in 2017, Im-

munoGen announced that the first patient was dosed in its pivotal Phase III study that investigates mirvetuximab soravtansine as a single agent treatment in platinum-resistant ovarian cancer, thereby positioning its novel antibodydrug conjugate well within the late-stage pipeline.

Marc C Hansel, Senior Healthcare Analyst, GlobalData, explains, “Mirvetuximab soravtansine is an anti-body drug conjugate that selectively targets cells expressing folate receptor alpha (FRA) and delivers its cytotoxic payload, DM4, to kill cells. Unlike previ-

ous FRA antibodies, ImmunoGen’s asset doesn’t solely rely on a patient’s immune system to kill cancer cells.

“This small detail is important, especially in heavilytreated patients whose immune systems can be compromised due to previous drug treatments and their overall health status. Furthermore, the FRA pathway is not important for ovarian cancer cell survival, so even if it is blocked, the cancer still grows.”

ImmunoGen’s long-term growth prospects in the ovarian cancer space are bolstered

by early stage investigations looking to improve single agent mirvetuximab soravtansine’s activity by combining it with Roche/Genentech’s approved ovarian cancer angiogenesis inhibitor, Avastin (bevacizumab); Merck’s immune checkpoint inhibitor, Keytruda (pembrolizumab); the first-line standard of care chemotherapy carboplatin; and pegylated liposomal doxorubicin.

These combinations are being investigated in the ongoing Phase Ib/II FORWARD II trial.

Their anticipated increased efficacy compared to the single agent regimen and current

standards of care could firmly entrench mirvetuximab soravtansine earlier in the treatment paradigm, especially if the combinations are well tolerated.

Hansel concludes, “ImmunoGen has a lot of work ahead, but the future is bright for its novel antibody-drug conjugate, which could simultaneously solve a major problem for platinum-resistant recurrent ovarian cancer patients and represent a major victory for the precision medicine movement.”

EP News Bureau

Bladder cancer market size to more than triple to over $1.1 billion by 2025 The growth will be driven by the increased incorporation of immunotherapies into treatment algorithms, the launch of new combination therapies THE BLADDER cancer space across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK and Japan, is set to more than triple in size from $360 million in 2015 to around $1.17 billion by 2025, at a compound annual growth rate of 12.5 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that this impressive growth will be driven by the increased incorporation of immunotherapies into treatment algorithms, the launch of new combination therapies, increased incident cases of blad-

der cancer across the 7MM, and the introduction of the pipeline agents CG-0070, Vicinium and Cyramza.

Historically the bladder cancer market has been highly generic, with Bacillus Calmette-Guerin (BCG) and chemotherapies dominating the landscape. However, with the launch of Tecentriq and the subsequent launch of other programmed cell death protein 1 (PD-1) modulators, bladder cancer treatment algorithms are expected to change during the forecast period.

Cai Xuan, Healthcare Analyst, GlobalData explains,

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“Though these PD-1 modulators are expected to have a significant impact on the treatment of bladder cancer, the reality is that the majority of these patients – upwards of around 70 per cent – will not respond to these drugs. In this way, pharmaceutical companies are looking at various ways to expand the treatable patient population. Strategies being employed include expanding into the non-muscleinvasive bladder cancer setting and using combination regimens to boost response rates.

“While big pharma companies are focussed on ‘me-too’

PD-1 modulators, smaller companies are developing drugs with novel mechanisms of action, including Cold Genesys, Eleven Biotherapeutics, and FKD Therapies Oy. GlobalData believes that the bladder cancer market is an attractive prospect for these companies due to the combination of a high level of unmet need and relatively low regulatory hurdles, which provides a suitable risk–reward balance for developers with limited financial resources.”

Although pipeline agents will reduce unmet needs, opportunities will remain. Indeed,

in the non-muscle invasive bladder cancer (NMIBC) setting, the late-stage pipeline agents CG-0070, Vicinium and Instiladrin are expected to provide viable alternatives to cystectomy. However, none of these are being explored in the firstline setting, where there remains an unmet need for a safer drug than BCG with higher cure rates, as well as treatment options for patients who are BCG-ineligible or intolerant.

Xuan continues: “In the advanced disease setting, the vast majority of late-stage pipeline drugs are PD-1 modulators.

EP News Bureau

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RESEARCH I N T E R V I E W

‘India has at least 60 million to 80 million people with chronic respiratory disease’ As we mark World Asthma Day on May 2, Dr Jaideep A Gogtay, Chief Medical Officer, Cipla explains to Viveka Roychowdhury why unlike the rest of the world, 70 per cent of COPD patients in India are non-smokers and why increasing patient compliance, monitoring and awareness are key to tackling chronic respiratory disease. Excerpts from the interaction Why do we see an increase in patients with chronic respiratory diseases (CRD)?

Globally, CRD are believed to affect one billion people.

Asthma and chronic obstructive pulmonary disease (COPD) are the two main CRD, while there are several others, like allergic rhinitis for example. Asthma affects just over 300 million, and for the first time, this year, estimates for COPD crossed asthma.

(One reason for the increase could be that) we are now able to diagnose more COPD cases in the last five to 10 years and with this better data, COPD incidence is today around 330 million, up from the previous estimate of 210 million. These figures are as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017 guidelines.

So, while there is a focus on cardiovascular diseases (CVDs), diabetes and cancer, CRD has now also been recognised as a big issue. In fact, COPD is included by the Government of India in the list of non-communicable diseases (NCDs). The challenge with some of the CRD is that in most countries, the ratio of patients diagnosed to undiagnosed is 1:8 or 1:9. So, COPD is vastly underdiagnosed. For example, there was a study in Latin America, which showed that 90 per cent patients were undiagnosed, as diagnosis requires a spirometry or a lung function test.

Where does India stand?

In India, again, the estimates

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are guesstimates. Asthma patients make up roughly 2-2.5 per cent of the population, which is 30 million people of India’s 1.2 billion total population. An equal number could have COPD. There are some who believe it may be more than 2.3 per cent. Our guesstimate is that there are at least 60 million to 80 million people with CRD in India.

The unique part of COPD in India is that 70 per cent, that’s almost two thirds of the COPD patients are non-smokers, whereas in most Western countries 90 per cent of COPD patients are smokers. The reason is that we have a huge contribution (to COPD figures) from biomass fuel, which women use for cooking in the rural communities. That is why we see the push to move to LPG for cooking. Biomass is also used for heating in the winter, which adds to the COPD burden among non-smokers in India. Of late, we realised that Africa, parts of Latin America too have high numbers of nonsmoker COPD patients.

Besides COPD, allergic rhinitis in India is quite high, estimated at around 15 per cent, meaning it is several times more common than asthma.

India also has a fairly large population of smokers, estimated around 15-18 per cent. What’s worrying is that while smokers in their 40s are giving up smoking, youngsters seem to be picking it up earlier than before. Also, more young women seem to be picking up (smoking) of late. And beedis do

be amplified.

not seem to have lost their appeal. So, we need to track these changes on the smoking front very carefully.

Air pollution too adds to the CRD burden. The Lancet has recently carried an article on the impact of air pollution in various cities and India ranks second in terms of PM2.5, following Bangladesh. This data tells us that air pollution is a big looming problem that will add to our lung health incidence.

We don’t as yet know what is the exact contribution of pollution to CRD but there is an interesting hypothesis put forward around a decade back, that when air pollution, like diesel exhaust, combines with allergies/allergens like dust mites, cockroach allergies, etc, the lungs amplify the allergic response. So while air pollution may not directly cause asthma, when combined with allergens, the symptoms of asthma may

How will these factors impact treatment?

You would see more severe asthma attacks, more difficult patients to deal with, etc.

Increasing urbanisation too will add to air pollution levels, with increasing number of vehicles, leading to increased incidence of CRDs. The recent Supreme Court ban on BS III vehicles is a welcome step to reduce vehicular pollution.

Another source of air pollution is dust from roads, construction site activities, industrial pollution. So all these factors are unfortunately very conducive to creating more respiratory problems for us.

Another hypothesis, called the hygiene hypothesis, is that as countries become more prosperous, and the number of infections and exposure to bacteria starts decreasing, the immune system develops a stronger allergic response.

Thus, the highest prevalence of asthma is in New Zealand and Australia. We don’t understand everything right now because the immunology (related to CRD) is quite complex.

What are the basic asthma treatment protocols?

Asthma treatment protocols are quite clear. It was very well established in the early 90s that inflammation is the real problem to deal with in asthma.

And if you can control the inflammation, you can control the symptoms of bronchospasm, coughs,

wheezes, breathlessness attacks, etc. The best drugs for controlling inflammation are corticosteroids. Steroids given by the oral route will always have problems, because they have systemic side effects. But if you give them by the inhaled route, used in the standard therapeutic doses, they have virtually no side effects in most patients. This is supported by data of almost 13-15 years of use of inhaled corticosteroids, even in children aged five to six years.

In many patients, you would need to add a long acting bronchodilator. So this combination is the standard treatment of choice. There may be 5 per cent patients who may need more medication. But 8890 per cent patients will do well on this treatment protocol, with no symptoms, no nocturnal attacks and no loss of activities, as long as they follow the doctor’s orders and take their treatment regularly.

What are the major challenges when addressing chronic long term respiratory conditions like asthma, COPD? Patient compliance is a huge challenge in treatment of asthma. There is a huge drop of around six months of the year, especially during the summer when it’s so hot that the chances of asthma attacks goes down. Most patients stop treatment, for a variety of reasons. Some feel well, the symptoms disappear so they stop taking their medication.

What patients don’t realise is that absence of symptoms does not mean absence of disease. So they stop the treatment, nothing happens for two-three months and then they have an asthma attack when the monsoons start. And then again during the winters, and spring till April. These are the prime times for asthma attacks. So while it’s difficult to get 100 per cent patient compliance in asthma, doctors will be satisfied if their patients stay on their asthma medications for at least nine months of a year, which would mean they are covered for at least 75-80 per cent of the time.

How would low compliance impact the patient in the long run?

If patients do not control their asthma well, then they could face other issues. For instance, normally the bronchi reverse very well but if patient compliance is low, it might reduce and some patients could get fixed airflow obstruction. Similarly, airway remodelling could occur if there is continuous inflammation. This means fundamental changes in the structure of the airways, with the basal membrane of the airway getting thickened. This reduces the flexibility of the airways and such patients may need higher doses of medication. Their lung function may reduce as well.

This is a very important reason for making sure patients take their treatment regularly.

How can patient awareness about compliance be increased?

Today every disease condition has a number. For example, a diabetic can track his sugar levels, a hypertensive patient can check his blood pressure, without going to a doctor or a hospital. But until recently, asthma patients did not have such a number to check their status, except to go to a doctor and get a spirometry test done.

Doctors now ask patients to use a peak flow meter to check their lung function, by measuring their peak

expiratory flow, which is a good marker, like the glucometer which reads the sugar levels in a blood sample. Now the peak flow meter gives them such a number, in the comfort of their homes, which gives them a reasonably good marker of how they are doing.

What role does device design play in overcoming low patient compliance?

We’ve seen many inhaler designs enter the market. The pressurised metered dose inhaler (pMDI) has been a very popular inhaler, because is it small and allows a patient to be very discreet while taking their medication. All they need to do is step aside and take a puff. But some patients take time to learn or do not have the motor coordination to manage a pMDI so they can use dry powder inhalers (DPIs). Then there are nebulisers, which do not need coordination.

Many patients like the capsules used in DPIs, because psychologically, they are used to medicines coming as capsules, tablets, etc. and feel reassured seeing the powder in the DPI. In a pMDI, the medication is delivered by a spray and the medication per se is not seen. Spacers are also used fairly widely, especially by patients who have poor motor coordination.

What are the latest innovations in inhaler design?

In Cipla, we’ve also been working on breath-activated inhalers. We introduced the autohaler some years ago, which was imported from the UK but the drawback of that was that it did not have a dose counter, which meant that patients did not know how many doses were left. Over the last three years, we have been developing our own breadthactivated device, Synchrobreathe, which is a novel, breath-actuated inhaler (BAI) with a dose counter. No device is ideal because there will always be some patients who will not like it but I think we are moving quite close to that.

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Synchrobreathe was launched in South Africa just this January so while it is too early to get patient feedback, physician feedback has been very positive. The whole problem of coordination is solved in a BAI as the patient has to breathe in slowly and deeply and it releases the puff automatically. BAIs are a big step forward as it’s a pMDI, that works like a DPI. There is data to show that if patients like a device, they will use it longer so we believe it will result in better patient compliance.

