Express Pharma (Vol.10, No.11) April 1-15, 2015

VOL. 10 NO. 11 PAGES 66

www.expresspharmaonline.com

Management A question of trust Research On parallel lines

1-15 APRIL 2015,` 40

CONTENTS Vol.10 No.11 APRIL 1-15, 2015 Chairman of the Board Viveck Goenka Editor Viveka Roychowdhury* Chief of Product Harit Mohanty BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das Bangalore Neelam M Kachhap Pune Shalini Gupta DESIGN National Art Director Bivash Barua Deputy Art Director Surajit Patro Chief Designer Pravin Temble Senior Graphic Designer Rushikesh Konka Senior Artist Rakesh Sharma Photo Editor Sandeep Patil MARKETING Regional Heads Prabhas Jha - North Dr Raghu Pillai - South Sanghamitra Kumar - East Harit Mohanty - West Marketing Team Rajesh Bhatkal GM Khaja Ali Ambuj Kumar E Mujahid Yuvaraj Murali Ajanta Sengupta PRODUCTION General Manager B R Tipnis

AQUESTION OF TRUST Though buying medicines online has become a convenience for the patients, the reliability and the authenticity of such online chemists have regularly been questioned by the experts | P24 P12: COMPANY WATCH SC stays Delhi HC order against Glenmark

MANAGEMENT

27

P27: REPORTS Targeted therapies offer novel treatment modalities for breast cancer: Frost & Sullivan

P37: VENDOR NEWS Safexpress opens logistics parks in Dhule and Jammu

28

GLOBAL TYPE I DIABETES TREATMENT MARKET VALUE DOUBLING TO $13.6 BILLION BY 2023: GLOBALDATA REORIENTING THE INNOVATION MANAGEMENT PROCESS

PHARMA ALLY

P59: APPOINTMENT Dr Anish S Majumdar elected as VP- Elect of Asia region of International Society of Cell Therapy

Manager Bhadresh Valia

P60: AWARDS

Scheduling & Coordination Mitesh Manjrekar

Glenmark’s Pithampur plant in MP wins MPFCCI Outstanding Achievement Award 2014

CIRCULATION Circulation Team Mohan Varadkar

MARKET

35

12

US FDA, DCG(I) EXPLORE MORE WAYS TO WORK TOGETHER

13

END OF WOCKHARDT’S CHIKALTHANA USFDA WOES?

14

SUN PHARMA CLOSES DEAL WITH RANBAXY

15

IPM REGISTERS ` 7194 CRORES IN FEBRUARY 2015

RESEARCH

30 32

ON PARALLEL LINES

34

STEM CELL CLONES COULD YIELD NEW DRUG TREATMENT FOR DEADLY BLOOD DISEASE

STUDY SHOWS LIPOSUCTION BY PRODUCT COULD LEAD TO ED CURE

‘WE WILL ENHANCE OUR RELATIONSHIP WITH OTHER ANTICOUNTERFEITING ASSOCIATIONS AS WELL’

Express Pharma Reg. No.MH/MR/SOUTH-77/2013-15, RNI Regn. No.MAHENG/2005/21398. Printed for the proprietors, The Indian Express Limited by Ms. Vaidehi Thakar at The Indian Express Press, Plot No. EL-208, TTC Industrial Area, Mahape, Navi Mumbai - 400710 and Published from Express Towers, 2nd Floor, Nariman Point, Mumbai - 400021. (Editorial & Administrative Offices: Express Towers, 1st Floor, Nariman Point, Mumbai - 400021) *Responsible for selection of news under the PRB Act. Copyright @ 2011. The Indian Express Ltd. All rights reserved throughout the world.

Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

EDITOR’S NOTE

Making hay while the Sun shines

A

fter a year long engagement, Sun Pharma finally weds Ranbaxy. And as in any marriage, the hard work starts once the honeymoon ends.

And getting to the root of Ranbaxy's non-compliance record will be a major hassle, particularly since Sun Pharma too has faced US FDA's ire in the recent past. Sun Pharma founder Dilip Shanghvi has admitted that "winning the confidence of regulators" will be key to the merged entity's future. It took top priority in his vision statement at the close of the FICCI Pharma Summit on March 23 as well as two days later at a major media meet to announce the blue print for the coming months.

Shanghvi's determination to "work towards overcoming the perception of quality of products made in India" is driven by the fact that the lowest denominator, the smallest company erring on this count is colouring the perception of the entire industry. Clearly, as the biggest pharma company in India, Sun Pharma cannot afford to be seen as anything other than law abiding.

But while it seems committed to doing "whatever it takes" to win back the confidence of regulators, Sun Pharma now has to monitor 45 manufacturing facilities across the globe, with less than half in India. Given that changing the mindset of the workforce in India will take time, as will revamping manufacturing facilities to incorporate the latest GMP-compliant technologies, will it find it easier to simply switch production to its 24 overseas facilities? Or look for more acquisition targets overseas, which come with their own manufacturing facilities so that each geography

Success hinges on the company getting its GMP right and surviving the glare of regulatory scrutiny

can be serviced by local hubs? Shanghvi has already said that if the opportunity is right, the balance sheet allows them to pursue targets in the $100 million range, even while they 'digest' Ranbaxy.

The fact that Sun Pharma's overseas facilities even today outnumber its domestic sites is a telling fact. Are Indian companies going to remain Indian in name only? Speakers at the FICCI Pharma Summit cautioned government representatives at the event that it is easier to set up operations overseas. Many managements have already frozen fresh investments in India and are looking at more welcoming destinations like Abu Dhabi's Khalifa Industrial Zone Abu Dhabi (Kizad), where it reportedly takes just two phone calls to set up a company.

Of course, it is understandable that Indian pharma companies have a 'dil maange more' attitude. The domestic opportunity just cannot match up to the global market. So when Shanghvi says that the the objective of the merger was “to emerge as India's first truly global pharma company, one which the country can be proud of�, he is pressing all the right buttons. But he too tempers this, saying he wants it to be a "better, not just bigger" company.

Success therefore hinges on the company getting its GMP right and surviving the glare of regulatory scrutiny. Shanghvi and team have turned around distressed assets before, and this time his son Aalok too is in the fray. It will be a rough but interesting ride.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

Email: commercialprojects@writercorporation.com

10

EXPRESS PHARMA

April 1-15, 2015

MARKET GROWTH TRACKER

IPM registers ` 7194 crores in February 2015 22 corporates have crossed the growth of IPM for the month of February 2015 amongst top 50 INDIAN Pharmaceutical Market (IPM) has clocked ` 7194 crores in February 2015 and has grown at 18.9 per cent. Amongst the top 10, Cipla grew by 24 per cent followed by Lupin at 23.2 per cent and Pfizer at 22.6 per cent. 22 corporates have crossed the growth of IPM for the month of February 2015 amongst top 50.

Amongst the top 50 corporates, Akumentis has the highest growth of 52.5 per cent followed

by Macleods at 39.4 per cent and JBCPL at 38 per cent. 45 corporates have shown growths more than 10 per cent amongst the top 50. Amongst the 11-20 ranked corporates, Macleods has the highest growth of 39.4 per cent followed by Glenmark at 33.3 per cent and Torrent at 30.8 per cent.

Amongst the 51-60 ranked corporates, Centaur grew at 33.4 per cent followed by Allergan at 30 per cent and Wanbury at 24.3 per cent. Amongst the 61-70 ranked corporates, Boehringer grew by 88.5 per cent followed

by TTK at 31.2 per cent and Tablets India at 30 per cent.

Indian companies have grown at 19.4 per cent versus 17.6 per cent for MNCs in February 2015. Amongst the top 50 in MNCs, Merck grew by 32.2 per cent followed by Sanofi at 30.7 per cent and MSD at 24.5 per cent. Under the Non-NLEM category, Indian companies grew at 20.8 per cent whereas MNCs grew at 17.7 per cent.

The DPCO containing molecules market grew at 13.9 per cent whereas the non-DPCO market grew by 20 per cent and non -Sch Para 19 Market at 14.4 per cent resulting in an overall growth of 18.9 per cent for February 2015. The NLEM and Non - NLEM category showed unit growth at 7.6 per cent and 10.1 per cent respectively. The NonSch Para 19 market grew at 9.9 per cent from units perspective.

The DPCO 2013 portfolio for Pfizer grew at 21.1 per cent, Ran-

EXPRESS PHARMA

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April 1-15, 2015

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MARKET baxy 20.7 per cent and Abbott 18.3 per cent.

From the therapy perspective, nine therapies have outgrown the IPM growth and 18 therapies have double digit growths. The respiratory market grew at 25.4 per cent, gastrointestinal market grew at 19.1 per cent, pain and analgesics market grew at 15.7 per cent whereas the anti-infectives grew at 19.6 per cent. The anti-diabetic market grows at 32.7 per cent and cardiac at 16.6 per cent in chronic business. The derma market grew by 18 per cent and urology market at 26.7 per cent.

From regional perspective, 16 regions have outgrown the IPM growth. Madhya Pradesh market grew the highest at 28.8 per cent followed by South Rajasthan market at 27 per cent and Telangana market at 26.3 per cent. No regions had negative growth in February 2015.

Amoxycillin + Clavulanic Acid market grew at 24.7 per cent whereas Glimepiride + Metformin grows at 17.2 per cent at number two position. The markets of paracetamol grew at 28.9 per cent, Atorvastatin 17.2 per cent, Probiotic Microbes at 19.6 per cent, Cefixime 21.3 per cent, Pantoprazole 20.1 per cent, Montelukast + Levocetrizine at 33.5 per cent, Glimepiride + Metformin + Pioglitazone at 31.3 per cent, Vitamin-D at 37.3 per cent, Hydroquinone + Mometasone + Tretinoin at 10.6 per cent, Voglibose + Metformin + Glimepiride at 60.2 per cent, Rosuvastatin at 26.9 per cent, protein supplements at 23 per cent.

Glycomet-GP grew at 23.6 per cent, Augmentin at 24 per cent, Monocef at 23.5 per cent, Dexorange at 21.4 per cent and Lantus at 32.9 per cent amongst the top 10 brands.

Few brands who have gained ranks include Pentaxim (+171), Januvia (+69), Janumet (+67), Shelcal (+54), Magnex (+52), Clexane (+50), Panderm Plus (+46), Jalra M (+43), Istamet (+40), Monocef – O (+27), Dolo (+23), Rosuvas (+19), Udilive & Tonact (+18), Pan D (+15), Taxim (+8), Pan (+3), Sinarest (+2) amongst top 100 brands over February 2014.