A very important part of inhaler use is the teaching and training required by a doctor.

Doctors don’t have too much time so with a BAI this teaching time is reduced, though not completely eliminated.

Does Cipla have in-house device design facilities or does it partner with or have joint ventures with such companies? Is this where Cipla's acquisition of a 60 per cent stake in Jay Precision Pharmaceuticals fits in?

We've been working with Jay Precision for a long time, who developed all of our devices earlier and have helped with the design of Synchrobreathe as well. Its fascinating what has to come together when it comes to devices. The pharmaceutical scientist, because it is a formulation; engineering because you are dealing with a device, and some understanding of physics. And all this has to be linked with what physicians and patients want, like aesthetics, ergonomics, ease of use. A decade back, patients did not pay much attention to such factors but nowadays, they want sleek, neat looking inhalation devices as well. For instance, when it comes to the choice of cell phones, some would prefer Apple while others would prefer Samsung, yet others would prefer other brands. Similarly, patients too would have preferences for certain inhalation devices.

Good patient feedback is essential to realise what is the preferred device design. For instance, however good a

device, in terms of giving a high dose deposition in the lungs for instance, if a patient doesn't like it, he will not use it and there is not much that can be done to change this preference.

So companies have to keep pace with what the patient wants. Of course, inhalers are more complex, because it involves testing the stability of the formulation, etc so it requires two to three years of various tests before you can come up with a device design, then patient usability studies to see if patients are able to use it.

What are the different formulations intrinsic to respiratory devices currently available in the market?

A typical pMDI contains a suspension or sometimes a solution, containing the drug, along with a surfactant or a lubricant, depending on the drug, to make it homogeneous combined with gas. We use hydrofluoroalkanes (HFA) gas, which is now the standard.

Dry powder formulations consist of the medication and lactose, which are mixed well and micronised to a certain particle size such that the lactose particles are slightly larger than the drug particles.

When a patient inhales forcefully and deeply, the two get de-aggregated so that the finer drug particles go down (to reach the lower parts of the lungs) and some of lactose may settle around the throat.

The third type of formulation is respiratory solutions used in devices like nebulisers, which are typically used in hospitals but of late, there is an increasing use of home nebulisation as the demographic profile changes.

For example, a physician narrated his experience of treating a COPD patient aged 90 years, who was having a problem breathing, and didn't have the motor coordination to use an inhaler. A home nebuliser allowed the family to take care of the patient's needs at home. A family member puts the prescribed medication in the nebuliser, fits the nebuliser mask on the patient who then breathes in the medication over

the next five minutes. Home nebulisers are thus a relatively new option.

In fact, companies like Philips are now developing hand held, battery operated nebulisers, so that patients can travel with them. Such devices are quite expensive right now but (more affordable) technology will eventually come. Such technologies will become more popular in this part of the world but it also depends on what patients are comfortable with. There is a consensus document coming out on the use of home nebulisers because while it is very popular in the US, Europe and the UK don't use it much, because they think that a pMDI plus spacer is good enough. But patients may not want this combination. Thus there is obviously a lot of cultural differences between countries.

(Patients in) India, China like home nebulisers while the EU, UK do not like them.

What is the way forward?

Increasing patient compliance, monitoring and awareness.

Cipla has tried to ensure that all key medications are available through the same device so patients need to learn to use only one type of device, which would increase compliance. Another part is advocating the monitoring (of the disease) by using a peak flow meter to measure the 'lung power'. Even though they may not be the best tools, they do give some idea of what's going on in the lungs, of the level of lung function sitting at home. It is also important to create awareness around lung health, for which Cipla started a campaign, Save your Lungs.

And finally, while awareness about heart health and cancer is high, awareness about lung health is very low. And this is very important because of late, there is a lot of work going on about the links between air pollution and diseases beyond CRD. Air pollution has been linked to CVDs, the health of pregnant women and even the foetus as the pollutants can go through the placenta as well. viveka.r@expressindia.com

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RESEARCH

Ganging up against Shigella virus India is set to develop the world’s first Shigella vaccine, which is likely to hit the market by 2024. Will it prove to be the remedy against a disease, a leading cause of deaths amongchildren worldwide?

By Prathiba Raju

A

n exclusive vaccine for Shigella, the chronic diarrhoeal disease, will be developed in India by 2024. Hilleman Laboratories, a global vaccine research and development organisation, along with National Institute of Cholera and Enteric Diseases (NICED), an Indian Council of Medical Research (ICMR) organisation, has signed an MoU

Dr Soumya Swaminathan, DG ICMR and Secretary, Department of Health Research MoHFW, addressing a press briefing on development and commercialisation of the Shigella vaccines with Davinder Gill, CEO, Hilleman Labs, Dr Shanta Dutta, Director, NICED and Prof Gagandeep Kang, Director, Hilleman Laboratories

to develop Shigella vaccines.

A threat ...

Sanitation and clean water access is still a major public health burden in developing countries like India. This in turn, makes them susceptible to Shigella infection, a waterborne disease. It has been one of the leading causes of death and casualties among the chil-

dren aged under five with bloody diarrhoea worldwide, especially in low-income developing countries of Africa and South Asia.

“Shigella causes dysentery as well as diarrhoea that may not necessarily be associated with blood. People thought that Shigella was no longer important as we have improved the environment sufficiently.

So, we would not need a vaccine for this bacterial pathogen. But very recently, there has been studies around the world demonstrating that after rotavirus, in developing countries of Asia and Africa, Shigella is the second most important pathogen. Having a vaccine will significantly impact the children who live in poorest environments,” said Prof Gagandeep Kang, Director, Hilleman Laboratories.

According to the 2015 Global Burden of Disease report, diarrhoeal diseases were collectively responsible for 1.3 million deaths across all age groups around the world. Of these, 500,000 deaths were among children less than five years of age, a majority of them in India.

Shigella alone resulted in 164,000 deaths in total, mostly in Africa, South Asia and India. To date, there are no approved vaccines for prevention of Shigella, only antibiotics are prescribed for this disease.

....and a Made in India solution Promising production of safe and effective Shigella vaccines, Davinder Gill, CEO, Hilleman Labs told Express Pharma, “We will develop the vaccine by 2024. The entire R&D will take

34 EXPRESS PHARMA May 1-15, 2017

place in India. This is a vaccine which would be presented for severe diarrhoea due to Shigella in children and adults.”

Gill further added, “We hope that oral formulation would be possible and our goal is to push this vaccine into earlier stages of clinical trials in the next 12 months. Since it is a new vaccine and there are no approved vaccines for Shigella, we have to go through step-by-step clinical testing. It will take atleast six to seven years to develop the vaccine. Moreover, we are pleased to collaborate with NICED and jointly develop Shigella vaccine for a disease whose basic pathology is not yet properly understood.”

“NICED comes with a variety of strengths in research and developing strategies for treatment, prevention and control of enteric infections. This will also be a strategic shift for Hilleman. Our focus will be to optimise existing vaccines and address the gaps in low resource settings. We will now endeavour to develop an entirely new line of treatment and will look forward to jointly abate this fatal disease which threatens the nation’s health,” Gill said.

Informing that such partnerships are boosting the Make in India initiative, Dr

RESEARCH

In view of the global emergence of multi-drug resistant bugs, and challenges in global drug discovery programme, vaccines are the only effective tool to fight against the disease. Candidate vaccines against the infection have been developed and tested at NICED by using the in-vitro animal models, which showed significant immune response and protection against the infection Dr Shanta Dutta Director, NICED

Shigella vaccine will be a very good example for Make in India concept as the work is set to be translated from lab up to product Dr Soumya Swaminathan Director General, Indian Council of Medical Research (ICMR)

Soumya Swaminathan, Director General, Indian Council of Medical Research (ICMR) said, “This is a step in a new direction. India has immense potential in clinical research, drug and device manufacturing and we would like to see more of these types of partnerships. Across the country, a lot of research in government academic centres, including universities are done, but unfortunately more often they are not translated into anything which has a very huge public health impact. Shigella vaccine will be a very good example for Make in India concept as the work is set to be translated from lab upto product.

We are keen that ICMR becomes more collaborative and partners with organisations in this direction and mutually expand capacities through cross-functional partnerships.”

Swaminathan mentioned that rotavirus vaccine was also developed through partnership with many different agencies and indicated that Government of India's biotechnology department and ICMR both played an important role. She said that such endeavours will surely help bring in more vaccines for different other pathogens.

“We are committed to support through all the phases of testing as we are aware that different institutions have different strengths. For example, we have an animal testing facility of ICMR in Hyderabad. However, for phase I testing, we don't have the facility at ICMR so it needs be carried outside. Phase II and III can be carried over in NICED, as they have done many vaccine trials,” Swaminathan added.

Talking about the efficacy of vaccine made in India, Swaminathan also said, “Any product, whether it is vaccine or any other product, has to go through a lot of phases of development. And, each phase of the product development -- be it phase I (the safety studies) or phase II (immunogenicity) or phase III (efficacy study) -- has to

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DIFFERENT PHASES OFTHE VACCINES DEVELOPED PHASE 1 Safety in healthy adult volunteers absence of serious or unexpected effects, including dissemination Increasing dosage One or several dose schedule Open uncontrolled study Usually less than 50 subjects not exposed to natural disease

PHASE 2 Population is target or high risk population Randomized, double blind controlled study (control is reference vaccine or placebo) Cascade of studies to determine dose, route schedule, association with other vaccines, response in presence of preexisting antibodies

PHASE 3 Target population-susceptible, exposed, several hundred to thosands Randomized, double blind, controlled trial Efficacy studies ◗ Measurement of protective effect of vaccine ◗ Safety profile ◗ Evaluation criteria are cases of disease meeting case definition

Post-licensure ◗ Safety ◗ Effectiveness ◗ Persistence of protection

Innoculating against infection Informing that vaccines are the only effective tool to fight against Shigella infection, Dr Shanta Dutta, Director, NICED said, “Shigella infection was treated with antibiotics and currently there is no vaccine to prevent it. In view of the global emergence of multidrug resistant bugs, challenges in global drug discovery programme vaccines is the most simple, powerful and cost-effective health intervention and an effective public

Davinder Gill CEO, Hilleman Labs

PHASE 4

comply with all regulatory requirements. Thereafter, registration of the product is strictly followed. Each phase carries a stringent process during the development of the product.”

The vaccine will be developed by 2024 and the entire R&D will take place in India. Since it is a new vaccine and there are no approved vaccines for Shigella, we have to go through the step-by-step clinical testing.

It will take atleast six to seven years to develop the vaccine

health tool. Our association with Hilleman Labs is in alignment with NICED’s mission to identify enteric infections, initiate appropriate multi-disciplinary research and develop strategies for treatment, control and prevention of enteric infections.”

“Candidate vaccines against the infection have been developed and tested at NICED by using the in-vitro animal models, which showed significant immune response and protection against the infection. With partnership, we are aspiring to unlock new knowledge behind enteric diseases like shigellosis and to come up with an appropriate and effective, preventive tool against this disease,” added Dutta. prathiba.raju@expressindia.com

After rotavirus, Shigella is the second most important pathogen and having a vaccine significantly will impact the children who live in poorest environments Prof Gagandeep Kang Director, Hilleman Laboratories

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May 1-15, 2017

RESEARCH UPDATES

Spine manipulation might help with low back pain Meaningful reductions in pain and improvements in function after six weeks of treatment SPINAL MANIPULATION therapy may work as well for easing lower back pain as anti-inflammatory medications, concluded a research review .

Based on data from 15 previously conducted trials involving a total of 1,711 adults, the study team found that spinal manipulation achieved meaningful reductions in pain and improvements in function after six weeks of treatment. The effect on pain was modest, and similar to what other studies have found with non-steroidal anti-inflammatory drugs (NSAIDS).

Based on a review of 12 trials, the researchers also found spinal manipulation associated with statistically meaningful improvements in functional abilities.

“Most doctors and patients have a good sense of what NSAIDs do - work great in some patients, don’t seem to work much at all in others, work somewhat in many more,” said senior study author, Dr Paul Shekelle of the West Los Angeles Veterans Affairs Medical Center. “I think spinal manipulation therapy is much the same,” Shekelle said.

Spinal manipulation is often done by chiropractors but may also be offered by physical therapists or physicians. It can include manually moving joints, massage and exercise. This type of treatment is designed to relieve pressure on joints and curb inflammation and it’s often used for back, neck or shoulder pain as well as for headaches.

For the current study, Shekelle and colleagues focussed on the gold standard for determining the effectiveness and safety of medical treatments: randomised controlled

36 EXPRESS PHARMA May 1-15, 2017

Spinal manipulation is designed to relieve pressure on joints and curb inflammation and it’s often used for back, neck or shoulder pain as well as for headaches

trials that compare outcomes for patients who are randomly assigned to a specific treatment, to a dummy treatment or none at all.

None of the trials uncovered serious side effects of spinal manipulation. However, minor side effects like pain, muscle stiffness and headache were common.

One limitation of the analysis is that the original studies included in the review had

a wide variety of designs, involved various kinds of providers with different training and compared spinal manipulation to assorted other types of treatment, the authors note.

There’s also not much agreement in the medical community about how big the reduction in back pain or improvement in function needs to be to make a clinically meaningful difference for patients, the researchers point out in JAMA.

Plus, back pain often clears up on its own within six weeks, the time frame researchers examined in the study, noted Dr Richard Deyo, author of an accompanying editorial and a researcher at Oregon Health and Science University in Portland.

“Many patients don’t even need to see a doctor, and many episodes of back pain are like the common cold: extremely frustrating, but rarely serious,

and usually destined to improve,” Deyo said.

Often, people may feel better after applying heat or taking over-the counter medications, Deyo said.

When that fails, new guidelines released this year from the American College of Physicians recommend non-drug options like spinal manipulation, massage, acupuncture and yoga before patients try prescription NSAIDs or muscle relaxants.

“This study incorporates the most recent data and seems to confirm that spinal manipulation is at least as effective as conventional care,” Deyo added. “It is also one of the few systematic reviews to rigorously address safety, and concludes that serious complications are extremely rare.”

Reuters

RESEARCH

Unexplained chest pain may signal higher heart risk After a follow-up period of up to 5.5 years, the patients with unexplained chest pain were 36 per cent more likely to have a heart attack MOST PEOPLE who complain to their general practitioner about first-time chest pain don’t get additional diagnostic testing to determine the cause, according to a recent UK study. But doctors should take it as a possible warning sign because even when the pain is not readily explainable by heart-related or other causes, these people have a higher risk of heart attacks and other cardiac problems over the next five years, say researchers.

“Most people who consulted their GP with chest pain, the cause was not clear, and rather surprisingly the study team found most of these people still did not have a diagnosis for their chest pain six months later,” said Dr Peter Croft, one of the study authors who works at the Research Institute for Primary Care and Health Sciences at Keele University in Staffordshire.

“We followed this group up for five years and found they had a small but definite extra risk of heart disease compared with the group who had been given a definite diagnosis unrelated to heart disease (five people per 100 in the ‘cause not clear’ group developed a heart-related

problem over five years compared to three per 100 in the ‘cause unrelated to heart’ group),” added Croft.

He said that patients should feel reassured, though, because the study also found that when people consulted their GPs about chest pain, the doctors were generally good at assessing who is most and least likely to have heart disease.

“If the GP decided the chest pain was not caused by heart disease but by other conditions like stomach problems or muscle strains or chest infection, then this group of patients had the lowest risk of future heart problems (measured over five years),” he said.

If the GP decided that chest pain was probably caused by heart disease or decided to send the patient for cardiac investiga-

tions anyway, then this group turned out to have the highest rate of future heart diagnoses, Croft added.

The study analysed data from UK electronic health record databases for more than 170,000 adults with no history of heart disease who saw their doctors for chest pain for the first time between 2002 and 2009. The patients ranged from 18 years old to over 75, with half under age 49.

For 72 per cent of patients, no cause for the chest pain was recorded by the doctor, the study team reports in The BMJ. Another 23 per cent had a diagnosis of chest pain caused by issues not related to the heart, and about five per cent had chest pain that was heartrelated, known as angina.

Less than 12 per cent of the patients with chest pain who didn’t have an established cause underwent further diagnostic testing for heart problems.

After a follow-up period of up to 5.5 years, the patients with unexplained chest pain were 36 per cent more likely to have a heart attack compared to those whose pain got a diagnosis that wasn’t related to the heart.

Croft said he believes people whose chest pain remains undiagnosed could benefit from advice to reduce their cardiovascular risk.

Chest pain is a potentially serious symptom so a person should always seek an explanation, said Dr Tim Holt, a researcher with the Medical Sciences Division of the University of Oxford.

“As the BMJ study has shown, we are probably missing cases by relying too heavily on symptom patterns, and there is a case for doing more investigations if needed to either confirm heart disease or to find a clearer alternative explanation,” he said.

“If it is of sudden onset, severe, or associated with other symptoms such as breathlessness, dizziness, palpitations or nausea, this is an emergency, and it should be reported without delay,’ he said.

Holt said pain that could be described as “'tight,' 'heavy,' 'crushing,' 'like someone squeezing or sitting on the chest'” is of particular concern. “This type of pain is more likely to be due to heart disease.”

Reuters

Bristol-Myers to license two drugs to Biogen, Roche Bristol, which will receive an upfront payment of $300 million from Biogen and $170 million from Roche, expects the deals to close in the second quarter BRISTOL-MYERS Squibb Co said it would license two of its drugs to Biogen and Roche Holding for an upfront fee of $470 million.

Bristol will license its experimental neurodegenerative disorder drug, BMS-986168, to Biogen as a treatment for progressive supranuclear palsy, which is characterised by brain cell damage. Biogen said the

drug also had the potential for use in Alzheimer's disease.

BMS-986089, Bristol's rare muscle-wasting disease drug, will be licensed by Roche for use in duchenne muscular dystrophy.

Bristol, which will receive an upfront payment of $300 million from Biogen and $170 million from Roche, said it expects the deals to close in the

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second quarter.

The deals come amid activist investor pressure. The Wall Street Journal reported in February that billionaire investor Carl Icahn had taken a stake in Bristol and saw the company as a possible takeover target.

Bristol also added three directors to its board in February, a move supported by JANA

Partners, an activist investor building a stake in the company's stock.

The drugmaker has fallen behind Merck & Co Inc in the key field of immuno-oncology after its Opdivo drug failed to prolong survival in previously untreated patients with nonsmall cell lung cancer, the largest cancer market.

Reuters

Roche’s emicizumab haemophilia drug shows positive results with children ROCHE HOLDING'S emicizumab drug for treating haemophilia A showed positive interim results in a phase III study with children with inhibitors to clotting protein factor VIII, the Swiss drugmaker said.

Roche is hoping to win a slice of the $11 billion-a-year haemophilia drug market with the drug, also known as ACE910 and designed to compete with more traditional treatments from Novo Nordisk and Shire.

Roche's drug is being closely watched because it could change the way the disease is treated.

Haemophilia patients, whose blood does not clot properly, need life-saving infusions of clotting factors, but development of inhibitors in many of those being treated can interfere with efforts to control their bleeding.

"At this interim analysis after a median of 12 weeks of treatment, emicizumab prophylaxis showed a clinically meaningful reduction in the number of bleeds over time," Roche said in a statement.

Roche said managing haemophilia A with inhibitors to factor VIII was especially challenging for children and their caregivers because bleeding was difficult to control and current treatments required frequent intravenous infusions.

Roche published encouraging data on the drug in December from a phase III study with adults.

Reuters

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RESEARCH

Bristol-Myers immunotherapy combination extends survival in melanoma The combination therapy won approval to treat the deadliest form of skin cancer based on its ability to delay disease worsening, known as progression-free survival PATIENTS WITH advanced melanoma who received Bristol-Myers Squibb's immunotherapies Opdivo and Yervoy had improved overall survival compared with those on Yervoy alone, with 64 per cent on the combination therapy still alive after two years, according to data released recently.

The combination therapy won approval to treat the deadliest form of skin cancer based on its ability to delay disease worsening, known as progression-free survival, with the condition that it ultimately helps patients live longer.

Data presented at the American Association for Cancer Research meeting in Washington for the first time demonstrated that overall survival benefit.

Prior to the introduction

of these new drugs that help the immune system fight cancer, including Keytruda from Merck & Co, advanced melanoma was a short-term death sentence.

The new drugs do come at a hefty price. The combination regimen used in the study

costs about $145,200, infomred the compnay.

In the 945-patient late stage trial, median overall survival for Yervoy, known chemically as ipilimumab, was 20 months.

Median overall survival had not yet been reached for the combination or for Opdivo

(nivolumab) alone, with a minimum follow-up of 28 months.

After two years, 59 per cent of those who got Opdivo alone were still alive, while 64 per cent of patients in the combination group were alive.

“This level of survival rate at two years is really unprecedented,” said Fouad Namouni, Bristol's Head of Medical and Oncology development.

Put another way, the combination therapy reduced the risk of death 45 per cent compared with Yervoy, the company said.

No new safety issues turned up in the study, Bristol-Myers said. However, the rate of serious adverse side effects was 58 per cent for the combination, 21 per cent for Opdivo and 28 per cent for Yervoy.

“It is exciting to see that initial results suggest that

the nivolumab plus ipilimumab combination provides favourable survival outcomes compared with ipilimumab alone,” Dr James Larkin, the study's lead investigator, said in a statement.

The higher rate of severe side effects should be considered when making treatment decisions, he added.

Bristol-Myers is looking to regain its standing in the burgeoning immuno-oncology field. It ceded its perceived lead to Merck last year, when Opdivo proved no better than chemotherapy as an initial treatment for advanced lung cancer, by far the biggest oncology market. Merck's Keytruda won approval as a first-line treatment for advanced non-small cell lung cancer.

Reuters

Scientists find common antibiotic could prevent or treat PTSD The antibiotic blocks certain proteins outside nerve cells, called matrix enzymes, which our brains need to form memories A COMMON antibiotic called doxycycline can disrupt the formation of negative thoughts and fears in the brain and may prove useful in treating or preventing post traumatic stress disorder (PTSD), according to research by British and Swiss scientists.

In a specially designed trial involving 76 healthy volunteers who were given either the drug or a placebo dummy pill, those who were on doxycycline had a 60 per cent lower fear response than those who were not.

Scientists said the antibiotic works in this way because it blocks certain proteins outside nerve cells, called matrix enzymes, which our brains need

38 EXPRESS PHARMA May 1-15, 2017

to form memories.

“We have demonstrated a proof-of-principle for an entirely new treatment strategy for PTSD,” said Dominik Bach, a professor at University College London and the University of Zurich, who co-led the research team.

In the trial, volunteers were given either doxycycline or a placebo and put in front of a computer. The screen would flash either blue or red, and one of the colours was associated with a 50 per cent chance of getting a painful electric shock.

After 160 flashes with colours in random order, participants learnt to associate the ‘bad’ colour with the shock.

A week later, under no medication, the volunteers repeated the experiment. This time there were no electric shocks, but a loud sound played after either colour was shown.

Fear responses were measured by tracking eye blinks, as this is an instinctive response to sudden threats. The fear memory was calculated by subtracting the baseline startle response — to the sound on the ‘good’ colour — from the response to the sound when the 'bad' colour was showing.

While the fear response was 60 per cent lower in those who had doxycycline in the first session, the researchers found that, importantly, other cogni-

tive measures - including sensory memory and attention were not affected.

"When we talk about reducing fear memory, we're not talking about deleting the memory of what actually happened," Bach said in a statement about the findings.

"The participants may not forget that they received a shock when the screen was red, but they ‘forget’ to be instinctively scared when they next see a red screen.

“Learning to fear threats is an important ability ... helping us to avoid dangers. (But) overprediction of threat can cause tremendous suffering and distress in anxiety disorders such

as PTSD.” PTSD is caused by an overactive fear memory and includes a broad range of psychological symptoms that can develop after someone goes through a traumatic event.

Bach said he and his team would now like to explore doxycycline's potential effects further, including in a phenomenon called ‘reconsolidation’ of fear memories - an approach to helping people with PTSD - in which memories and associations can be changed after an event when the patient experiences or imagines similar situations.

Reuters

RESEARCH

Merck aims to role out child formula for schistosomiasis drug The company said it has donated 500 million tablets of praziquantel to the WHO over the last 10 years MERCK IS developing a children's formula of its drug to treat schistosomiasis, a parasitic worm disease that infects millions of poor people in Africa and Asia.