A total of 144 brands were launched in February 2015. The top new brands for February are

16

EXPRESS PHARMA

April 1-15, 2015

With Bonus Units at Full Value Val in Crs

(Val in Crs)

Rank

CORPORATE

MAT

MAT Feb -15 MTH

IPM

Feb-15

Val (Cr)

MS%

GR%

Val (Cr)

MS%

GR%

85012

100.00

11.8

7194

100.00

18.9

Abbott + Abbott HC + Novo

1

1

5281

6.21

8.8

470

6.53

21.1

Sun Pharma

2

2

4627

5.44

14.5

388

5.39

15.8

Cipla

3

3

4262

5.01

14.1

380

5.29

24.0

Zydus + Biochem

4

4

3647

4.29

8.7

301

4.18

8.0

Mankind

5

6

3058

3.60

14.2

246

3.42

18.7

Alkem + Cachet + Indchemie

6

5

3042

3.58

13.4

247

3.44

17.8

Glaxo

7

7

2993

3.52

-1.0

238

3.31

5.6

Ranbaxy

8

10

2983

3.51

7.2

227

3.15

4.0

Lupin

9

8

2866

3.37

15.2

234

3.26

23.2

Pfizer

10

11

2564

3.02

15.7

220

3.06

22.6

Macleods

11

9

2513

2.96

28.8

227

3.16

39.4

Emcure + Zuventus

12

12

2290

2.69

12.1

192

2.68

12.2

Intas

13

13

2242

2.64

16.7

191

2.65

20.4

Sanofi India

14

14

2150

2.53

10.9

185

2.57

30.7

Aristo

15

15

2127

2.50

18.1

183

2.55

28.0

Torrent

16

17

1934

2.28

14.1

174

2.41

30.8

Glenmark

17

16

1896

2.23

16.9

179

2.49

33.3

Dr. Reddys

18

18

1793

2.11

10.4

152

2.11

16.1

USV

19

19

1662

1.96

18.6

139

1.93

25.1

Micro + Bal

20

20

1660

1.95

8.5

136

1.89

12.3

Ipca

21

24

1215

1.43

20.9

90

1.25

35.9

Novartis

22

23

1163

1.37

2.0

91

1.27

2.6

Val in Crs

MAT Feb-15

Super Group

VAL IN CRS

GR%

Month Feb-15 VAL IN CRS

GR%

IPM

85012

11.8

7194

18.9

ANTI-INFECTIVES

13558

8.2

1150

19.6

CARDIAC

10557

12.1

896

16.6

GASTRO INTESTINAL

9765

12.9

796

19.1

VITAMINS / MINERALS / NUTRIENTS

7700

11.7

615

14.9

RESPIRATORY

6687

12.7

659

25.4

ANTI DIABETIC

6536

23.6

580

32.7

PAIN / ANALGESICS

5967

10.4

479

15.7

NEURO / CNS

5150

8.8

431

13.8

DERMA

4882

15.9

406

18.0

GYNAECOLOGICAL

4272

7.1

349

10.4

OPHTHAL / OTOLOGICALS

1562

13.2

127

17.2

HORMONES

1424

5.9

118

11.2

VACCINES

1420

-1.2

133

30.5

ANTI-NEOPLASTICS

1373

22.6

109

7.9

BLOOD RELATED

952

4.6

75

9.1

OTHERS

916

14.2

90

38.3

UROLOGY

901

23.0

74

26.7

ANTI MALARIALS

550

6.3

34

19.5

SEX STIMULANTS / REJUVENATORS

470

5.2

43

15.0

STOMATOLOGICALS

371

13.3

32

21.1

Materna, Rosuvas CV and Dienofem.

About PharmaTrac PharmaTrac is a the secondary sales data audit conducted by AIOCD Pharmasofttech AWACS, a pharmaceutical market research company formed by All Indian Origin Chemists & Distributors (AIOCD ) in a joint venture with Trikaal Mediinfotech. AWACS (Advanced Working, Action & Correction System) reflects the underlying philosophy behind AIOCD AWACS’ research tools to reduce time to information by 50 per cent or more and to significantly improve on accuracy of information.

Terminologies used MAT – Moving Annual Total MTH – Month Val (Cr) – Value in Crores MS per cent – Market Share in Percentage GR per cent – Growth in percentage.

For more information, visit http://www.aiocd.net

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PHARMA Pro & Pack Expo 2015

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Over 400 overseas buyers from focus areas are being invited to participate in the exhibition. It will be co-located with

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PHARMA Pro&Pack Expo 2015.

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erc cia al Cont Co ntact: ct: t Indi dia Commercial Contact: India Tel.:: (+9 (+ (+91 91 22) 22)) 2806 2806 – 35 3526/27 3526/2 6/27 Fax: 3528 Fax x: (+9 ((+91 +9 91 22) 22) 2806 280 2806 6 – 35 528

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April 1-15, 2015

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sales@scope-india.com sale sa ales es@ s@sco s@sc copeop pe-ind p pe e india.com e-indi india.com ndia.co dia.com .com m mumbai@scope-india.com m mu mumbai@sc mumbai@scop mumbai@scope mumbai@ mum umb umbai@scope mbai mbai@ mbai@sco bai@ ba @ www.scope-india.com w www ww

cover )

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(

THE MAIN FOCUS

Genetic testing is gaining ground in India with a spurt in the number of companies offering personalised tests. And while most of them might just be scratching the surface, there’s no doubting the potential

BY SHALINI GUPTA

A

ngelina Jolie’s recent op-ed in a leading newspaper in the US might have prompted a discussion on women’s health, but it has also pointed out the importance of genetic tests, one that went on to reveal her mutation for the

BRCA1 gene. Soon after the discovery of the DNA, scientists have attempted the sequencing of the genome to better understand risks and mutations that genes carry.

While the first sequenced human genome cost nearly $3

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billion, sequencing costs have dropped substantially since then, and today doctors, particularly in the US have begun using some patients’ genome sequences to improve their care. The $1000 genome is almost here too. India is also

seeing a surge in personalised genetic testing, although it is pretty nascent.

Exploiting the market Genetic testing represents the most rapidly expanding segment of the molecular diagnos-

tics market worldwide, with the US being the largest market.

Within genetic testing, the market for newborn screening, diagnosing rare and fatal disorders, and predicting the probability of occurrence of diseases is likely to expand. When

EXPRESS PHARMA

19

April 1-15, 2015

cover ) it comes to India, many believe these are early days and although the potential is huge, less than one per cent of the probable market is being exploited right now. However, all is not lost. In a recent development, Mapmygenome, a Hyderabad- based start up in this space, raised approximately $1.1 million from a group of angel investors. The excitement is palpable.

Anu Acharya, Chief Executive Officer, Mapmygenome, a company that she incepted in 2011, which started selling tests in 2013 (after a two year incubation period) shares her views, “Genomics can help pre-empt a disease one might be at a risk for, rather than struggling with the problem, one can take corrective steps before the disease strikes.

Although these are still early days, we are hopeful it will take off, even if it takes time.

Better understanding of genes and mutations can help us spend whatever little we spend on health right now, in a much better way.”

The company’s flagship product, Genomepatri can scan for 120 conditions by looking at 70,000 markers and has sold more than 2000 tests so far.

Even as supposedly healthy individuals can go for a test to understand their health risks, global Prenatal and Newborn Genetic Testing market is expected to grow at a CAGR of 31.91 per cent over the period 2014-2019 as per some reports. Increasing awareness on the importance of prognostic and predictive screening, such as maternal screening, has also seen players targeting this segment.

For instance, Igenomix India, a subsidiary of its parent company Igenomix in Spain, specialises in reproductive genetic testing. The company which has done business worth $916,000 in 2014-15 and is growing at the rate of 45 per cent annually, sees India as a promising market.

Chips in Francisco Rodriguez, Business Develop-

20 EXPRESS PHARMA April 1-15, 2015

ment Director – India and Middle East, Igenomix, “The knowledge and awareness of reproductive genetic tests in other developed countries such as the US and Europe in comparison to India is higher, since they have been readily available to all for more than a decade now. India has just started to see the tip of reproductive genetics. There is a lot

Bioscience. The company which was getting 100-150 samples per month a few months back, has been steadily growing. Today the company has clinics at Kokilaben Dhirubhai Ambani Hospital and Breach Candy hospital, both in Mumbai.

“There is no hospital in the US which is not offering personal genomics, in India when we started there was not one such hospital. We wanted to replicate the model seen at institutions abroad where hospitals offer allied services shifting focus from reactive to predictive healthcare,” he adds.

A viable strategy Unof potential in this market and very few players.

We are glad to have brought such advanced services and technology to a growing market.”

Positive Bioscience which started a personal genomics clinic last year at Medanta, Delhi offers tests for healthy individuals as well as those specifically for cancer patients to direct them to the right treatment. “Genetic testing historically has looked at a very small piece of the pie-1 or 2 genes vs 25 to 30,000 genes while genomics is the study of all or most of the genes. We started with the idea to bring genomics in India, have a meangingful impact on the Indian health system. Our cancer test rank high in revenues as compared to personal genomics which is slowly catching up,” says Samarth Jain, Chief Executive Officer and Co-founder, Positive

like the US, where such tests have been there for a decade now, it is been only a year and a half for some players while others are still setting up shop.

Analysing the market, Amit Mookim, Country Principal, South Asia, IMS Health offers an overview, “There are three to four companies out there on the radar, most of them are subscale. It is an emerging industry, with most of the companies following a basic model collaborating with leading hospitals given that 80-85 per cent of the growth in diagnostics is closely related to infrastructure development in hospital chains and insurance.” Mapmygenome for instance has tied up with over 38 hospitals pan India. Consumers can also purchase the products directly from company website or through their e-commerce partners such as SnapDeal.com or Amazon.

The most basic test is a cognitive test for ` 1500 that calculates your risk for depression while BRCA 1/2 gene sequencing for breast cancer comes at approximately ` 20,000. They also offer molecular tests for TB and other infectious diseases which offer accurate results while being

Genomics can help pre-empt a disease one might be at a risk for, rather than struggling with the problem, one can take corrective steps before the disease strikes.

Although these are still early days, we are hopeful it will take off, even if it takes time Anu Acharya, CEO, Mapmygenome

The knowledge and awareness of reproductive genetic tests in other developed countries such as the US and Europe in comparison to India is higher, since they have been readily available to all for more than a decade now. India has just started to see the tip of reproductive genetics. There is a lot of potential in this market Francisco Rodriguez, Business Development Director – India and Middle East, Igenomix

( affordable. “Most of these tests use imported raw materials which makes them expensive, we are constantly striving to bring down the cost of the tests.

For us the real barrier now is the cost of the kits that we import which can be eased if the government can reduce the import duty,” Acharya chips in.

For Igenomix, the increasing infertility rate worldwide and particularly in India, presents an opportunity to offer specific tests in close collaboration with IVF clinics to analyse an embryo at a molecular level, select those that do not have a single gene disorder or any aneuploidies and ensure that the baby being born is healthy.

Says Rodriguez, “According

THE MAIN FOCUS

Genetic testing represents the most rapidly expanding segment of the molecular diagnostics market worldwide, with the US being the largest market.Within genetic testing, the market for newborn screening, diagnosing rare and fatal disorders, and predicting the probability of occurrence of diseases is likely to expand to WHO, approximately 60-80 million couples around the world are infertile. Having a population size of approximately 1.2 billion, the infertility rate in India is remarkably high.

As a result, the need for IVF

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clinics increases. We entered the Indian market with an aim to offer a solution to patients undergoing IVF, having repeated implantation failures or miscarriages, for those who know they are carriers of single

gene disorders or even those who are unsure if their child may be affected with a genetic disorder.” The company has so far analysed 1800 samples in India since its inception.

At Positive Bioscience, the

most expensive test is for `1 lakh (asseses healthy individuals for 1,000 diseases barring rare diseases) and cheapest at ` 20,000. A test for a cancer patient costs ` 60,000.

Commenting on the pricing Jain says, “Doctors in India need to be educated about the advantages of these tests, unlike their counterparts in the US, and once that happens we will be able to reach 10 times more patients. Sheer scale in terms of number of samples alongwith machines getting faster and cheaper could be a gamechanger.”

Jain emphasises that the quality of test will differ from company to company depending on the resources companies

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April 1-15, 2015

cover ) put into analysis and how they direct the customer to the right drug. “We have been accumulating and analysing data for the past two years, so anyone who starts now, will have missed the curve. In genomics, it depends on how good your analysis is.