Schistosomiasis kills 280,000 people each year in Africa alone, the German drugmaker said. It can cause anaemia, diarrhoea, bladder cancer, slow cognitive develop-

ment, as well as infertility problems in females.

The company said it has donated 500 million tablets of praziquantel to the World Health Organisation (WHO) over the last 10 years for use in 39 African countries, primarily targeting children who catch the disease in contaminated rivers and lakes.

However, the pill is large,

bitter and difficult for children to swallow, therefore, the new formula will be sweeter informed Belen Garijo, CEO of healthcare at Merck, in Geneva.

"We have learned that we need to customise the formulation of praziquantel to the patients that we want to treat.

This is why we are developing a children user-friendly formulation that we expect to bring to the market in the next couple of years."

"We are actually very close to filing because we are aiming to file in early 2019," Garijo said.

"We will be filing in as many countries as possible in Africa.

We don't anticipate any major challenges in production so we will scale up as quickly as we can in order to be able

to put a sweetened formulation in front of the paediatric population."

Merck's initial commitment 10 years ago to donate 25 million tablets a year from its plant in Mexico has grown ten-fold. Its annual donation has a value of around $30 million, she said.

"Now we have stepped up to 250 million tablets per year.

We believe that with the tablets we are donating we can treat approximately 100 million patients a year. This is going to last until elimination."

Reuters

Anti-depressant use before,during pregnancy tied to autism risk Researchers, looking at six studies with 117,737 participants,found that children were 81 per cent more likely to be diagnosed with an ASD if they were exposed to antidepressants during pregnancy ANTIDEPRESSANT USE right before and during pregnancy may be linked with a higher risk of an autism spectrum disorder (ASD) in children, hints a new analysis of past research.

But pregnant women on antidepressant medications should not stop taking them, because the data that tie their use in pregnancy to ASDs are weak, said the study's senior author. Additionally, there could be consequences to not treating depression during pregnancy.

"Each prescription should be evaluated individually," said Dr Florence Gressier, of the Bicetre University Hospital in Le Kremlin-Bicetre, France.

Gressier and colleagues write in JAMA Pediatrics that up to 15 per cent of women have depression during pregnancy.

Women with untreated depression are at an increased risk of complications and poor follow up for a number of chronic health conditions like diabetes and high blood pressure.

The use of antidepressants

during pregnancy is increasing around the world, write the researchers. The most popular ones, known as selective serotonin reuptake inhibitors (SSRIs), are linked to a number of risks and some benefits during pregnancy.

The researchers add that other research suggests children exposed to antidepressants in the womb are at an increased risk for ASDs, which the US National Institute of Mental Health says are a group of developmental disorders that may affect communication, social and other skills.

For the new analysis, the researchers combed academic databases for studies that examined the link between antidepressant exposure in the womb and the risk of ASDs. They found 10 studies with mixed results.

When the researchers looked at six studies with 117,737 participants that compared people with autism to people without, they found that children were 81 per cent more

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likely to be diagnosed with an ASD if they were exposed to antidepressants during pregnancy.

Some of that excess risk, however, could be explained by the mothers' past history of mental illness.

The researchers found similar results when they looked at antidepressant exposure during specific trimesters.

There was no link between antidepressant use during pregnancy and ASDs when the researchers looked at two studies that followed 772,331 children over time.

Data from four studies did show 77 per cent higher odds of ASDs among children born to women who used antidepressants before pregnancy, however.

"I think this is one of these situations where this gets a lot of attention in the media, but the results are actually pretty challenging to interpret," said Dr Jeremy Veenstra-VanderWeele, of the Columbia University Department of Psychiatry in New York. "In some ways, the strongest association with preconception exposure and increased risk of ASDs suggests to me at least there is something hidden here."

Veenstra-VanderWeele, who was not involved with the new analysis, told Reuters Health it's difficult to account for several factors that may also explain the increased risk of ASDs. For example, the researchers can't control for the severity of the mother's mental illness and how resistant it is to treatment.

"From my perspective, the data on antidepressant use during pregnancy in relation to autism risk would not prevent me from prescribing these medicines," he said.

Reuters

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IT @ PHARMA

Digitizing Drug Development: How much can it save?

The potential of data/IT to transform drug development is a debate unfolding across healthcare and technology. Emerging cracks in pharma's pricing power may force healthcare companies to embrace change sooner than many expect. Technology could disrupt the traditional R&D process, finds a Morgan Stanley Investment Management report. Excerpts Alphabet, has set up two separate healthcare ventures, Verily and Calico. Interestingly, technology executives hold an estimated ~7 per cent of healthcare company board seats (over 40 per cent of whom have joined since 2014).

From consumer-focused wearables to machine-learningdriven, evidence-based medicine, digitisation is emerging across all segments of healthcare.

H

ealthcare, specifically biopharma, remains one of the industries least affected by digitization. While scientific breakthroughs such as genomics and immuno-oncology have created better medicines, the

40 EXPRESS PHARMA May 1-15, 2017

industry has yet to fully exploit technology to create more efficient processes in drug development and the supply chain.

High regulation and low transparency into pricing and profitability pools are responsible.

As soaring drug prices stress

the healthcare system, political and public pressure may force biopharma to seek efficiencies and lower costs. Technology can potentially reduce prices for individuals while improving the efficacy of R&D and enabling more medical

breakthroughs.

Do cash-flush tech companies spy opportunity in healthcare inefficiencies?

IBM has invested ~$4 billion in healthcare acquisitions and Google's parent company,

Our global therapeutic, healthcare services, and technology teams have developed a matrix to frame potential outcomes along two vectors. One registers the impact of digitisation on price transparency from low to high. With low transparency, companies enjoy historical levels of pricing power, while high transparency lowers price inflation to zero and then negative single digits, as seen in European markets.

The other vector indicates digitisation's impact on innovation, with improvements that include enhancing R&D yields, finding new patients to treat, and increasing prescription fill rates, adherence, and persistence. The resulting quadrants yield four scenarios that we explore in depth: Balancing Act, Rainbow's End, Status Quo,

IT @ PHARMA and "Doomsday."

We see consistent trends across industries that have experienced increased digitisation, such as Media, Hotels, and Airlines: ◗ Despite concerns over stock performance and potential early underperformance, the industries outperform the S&P over the long term. ◗ New disruptive companies always win. ◗ Incumbents also outperform if they are able to adapt. Intellectual property is a driver of incumbent success, which could favor much of healthcare, considering the scientific and regulatory knowledge required. ◗ In most cases, pricing pressures occur but are more than offset by resulting higher utilisation rates and cost efficiencies from digitisation.

What's in the Stocks?

Analysing the potential impact of increased technology use across drug development companies and the supply chain suggests as much as ~10 per cent more downside to pharma, biotech, and distributor market capitalisation in our Balancing Act scenario. This implies the industry needs to further sharpen its pencils to lower cost structure. Contract research organisations (CROs) should thrive from increased innovation but risk being disrupted if they are unable to keep up. Healthcare initiatives aren't yet embedded in technology company valuations.

Apple, Fitbit, Alphabet, and IBM have the biggest potential upside.

We explore potential outcomes through a quadrant analysis, with technology impacts on one vector and drug price changes on the other. Our four scenarios are Balancing Act, Rainbow's End, Status Quo, and "Doomsday" (see Exhibit 1) which we outline below and explore in detail later in the report. For each scenario, we identify stocks to own and avoid. In the process of developing this analytical framework, our teams’ thinking has evolved. ◗ On pricing, our views have converged (Balancing Act and "Doomsday"). We expect drug

Exhibit 1: Scenario Analysis: How will drug efficiencies and technology collide in healthcare?

Source: Morgan Stanley Research

companies to raise list prices less aggressively due to political scrutiny as they continue to face rebate and competitive pressures. At this point, divisions in Washington remain an obstacle to broad legislation to lower drug prices, though this situation could change. ◗ On the level of technology integration, we diverge into two camps. One group believes that over the longer term, increased use of technology will improve the clinical trial process (Rainbow’s End or Balancing Act).

The other group thinks technology will contribute to medical cures as in the past and that technological progress can enhance innovation, but it will not drive a step change in cures. R&D productivity will continue to be dominated by “traditional” factors such as genetics and biological innovation, with technology aiding discoveries but not becoming the major driver (Status Quo or "Doomsday"). Our internal debate mirrors what we have learned from communicating with industry participants.

Some drug companies believe that data can transform clinical trials and are pursuing partnerships, while others are pushing back.

The drug industry has historically been relatively insulated from pricing pressure, but change is coming.

Over the past three to five years pressure from payors (in the form of higher rebates) has materially increased and is un-

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likely to abate for the foreseeable future. Escalating drug price increases are creating systemic stress. Drug companies, pharmacy benefit managers (PBMs), and plan sponsors are passing along gross price increases to consumers, who are unable to pay. The resulting erosion in the quality of healthcare is attracting public scrutiny, and as pressure mounts, high drug prices are becoming a bipartisan issue.

External forces may sharpen drug companies’ focus on costs, including the shift toward a value-based reimbursement system and more attention from policy makers (the government is the largest payor at 45 per cent of US healthcare expenditures).

Technological “transformation” has come later to biopharma than other sectors, but is gaining a foothold.

First, strict guidelines in the FDA approval process have constrained innovation. Second, the business model of taking risks to develop drugs (or purchasing companies that have developed them) has been immune to price pressure from competition and regulation. Finally, unresolved questions in fundamental biology have limited the scopefor technological efficiencies – if you don’t fully understand a problem, fixing it is a challenge. However, the FDA is taking its first steps toward adopting changes. The agency has expanded the use of wearable technology for pa-

tient reporting as part of clinical trial design and provided clearer guidelines for the use of risk-based monitoring.

Recent activity at the periphery of the healthcare drug development space may be a harbinger of change.

Inefficiencies and large investment budgets have motivated tech giants to expand the field of opportunity of IT to healthcare. IBM has invested ~$4 billion in healthcare acquisitions, and Google's parent company, Alphabet, set up two separate healthcare ventures - Verily and Calico. The changing composition of boards across Tech and Healthcare companies offers further evidence of change.

We estimate ~ seven per cent of healthcare company board seats are held by technology executives and a slightly higher percentage of technology company board seats, by healthcare executives (over 40 per cent of whom have joined since 2014). Most recently, Apple's marketing head, Phil Schiller, joined Illumina's board of directors in July. IBM and Pfizer lead in board positions assigned to healthcare and technology executives, respectively.

In evaluating a company’s governance, we view board experience as a key pillar. As healthcare and tech companies team up in symbiotic partnerships, it will be increasingly important for relevant "cross-pollinating" of skill sets at the board level. At the executive level, companies like Alpha-

bet's healthcare subsidiaries have been aggressively hiring talent in the biotech and life sciences industries, including Arthur D. Levinson, former CEO of Genentech and current Apple Inc. chairman, who is Calico's CEO; Tom Insel, the former head of the National Institute of Mental Health, who is at Verily; and Jessica Mega, a former cardiologist at Harvard Medical School and Brigham and Women's Hospital, now at Verily. Additionally, Alphabet's Sidewalk Labs recently posted job listings for engineers, a chief health officer, and a head of community health in order to digitally transform how care is delivered.

Potential win-win for individuals and the society at large. Increasing both cost efficiency and price transparency can make healthcare more affordable for consumers – a social responsibility pressed upon healthcare companies, especially lately. In addition, pharma and biotech company R&D spending (together with government funding) benefits society through important medical knowledge and discoveries. Technology can potentially improve affordability for individuals while improving the efficacy of R&D and making more medical breakthroughs possible.