For eg. there are 300 mutations linked with heart disease or 100 with lung cancer. Our competitors might look at two or three of those mutations, we would go through the whole, that makes us more expensive,” he stresses.

Crystal balling With health and wellness gaining ground, the proof lies in the pudding. Mapmygenome’s Genomepatri contributed 50 per cent to the company’s revenue last year and its Sugargene test also seems to be doing well. Acharya adds that the

22 EXPRESS PHARMA April 1-15, 2015

Genetic testing historically has looked at a very small piece of the pie-1 or 2 genes vs 25 to 30,000 genes while genomics is the study of all or most of the genes. We started with the idea to bring genomics in India, have a meangingful impact on the Indian health system. Our cancer test rank high in revenues as compared to personal genomics which is slowly catching up Samarth Jain, Chief Executive Officer and Co-founder, Positive Bioscience

company which saw its growth more than double over last year is looking at crossing the million dollar mark next year when it comes to revenues. Igenomix

too is planning to launch new reproductive genetic services, which will minimise the prevalence of genetic abnormalities in the Indian population and

help high-risk couples achieve a healthy pregnancy. “We will be introducing a genetic test that screens the BRCA1 and BRCA2 genes via high- throughput mas-

sive sequencing (also known as next generation sequencing or NGS) with the aim of locating mutations in either gene,” reveals Rodriguez.

However, it needs to be remembered that these tests are not 100 per cent accurate, a caveat that needs to be kept in mind. “The tests are not deterministic in nature, this needs to be understood. We haven't done studies across the board for everything, we've tried to take the best possible data based on our statistical knowledge, sort out data that is not good. We are trying to make the best of the knowledge that we have. It is much better to understand the probability than become a statistic,” exhorts Acharya.

Jain is excited about exploring partnerships. “We are in talks with partners in Europe,

(

THE MAIN FOCUS

While the first sequenced human genome cost nearly $3 billion, sequencing costs have dropped substantially since then, and today doctors, particularly in the US have begun using some patients’genome sequences to improve their care.The $1000 genome is almost here too. India is also seeing a surge in personalised genetic testing

America, the Middle East, Singapore tec. They can just give us the data and we can do the analysis and return the report online. They get best analysis for their patient. There is terrific growth in India and overseas as testing becomes more mainstream,” he adds.

There is definitely a potential given the fact that companies are tight lipped about sharing revenues as well as specific future plans, since these are still early days and they are trying to find the best path forward while also navigating through the roadblocks.

That said, it will also take time to build awareness and scaleup to break even.

Genomics is still new to India and while regulations are being formulated else where Indian regulators haven’t got their act together still.

Whether that is an enabler or will regulations help streamline the emerging

industry is a questions that remains to be answered given that newer ones are coming up. Most of the companies are concentrating on scaling up for now.

Unlike 23andMe which announced earlier this month that it’ll be now looking at manufacturing drugs, Indian companies are not looking at going down that path anytime in the future. Also, a good thing is that most of them stress the importance of having counsellors in place alongwith medical consultation to the patient, instead of going direct to consumer which has its pitfalls. It was one of the reasons why 23andMe faced USFDA’s ire last year. Personalised medicine seems to be taking baby steps and it remains to be seen how it’ll shape up in India, perhaps for the better. shalini.g@expressindia.com

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April 1-15, 2015

MANAGEMENT

AQUESTION OF TRUST Though buying medicines online has become a convenience for the patients, the reliability and the authenticity of such online chemists have regularly been questioned by the experts

BY SACHIN JAGDALE

E

nsuring availability of medicines to every needy person in a geographically vast country like India is a big challenge. Retail drug outlets have been the source of medicines for patients. But with the rise in population, broader disease portfolio and introduction of new brands, procuring medicines have become a big worry.

This is where online chemists have come into the picture and were able to resolve this problem to a much greater extent.

However, buying medicines online has its own share of doubts and arguments as well.

Online convenience Besides providing easy procurement of medicines, there are many benefits, which online chemists offer. Cost effective medicines prompt patients to buy online. Many times information regarding a particular type of disease, possible medications to treat etc. is easily

24 EXPRESS PHARMA April 1-15, 2015

available online, which prevents patients from visiting a clinic. A considerable number of online chemists even offer teleconference facility for patients where specialist doctors would talk with them over the phone. After all, the medicine is home delivered and as a result the patient is able to save on travelling expenses.

“Acquiring medicines online may initially offer some cost benefits and will minimise the stress and the time which usually happens in Western countries. In Western countries laws are very strict and a lot of time is spent in queues where patients have to wait for pharmacists to fill their prescriptions,” says Dilip Kadam, Executive Member, All India Organisation of Chemists and Druggists (AIOCD).

“Privacy or anonymity is the key benefit offered by online chemists,” opines Shashank Sandu, Director, Sandu Pharma.

Though online medicines look like a promising trend today, still, the penetration of this concept in India is negligible.

Urban areas might have been connected with online chemists, however, rural areas are yet to get their deserving share.

Sudhir Deshpande, Legal Consultant, Pharmalex, opines, “If operated within the legal framework, online medicines or Internet pharmacy provides easy and convenient tool for the consumers to procure medi-

cines required by them. As prescription drugs will be supplied against scanned copy of the prescription which will be retained by the Internet pharmacy operator. Compliance of conditions of licenses will be better. It will also be easier for the regulatory officers to verify the compliance by going through the prescription copies retained by the Internet pharmacy unlike the conventional pharmacy. This will also help regulatory officers to ascertain as to whether the

medicines were prescribed by a registered medical practitioner or otherwise. The online medicines or Internet pharmacy will enable needy patients to procure medicines easily and will prevent them from moving around to look out for drugs during an emergency situation.”

Online woes Besides the advantages, online chemists is something like a double-edged sword. Video or telecalling can’t replace

valuable time and personal interaction between a doctor and a patient.

Kadam opines, “According to a new study, consumers are increasingly experiencing less satisfaction as far as online shopping of medicines is concerned. It is not the case in India as there are an ample number of retail shops to take care of stress and time of people. Besides this, there will not be personal touch that the retailer has with his customer. You cannot

satisfy yourself by personally asking your queries about the prescription medicines, its effects, side effects, dosage regime etc.”

Spurious drugs have made inroads into retail medicine shops, which is still the biggest source of medicines for patients in India. However, according to industry experts, online chemists will be the easiest gateway for spurious drugs than their retail counterparts.

Kadam informs, “There are

EXPRESS PHARMA

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April 1-15, 2015

MANAGEMENT

According to a new study, consumers are increasingly experiencing less satisfaction as far as online shopping of medicines is concerned Dilip Kadam Executive Member, All India Organisation of Chemists and Druggists (AIOCD)

many websites that operate illegally and offer to sell all sort of medicines which can be misbranded, spurious, counterfeit and whose quality and safety is unknown. There have been many instances where during online purchasing of bulk drugs, the seller has deceived buyer by supplying sub-standard drugs.”

“Purchasing of online medicines increases the risk of consuming spurious drugs,” cautions Dr CR Revankar, Independent Public Health Medical Consultant. He adds, “Online purchase of medicines should be avoided by the patients/their family members since one do not know how authentic the supplier and the products are. I recommend and encourage the patients to buy from the retail/authorised pharmacy shops. Since antimicrobial resistance is on the increase due to irrational use of them (prescribed and self prescription), patients should be well educated on this issue so that microbial resistance will not be unmanageable in the future.”

Online pharmacies do have a considerable number of ayurvedic products for sale.

Such products, even from the branded companies, are already under scrutiny for their composition. Online sale of such drugs increase the chances of dispensing spurious ayurvedic drugs to the patients.

“Many ayurvedic formulations which lack appropriate standardisation may be sold through online sale techniques.

Many small scale pharmacies don't claim complete composition of the products on the labels. Sometimes brand names,

26 EXPRESS PHARMA April 1-15, 2015

outer packing and physical appearance of some medicines may match the leading brands in the market to misguide the patients,” says Sandu.

Legal perspective According to experts, online chemists stand on shaky legal grounds. They are more prone to legal scrutiny, thanks to frequent reporting of illegal operation by them. In India, electronically business transaction of prescription medicine is not included in the Drugs & Cosmetics Act and Rules there under. Therefore sale of medicines by online shopping will not be legally permitted by the Food & Drugs Department. Even online correspondence, scanned copies are also not permitted by the law. Such system is not approved by the Drug Department.

Kadam gives details of what is mentioned in the Drugs & Cosmetics Act. He says, “Drugs & Cosmetics Act clearly mentions that any supply of drugs is to be made by the direct supervision of a registered pharmacist against the written prescription of a registered medical practitioner. Such supply, carbon copies duly signed by registered pharmacists are compelled to be maintained by the law.

Even today, you cannot say that the sale copy (second copy) of the sale bills are recorded and preserved in the computer and can be provided as and when asked for inspection unlike other businesses. The definition of the nature of prescription,

legal procedure to sell medicines and to maintain its records are well specified in the Act and it is mandatory.”

Deshpande’s assessment of the situation might give some relief to online pharmacy operators. However, he is of the view that any sort of illegal behaviour by online chemists would invite legal action on them.

Deshpande says, “The concept of online medicines or Internet pharmacy is relatively new in India. Internet pharmacy per-se is not illegal, however, unfortunately, due to alleged illegal activities committed through Internet pharmacy, the system is considered by the regulatory officers as a system prone to abuse. As a result, the system is subjected

It’s too early to say whether online medical consultation will see its boom or not in India like other forms of online shopping. It does have its share of advantages and disadvantages Shashank Sandu, Director, Sandu Pharma

If operated within the legal framework, online medicines or Internet pharmacy provides easy and convenient tool for the consumers to procure medicines required by them Sudhir Deshpande, Legal Consultant, Pharmalex

to intense scrutiny. A major disadvantage of the system is its difficulties in complying with certain provisions of the Drugs and Cosmetics Rules, 1945 e.g.

Rules requiring stamping the original prescription at the time of dispensing of medicines by the pharmacist.”

An alternative to retail pharmacy?

Retail pharmacy has so far remained the biggest source of medicines for the Indian population. Remote areas in the country too are benefited with retail pharmacies only. Perhaps, since they are not aware of the concept called online pharmacy or lack of basic requirements like Internet, a huge section of the Indian population is not buying medicines online.

However, now things are changing. With the introduction of devices like smart phones, coupled with government and private sector initiatives, Internet is reaching almost every nook and corners of the country. Are these changes indicators of online pharmacies outweighing retail pharmacies in the future?

“It’s too early to say whether online medical consultation will see its boom or not in India like other forms of online shopping. It does have its share of advantages and disadvantages. But, with time, people will rely on online facilities for medical help. It is time-saving and cost effective. With technology making life simple and easier all across the spectrum, online healthcare will also gain its popularity immensely by the convenience

it offers,” opines Sandu.

According to Kadam, retail pharmacist is the mediator between the patient and the doctor. Personal interaction makes the entire process more reliable. And since such interaction lacks with online pharmacy business, the latter is no match to retail medicine shops.

However, Kadam makes unpleasant statement for few doctors. He says, “Today’s biggest threat to retailers are from the doctors who have become traders in this business.”

Deshpande is confident that Internet pharmacy or online medicines will certainly not replace the retail stores because the concept of Internet pharmacy is not recognised under the Drugs and Cosmetics Act, 1940 and Rules, 1945. He explains further, “Any firm / person setting up web platform for receiving orders online will also have to provide physical store duly licensed and have to comply with the necessary conditions of retail licenses such as ensuring supervision of registered pharmacist, selling drugs on prescription etc. or will have to tie-up with licensed dealers to execute orders received online.”