Better health outcomes are relevant for “impact investors,” who seek exposure to business models that solve social problems – the healthtech intersection could expand this investable universe. Asset managers increasingly seek to identify impact investing opportunities in order to address growing interest from asset owners. Framing the debate through quadrant analysis and scenarios we offer a quadrant analysis resulting in four scenarios: Balancing Act, Rainbow's End, Status Quo, and "Doomsday." ◗ Balancing Act: In this scenario we assume a shift towards a tighter price environment by 2024, triggered by either a move towards value-based pricing or price controls. This will be offset by R&D efficiencies in the clinical

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IT @ PHARMA trial process from a combination of: 1) electronic health record mining, 2) electronic source data verification, 3) mobile technologies (for data capture), and 4) at-home testing. Savings on Phase I-III development costs could reach ~30 per cent based on analysis by the Eastern Research Group. Based on our analysis of hypothetical profit streams, we see more downside to Pharma, Biotech, and Distributors' market value assuming no other cost-cutting measures or further upstream (preclinical) enhancements. Contract Research Organisations (CROs) benefitting from improved productivity and increased outsourcing stand out as a group with upside opportunity, although we caution that more involvement from traditional tech companies has the potential to shift some of the value creation away from the CROs. ◗ Rainbow's End: Innovation benefits from a combination of advances in biology and technology. Basic science has historically led to advances in therapeutic approaches to disease treatment, whether the advent of antibiotics, sequencing the human genome, or harnessing the body’s own immune system in new oncology therapies. The combination of technology and biological innovation leads to differentiated drugs which command a premium price without the pricing pressures experienced in the Balancing Act scenario.

In this scenario, all subsectors stand to benefit, with upside ranging from 49 per cent for PBMs to +23 per cent for Biotech. Under such a scenario, pharma and biotech multiples could expand to a ~10x premium to the S&P 500, in line with levels seen in 19992001 when the mapping of the genome drove multiple expansion. This would imply a 27.5x PE based on current S&P multiples, leaving room for even more upside for stocks. ◗ Status Quo: The Status Quo scenario is based on Morgan Stanley global team estimates assuming price inflation continues at its current pace, new innovative products enter the market at premium prices, and

42 EXPRESS PHARMA May 1-15, 2017

the cost structure remains unchanged. Under thisscenario, PBM shares are most undervalued (20 per cent upside) while CROs would see least upside (+2 per cent). ◗ Doomsday: In this scenario we examine the potential impact on industry profits if price regulation takes its toll on industry profits with no corresponding improvement in the current cost structure, productivity, or risk profile. The Biopharma profit pool could be cut almost in half, likely resulting in players exiting the market and stifled innovation. In this scenario, our net present value of Pharma companies implies ~39 per cent downside to current market cap and ~34 per cent downside for the Biotech group.

In this scenario, pharma and biotech multiples could contract to 4x vs. the S&P500, in line with trough levels experienced in 2009-2010 when the entire sector derated on patent cliff fears. This would imply a 13.5x PE based on current multiples.

Our analysis holds constant cost of goods and selling and marketing as a percentage of revenues across two scenarios (Balancing Act and Rainbow's End) but assumes no adjustments to cost structure in the "Doomsday" scenario.

How does technology lower R&D costs?

Our analysis in this report is focused on the clinical phases where we can identify tangible opportunities for technology to lower cost. We believe there is room to further optimise lead generation in pre-clinical stages ultimately resulting in lower downstream failure rates, but given a lack of transparency as to the specific technologies deployed, we do not include such potential savings in our analysis.

Sizing the opportunities According to the Tufts Center for the Study of Drug Development (see here), the estimated average cost per approved drug is $2.6 billion. A material cost driver has been the high failure rates for drugs tested in human subjects: ~57 per cent of cost is spent on phases I to III vs. ~30

Exhibit 2: Where do we go from here? A road toward each scenario image

Source: Morgan Stanley Research

per cent in discovery and ~13 per cent in pre-clinical testing.

We note Biopharma companies include the time value of the opportunity cost foregone when a drug is in development as a capitalised cost on their balance sheets (on average an incremental $1,259 million to out-of-pocket costs per approved drug). While our individual company analysis is based on out-of-pocket costs, we note that if technology were to indeed lower failure rate/risk, the opportunity cost will be reduced as well.

Analysis of the potential for late-stage technology efficiencies based on academic publications and data from Medidata points to the potential to save ~13 per cent to 32 per cent of Phase I-III costs, or $59 million to $151 million in savings per drug candidate or ~ $191 million to $470 million per approved drug (see Exhibit 3).

According to the FDA, the US agency has averaged 28 novel drug approvals per year from 2006 through 2014. While trials could vary meaningfully in scale and savings opportunities, assuming the average cost savings outlined above (~$330 million) per approved drug would yield an average $9.3 billion in savings over the course of the clinical trial

Much public discussion is focused on how technology can help improve the US Healthcare delivery system.We see a substantial opportunity to improve R&D efficiencies and lower the cost of drug development.

Upstream opportunities (moonshots) focus on improving the yield rate in preclinical stage. Downstream opportunities (low-hanging fruit) center on automating and improving data capture and analysis in the clinical phases Exhibit 3:On average, IT could save 23 per cent of capitalised trial costs, or $105m per drug candidate and $330m per approved drug Phase 1-3

Min

Max

Mid-point

Total potential savings %

13%

32%

23%

capitalised savings per project - $m

$59

$151

$105

$470

$330

capitalized savings per approved drug - $m $191

Source: Eastern Research Group, Nature, Medidata, Morgan Stanley Research

process (~8-15 years from discovery to marketplace) for approved drugs.

The Eastern Research Group working under contract to the US Department of Health and Human Services (HHS) identifies sources of technology-driven savings (more detail and further cost savings can be found in the Eastern Research Group report, here). Our analysis focused on those which we think are the most relevant within the context of this report. ◗ Home testing and flexible facilities: Flexibility of patient follow-up during clinical trials could reduce labor costs in centralised hospitals (both in hours

and skills needed to collect data), increase the frequency of data collection, and improve patient retention in trials. Home testing could improve the quality of data due to continuous tracking of certain parameters.

One example is Apple's acquisition of Gliimpse. The platform enables users to record theiremotional state of mind, track laboratory results, and record levels of pain to inform a physician. Medtronic as well works through its Integrated Health Solutions division to expand into patient monitoring (e.g. acquisition of Cardiocom in 2013).

Similarly, point-of-care testing has increasingly become a focus for healthcare stakeholders,

IT @ PHARMA Exhibit 4: On average, drug development out-of-pocket costs equate to $343m per drug candidate and $1.3bn including failures or $511m in capitalised costs and $2.6b in capitalised cost per approved drug

Source: Tufts Center for the Study of Drug Development; Eastern Research Group; Nature; Medidata; Morgan Stanley Research Exhibit5: Main source of savings include higher use of flexible testing location /home testing and mobile technologies for data capture and processing Phase 1

Phase 2

Phase 3

Potential savings Min

Max

Min

Max

Min

Max

Electronic health records (EHR)

0%

2%

1%

2%

1%

2%

Source data verification (SDV)

0%

0%

0%

1%

0% 1%

Mobile technologies (data capture)

3%

8%

6%

12%

4%

12%

At-home testing

7%

16%

10%

22%

7%

17%

Total potential savings

10%

26%

17%

37%

12%

33%

Capitalised cost per project - $m

$50

$95

$315

Capitalised cost per approved drug - $m

$419

$479

$562

Capitalised savings per project - $m

$5

$13

$16

$35

$37

$103

Capitalized savings per approved drug - $m

$43

$107

$81

$179

$67

$184

Source: Eastern Research Group, Nature, Medidata, Morgan Stanley Research

with diagnostics companies developing services for these purposes (e.g. Qiagen acquires point-of-care test maker Amnisure in 2012). Despite these moves, we have yet to see penetration in the home testing market. As a result, in our view, this remains an opportunity and we estimate savings from home testing and flexible facilities could save between seven per cent - 22 per cent per phase or ~$114 million and ~$267 million per approved drug. â—— Mobile technologies for electronic data capture (EDC): Wearable devices is one of the fastest and most flexible new technologies to penetrate healthcare, creating the opportunity to gather larger quantities of biometric information on a continuous basis. They are becoming more mainstream, with 23 per cent ownership

penetration of US consumers vs. 58 per cent owning traditional watches, according to our survey in 2015. Additionally, Fitbit has been used in over 200 clinical trials, ranging from obesity to diabetes to cystic fibrosis to cancer, according to the company.

These devices can serve as a data source for drug trials, which is more precise than previously self-reported information by phone surveys, and provide management of data in the trend toward real-world evidence for reimbursement both pre- and post-trial. Potential cost savings from integrating mobile technologies is estimated to be 3 per cent - 12 per cent per clinical phase or ~$66 million and ~$160 million per approved drug. â—— Electronic health records (EHR): Over the last seven

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years since the HITECH Act (Health Information Technology for Economic and Clinical Health Act), EHR penetration has reached ~80 per cent, establishing an infrastructure of data and technology for drug companies to tap into to analyse patient information to enhance the clinical trial process.

Despite this progress, only 58 per cent of physicians report the ability to generate patient lists by disease via their electronic system. This shows the disconnect between the infrastructure and the ability to analyse complex data sets in real time for clinical analyses (where we see the potential for cost savings). In order for a system to efficiently find patients for clinical trials, it will have to comb through much more complicated data than

an ICD-10 code, including lab results and medical history, something few systems have the ability to do today. IBM Watson has been a leader in this area, partnering with contract research organisation ICON and the Cleveland Clinic and Mayo Clinic to interpret clinicians' notes and lab results in 80 million patient medical records to match patients who qualify for a study's inclusion and exclusion criteria. Initial efforts are focused on breast, lung, colon, and rectal cancer trials.

Potential costsavings from mining the data in EHRs is estimated to be ~2 per cent per clinical phase. â—— Source data verification (SDV): The process of data collection in clinical trials requires regular and frequent site visits and source data verification (every 4-8 weeks on average). This process usually requires physical presence, which can be reduced by using technology such as smartphones and tablets, as well as platforms such as Medidata's Targeted Source Document Verification and targeted monitoring through analytics.

According to estimates from contract research organisations (CROs) we have spoken with, ~50 per cent of Biopharma companies have adopted some form of riskbased monitoring, but we estimate that only between 15 per cent and 25 per cent of clinical trials use risk-based monitoring currently. Accord-

ingly, we see a significant runway of savings as penetration accelerates.Potential cost savings from technology- enabled risk-based monitoring are up to ~1 per cent per clinical phase, according to the Eastern Research Group.Across all therapeutic areas, we estimate that IT-driven savings could represent on average 18 per cent of Phase 1 costs, 27 per cent of Phase 2 costs, and 22 per cent of Phase 3 costs.

Phases 2 and 3 unsurprisingly offers the highest potential for savings at ~$130 million on average per approved drug.

We acknowledge that 100 per cent adoption of the addressable savings we discussed is likely unrealistic or would take a long time to fully materialise due to regulatory constraints and potential imitations associated with specific therapeutic categories and patient populations. Regulatory requirements mean not all costs associated with drug development are variable, and fear of nonapproval makes drug companies less likely to adopt new methods. That said, regulatory agencies do appear to be catching up. For example, one CRO we spoke with highlighted a shift in client interest in risk-based monitoring for source data verification based on recent FDA guidance to the industry for how to implement.

Which therapeutic categories are more levered to potential cost savings?

Hematology, Respiratory, and Pain/Anesthesia are most levered to benefits from higher technology penetration. While this report highlights opportunities, we note that some of the results are counterintuitive (e.g., Cardiovascular is a low cost savings area despite very large patient numbers in trials and Hematology is highlighted as having cost-savings potential but Oncology is not). This is not to say that Cardiovascular and Oncology will not also benefit from emerging technology, but that based on the 4 IT/Data opportunities outlined above, they are not at the top of the list.

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IT @ PHARMA INSIGHT

Choosing the right FDAESG digital certificates Aditya Anand, DGM - SAARC & ME, GMO GlobalSign, explains about the role of digital certificates and the process of acquiring the right one to fit the purpose PHARMACEUTICAL companies need to stay compliant with various processes and approvals which involves excessive paperwork and administration challenges associated with it. Digital signatures are required by pharma companies to submit essential documents in electronic format to the Food and Drug Administration (FDA).

FDA Electronic Submissions Gateway (ESG) serves to streamline the process of accepting electronic regulatory submissions. ESG provides pharma, biotech, food, tobacco and other regulated industries, that perform research, product development, testing, or manufacturing of FDA regulated products, a method to electronically submit a wide-range of forms including AERS – Adverse Event Reports to the FDA. Both pre-market and postmarket regulatory information can be submitted for review via FDA ESG channel. It ensures that information submitted electronically travels securely and automatically reaches the intended FDA centre or office, without having to open or review the submissions. Setting up a WebTrader account requires the participants or senders to acquire a x.509v3 digital certificate.

Digital certificates ensure private and secure submission of electronic documents.