Overall, as of now there seems to be no big threat to online chemists' business. They will survive but their growth depends on how much they will manage to fit themselves in the legal framework. Internet pharmacy will be a win-win situation for consumers and dealers.

However, certain changes in law and change of mind-set of the regulators are necessary for this concept to succeed. sachin.jagdale@expressindia.com

MANAGEMENT REPORTS

Global Type I diabetes treatment market value doubling to $13.6 billion by 2023: GlobalData Across the eight major markets of the US, France, Germany, Italy, Spain, UK, Japan and Canada, growth will be driven primarily by increasing T1D incidence and the substantially higher annual cost of therapy in the US THE GLOBAL treatment market for Type I Diabetes (T1D) will expand from $6.6 billion in 2013 to an estimated $13.6 billion by 2023, representing a Compound Annual Growth Rate (CAGR) of 7.6 per cent, according to research and consulting firm GlobalData.

The company’s latest report states that across the eight major markets of the US, France, Germany, Italy, Spain, UK, Japan, and Canada, growth will be driven primarily by increasing T1D incidence and the substantially higher annual cost of therapy (ACoT) in the US. The US had a 74 per cent share of the global T1D treatment space in 2013 with revenues of $4.8 billion. This share will rise to 78 per cent

by 2023, with the market expanding at a CAGR of 8.2 per cent to reach $10.5 billion.

Valentina Gburcik, Therapy Director of Cardiovascular and Metabolic Disorders, GlobalData says, “The US will remain the leading market largely thanks to its average insulin price, which is about five to six times greater than in the other major markets.

For example, the ACoT of Sanofi’s Lantus is $1,621 in the US, compared to around $320 in EU countries. Furthermore, the uptake of novel ultra-longacting insulin analogs, novel ultra-rapid formulations of insulin analogs, and adjunct therapies for T1D in the US market will help to offset the dip in sales caused by the patent expiries of seven in-

sulin products by 2023.”

GlobalData’s report also states that human insulins and insulin analogs will remain

front-line therapies for T1D, as none of the treatments on the horizon for the next 10 years will have the capacity to en-

able full regeneration of pancreatic beta cells.

However, Gburcik notes that therapies currently used for Type II Diabetes (T2D), namely GLP-1 RAs and SGLT-2 inhibitors, are expected to be approved for T1D from around 2017. They will have a considerable impact on the global T1D market by 2023, constituting nine per cent and 11 per cent of the arena, respectively.

“These therapies will not compete with the insulins, as they will be prescribed as adjunct, add-on treatments.

They will be used particularly in obese T1D patients and those with a mixed T1D/T2D phenotype,” the director concludes.

EP News Bureau-Mumbai

Targeted therapies offer novel treatment modalities for breast cancer: Frost & Sullivan The use of combination targeted therapies will improve progression-free disease as well as survival rates DESPITE THE availability of approximately 25 drugs for the treatment of breast cancer, the unmet need in the global market is vast. To address this drawback, pharmaceutical companies have established a robust pipeline that currently has about 52 drugs in development. While chemotherapy remains the most important class of drugs for breast cancer treatment; the trend toward targeted drugs is on the rise.

New analysis from Frost & Sullivan, A Competitive Analysis of the Global Breast Cancer Therapeutics Market, finds that the market earned revenues of approximately $10.0 billion in 2014 and estimates this to reach $13.38 billion in 2018.

Breast cancer drugs are expensive and have placed a huge burden on patients and health insurance agencies. The lack of effective therapies, especially for triple negative breast cancer, is

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another excruciating challenge.

“The emergence of a new class of targeted therapies is likely to redefine the survival rates of patients with triple-negative cancers,” said Frost & Sullivan’s Healthcare analyst. “Poly-adenosine diphosphate ribose polymerase or PARP-based targeted therapies are under development and are expected to effectively treat breast cancers.”

Although Herceptin and Tykerb are the only targeted

therapeutics available for breast cancer, the recently approved Kadcyla and Perjeta will bolster the portfolio of targeted drugs.

Key drugs to watch between 2015 to 2017 are: ABT-888 (Abbvie); NeuVax (Galena Biopharma); Palbociclib (Pfizer); NKTR-102 (Nektar Therapeutics); CT-P6 (Celltrion).

“Focus has shifted to combination therapeutic modalities that have displayed the potential to improve progression-free sur-

vival rates,” observed the analyst. “The combination of therapeutic modalities, targeted therapies along with chemotherapy, could also make treatment affordable for patients.”With technological advances likely to improve the scope of diagnosis and offer personalised treatment for patients, the race to formulate effective therapies for breast cancer is well and truly on.

EP News Bureau-Mumbai

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April 1-15, 2015

MANAGEMENT INSIGHT

Reorienting the innovation management process In the search for growth, pharmaceutical companies often face harsh reality when new OTC launches flop because they did not match the market’s need.

Dr Michael Scholl, Managing Director and Richard Laven, Consultant, Homburg & Partner, Mannheim, Germany propose a market-oriented innovation management approach, where pharma companies turn around the launch process, by first properly positioning products into carefully identified market gaps WHEN SEARCHING for growth opportunities, consumer health companies frequently experience deadlocks.

Within these companies, various ready-to-launch substances together with compelling stories oftentimes exist. Basically, these substances are approved, registered and are said to be welltolerated. However, it is unclear whether there is a market for them. Most consumer health companies in India know this problem.

Within numerous projects at Homburg & Partner, we have discovered that marketing these substances may end in a deadlock. In many cases, target groups are too small, marketing hurdles are too high, competitive environments are too intense, or customer demand is simply lacking. Positive feedback from enthusiastic individual users do not change this either.

The consumer health market is particularly vulnerable to these kinds of flops. In the prescription market, considerations focusing on the patient/ market potential or the willingness-to-refund respectively are always evaluated in advance due to exorbitant development costs. In contrast, the innovation approach occurs at-will within most medium-sized consumer

28 EXPRESS PHARMA April 1-15, 2015

By combining the company’s strategy and capabilities with the market analysis, structured market gaps appear – market gaps of sufficient size and sufficient accessibility. With the help of this systematic analysis, products that are properly positioned into the market gaps can be expected to be most likely successful

health companies. Although multifunctional teams can roughly narrow down the suitability of their ideas, substantial development budgets are cleared repeatedly, without a systematic assessment of market acceptance. This way, overall development costs quickly exceed the costs of an early review. In case such an idea is driven by the board or by the head of development, the willingness to conduct an evaluation decreases even further, according to our experience.

Alternative: Marketoriented innovation management In the previous paragraph, we suggested a review of the marketability of internally-de-

veloped product ideas in time.

By doing so, we typically determine that only one-third of these product ideas at most are marketable. The reasons are diverse, ranging from the already described aspects to small emotional hurdles.

As an alternative to this approach, the principle of “market-oriented innovation” exists. At its heart, this means that the innovation process is completely reverted. Instead of starting with finding a substance and reviewing whether the own substance or the product idea would fit into a market, we define a systematic innovation process together with the consumer health company.

In a first step, it is necessary to define which indica-

tions generally align with the company. By conducting a workshop, we develop a growth map including a long list of suitable indications.

The central question at this point concerns the overlap of selected indications with actual served markets. For instance, a very small overlap could lead to a lack of focus due to missing synergies in cultivating the market. This holds particularly true in the case that different indications imply addressing different patient groups, specialist groups or pharmacy shelves. This first indication map should prevent a lack of focus since a mid-sized consumer health company may normally serve only a small selection of indication fields.

DR MICHAEL SCHOLL, Managing Director, Homburg & Partner

RICHARD LAVEN, Consultant, Homburg & Partner

In a next step, we analyse these indication fields and identify all contained sub-indications, including market size as well as market occupation. This way, we see more than 15 sub-indications in the area of the common cold that may be systematically-reviewed, for instance.

By combining the company’s strategy and capabilities with the market analysis, structured market gaps appear – market gaps of sufficient size and sufficient accessibility. With the help of this systematic analysis, products that are properly positioned into the market gaps can be expected to be most likely successful. Of course, further marketing hurdles exist, such as the danger of another company occupying this niche.

However, it can be successively ruled out that a newlydeveloped product will fail due to existing market conditions.

In a last step, market gaps are systematically analysed together with research and development experts. These market gaps and possible product ideas should especially be orderly tested for possible positioning. For this purpose, Homburg & Partner developed a three-step positioning approach that can also be tested with doctors,

MANAGEMENT patients and pharmacists.

The core of these tests includes the localisation of subindications and the integration of indication-specific developed products into the therapy path. As a result, we clearly prioritise which positioning is most promising.

Specifically, we clearly and systematically explain why certain positioning models should be rejected.

Based on this positioning measurement, an initial business case may be developed to show potential revenues contingent on investments. Here, initial costs or test market investments also play a role.

Case study We have performed innovation assessments for a globally leading company in the consumer health market – also successful in India – for more than 10 years. Through

these assessments, we have saved the company from several flops and have identified why certain products would not have a chance to be successful, based on the previously-described criteria.

When the company decided against our recommendation to bring two products to the market, the launch failed because of the previously-predicted hurdles. The motivation to bring new products to the market was very low.

In an intense discussion with global management, business development and R&D leadership, we suggested a reversal of the innovation process and conducted a project on market-oriented innovation. Based on a systematic analysis of market gaps, we defined three innovation fields. Now, the company focusses on these three fields within its market approach.

Marketoriented innovation management is the key to successful growth of consumer health companies.

There is no shortage of ideas in the industry

The first innovation field was located among the three biggest consumer health indications. We systematically determined a free market gap and demonstrated that an existing substance could fill the gap via a repositioning strategy. With the help of positioning tests, we found that certain positioning options are dangerous due to competitive occupation, patient taboos or belittlement by medical professionals.

Based on our positioning analysis, a clear and sharp product profile, as well as patient profile, was developed.

For this profile, patient and market potential was already validated by the help of our preliminary study. Resting upon an existing drug approval, the product at-hand was able to be newly positioned. Already shortly after market introduction (silent

launch), plenty of pre-economic indications worked: the relevant target group accepted the product immediately and discussed it in social networks, medical professionals looked for information from the producer and sales representatives were approached regarding the product. A situation that differed from several other previous product launches: in spite of intense effort, there were no or even negative reactions from the market.

From our perspective, market-oriented innovation management is the key to successful growth of consumer health companies. There is no shortage of ideas in the industry; there is a lack of structured measurement of market gaps. Consultants like Homburg and Partner can help in successful growth of consumer health companies.

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RESEARCH

On parallel lines PCR might have been the big discovery of 1983, and now a researcher has developed a new technique, a step ahead of it. Shalini Gupta reports

I

n 1983, Dr Kary Mullis developed a breakthrough technology, PCR, that helped scientists to better understand the functions of a living cell by amplifying the DNA many times over. The invention went on to get Mullis a Nobel Prize. PCR findings confirm that traditional culture-based analyses miss many bacteria that fail to grow readily. The sensitivity provided by these nucleic acid amplification technologies continues to advance our understanding of complex microbial communities. It has already had a major impact on life science and is a well-recognised tool in forensic sciences and is being widely used to study various diseases including cancer, TB, AIDS etc It has already had a major impact on life science research by speeding up the sequencing of genomes and is a monumental technique of molecular biology with the gene amplification market predicted to grow to $2.2 billion by 2017. However, despite their great specificity, early PCR techniques were not suitable for routine use by the clinical diagnostic community due to the inability to effectively implement them on a large scale.