The digital certificate binds together the owner’s name and a pair of electronic keys (a public key and a private key) that can be used to encrypt and sign documents. A PersonalSign Digital certificate is a Digital ID issued to an entity (i.e. individual or a department) that helps to prove the entity’s identity. The Digital ID binds an individual’s

44 EXPRESS PHARMA May 1-15, 2017

verified identity (typically including the name, company name and email address of the Digital ID owner) to a unique cryptographic credential. A digital certificate enables individuals and organisations to secure business and personal transactions across communication networks. PersonalSign Certificates identify, prove and contain different levels of information which are defined as classes. Each class represents the level of identity verification - from simple email verification to full identity assurance. PersonalSign Certificates allow individuals and organisations to represent their digital identities through the use of digital signatures in many applications - from secure email to two factor authentication to document signing. Digital certificates can be obtained from either a public or private Certificate Authority (CA). It must be an X.509 version 3 certificate and all data fields in the Issuer and Subject fields must be completed. The FDA has approved several CAs including GlobalSign as a source of FDA ESG compliant digital certificates. In the simplest of definitions, digital certificates issued to individuals and/or organisations, also known as digital IDs, are the electronic counterparts to driver licenses, passports and membership cards. A digital certificate can be presented electronically to prove your identity or your right to access information or services online. Digital certificates bind an identity to a pair of electronic keys that can be used for encrypting and signing digital information. A stricter definition is as follows - The public key of a subject and the associated information, digitally signed with the

criteria to be accepted as a member. Once accepted, the CA can issue SSL Certificates that are transparently trusted by browsers, and subsequently, people and devices relying on the certificates.

Shared accounts

private key of the issuer of the certificate.

What is a certificate authority?

Certificate Authorities, or CAs, issue digital certificates.

They are verifiable small data files that contain identity credentials to help websites, people, and devices represent their authentic online identity (authentic because the CA has verified the identity). CAs play a critical role in how the Internet operates and how transparent, trusted transactions can take place online.

CAs issue millions of digital certificates each year, and these certificates are used to protect information, encrypt billions of transactions, and enable secure communication. Browsers, operating systems, and mobile devices operate authorised CA ‘membership' programmes where a CA must meet detailed

The Electronic Submission Gateway accounts cannot be shared. Each individual must have their own account.

Although there is no limit to the total number of accounts held by a company, each individual is limited to one account. Another specific requirement is that the registered e-mail address must be for an individual and not a group e-mail id.

Digital certificates cannot be shared because they are associated with individual accounts. WebTrader accounts also cannot be shared.

Digital certificates are associated with WebTrader accounts to establish the origin of a submission. There are also additional requirements to it: ◗ FDA must be able to establish origin of a submission to supply electronic information for FDA review ◗ Use of a PKI Digital Certificate and account name determines origin of the regulatory submission ◗ PKI Digital Certificate utilises public/private key exchange for encrypting and decrypting as the submission signature

Self-signed certificates The FDA references an option to create a self-signed certificate using Adobe Acrobat.

Self-signed certificates are not legally binding as an independent certificate authority has not verified the contents of the digital ID. The FDA requires certain forms (e.g.,

1571, 356h) have an embedded signature, whether it's a scanned signature or placed from a certificate prior to submission through the ESG. These certificates are only for visible signatures inside PDFs and cannot be used to sign a full submission to the ESG.

Class of certificate The minimum requirement for a digital certificate for use with the FDA Electronic Submissions Gateway is a Class 1 Personal Identification Certificate. Although the Digital Certificates- Class 1 and Class 2, are available for varied validity periods, ranging from one year to three years, the FDA recommends a threeyear certificate validity. This reduces redundant steps in future. Class 1 Certificate binds to only email address and is sufficient for clients requiring Digital IDs for general use. Class 2 Certificates are Digital IDs used to represent themselves as an individual, since they bind with an email address and individual, both.

Support The certificate acquiring process for use with the FDA ESG Gateway WebTrader includes a series of steps and extends upto two to three days. Broadly, the steps in the process are as follows: ◗ Select a provider and place order for your digital certificate ◗ Install your digital ID using Internet Explorer browser ◗ Make a copy of the public certificate (.cer/p7) and submit to FDA ◗ Make a copy of the public/ private certificate (PKCS12) and submit to FDA ◗ Hence, it is wise to select a provider which extends tangible support in the process.

PHARMA ALLY VENDOR NEWS

VICAM introduces new rapid,solvent-free method for ochratoxin Adetection in coffee and wheat The Ochra-V AQUA eliminates the use of organic solvents while also significantly reducing testing time

W

aters Corporation's VICAM now offers a rapid, eco-friendly lateral flow strip test specifically for the detection of ochratoxin A in green coffee and wheat.

Compared to traditional methods, the Ochra-V AQUA reduces ochratoxin A testing time by

half and eliminates the use of organic solvents completely.

Traditional laboratorybased methods of ochratoxin A monitoring can take a substantial amount of time and resources to complete. The Ochra-V AQUA enables on-site monitoring that provides pre-

cise quantitative results minutes after sample extraction.

This allows producers and processors the ability to quickly select safe, high quality raw materials for milling (wheat) and roasting (coffee).

“VICAM is committed to developing products that deliver

significant efficiencies to our customers while also being ecofriendly,” said Marjorie RadloZandi, MD, VICAM. “With Ochra-V AQUA, we are able to test for all global regulatory levels required for ochratoxin within minutes.”

The Ochra-V AQUA is the

latest in a series of solvent-free testing solutions from VICAM that can be used with the Vertu lateral flow strip test reader.

The Afla-V AQUA (aflatoxins), Fumo-V AQUA (fumonisin) and DON-V (vomitoxin) are also available.

EP News Bureau

ABITEC Corporation, IMCD in distribution agreement The new partnership will distribute speciality lipids into the pharmaceutical and nutritional markets in Asia and South America ABITEC CORPORATION has executed a multi-year agreement with distribution partner IMCD, to promote and sell its speciality lipid products into the Brazil, China, India, and Taiwan markets. The arrangement strengthens an already existing relationship between the two companies and aims to fulfill market innovation and customer demand requirements for ABITEC’s functional

lipid products in these new locales.

Neil Houston, Director of Pharmaceuticals Americas, IMCD, notes, “The expansion of our relationship with ABITEC is an excellent fit with our business as we continue to align with world class suppliers of pharmaceutical ingredients on a multi-regional basis. We recognise ABITEC’s portfolio of unique lipids as being a vital in-

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gredient to provide our customers with formulation solutions, particularly with poorly soluble API’s.”

Dr Donald Kelemen, Head of Corporate DevelopmentABITEC states, “ABITEC’s relationship with IMCD has quickly transitioned into an effective and mutually beneficial partnership centered on trust, a shared common vision and commercial growth. In addition

to having access to their global teams of highly trained scientists, IMCD provides ABITEC with an understanding of local market dynamics. Together, this agreement will allow both companies to expand our presence in markets of growing world economies and will greatly assist regional and multinational pharmaceutical and nutritional companies to develop products of the highest

quality for their customers.”

ABITEC’s specialty lipids include Capmul, Captex, Caprol, Acconon, Sterotex, Nutri Sperse, Hyrdo-Kote and Pureco and can be used for a variety of applications, including pharmaceutical, nutritional and cosmetic products, as well as in the manufacturing of foams, creams, ointments and lotions.

EP News Bureau

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PHARMA ALLY PRODUCTS

Mettler-Toledo Product Inspection launches ProdX 2.0 data management software system METTLER-TOLEDO Product Inspection has launched the enhanced ProdX 2.0 data management software system.

Designed for use on food lines, as well as in pharmaceutical and chemical processing, the new and improved data management software package connects product inspection equipment across the entire production line into a single, unified network. In doing so, it is able to collect in-depth data about productivity and product quality issues, such as foreign body contamination, and access it in real time from one centralised location. ProdX 2.0 not only records the date, time, location of the reject, and the reason for removal, it now enables manufacturers to store verifying documentation about the active managerial control measures taken to prevent incidents re-occurring in the future. This ensures compliance with the new Hazard Analysis and RiskBased Preventative Controls (HARPC) requirements of the FSMA, and with those of a wide range of international food standards approved by the Global Food Safety Initiative (GFSI), as well as pharma and product quality guidelines.

To ensure optimum product

46 EXPRESS PHARMA May 1-15, 2017

inspection documentation for manufacturers, ProdX 2.0 is able to manage data from a wide range of product inspection machines, including X-ray systems, metal detectors, checkweighers and, for the first time, vision inspection equipment. It is even capable of storing x-ray and vision inspection images of rejected packs to allow further analysis of rejection incidents by operatives at a later date.

In addition to helping to opti-

ProdX 2.0 is able to manage data from a wide range of product inspection machines, including X-ray systems, metal detectors, checkweighers

mise food safety, ProdX 2.0 can support manufacturers in boosting productivity. Featuring a new standardised OPC Unified Architecture (OPC UA) server interface, and able to support PackML tags, the software can be seamlessly integrated into existing production line networks, not only connecting MettlerToledo systems, but also equipment and computer interfaces supplied by other manufacturers. This enables the software to

collect data about the performance of all the inspection machines on the production line, from throughput speed to instances of product over- or under-fill, enabling the calculation of the overall equipment effectiveness (OEE) of the manufacturing process by the company’s control and MES system.

ProdX 2.0 is available as a turn-key starter pack that can be easily installed on standardsized production lines and exist-

ing network equipment, as well as an expandable base pack that can be scaled to manufacturers’ specific size and connectivity needs. Mettler-Toledo will showcase the software at Interpack in Düsseldorf, Germany, from May 4-10,May 2017. Visitors will be able to see the software for themselves at Mettler-Toledo’s stand B55 in Hall 11.

Contact details www.mt.com/pi-prodx

PHARMA ALLY

Rommelag to showcase its products at interpack 2017 ROMMELAG GROUP offers packaging technology for the pharmaceutical, chemical and food industries and is divided into four service areas Rommelag Engineering, Rommelag CMO, Rommelag Flex and Rommelag Service. Products for the pharma industry, such as the aseptic, fully isolated filling process or the fully-automated inspection of BFS containers will be displayed at interpack in Düsseldorf. Interpack will be held from May 4 to 10, 2017.

As the slogan ‘Filling your needs’ says, the Rommelag Group is presenting special solutions that make these applications easier, safer and faster to use. The products will be displayed at stand D38 in Hall 16. Rommelag Service, which offers comprehensive maintenance and customer service, has an information point set up specifically for this purpose.

The following innovations will be on display Rommelag Engineering will demonstrate the aseptic BlowFill-Seal filling process live and in 3D. The bottelpack bp 434 has a completely sealed parison with just one rotating mould. The advantages here are maximum safety when filling high-value products and simple format changes.

Until recently, several steps with manual interventions were necessary to detect particles and cosmetic defects in containers. The particle inspection machine (PIM) now enables a 100 per cent inline check. BFS containers can now be checked fully automatically for particles and cosmetic defects.

Rommelag CMO, the service area that offers contract filling, has a new method for the filling of temperature-sensitive products in its portfolio.

The Blow-Fill-Seal process can

Rommelag has customers in over 80 countries and employs over 1,800 people

Blow-Fill-Seal process with one mould and sealed parison

There are practically no limits with regards to container design for bottelpack BFS containers

To subscribe: bpd.subscription@expressindia.com

now be applied to temperature-sensitive products, such as vaccines, with the ‘coolBFS’ application.

Rommelag Flex will be demonstrating new application options for transport, storage, transferring and weighing in the field of flexible containment solutions for powders and bulk goods. Including Flecofilm, a film approved for the pharma industry. The antistatic property of this film increases product yields.

Rommelag is the inventor of the Blow-Fill-Seal technology (BFS) and global market leader in the aseptic filling of liquids and semi-solid substances using bottelpack systems. Everything began in 1952 with film extrusion, followed in 1962 by the first prototype of a bottelpack system. Since then, we have continuously refined our know-how regarding plastic packaging solutions. Rommelag has customers in over 80 countries and employs over 1,800 people.

Contact Details: Andreas Häußner Director Marketing Rommelag Kunststoff – Maschinen Vertriebsgesellschaft mbH Mayenner Str. 18-20 71332 Waiblingen, Germany E-mail: Andreas.Haeussner@rommelag.com Website: www.rommelag.com

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Alfa Laval Touch Control is new standard of control for marine boilers ALFA LAVAL Touch Control is being rolled out successively for new and existing Alfa Laval Aalborg boilers.