In a new development Dr Vikash Bhardwaj, a scientist from Lovely Professional University has researched on DNA more and developed a new PDPCR(‘Parallel DNA Polymerase Chain Reaction’) technique which claims synthesis of a new DNA having polarity opposite to the template used. A step further than Nobel Prize winning scientific techniques of the 20th century, it was published in the prestigious F1000Research

30 EXPRESS PHARMA April 1-15, 2015

Vikash Bhardwaj

Journal of UK. Talking about his discovery Bhardwaj shares: “It took nearly 85 years to universally accept DNA as a key molecule which contains all information necessary for the sustenance of an organism. Initially, it was really challenging for me to think beyond conventional knowledge. This research will be helpful in tracing all errors hitherto committed and their analysis will further help researchers to find better solutions to eradicate fatal diseases like cancer, tuberculosis, AIDS etc.

Native of Kanjhwala, a rural village in Delhi, Bhardwaj has been a bright student right since childhood when he cleared Jawahar Navodaya Vidyalya (JNV) entrance exam and got free education at JNV Mungeshpur Delhi upto class 12. He completed his graduation from University of Delhi and qualified for JNU-DBT combined biotechnology entrance exam. He was selected for M.Sc. Industrial Biotechnology programme of Sardar Patel

University Gujarat where he topped with first class distinction. It was during his post graduation study, that he cleared UGC-CSIR NET, DBT JRF, ICMR JRF and GATE Exam (97.2 percentile). In 2006, he applied for SCMM JNU PhD exam and finally topped that completing his PhD under the guidance of Dr Chinmay Mukhopadhyay. His PhD work was awarded Best Poster Award at SBC conference held at IISC Banglore in 2010.

Bhardwaj joined Sardar Patel University Gujarat as Asst.

Prof/ Research Scientist post his PhD and is currently teaching biotechnology (Molecular Biology) to M.Sc students at Lovely Professional University along with his routine research interest on “Parallel stranded DNA”. He has spent eight years so far in molecular biology research.

So how did he get the idea for this discovery? “I was aware about one of research published by scientists from Paris where they tried to prove parallel

DNA synthesis but were finally unsuccessful to accomplish it. It was challenging to find out the reasons behind that, since they did not discuss much details. In collaboration with Kulbhushan Sharma (who is also a hardcore molecular biologist involved in exploring various cell signalling pathways at INMAS,DRDO), I accepted the challenge and started proving parallel DNA synthesis using many different possible ways,” he reveals. It was during one of the reactions that they were surprised to see the amplification of same size PCR product as similar to control reaction. “It was not a direct approach to develop this reaction. We used few combinations of primers in different ways but were surprised to see a similar reaction as a control reaction. Then we re-analysed our whole strategy, checked the pair of primers used and developed PD-PCR this way,” he adds.

In a conventional PCR reaction, oligonucleotide primers binds to a template DNA in an antiparallel complementary ways and DNA is amplified as it is. In a PD-PCR reaction, Bhardwaj along with his fellow researcher has shown that using a single stranded DNA as template, even parallel complementary primer can initiate a DNA synthesis reaction and finally a different but related product can be synthesised.

Thus two PCR products can be synthesised from a single stranded DNA, one by conventional PCR and another by PDPCR. So when the discover of PCR can have far reaching applications, the discovery of this kind of DNA amplification would definitely be a

gamechanger in molecular biology.

“One main application of our work can be to resolve errors observed in other molecular techniques (Southern/northern blotting, microarrays, RNAi technique, and even PCR), which all are based on complementary binding of two strands of nucleic acid. Various scientists have proposed numerous technical reasons behind non-specific errors of these techniques, but none of the scientific reports have taken into consideration the parallel complementary binding of two strands of DNA. We strongly believe that many molecular techniques developed so far can be further improved in the future considering both parallel and antiparallel complementarity of DNA. We strongly believe that researchers will understand the significance of our work, which will lead to a clearer understanding of the various biological phenomenons. Higher accuracy in molecular biology research worldwide will lead to better solutions for mankind’s problems," stresses Bhardwaj.

It is believed that most of our DNA contains 'Junk DNA' and over the years, researchers have found evidence to suggest that junk DNA may provide some form of functional activity. “We believe strongly that nature do not create anything 'Junk.' Hopefully our study will help in better understanding of Junk DNA also. Initially, we are exploring various genomes and have successfully developed a manual strategy to find sequences in DNA which can form both parallel and antiparallel stranded DNA. Our initial

finding says that most of genes contain DNA sequences which have the potentiality to form both parallel and antiparallel DNA. It’s again a challenge for us to find out the function of those sequences in future,” he opines.

Bhardwaj currently does not have any grants to carry out the research further, but he will be applying to various funding agencies for the same. When asked if Indian R&D is suffereing due to few grants and the role of academic institutions in the same, he agrees that while it is true that researchers in West receive huge grants to work on their ideas, however, Indian scientists are also getting huge grants. However, these aren’t available to young researchers. “I feel funding agencies can make a difference by understanding that many

In a conventional PCR reaction, oligonucleotide primers binds to a template DNA in an antiparallel complementary ways and DNA is amplified as it is.

In a PD-PCR reaction, Bhardwaj along with his fellow researcher has shown that using a single stranded DNA as template, even parallel complementary primer can initiate a DNA synthesis reaction and finally a different but related product can be synthesised great discoveries in science were by young people. They must be liberal to adopt and fund young researchers,” he says.

Congratulating Dr Bhardwaj, LPU Chancellor Ashok

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Mittal offers another perspective, “Government funding agencies should be liberal in adopting researchers to stop brain drain. Research work is a never ending process which brings more and more of posi-

tive results, as such funding agencies should not limit a researcher right from the beginning about the results. Sometimes, research results can be diversified also. However, I feel that researchers should lay de-

termined stress on the not traversed or unsuccessful areas to provide possible novel results.”

Meanwhile, Bhardwaj has been invited to give a talk in a PCR Congress which is going to held in San Diego USA where approximately 175 biotechnology scientists from top of the world institutions will be taking part. He is confident of making an inpact on the scientific and research community and hopes to collaborate with them in the future.

“This research work is my leap towards the aim of my working place LPU to get included in the list of top 200 universities of the world by the year 2025. I am now really excited and looking for grants to carry out further research,” he concludes. shalini.g@expressindia.com

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April 1-15, 2015

RESEARCH RESEARCH UPDATES

Study shows liposuction by product could lead to ED Cure The study, conducted in rats, compares the effectiveness of using a byproduct of liposuction — uncultured stromal vascular fraction with adipose-derived stem cells cultured in the lab to treat ED caused by injury to the cavernous nerve A NEW study appearing in STEM CELLS Translational Medicine has moved science one step closer to finding a simple treatment for erectile dysfunction (ED) after prostate cancer surgery, eschewing the usual pharmaceutical drug route with potential for harmful side effects, in favour of stem cell therapy that can help the body regenerate.

The study, conducted in rats, compares the effectiveness of using a byproduct of liposuction — uncultured stromal vascular fraction (SVF) — with adipose-derived stem cells (ADSCs) cultured in the lab to treat ED caused by injury to the cavernous nerve (CN). This nerve, which facilities erection, is sometimes injured during a radical prostatectomy to treat prostate cancer.

ADSCs are harvested from fat and are an attractive source of stem cells for several reasons: They are abundant and can be easily obtained using minimally invasive liposuction. Also, they have characteristics similar to bone marrow-derived stem cells in terms of self-renewal and multipotency.

Furthermore, ADSCs retain their ability to divide and grow longer than bone marrow-derived stem cells, which may be beneficial in treating chronic conditions.

On the other hand, cultured ADSCs have limitations, including the cost and time of culturing them, the

32 EXPRESS PHARMA April 1-15, 2015

potential for contamination, changes in cell characteristics during culturing procedures, and their tendency to sometimes form tumors. To avoid these risks, uncultured SVF has emerged as an easier and safer way to use stem and progenitor cells (which are further along in the differentiation process) derived from adipose tissue.

SVF comes from the disposable byproduct of liposuction.

However, no study had yet reported side-by-side comparisons of uncultured SVF and cultured ADSCs in treating ED. That was the objective of this study, led by Dalsan You, and Choung-Soo Kim, and their colleagues at the Asan Medical Center and University of Ulsan College of Medicine in Seoul, Korea. They tested the cells

using 40 rats with and without injured CNs. One group of animals was injected with cultured ADSCs; one received uncultured SVF, and a control group received no stem cells. Four weeks later, both sources of stem cells had significantly improved the animals’ erection function over the control group.

Also, both stem cell types significantly increased the number of nNOS-positive nerve fibers, suggesting that they stimulated nerve regeneration.

“However,” Dr Kim said, “The cells coming from uncultured SVF outperformed the cultured ADSCs in terms of smooth muscle/collagen ratio and endothelial cell content in the blood vessels, which are also important factors in repairing ED.” “Further research is now

Pfizer,Lillyto resume study testing pain drug

ongoing to determine the optimal protocol for cellular therapy of ED following CN injury,” Dr You added. “We want to follow the progress of the animals over the long term and also we want to see what happens with multiple stem cell injections, rather than just the one given in this study.”

“This first study to compare two types of cells derived from fat tissue in a rat model of erectile dysfunction after prostate cancer surgery is an important step in identifying effective new treatments for this condition,” said Anthony Atala, Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine.

PFIZER AND Eli Lilly and Co will resume late-stage studies of their drug tanezumab for chronic pain after the US Food and Drug Administration lifted a partial hold on trials of it and similar medicines. The FDA, in December 2012, restricted clinical studies of tanezumab and other pain drugs that work by blocking a protein called nerve growth factor (NGF), because of nervoussystem side effects seen in animal studies conducted by other companies. But the agency allowed trials of the non-narcotic medicine against terminal cancer pain to continue.

Pfizer and Lilly said they will now resume the chronic pain studies because the FDA, after reviewing positive nonclinical data on the nervous system responses to tanezumab, had lifted the partial hold. If tanezumab is approved, it could have sales of $100 million in 2020, Cowen and Co has forecast, which could grow further as the drug is approved for new pain conditions.

Still, Tanezumab could face competition from anti-NGF drugs being developed by others, including a partnership of Regeneron Pharmaceuticals Inc and Sanofi.

Pfizer and Lilly agreed in 2013 to jointly develop and sell tanezumab for several pain-related conditions, with the companies equally sharing development expenses and future sales.

Tanezumab had shown initial promise in relieving pain in the knee and lower back, but Pfizer in 2010 suspended large late-stage trials of the drug for those conditions due to reports that patients' osteoarthritis had worsened. The FDA, however, later recommended that the osteoarthritis trials continue if safeguards were put in place and patients did not simultaneously take other nonsteroidal anti-inflammatory drugs.

EP News Bureau-Mumbai

Reuters

RESEARCH

Stem cell clones could yield new drug treatment for deadly blood disease FA is a hereditary blood disorder that leads to bone marrow failure (FA-BMF) and cancer SCIENTISTS REPORT in the current issue of STEM CELLS Translational Medicine that they have been able to clone a line of defective stem cells behind a rare, but devastating disease called Fanconi Anemia (FA).

Their achievement opens the door to drug screening and the potential for a new, safe treatment for this often fatal disease.

FA is a hereditary blood disorder that leads to bone marrow failure (FA-BMF) and cancer.

Patients who suffer from FA have a life expectancy of 33 years. Currently, a bone marrow transplant offers the only possibility for a cure. However, this treatment has many risks associated with it, especially for FA patients due to their extreme sensitivity to radiation and chemotherapy.

“Although various consequences in hematopoietic stem

cells (the cells that give rise to all the other blood cells) have been attributed to FA-BMF, its cause is still unknown,” said Megumu K Saito, of Kyoto University’s Center for iPS Cell and Application, and a lead investigator on the study. His laboratory specialises in studying the kinds of pediatric diseases in which a thorough analysis using mouse models or cultured cell lines is not feasible, so they apply disease-specific induced pluripotent stem cells (iPSCs) instead.

“To address the FA issue,” he explained, “Our team (including colleagues from Tokai University School of Medicine) established iPSCs from two FA patients who have the FANCA gene mutation that is typical in FA. We were then able to obtain fetal type immature blood cells from these iPSCs.” When observing the iPSCs,

the researchers found that the characteristics of immature blood cells from FA-iPSCs were different from control cells. The FA-iPSCs showed an increased DNA double-strand break rate,

as well as a sharp reduction of hematopoietic stem cells compared to the control group of non-FA iPSCs. “These data indicate that the hematopoietic consequences in

FA patients originate from the earliest hematopoietic stage and highlight the potential usefulness of iPSC technology for explaining how FA-BMF occurs,” said Dr Saito.

“Since conducting a comprehensive analysis of patientderived affected stem cells is not feasible without iPSC technology, the technology provides an unprecedented opportunity to gain further insight into this disease.”

“This work shows promise for identifying the initial pathological event that causes the disease, which would be a first step in working toward a cure,” said Anthony Atala, Editor-in-Chief of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine.

EP News Bureau-Mumbai

Merck halts study as melanoma drug meets goal An independent monitoring committee determined that the drug succeeded in its goal of prolonging survival in previously untreated patients at advanced stage of the disease MERCK & CO said that it would stop a large study of its Keytruda melanoma treatment early because an independent monitoring committee determined the drug succeeded in its goal of prolonging survival in previously untreated patients at advanced stage of the disease.

The medicine, a PD-1 inhibitor that works by taking the brakes off the immune system, is already approved to treat patients who have failed to benefit from standard treatments, including BristolMyers Squibb Co’s Yervoy. Patients taking Keytruda showed meaningful improvement in overall survival and in

34 EXPRESS PHARMA April 1-15, 2015

delayed progression of disease, compared with those taking Yervoy, Merck said.

The data, if regulators agree, could allow Merck to widen its marketing of Keytruda to people being treated for the first time for the dangerous skin disease.

"Keytruda is the first anti-PD1 therapy to demonstrate a survival advantage compared to the standard of care for the first-line treatment of advanced melanoma," Merck said. It noted that data from the study will be presented at a medical meeting next month in Philadelphia.

About 76,000 Americans are diagnosed every year with

About 76,000 Americans are diagnosed every year with melanoma, which is highly linked to sun exposure melanoma, which is highly linked to sun exposure, and more than 9,700 die from the disease, according to the Na-

tional Cancer Institute. Merck said safety of Keytruda in the halted study was similar to that seen in earlier trials, where the most common side effects were fatigue, coughing, nausea and other mostly mild reactions.

Keytruda in September became the first PD-1 inhibitor approved by US regulators.

Three months later, the US Food and Drug Administration approved Bristol-Myers' Opdivo, also for patients with advanced melanoma who no longer respond to other drugs. It also works by blocking the PD-1 protein. AstraZeneca Plc, Pfizer and other drugmakers are also de-

veloping PD-1 inhibitors, or similar drugs known as PD-L1 inhibitors. Wall Street expects the products to generate combined annual sales of more than $30 billion by 2025, with lung cancer seen as the most lucrative potential use. Merck aims by midyear to seek US approval of Keytruda for non small cell lung cancer, the most common form of the disease. Bristol-Myers in January said it was halting a trial of Opdivo for lung cancer, also at the advice of independent monitors, when it became clear the drug extended survival compared with standard chemotherapy.

Reuters

PHARMA ALLY I N T E R V I E W

‘We will enhance our relationship with other anti-counterfeiting associations as well’ In India drugs counterfeit market is growing drastically and to curb this menace; the government, industry and associations are ready to imply newer and better techniques.

Nakul Pasricha, Vice-president, Authentication Solution Providers’ Association and Chief Executive Officer, PharmaSecure talks about the association’s agenda and also discusses about the company's strategies and plans with Usha Sharma

Being the Vice-President of India’s first self-regulated non-profit association, Authentication Solution Providers’ Association (ASPA), what immediate steps you have set in your agenda and how are you going to execute them?

We have decided to actively work with various trade bodies. Some of them are as follows: Presentation to sector associations: ASPA will be propagating the importance of ISO 12931 standards in the context of authentication methodologies with various national body association as well as industry-specific trade association such as Organisation of Pharmaceutical Producers of India (OPPI) OPPI, Indian Drug Manufacturers' Association (IDMA) etc. educating them about ISO and GS1 standards and our activities.

Partnership with anticounterfeiting association for mutual understanding: ASPA works closely with global authorities such as International Hologram Manufacturers Association (IHMA), Counterfeit Intelligence Bureau (CIB) and

Interpol, as well as industry bodies in India such as FICCI CASCADE, CII, ASSOCHAM and Indian Institute of Packaging and plays constructive role in ensuring that its members uphold a high pedigree of business ethics and values as prescribed by the ASPA code of conduct. We will enhance our relationship with other anti-counterfeiting associations as well. As the Vice President of the association, I will provide my inputs and opportunities to fulfil these objectives. ASPA has formed a committee to develop highest standards for authentication solutions providers and being a member of this committee, I will provide my inputs on digital authentication solutions.

Tell us about the association’s governance mechanism and how does it work?

Formed in 1998, ASPA has a rich heritage of 16 years and is known globally as a regulated and ethical organisation. We have adopted the highest standards in terms of our election process. The term of the governing body is for two years. Five governing

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body members are elected by general members through a secret ballot election process at a properly convened meeting. This governing body is responsible for setting and implementing an agenda that meets the objectives of the association and drives the growth of the authentication solutions industry in India and around the world. There are checks and balances in the memorandum of association of ASPA that ensure proper governance and accountability.

ASPA has formed a committee to develop highest standards for authentication solutions providers

How big is the anticounterfeit packaging market and by what percentage it is expected to grow in 2015?

The estimates vary, but the anti-counterfeit packaging market is expected to grow to about $128 billion by 2019 at a CAGR of 14.1 per cent.

(Source: http://www.packworld.com/tre nds-and-issues/traceabilityauthenticationserialization/anticounterfeiting-packagingmarket) Global regulatory compliance issues have tarnished the image of

Indian pharma companies in the global arena and counterfeit drugs are adding mileage to this damage.

What needs to be done both by the government and pharma companies?

The Directorate General of Foreign Trade (DGFT) in India has already mandated and enforced barcoding on tertiary and secondary packaging for all exported drugs but serialisation on the primary packaging is yet to be implemented due to some resistance from the industry.

ASPA would encourage the government to continue its leadership role in getting such authentication solutions mandated and rolled out. At the same time, solution providers (i.e. ASPA members) need to work closely with pharma manufacturers to develop and put in place technically sound and cost-effective solutions that don’t just meet a mandate but support the business objectives of the companies in question.

Which five things needs to be in place to fight against counterfeit menace?

The foremeost things that need to be in place to fight

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April 1-15, 2015

PHARMA ALLY against the counterfeiting menace are awareness of the issue, government support, strict laws and enforcement of those laws, scalable, costeffective and reliable technology solutions and value addition for industry — don’t make fighting counterfeiting a burden.

You are also associated with PharmaSecure. What services do PharmaSecure offer to the pharma fraternity and how useful are they?

PharmaSecure offers the following services to the pharma industry. They are Regulatory serialisation: PharmaSecure has a proven track record of implementing quality solutions for markets like Nigeria, China, and South Korea. Our solutions require minimum deviation from existing processes and negligible down time of manufacturing lines.

Brand protection: PharmaSecure enables manufacturers to identify each consumer pack by applying unique codes directly on the packaging or using preprinted labels. Consumers can verify the authenticity of this specific product by messaging the code to a pre-printed mobile number /short code, using our mobile apps or simply going to web portal.

This technology can also be used to identify loyal

36 EXPRESS PHARMA April 1-15, 2015

WHO has estimated that the size of the counterfeit drug trade globally is in excess of $75 billion. PharmaSecure is at the forefront of this battle and is working with other members of ASPA to ensure that authentication solutions can be adopted as widely as possible customers accordingly reward them. Besides external controls, out solutions enable controls between brand owners and outsourced production/packaging facilities.

Market intelligence We use technology that associates a uniquely identified unit of product with the individual patient to help manufacturers understand key behavioural metrics of bonafide patients and their prescribers. Thus it provides the real-time, regional intelligence which is needed to confidently implement strategic change and monitor effectiveness of field force, etc.

What all authentication solutions do PharmaSecure offer. How big is the market and what are the drawbacks?

PharmaSecure is a USbased organisation that has

been fighting the counterfeit drug problem in India for the past six years. By putting unique, random, alphanumeric codes onto each individual blister pack, bottle or injectable vial, PharmaSecure enables the verification of that product by simply SMSing the code. Over 1.2 billion products (i.e. one for every Indian citizen) have been protected to date through this technology, with close to 50 companies in India and other countries having already adopted the solution.

With regulations being adopted by most governments, including India, such solutions that incorporate unique identification of products with verification, and add a layer of track-and-trace, will be required in order to meet the regulatory demands and also protect consumers. WHO has estimated that the size of the

counterfeit drug trade globally is in excess of $75 billion. PharmaSecure is at the forefront of this battle and is working with other members of ASPA to ensure that authentication solutions can be adopted as widely as possible. Of course there are challenges such as consumer awareness, technology infrastructure in rural areas and low margins on medicines, but we have been working hard to address them.

Tell us the success review of the latest launch psConnect? What plans do you have to accelerate your reach through this product? psConnect is PharmaSecure’s patient engagement offering, enabling brand managers or public health representatives to better understand patient behaviour, reasons for nonadherence and satisfaction

levels with their product, as well as improve outcomes through information, communication and ethical incentivisation. We have seen widespread adoption across the pharma industry as well as in public health, with the Bill & Melinda Gates Foundation and USAID selecting PharmaSecure as a recipient in the “Grand Challenges in TB Control” initiative.

PharmaSecure intends to aggressively grow this vertical within and outside India, aiming to be managing 100,000 patients’ health by 2016.

Tell us about the association's future plans.

There is a wave of regulation coming over the next few years. India is already ahead of many countries, but the US, Europe, Brazil, Saudi Arabia, Iran, South Korea and China are all in the midst of implementations for regulatory compliance.

PharmaSecure’s technology platform positions us well to help companies around the world meet these regulations.

In addition, we continue to be interested in supporting patient engagement and public health endeavours using our psConnect suite and will be growing in this area of our business rapidly. u.sharma@expressindia.com

PHARMA ALLY VENDOR NEWS

Safexpress opens logistics parks in Dhule and Jammu The logistics park will be operational 24x7, 365 days in a year to provide time-definite deliveries

SUPPLY CHAIN and logistics firm Safexpress has launched its high-tech logistics parks at Dhule in Maharashtra and Jammu. The logistics park in Dhule is spread over an area of 12,50,000 sq feet, located on NH 8. The logistics park in Jammu is spread over an area of 80,000 sq feet and is located on Jammu-Pathankot National Highway 1A. Speaking about the Dhule logistics park, Rubal Jain, Director - Corporate Strategy, Safexpress said, “Dhule is an emerging city of Maharashtra. The city comprises numerous small scale industries that fall under Maharashtra Industrial Development Corporation (MIDC). Dhule is a hub for both agricultural and textile industries. A large number of edible oil manufacturing plants and food processing units are located in this belt. Raw materials for

Logistics park in Dhule

paper mills, cotton mills and readymade garment industry are also available from this region.”