Alfa Laval Aalborg OL and OC-TCi boilers will now feature advanced control with a simple touch.

With its graphical touchscreen display and intuitive two-touch navigation, Alfa Laval Touch Control is a major leap forward in boiler control technology. As the new common control platform for all Alfa Laval Aalborg boilers, the system will be a familiar interface for crews, regardless of which boiler they work with. Already it can be found aboard a range of newbuilds,

and additional deliveries are underway.

Alfa Laval Touch Control is a tried-and-tested solution.

Built with Alfa Laval technology, it has already been proven in the engine room on other marine systems from Alfa Laval. In addition, it is used at the Alfa Laval Test and Training Centre, where it steers the centre's own boilers and aids the continuous development and optimisation of systems for new boiler types.

What Alfa Laval Touch Control offers is entirely new for boilers, as customers who experience the test rig at the Alfa Laval Test & Training Centre quickly recognise.

Simple and effective boiler operation Intuitive control means easier and better boiler operation.

With a complete view of the plant and easy access to all functions, crews can make faster, smarter decisions that optimise boiler use. Supporting those decisions are features such as integrated manuals and user-defined trend pages.

Flexible, future-proof and available for retrofit During trainings, the rig is used to show the many ways in which boiler operation can be optimised.

Alfa Laval Touch Control is PLC-based, which gives it plug-and-play simplicity and high durability in the engine room. With coverage for all

major bus interfaces, it is easily connected to on-board communication systems. Likewise, Alfa Laval Service engineers can quickly retrofit it to an existing Alfa Laval Aalborg OL, OS-TCi or OC-TCi boiler, as has already been done on a number of tanker vessels. In addition, Alfa Laval Touch Control offers the flexibility of firmware upgrades. This will let the system adapt as new needs arise.

Contact details Amit Khare amit.khare@alfalaval.com +91-9881727315 Business Leader - Marine and Service Alfa Laval India

Dock levellers offered by Gandhi Automations designed as per EN 1398 standard GANDHI AUTOMATIONS, an ISO 9001: 2008 entrance automation and loading bay equipment company, have been manufacturing, importing, distributing and installing products that are problem free and easy to operate, since its inception in 1996. The company offers complete logistics solutions by providing dock levellers, dock shelters, sectional overhead doors and dock houses.

Electro-hydraulic, mechanical and air-powered dock levellers offered by Gandhi Automations are not only ‘a bridge for connecting a vehicle,’ but also facilitate fast, smooth and safe transition by compensating the difference in heights between the loading bay and the vehicle.

This contributes to minimising energy used and savings on heating and chilling costs resulting in maintaining the quality of the transported goods. Dock levellers offered by Gandhi Automations are designed as per EN 1398 standard for the most demanding loading and unloading operations.

Efficient loading and unloading the goods The importance of efficient load-

48 EXPRESS PHARMA May 1-15, 2017

ing the goods has always been evident, and it has increased over the years, essentially for two reasons: the lesser availability and the higher cost of manpower. Consequently, lesser qualified manpower is being utilised which leads to damage in the goods.

The cost of loading and unloading the goods can be calculated precisely and is exactly definable, which allows for a scientific approach to find out the investment that goes into the process. Gandhi Automations has always designed solutions based on such scientific approach and feedback from

clients. The dock levellers offered by the company ensure loading and unloading with lesser effort and minimal cost.

It is possible to load and unload the products in a safe way and in the process obtain remarkable energy savings. The loading bay remains with the dock leveller in rest position and the sectional overhead door closed, until the vehicle is positioned. The driver drives back centring to the dock shelter and stops the vehicle the moment it gets in contact with the bumpers.

The sectional overhead door is then opened only when the ve-

hicle is positioned, brakes applied and engines shut off .This eliminates the exit of hot air, intake of cold air (or the opposite in hot and inside conditioned places) and intake of exhausting gases in the warehouse. After the sectional overhead door opens, the lip of the dock leveller connects to the truck bed for loading / unloading to take place.

At the end of the loading/unloading, the dock leveller is put in rest position and the sectional overhead door is closed, without moving the vehicle. The vehicle then departs at the end of the process.

Following are the two types of

dock levellers: ◗Radius lip dock levellers Radius lip dock levellers allow the dock to connect with the truck bed, thus making it possible to drive directly on and off with forklift trucks etc. The selfcleaning lip hinging system does not retain rubbish with automatic end-of-run, so as to keep the 25 mm security distance between the folded lip and structure as per EN 1398 & EN 349. ◗Telescopic lip dock levellers Telescopic lip dock levellers are ideal for connecting vehicles unable to drive near dock i.e. sea containers, side loading railway wagons etc. These types can be supplied with a lip extending up to 1 m.

Gandhi Automation’s dock levellers are equipped with the most secure safety devices and accessories.

For further details contact: Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064 Off: +91 22 66720200 / 66720300 Fax: +91 22 66720201 Email: sales@geapl.co.in www.geapl.co.in/dock-levelers.html

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Do you know about weights calibration?

METTLER TOLEDO is the world's leading manufacturer of weighing instruments and significant supplier of weights, weights sets and related weight calibration services. · Accurately calibrated weights are at the base of accurate weighing results. · Balances should always be checked with reference weights you can rely on and trust. · The Calibration Services cover the reporting of convention mass, expanded uncertainty and traceability in accordance with ISO/ IEC 17025:2005 requirements.

Mettler-Toledo India Pvt. Ltd. introducing Mass Calibration Laboratory(MCL) for calibration of weights/ weight box.

Benefits: · Accredited by NABL with accreditation certificate no. C-1477 · MCL meet or exceed ISO/IEC 17025, FDA, GMP and requirements of nuclear industry. th · Reference Standard weights with expanded uncertainty (1/5 ) of MPE of E1 accuracy class of weights. · Door to door logistic service with insurance on transit damage For more on Weights Calibration Services Call Toll free No. 1800 22 08884 / 1800 10 28460 Mail us at mclindia@mt.com

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www.mt.com/service

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Multiple Products Under One Roof for Food & Bio-Pharma Industries We are specialized in manufacturing Platinum Cured Silicone Tubes, Braided Hoses, Inflatable Seals / Gaskets and customized polymer solution for food, medical and pharmaceutical industries application.

Imaprene™ Thermoplastic Elastomer Tube (TPE)

Imachemton™

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Fluoro Elastomer Tube (FKM)

Platinum Cured Silicone Hose Reinforced with Polyester Braiding and SS 316 Helical Wire

Imavac™ Platinum Cured Silicone Hose Reinforced with SS 316 Helical Wire

Imaseal™ Silicone Inflatable Seals and Gaskets

TM

Ami Polymer Pvt. Ltd.

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OSMOMETER 3250

Peristaltic Pumps Smart loading and locking cascadable heads

3 Rollers Higher Flow rate

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Milk Cryoscopes Available

127, Bussa Udyog Bhavan, Tokershi Jivraj Road,Sewri, Mumbai - 400015. India

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Tel: +91-22-24166630 Fax: +91-22-2662776 E-mail: support@rosalina.in Web: www.rosalina.in

HVAC System Modular Clean Room PUF/EPS WALL/CEILING Partitions-Thickness Range : 50-200 mm.

Reverse Laminar Air Flow (Dispensing & Sampling Booth)

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The leading air management solution provider...

Airtech is a customized air solutions provider. Since its inception in 1992, Airtech has cultivated an in-depth understanding and expertise of executing turnkey HVAC & Clean Room Projects.

Airtech undertakes complete project management comprisig of design, supply, installation & commissioning and validation of HVAC and Clean Room Systems.

Airtech’s Clean Room system provides an ultra-clean environment ranging from Class 100 to Class 100000 with effective control of Air flow, Pressure, temperature, Relative humidity and Filteration suitable for Clan room applications.

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s which lidation service Airtech offers Va otocols pr PQ & , IQ, OQ comply with DQ ational rn te llowing In conforming to fo cts) : oje Pr ld Fie en re Standards (G

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Wiper Type Sight Glass

DIN 100 Light Glass LED

Swastik Associates Shed No. 1, 2 & 3, Sr. No. 30/7, Behind Dran Company, Dhayari-Pune 411041 Phone : 020 24690268 / 24690041, 9923124949 / 9028716622, 9028716222 Email : sale1swastik@gmail.com swastikpune1@gmail.com

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Pharmaceutical Formulation Efficacy, Stability and Applicability Developing a pharmaceutical formulation with appropriate efficacy, stability, and applicability is one of the key stages of drug development. Malvern’s formulation development platform optimises the bioavailability, shelf-life and usability of your product – increasing quality and reducing waste.

Particle Size

Shelf-life

Applicability

Particle size controls the dissolution characteristics of tablets and delivery uniformity in suspensions – Malvern’s Mastersizer 3000 (pictured) and Zetasizer systems give accurate, precise and repeatable particle size characterisation

Comprehensive understanding of stability reduces the cost of batch expiration - Malvern’s Zetasizer ZSP and Kinexus range are used to assess the electrostatic and kinetic stability of formulations

Flow characteristics define the applicability of a formulation - Malvern’s Kinexus (pictured) range has the versatility to assess the flow properties of a formulation under applicationrelevant conditions

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EXPRESS PHARMA LABORATORY EQUIPMENTS Walk-in chamber

Cyclomixer Mini Rotary Shakers

Ultra Low Frezeer

Double Door Refrigerator

Hot Plate Magnetic Stirrers

Refrigerated Centrifuge Laboratory Centrifuge

Incubator Shaker

Lab Stirrers

REMI SALES & ENGINEERING LTD.

Remi House, 3rd Floor, 11, Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai-400 063. India Tel: +91 22 4058 9888 / 2685 1998 Fax: +91 22 4058 9890 E-mail: sales@remilabworld.com Website: www.remilabworld.com l

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Osworld Scientific Equipments Pvt. Ltd.

B-44, New Empire Industrial Premises, Kondivita, J. B. Nagar, Andheri (East), Mumbai - 400 059. India Tel.: +91-22-28320880 / 28390487 E-mail: info@osworldindia.com

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B.O.D INCUBATOR

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VISION & AMBITION TOP MANAGEMENT

Mr. Sanjay Shah

S

akar Healthcare co m m e rc i a l i s e s pharmaceu cal products since 2005. Founder and Managing Director Sanjay Shah plays a key role in ar cula ng the innova on that propels the company ’s growth. Mr Shah’s honed his skills and exper se in the plas cs and mineral water industry over decades, prior to entering the crowded pharmaceu cals domain.

In the process, he pushed boundaries and came up with visionary ways to progress in this compe ve business.

Mr Shah strongly believes that by obtaining a M BA degree has acquired the necessary skills needed to successfully run a company. At the same me, it is of vital importance to maintain a naturally good outlook and take care of employees. According to his personal vision, passionate people can change the overall

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culture and help s h a p e a n incredible environment. This philosophy, and a fair measure of business acumen, allowed Mr Shah to deliver on promises and b u i l d t h e credibility of Sakar Healthcare.

C u r r e n t l y, h e spearheads the corporate strategy decision-making p r o c e s s , leveraging core competencies and foresight.

Whether it is greater market share, larger profits, a higher stock price, or preferably all three; Rita Shah, promo ons director at Sakar Healthcare and a science graduate, excels at ensuring the company runs smoothly. Mrs Shah is in charge of administra ve and human resource opera ons. She defines her success through challenging limita ons, facing the odds, and developing insights: determinant factors that command respect.

Aarsh Shah, a pharmacist with a MBA from University of Cardiff (UK), is joint managing director at Sakar Healthcare. With a welldeveloped understanding of contemporary business models and opera ons, Aarsh Shah manages the company’s business opera ons with precision. He also leads the interna onal

business development project, expanding into overseas markets and establishing credible channel partnerships. His contribu on helped Sakar Healthcare leverage its core competency of manufacturing pharmaceu cal formula ons that are used in 35 countries. The product por olio includes small volume parenteral, (including lyophilised products in vials), cephalosporin (tab, cap, sachet, dry syrup, dry powder injec on), and oral liquids.

J.K.Rowling once quoted that “It is our choices that shows what we truly are, far more than our abili es.” Foregoing a promising in fashion technology, following of her studies at the London College

Mr. Aarsh Shah

of Fashion, Aayushi Shah, with an execu ve MBA from Cambridge University, decided to join the family business. Her flexibility in approach, inquisi veness, ability to convert ideas into reality, help align internal func ons through opera onal excellence. It also allowed Sakar Healthcare to g ra d u a l l y b ro a c h re g u l a te d markets.

Management excellence coupled to top operaƟonal performance have powered Sakar Healthcare to claim an enviable market posiƟon from which the company now aims to grow further, establishing, as it does, a truly global footprint.

Ms. Aayushi Shah

Mrs. Rita Shah

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PHARMA LIFE INSIGHT

Pharma industry — where innovation impacts lives Dr Rebecca Leyland, Lecturer and Scientific Researcher in Immunology, Sheffield Hallam University, UK, enumerates the various opportunities and benefits for candidates opting for a career in the pharma industry thousands of hours of trials and tests to understand its potential.

Scientists are at the heart of this process to evaluate the success of a drug. Strong team work and motivation are required to deliver this work. There continues to be a strong appetite to invest in research and development (R&D) in pharma globally. For example, according to the Make In India campaign, the Indian pharma industry is expected to become the third largest in the world by 2020, worth an estimated $45 billion.

The UK is considered to be one of the world's leading centres of pharma R&D. The Association of the British Pharmaceutical Industry states that of the 73,000 people who work in the industry, an estimated 23,000 work in R&D. The Association also quotes the latest figures released by the UK's Office of National Statistics, which show that the Gross Value Added generated per employee within the pharma industry in 2013 was approximately ÂŁ128,000. This is significantly higher than income per head in other comparable high-tech manufacturing industries in-

Innovation in research and development Behind every drug and vaccine which comes to market are

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DR REBECCA LEYLAND, Lecturer and Scientific Researcher in Immunology, Sheffield Hallam University, UK

cluding chemicals, motor vehicle and electrical equipment.

Though many of the graduate roles offered are for research scientists, there are also career opportunities in the industry for scientific and non-scientific roles including chemists, biologists, bioinformaticians, software engineers, marketers, regulators, quality control engineers, senior managers and technical writers.

Best practices in pharma research As in any scientific-based role, one of the key skills is knowing

According to the Make In India campaign, the Indian pharma industry is expected to become the third largest in the world by 2020, worth an estimated

45

$

billion

B

reakthroughs in the pharma industry have the potential to make a positive impact on the lives of millions of people all over the world. Major breakthroughs and advances don't happen every day but every trial brings us a step closer to understanding something which could eventually lead to a cure or a vaccine.

These are changes which we can expect to see in our lifetimes. My research field, immuno-oncology, is a form of cancer research which investigates the mechanisms of how cancer cells can be killed by harnessing the power of the body's own immune system.

This research field is currently at the forefront of science and there is a significant amount of academic and translational research ongoing worldwide to enable the successful development of immunotherapy drugs. Unlike chemotherapy which kills both healthy cells and cancer cells, immunotherapy aims to train the body's own defence system to attack cancer cells. Advances in this field could make a genuine difference to a cancer sufferer's quality of life or life expectancy.

Working in the pharma industry offers many opportunities for a varied and challenging career in companies and organisations across the world. Far from a tired industry, it is one where successes are closely related with drive and innovation.

It is generally an industry which provides one with a wide range of options for career progression and positive staff incentives, often including healthcare insurance, pension plans and training opportunities.

how to accurately document your data. This is especially important in the case of publication in scientific journals, regulatory documents and patents, which are required to protect the rights to a potentially successful new invention. Other key skills crucial for the progression of the drug development process include good communication and organisation skills which are invaluable while working in multidisciplinary teams to ensure efficient and effective teamwork and meet deadlines.

Qualifications required in industry As with any career, one is likely to need qualifications and training in a relevant area.

Candidates looking for a career in the pharma industry could consider masters level study to demonstrate their commitment to the field. It's important to choose the educational institution carefully and be sure that they offer opportunities and laboratory facilities where theories learnt can be put into practice. Many major pharma companies also offer graduate programmes where one will have the chance to gain experience across different teams and business sectors.

It isn't essential to have a PhD but, as always, this can give more options in terms of career progression. It's generally common practice that those leading research teams do have doctorates. Unlike other businesses, there are many similarities between a career in industry and academia.

In both, the candidates are required to represent their institution or organisation at conferences and publish their research. Collaboration is also

an important skill. Many research projects are collaborations between a number of organisations or funding bodies.

How to start a career in the pharma industry?

Working in the pharma industry is a global career choice. If one works for any of the major companies then it's likely that he/she will be working with people from all over the world.

The industry benefits greatly by recruiting people from different backgrounds and viewpoints, particularly when it comes to techniques and approaches to research. Having experience of working or studying overseas can help prepare for working in culturally diverse workplaces.

Bringing a drug to market requires input from many different teams. It is important to be able to communicate with people who do not share your level of expertise on a subject.

Gaining experience of working on complex, multi-faceted projects is a good way of demonstrating your ability to work well with others to future employers. You'll also benefit from experience in all professional skills. You'll need to represent the company externally so it's important to have strong presentation and networking skills.

Pharma companies are often large business operations which bring a wide range of opportunities. You'll be exposed to many different stages and aspects of drug development.

You'll often be working on multiple projects so there is always something new to learn. If you enjoy the challenge of managing your time effectively then it's likely that you'll find many positives in a career in the pharma industry.

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PHARMA LIFE I N T E R V I E W

‘Leaders today need to learn the Art of Persuasion’ Sangbreeta Moitra is a motivational speaker based in The Netherlands, specialising in leadership communication, corporate storytelling and public speaking. With her background in global management in the pharma industry, she has unique insights on today’s dynamic leadership needs. Lakshmipriya Nair caught up with her at a conference in Mumbai to understand more about the secrets of leadership communication What are the three common communication mistakes made by leaders? How can they be avoided?

There is no formula for leadership. Everyone, including you and me, has a distinct leadership style that is influenced heavily by our experiences, our personality and how they shape us.

However, working with corporates across different industries on inspirational leadership communication, I noticed some elements that needed reinforcing, despite the difference in the industry, cultural background or experience. Here are my top three: ◗Ignoring personal values.

Working in a large corporate environment, it is very easy to lose yourself. When you walk through the doors of your company, immediately you’re a manager in a sea of managers with very similar skill-sets, working on very similar projects and with overlapping career graphs and aspirations. It becomes very difficult to retain your identity, your ‘uniqueness’ in such an ambience. Thus, it’s important to discover your own personal core values that drive and define you. It is these values that influence the kind of leader you will be, and the legacy you leave behind. ◗Authoritative vs Persuasive.

The image of a leader has changed drastically through history. Look at the earliest leaders of civilisation: the kings.

Kings were feared leaders back in

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the day. Ivan the Terrible. Vlad the Impaler. Attila the Hun. The leadership style then was straightforward and clear. One man. One decision. One outcome.

And dare you not agree... off you go to the prison dungeons.

Fast forward to the 20th century, leaders had a more authoritative style of communication. Sure, employees wouldn’t have their heads chopped off for disagreeing with decisions made by their leaders (well, not all), but their opinion and feedback wasn’t taken into account. “Deal with it” was the mantra in the workplace.

Today however, times have changed. Drastically.

Authoritative leadership is unwelcome; it is considered unhealthy for the employees and the company to have an inflexible honcho forcing decisions without discussions. Thus leaders today need to learn the art of persuasion. Instead of telling people what should be done, persuade them. Accept their questions and address them by showing the benefits and reasons behind the decision. Persuasion is your friend; it will ensure that your team sees you as a trustable leader. A beautiful quote by Brian Tracy comes to mind. “Become the kind of leader that people would follow voluntarily; even if you had no title or position.” ◗Harsh criticism. This is one of the biggest issues in people management. You will find promising and driven employees quitting their jobs due to harsh feedback by their superiors. As leaders, we need to be aware of

PHARMA LIFE the weight of our words, and just how much impact they carry. Venting our frustration in a negative and condescending manner might give you temporary emotional respite, but you risk losing the respect and loyalty of the team who should swear by you.

Eleanor Roosevelt once said, “To handle yourself, use your head; to handle others, use your heart.”

Thus, be mindful. Instead of telling your employees how bad their performance is, guide them how they can perform better. Inspire them to believe in themselves despite their current weak points. Whether reinforcing their strengths or discussing improvement, the end result should be the same; your employee is driven to reach new heights and be the best they can in their role.

Collaborative leadership is being touted as the way forward for many industries.

What are the steps involved in building such leadership?

“What’s in it for me?” was the old favourite. We were individualistic in our approach to work and building relations with new vendors and clients.

Today, however, the scene is different. If you want to create

As leaders, we need to be aware of the weight of our words, and just how much impact they carry.

Venting our frustration in a negative and condescending manner might give you temporary emotional respite a win-win situation, ask “What can we do together?” This is not just a leadership style; it’s the new communication style for presentations, pitches and negotiations. How can we help each other grow, by collaborating through our strengths? Immediately, we transcend from an individualistic perspective to a common vision, one that doesn’t just benefit a party; but strengthens trust and loyalty in a professional relationship.

How can leaders create impact and inspiration when speaking to an audience?

Leadership communication is one of the most essential tools required today. You have the knowledge, the skills, and the legacy to share with your audience. But how can you create an impact? How can you

convince them that your proposal, your idea and your vision is worth their time? Ever too often you’ll see senior leaders on stage at top conferences and events, droning on about numbers and statistics to a completely distracted audience. The last thing you want when you’re presenting crucial information is an audience playing Candy Crush on their phone.

I’ll go far enough to say that a presentation that falls on deaf ears is a failed presentation, if unable to hold the interest of your audience in yourself, your proposal and the organisation you represent.

In my inspirational leadership communication workshops, executives learn to step out of their comfort zone of hiding behind text and slides. Numbers and statistics

don’t buy trust, you do. It’s essential to show ‘the individual behind the words’.

It’s important to show your audience why you care, what’s driving you, and why you believe that it is important for your audience to know this information. By learning how to create inspiration and power in your content and style of delivery, even if they’re about numbers on a slide, you will create a strong bond with your audience that makes you memorable and respected as a leader.

To what extent do leaders shape organisational cultures and create a sense of belonging in individuals?

Humans are so tribal by nature. We love our sense of belonging; whether with family, partners, friends, even

nationality, culture or religion.

So what’s stopping us from feeling connected to our organisation? Where’s the sense of belonging, the sense of tribe there?

As a leader, especially in today’s world where technology is fast replacing people, and with countries still reeling from the after-effects of recession, there’s a lot of insecurity in the air. Employees are scared of the next reorganisation; they don’t know who to trust. In such a volatile situation, it is essential to reassure to your employees that they matter. A yearly appraisal and bonus is sufficient, but deep relationships aren’t born out of mere sufficiency. Whether it is investing in their personal development and growth, creating a social infrastructure for the employees to know each other better, or giving them the recognition and respect they deserve; bring back the tribal relationship that drives our personal life and decisions so deeply. After all, as Maya Angelou once said, “People will forget what you said, people will forget what you did. But people will never forget how you made them feel.” lakshmipriya.nair@expressindia.com

APPOINTMENT

Sanofi appoints Nikhilesh Kalra to lead Consumer Healthcare business for India and South Asia Kalra is an MBA from IIM Lucknow and brings with him over two decades of varied experience in global and country roles SANOFI HAS appointed Nikhilesh Kalra as the General Manager of its Consumer Healthcare (CHC) business in India and South Asia.

Commenting on the appointment, Dr Shailesh Ayyangar, MD — India and Vice President — South Asia, Sanofi, said, “Kalra joins us at a time when we are building strong presence in con-

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sumer healthcare in India, with the recent closure of business swap with Boeringher Ingelheim and its incoming CHC brands. We greatly value Kalra’s diverse and rich experience of over 20 years across varied consumer goods and OTC healthcare categories, and are confident that under his strong leadership we will ac-

celerate the growth of our CHC business in India and South Asia.”

Kalra is an MBA from IIM Lucknow and brings with him over two decades of varied experience in global and country roles. Prior to joining Sanofi, Kalra was working with General Mills based out of Singapore as the Regional Marketing Director, Asia &

Middle East Africa. He started his career with Reckitt Benckiser, and worked in various roles in Sales & Marketing across India, Europe and Asia gaining rich experience across the Household, Personal Hygiene and OTC healthcare categories.

EP News Bureau

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