Vineet Kanaujia, VP – Marketing, Safexpress said, “Our logistics park at Dhule has a column-less span of over 131 feet and enables loading/unloading of over 108 vehicles simultaneously. The dedicated bays and docks at our logistics park in Dhule provide an uninterrupted and

Logistics park in Jammu

unidirectional flow of inbound and outbound goods. The logistics park has a floor load capacity of six metric tonne per square metre and has a truck docking area width of over 80 feet. We have installed high-tech equipment. Moreover, to make our logistics park eco-friendly, we have taken special go-green initiatives by investing in rainwater harvesting and developing special green zones.”

Kanaujia added, “This logistics park will be operational 24x7, 365 days in a year to provide time-definite deliveries. Due to our non-stop operations, we will be providing the fastest transit time for deliveries all across India to over 610 destinations from Dhule.”

Speaking about the Jammu logistics park, Jain said, “Jammu logistics park has a column-less span of over 100 feet and enables

loading/unloading of over 26 vehicles simultaneously. The dedicated bays and docks at our logistics park in Jammu provide an uninterrupted and unidirectional flow of inbound and outbound goods. The logistics park has a floor load capacity of six metric tonnes per square metre and has a truck docking area width of over 40 feet.”

EP News Bureau-Mumbai

Isaac Rahman joins Balitmore Innovations Rahman will offer quicker response-times to customers, during the growth period for Baltimore ISAAC RAHMAN, Business Development Executive had recently joined Baltimore Innovations’ commercial team to enhance the technical support offered to customers in the medical device, diagnostic and pharmaceutical industry for barrier foil and desiccant products.

Simon Poulter, Sales Direc-

tor Speciality Products Division, Baltimore Innovations, “Rahman’s business ethos and consultative approach has already shone through in his first few months of service.

His dedication to ensuring successful completion on projects has quickly gained him an accomplished reputation and helped customers on wider in-

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dustry projects beyond the Biopharma space.”

“Rahman’s experience in pharma sales will be in an invaluable resource, and he will enable us to offer even quicker response-times to customers, during this exciting growth period for Baltimore,” says Saul Edwards, International Sales Director,

Baltimore Innovations.

Founded in 1996, Baltimore specialises in desiccants and moisture-proof packaging.

Known as the Moisture Masters and named after the city in which industrial desiccants were first synthesised, the company now services over 50 countries world-wide.

Their products are supplied to the smallest SMEs as well as to some of the world’s largest companies such as Alere, GlaxoSmithKline, and BP to name a few.

Baltimore has its headquarter and worldwide distribution centre in Buckinghamshire close to London’s Heathrow Airport, is a member of the Pharmaceutical Quality Group and holds several awards including an Interphex Award for its new desiccant technology in the best new or redesigned pack or device for ethical or OTC pharmaceuticals category.

EP News Bureau-Mumbai

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PHARMA ALLY

DuPont Knowledge Center receives LEED Certification in gold category The award has been granted by the United States Green Building Council (USGBC) for Existing Buildings Operations and Maintenance (EBOM) DUPONT WAS awarded the LEED Certification in gold category for the DuPont Knowledge Center (DKC) in Hyderabad. DKC is an integrated science and technology centre that does global R&D and Application Development in agricultural, nutrition and health, biobased industrials and advanced material sciences for India and ASEAN. The award has been granted by the United States Green Building Council (USGBC) for Existing Buildings Operations and Maintenance (EBOM).

Ranjan Patnaik, Director, DuPont Knowledge Centre

(DKC) said, “This certification stands testimony to our respect for environment. The energy-efficient design and eco-friendly maintenance features used in the centre aim to ‘conserve and preserve’ rather than ‘waste and exploit’ the natural resources, offering a healthier and cleaner environment. We feel honoured to have been recognised for our environmental achievements.”

In the past year, the team at DuPont Knowledge Centre has consciously employed sustainable practices in its buildings and focused on resource conservation and preservation

DKC was inaugurated in 2008 and operates in a 25 acre campus in IKP Knowledge Park at Genome Valley

tactics. This outstanding achievement can also be attributed to DKC’s constant and innovative efforts in improving indoor air quality, using better building materials, conserving energy and reducing water consumption. Few examples of the savings include water reuse through the sewage treatment plant, solar powered lights, LED lights, motion sensors for lighting, exhaust systems and rest rooms, CFC free refrigerant, paper waste recycling and vermin compost and usage of green sealed certified chemicals for house-keeping.

DuPont Knowledge Center

(DKC), Hyderabad, was inaugurated in 2008 and operates in a 25 acre campus in IKP Knowledge Park at Genome Valley near Hyderabad. Over 400 scientists and engineers work at this centre. In collaboration with over 10,000 DuPont scientists and engineers around the world, DKC is already LEED Silver certified by Indian Green Building Council (IGBC) in March 2010 for successfully achieving the Green Building Standards required under LEED India Green Building Rating system for new construction.

EP News Bureau-Mumbai

Phenomenex announces winners of Humanity in Science Award The Humanity in Science Award is an international research prize launched in 2014 by Phenomenex and The Analytical Scientist, recognising a breakthrough in analytical science that has truly changed lives for the better PHENOMENEX, A global leader in the research and manufacture of advanced technologies for the separation sciences, along with The Analytical Scientist, recently announced the inaugural winners of the 2015 Humanity in Science Award. Dr Peter H Seeberger and Dr Andreas Seidel-Morgenstern of the Max-Planck Institutes in Potsdam and Magdeburg, Germany for their ground-breaking work on antimalarial drugs.

The Humanity in Science Award is an international research prize launched in 2014 by Phenomenex and The Analytical Scientist, recognising a breakthrough in analytical science that has truly changed lives for the better. Applications were received from around the world, addressing humanitarian challenges such as keeping our food and water safe to develop-

38 EXPRESS PHARMA April 1-15, 2015

ing new and better medicines.

“It has been such a pleasure for us to discover the incredible contributions to humanity by so many analytical scientists around the world,” says Fasha Mahjoor, President and Chief Executive Officer, Phenomenex.

“Scientists are humble people and, often, their work goes without publicity. We are so pleased to bring light to this amazing life-saving work and to honour our deserving winners with the grand prize.”

Seeberger and Seidel-Morgenstern’s winning essay is titled, 'Continuous Flow Production and Purification of Malaria Medications' which allows for cheaper antimalarial medications to be produced.

By coupling flow chemistry with advanced chromatography methods, Seeberger and SeidelMorgenstern discovered that

ACTs can be produced from plant waste material, air, and light. The new process, currently being implemented in a pilot plant in Vietnam, produces an active pharmaceutical ingredient with an HPLC purity of greater than 99.5 per cent, which meets the standards set by the FDA and WHO. Seeberger and Seidel-Morgenstern will receive $25,000 in prize money and have their inspiring essay published in The Analytical Scientist magazine in 2015 in print and online. They presented their essay at two special Humanity in Science Symposia held at Pittcon recently.

“This recognition of our work by an international jury of leading scientists encourages me to continue our work on translating our scientific breakthrough into a production facil-

ity. Thereby, those in need of malaria medications will benefit from better access and lower prices while the dangers of fake medications are reduced,” said Seeberger.

“An efficient isolation of a continuously synthesised target component requires the development of advanced separation processes. Considering the reactor effluents generated in Peter’s group as pseudo-ternary mixtures (an impurity fraction 1, the target, and an impurity fraction 2), artemisinin and artesunate could be purified with our process using several periodically operated chromatographic columns. The approach can be applied to also solve other challenging separation problems,” added Seidel-Morgenstern.

Three runners up will all have their work published in

The Analytical Scientist in print and online in 2015. They are Michael H Gelb & Frantisek Turecek (Department of Chemistry, University of Washington, Seattle) for 'Analytical chemistry in newborn screening'; Don Farthing, H Thomas Karnes, Lynne Gehr, Christine Farthing, Todd Gehr, Terri Larus, and Lei Xi (Virginia Commonwealth University) for 'Translational research on the use of a rapid analytical methodology for detecting acute cardiac ischemia, at early onset of a heart attack' and Serge Rudaz and Julie Schappler (School of Pharmaceutical Sciences, University of Geneva) for 'Low-cost analytical device based on capillary electrophoresis (CE) for counterfeit drug detection and sub-standard drug quality control'.

EP News Bureau-Mumbai

PHARMA ALLY VALUE ADD

DHL GLOBAL FORWARDING

Setting new standards in temperature controlled shipping Samar Nath, Chief Executive Officer, DHL Global Forwarding, India share insights about DHL Thermonet, a new temperature controlled air freight product tailored to the life sciences and healthcare sector

IN THE past few years, the Indian pharmaceutical industry has continued to be one of the most attractive investment destinations in the world with an expected CAGR of 14 per cent1 and anticipated to reach a turnover of `2.91 trillion ($47.06 billion) by 2018.

Presently, valued at `1.6 trillion ($ 25.87 billion)2, it is also expected to grow in the local market with aggressive rural penetration by pharma manufacturers, increased government spending on health and growing awareness among people.

The drug manufacturing industry, one of the top contributors to the country’s exports, is a focus area for the government’s ‘Make in India’ campaign. Taking in view the governments ‘Pharma Vision 2020’, it is expected to reduce the approval time for new facilities so as to boost further investments.

In recent years, temperature controlled products for the pharma industry have gained significantly in importance.

The driving force has been the biotechnology products, which generally must be kept within a

40 EXPRESS PHARMA April 1-15, 2015

strict temperature range during transportation. Transporting and warehousing temperature controlled shipments securely and safely requires a unique combination of skills and expertise.

DHL Thermonet, a new temperature controlled air freight product tailored to the life sciences and healthcare sector is an addition to DHL’s network of life sciences and healthcare facilities. This global service offers customers a transparent and a regulatory compliant platform, enabling DHL to manage their temperature sensitive shipments of pharma products and medical devices. It does so by bringing together several technical and product offerings from the Group, including the exclusive IT platform, LifeTrack and the DHL SmartSensor, the temperature monitoring technol-

SAMAR NATH Chief Executive Officer, DHL Global Forwarding, India

ogy developed by DHL Solutions & Innovation.

Samar Nath, Chief Executive Officer, DHL Global Forwarding, India said, “You need a partner who can bring together dedicated infrastructure, global standard operating

procedures designed around your specific needs, trained staff who work to identical protocols, and leading edge monitoring, tracking and reporting technology.”

DHL Thermonet provides seamless temperature visibility

DHL’s investment in the Free Trade Zone aims at simplifying trade and encourages foreign trade and warehousing activities in India, thereby creating more employment

along the supply chain, 24/7 proactive monitoring and intervention based on pre-determined touch points and DHL’s RFID SmartSensor technology, that is GDP certified. Temperature data and logistics events can be accessed via the proprietary LifeTrack IT platform that also houses all product-specific SOPs, facilitating early intervention and simplifying document control.

Additionally, DHL’s Free Trade Zone (FTZ) facilities offer one stop solution for all logistics and inventory management needs. They also include dedicated temperature controlled facilities for life sciences and healthcare products with temperature and humiditycontrolled storage chambers which are GDP compliant.

DHL’s FTZ facilities thus provide end to end cold chain management under a controlled environment and speedy clearances from Drug Controller office, including customs on site.

Being the first global logistics company in the country to have two advantageously located sites within FTZ areas — at Panvel, Mumbai which han-

PHARMA ALLY

dles 55 per cent and Sriperumbudur, Chennai handles 25 per cent of India’s container inbound and outbound traffic, DHL Global Forwarding has the first mover advantage of being able to offer a number of benefits to customers.

“With cost-effective skilled labour, transportation facilities, integrated warehouse management and sophisticated equipment, we are well positioned to capitalise on the rapidly growing domestic market,” said Amit Dawar, Director – Value Added Services, DHL Global Forwarding India.

DHL’s investment in the Free Trade Zone aims at simplifying trade and encourages foreign trade and warehousing activities in India, thereby creating more employment and providing a platform for overseas entities to transact from and into India. DHL’s Temperature Management Solutions are customised to protect the integrity of life sciences and healthcare products during global transportation.

References 1. www.ibef.org 2. Care Ratings

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PHARMA ALLY PRODUCTS

Bosch Packaging Technology launches GKF capsule filling machine BOSCH PACKAGING Technology has launched the new capsule filling machine GKF 2600. This high-performance machine doses powders, pellet, tablets and liquids, as well as combinations precisely and reliably. An output of up to 2,600 capsules per minute can be achieved. Due to its extended machine platform and very good accessibility, the capsule filling machine can be adapted to fill different products in a very short time.

Thanks to these characteristics, add-on modules can also be integrated quickly and easily. New development with numerous expansion possibilities The development of the new capsule filling machine is consistently based on the demands of the pharmaceutical industry and profits from the long-term experience of Bosch in capsule filling operations. The optimised containment with more tightly sealed doors further ensures that the highest hygiene standards are maintained during production.

Apart from the standard functions, numerous options are available, such as the new capsule checkweigher KKE 2600 with enhanced product control. Additionally, the GKF 2600 can be upgraded with a feedback loop, which automatically regulates overfilling and underfilling of capsules via tendency control

of the KKE. An inspection unit can further be integrated into the capsule filling machine. It conducts weight and quality inspections with x-ray technology and an x-ray sensor.

Contact Karl-Heinz Kappes phone: +49 711 811-57255

The newly developed GKF 2600 from Bosch combines proven and new technologies at a high output of up to 156,000 capsules per hour

Due to its extended machine platform and very good accessibility, the capsule filling machine GKF 2600 can be adapted to fill different products in a very short time

The standard functions of the capsule filling machine GKF 2600 include,for instance, an automatic anti troubleshooting (ASB) function, as well as user-friendly handling with improved accessibility of the filling stations

Radleys developes AVA Lab control software AVA SOFTWARE, developed

by Radleys (Saffron Walden), is a major step-change in lab control software to enable the scientist to work smarter and complete projects faster. AVA is easy to use and can control and log data from a variety of manufacturer’s laboratory equipment. It offers four soft-

42 EXPRESS PHARMA April 1-15, 2015

ware levels to suit the application and budget, controlling a single stirring hotplate up to a multi-device jacketed reaction system.

Scientists can use AVA to control a wide range of laboratory devices including stirring hotplates, overhead stirrers, circulators, balances,

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PHARMA LIFE APPOINTMENTS

Dr Anish S Majumdar joins as VP- Elect of Asia region of International Society of Cell Therapy Majumdar has delivered more than hundred lectures on various aspects of his research at various national and international conferences DR ANISH S Majumdar who serves as the Chief Scientific Officer and Executive VP at Stempeutics Research, a MEMG Group Company in Bangalore has been elected as the Vice President- Elect of Asia region of the International Society of Cell Therapy to represent India and Asia.

Majumdar who has been with Stempeutics Research since 2010, has been leading the R&D for mesenchymal stem cell research and therapy. The internationally

known stem cell researcher also has been working since 20-25 years towards elucidating the potential of various stem cells and their applications for incurable diseases at Indian and the US organisations. Being nominated a member of the Industry Committee of the International Stem Cell Research and Therapy, Majumdar has delivered more than hundred lectures on various aspects of his research at various national and international conferences.

Majumdar said, “Stem cell research and therapy will eventually reshape the healthcare industry and I am honoured to be a part of the International Society of Cell Therapy to be representing India as well as Asia at an international level. At Stempeutics Research, we have the opportunity to deliver breakthrough solutions which will bring value to our investors, clients and stakeholders.”

EP News Bureau-Mumbai

Jaap Venema joins USP as CSO Venema will provide overall leadership for USP’s scientific and standards-setting activities THE UNITED States Pharmacopeial Convention (USP) announced that Jaap Venema will become the Chief Science Officer on April 15 and Chair of USP’s standards-setting body, the Council of Experts, at the beginning of USP’s next five-year cycle on July 1, 2015.

Venema most recently was Therapeutic Area Lead Biotherapeutics, Global Medical Affairs, Biologics Strategy Development, at Abbvie (formerly Abbott Laboratories), where he provided scientific and medical leadership on key aspects of biotherapeutics across all therapeutic areas, including biosimilars and immunogenicity. In this role, Venema had global oversight for Asia, Europe, Latin Amer-

Venema will report to the chief Executive officer and serve as a member of USP’s executive team.

He will provide overall leadership for USP’s scientific and standards-setting activities and will have management responsibility for more than 150 staff around the world

ica and US. His 15-year tenure at Abbott and Solvay (acquired by Abbott in 2010) in-

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cluded leadership roles in immunology medical affairs, international medical development, vaccines development and exploratory target biology. Venema earned his Ph.D. at the University of Leiden in the Netherlands. He also served on the faculty of Vrije Universiteit Amsterdam (Free University Amster-

dam), Netherlands.

Venema will report to the Chief Executive Officer and serve as a member of USP’s executive team. He will provide overall leadership for USP’s scientific and standards-setting activities and will have management responsibility for more than 150 staff around the world. Ven-

ema will work closely with scientific staff at USP’s global laboratory operations in Rockville, Md., US; Hyderabad, India; Shanghai, China and São Paulo, Brazil as well as USP locations in Ghana, Switzerland, Ethiopia and Indonesia.

EP News Bureau-Mumbai

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PHARMA LIFE AWARDS

Glenmark’s Pithampur plant in MP wins MPFCCI Outstanding Achievement Award 2014 The plant bagged the first prize in health and safety category among large enterprises GLENMARK GENERICS' Pithampur plant near Indore, Madhya Pradesh was recently awarded the ‘Outstanding Achievement Awards 2014’ for excellence in Health & Safety by The Federation of Madhya Pradesh Chamber of Commerce and Industry (MPFCCI). The recognition was presented by Shivraj Singh Chauhan, Chief Minister, Madhya Pradesh at a recently held ceremony in Bhopal.

Glenmark’s Pithampur plant bagged the first prize in Health & Safety category among large enterprises. More than 500 participants including the award

winners attended the event.

“We are delighted at receiving the award from a prestigious

body like MPFCCI. The recognition is a testament of Glenmark’s unwavering commitment to-

wards Health & Safety. Our Pithampur plant has implemented a comprehensive environmental, health and safety system in compliance with ISO 14001 and OHSAS 18001 standards of excellence.” said Cheryl Pinto, Director Corporate Affairs – Glenmark.

Certified by OHSAS 18001 and ISO 14001, Glenmark’s Pithampur plant has implemented best-in-class health and safety infrastructure which includes well equipped occupational health center, fire prevention system, fire detection systems, fire control systems (Fire Extinguishers and fire hydrant sys-

tem) and emergency evacuation processes in addition to standard operating procedures including work permit system, safety training, safety committee, employee consultation, incident reporting and many more, apart from formulating a robust safety organogram to support health and safety programme at the plant. This state-of-the-art formulations facility manufactures oral solids, semi solids and injectables. It has received approvals from leading regulatory agencies worldwide like the USFDA and UK MHRA. EP News Bureau-Mumbai

RSF honours outstanding scientists 21st Annual Symposium on 'Neurodegeneration' was also held RANBAXY SCIENCE Foundation (RSF), a non-profit organisation set-up by Ranbaxy Laboratories (Ranbaxy) announced Ranbaxy Research Awards for excellence in original research work in medical and pharmaceutical sciences. The foundation also announced the Science Scholar Awards to the young and brilliant new generation of scientists.

The coveted Ranbaxy Research Awards in the field of Medical Sciences were given to Dr Amit Sharma, International Centre for Genetic Engineering and Biotechnology, New Delhi for his pioneering work in understanding function of malaria parasite proteins; Dr Balram Bhargava, All India Institute of Medical Sciences, New Delhi for his work on developing the indigenous low cost platinum iridium coronary stent; Dr Gagan-

60 EXPRESS PHARMA April 1-15, 2015

deep Kang, Christian Medical College, Vellore for his comprehensive research on diarrhoeal disease that led to important advances in Indian public health and Dr V Mohan, Dr Mohan's Diabetes Specialities Centre, Chennai for his research work on pancreatic diabetes that led to development of 'Mohan’s criteria'. In the field of pharmaceutical sciences, the sole award was given to Dr Santanu Bhattacharya, Indian Institute of Science, Bangalore for his work promoting gene therapy.

The Science Scholar Awards, given to upcoming new generation of scientists in the Biomedical Sciences category went to Anuj Kumar, Indian Institute of Science, Bangalore for his research work in understanding hepatitis C virus replication and Bidyut Purkait, Department of Molecular Biology, Rajendra

The foundation presented Science Scholar Awards to the young and brilliant new generation of scientists Memorial Research Institute of Medical Sciences (RMRIMS) (ICMR) Patna for designing better chemotherapeutic options for kala-azar. In the pharma sciences category, the awardees

were Preshita P Desai, Institute of Chemical Technology, Mumbai for the development and scale up optimisation of curcumin solid solution; Jasmine Kaur, National Institute of Pharmaceutical Education and Research, Punjab for the development of a diagnostic agent called Aptamer used both for detecting cancer and delivering pharma substances specifically to cancerous cells and Bhushan Munjal, National Institute of Pharmaceutical Education & Research (NIPER), Punjab for his work on lyophilisation used to preserve perishable material and make them convenient for transport.

The awards were presented by scientist, Prof Rudi Balling Director, Luxembourg Centre for Systems Biomedicine (LCSB), University of Luxembourg in presence of Dr Tsutomu Une, Chairman, Ranbaxy,

Dr Nitya Anand, Chairman, RSF, Arun Sawhney, Chief Executive Officer and Managing Director, Ranbaxy and Dr Rajinder K Jalali, Member, Governing Council, RSF. RSF also held its 21st Annual Symposium on 'Neurodegeneration' which saw participation of TS Rao, Department of Biotechnology, Government of India; Nirmal Kumar Ganguly, Policy Center for Biomedical Research, Translational Health Science & Technology Institute; MV Padma Srivastava, All India Institute of Medical Sciences; Subrata Sinha, National Brain Research Centre and PN Tandon, National Brain Research Centre amongst others. The keynote speaker, Prof Balling delivered a special lecture at the symposium on neurodegenerative diseases.

EP News Bureau-Mumbai

REGD.WITH RNI NO.MAHENG/2005/21398 REGD.NO.MH/MR/SOUTH-77/2013-15, PUBLISHED ON 5TH & 20TH EVERY FORTNIGHLY & POSTED 6-7-8 & 21-22-23 OF EVERY FORTNIGHLY. POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE.