Express Pharma (Vol.12, No.7) February 1-15, 2017

VOL. 12 NO. 7 PAGES 70

www.expresspharmaonline.com

Market

IPM clocks ` 9,321 crores in December 2016

1-15 FEBRUARY 2017, ` 40

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CONTENTS Vol.12 No.7 FEBRUARY 1-15, 2017 Chairman of the Board Viveck Goenka Sr Vice President-BPD Neil Viegas Editor Viveka Roychowdhury*

Resurrecting Brand AP

MARKET

Visakhapatnam and Nellore to play pivotal roles in rebuilding Andhra Pradesh’s reputation as a leading pharma hub | P20

Chief of Product Harit Mohanty

14

HEALTHCARE SABHA 2017: CO-CREATING A MANIFESTO FOR A HEALTHY INDIA

15

BENGALURU TO HOST INDIA PHARMA 2017

BUREAUS Mumbai Sachin Jagdale, Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Mansha Gagneja New Delhi

P18: GROWTH TRACKER IPM clocks ` 9,321 crores in December 2016

RESEARCH

Prathiba Raju DESIGN

National Design Editor Bivash Barua

P24: REPORT US regulations hit global PMB M&As

Asst. Art Director Pravin Temble

P25: REPORT

Senior Designer

APAC COPD market set to hit $7.3 bn by 2022

Rekha Bisht Graphics Designer Gauri Deorukhkar Senior Artist

P27: UPDATES

26

ALCOBRA TO STOP TESTING SOLE DRUG FOR ADHD AFTER STUDY FAILS

28

INOTEK’S EYE DRUG FAILS LATE-STAGE STUDY

29

SYNTHETIC BIOLOGICS' C. DIFFICILE MID-STAGE STUDY MEETS MAIN GOAL

Egalet painkiller wins FDA approval but label disappoints

Rakesh Sharma, Vivek Chitrakar Photo Editor Sandeep Patil

LOGISTICS SPECIAL

MARKETING Regional Heads

INTERVIEW

Prabhas Jha - North

‘LOCUS AIMS TO BE A

Harit Mohanty - West

MARKET LEADER IN THE 30 HEALTHCARE SERVICES

Pg

Kailash Purohit – South Debnarayan Dutta - East

DOMAIN’

Marketing Team

NISHITH RASTOGI, Co-Founder and CEO, Locus

Ajanta Sengupta

‘PLUSS IS TODAY WORKING WITH ALL MAJOR PHARMA AND VACCINE MANUFACTURERS IN INDIA TO EDUCATE AND GROW ITS MARKET SHARE’

Ambuj Kumar E Mujahid Mathen Mathew Nirav Mistry Rajesh Bhatkal PRODUCTION

SAMIT JAIN, MD, Pluss Advanced Technologies

General Manager

31

Pg

BR Tipnis

Express Pharma®

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

Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2016-18.

Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at 2nd floor, Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) 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.

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EXPRESS PHARMA

11

February 1-15, 2017

EDITOR’S NOTE

Pharma PSUs: Missed opportunity?

T

he turnover of the Indian pharmaceutical industry was estimated at `2,04,627.1 crores in FY2015-16, registering a growth of 29 per cent compared to the growth of 12 per cent from `158,671 crores during FY2013-14. A report released by the Department of Industrial Policy and Promotion and the Department of Pharmaceuticals on January 18 highlights the achievements of the pharma sector under the Make in India initiative.

A key source of revenue is exports. As the report points out in FY2015-16, exports of drugs, pharmaceuticals and fine chemicals was `1,06,212.4 crores. In the generics market, India exports 20 per cent of global generics, making it the largest provider of generic medicines globally.

The report also reveals that Indian Drugs and Pharmaceuticals Limited (IDPL), a Central Public Sector Enterprise under Department of Pharmaceuticals, has modernised the tablet manufacturing section of its Gurgaon plant, which was commissioned with an investment of `3 crores.

This has enabled the PSU to mass manufacture new products in the field of diabetes, oncology, nephrology and cardiology at affordable prices.

But this contradicts an earlier announcement on December 28, when the Cabinet had approved the need-based sale of surplus land of the four pharma PSUs to meet their outstanding liabilities. The note goes on to state that further steps would be taken to close IDPL and Rajasthan Drugs & Pharmaceuticals Limited (RDPL) while the option of strategic sale will be explored for Hindustan Antibiotics Limited (HAL) and Bengal Chemicals & Pharmaceuticals Limited (BCPL).

On one hand, the Bureau of Pharma PSUs of India (BPPI) is shutting down pharma PSUs. And on the other hand, as the nodal agency for the implementation of the Pradhan Mantri Bhartiya

Pharma PSUs would need tremendous investments to revamp their facilities but they could have been the source for affordable generics

Janaushadhi Pariyojana (PMBJP), it is tasked with setting up 1000 Pradhan Mantri Bhartiya Janaushadhi Kendras in both urban and rural places of the country to dispense affordable medicines. Its target is ‘Mission 3000’ kendras by March 2017.

According to the release, to date, there are over 750 such stores with a portfolio containing 600 drugs as well as 154 surgicals and consumables.

No doubt, the pharma PSUs would need tremendous investments to revamp their facilities but they could have been the source for affordable generics, and it looks as if this strategy has been implemented in IDPL. But clearly, the results have not been good enough for the government to continue the exercise at other pharma PSUs. Thus leaving the field open for private pharma companies, presumably both domestic and MNC, to bid for these tenders.

The fact that the National Yuva Cooperative Society (NYCS) has been roped in as a partner in the PMBJP is also noteworthy, as the scheme is being seen as a means to provide employment. As Mansukh L Mandaviya, Minister of State for Road Transport & Highways, Shipping, Chemicals & Fertilizers put it, “By joining hands with NYCS, the energy of the youth of the country would be channelised in achieving this goal.” Kendras set up in government hospitals will get financial aid of `2.5 lakh and there will be incentives to individuals, with special and softer terms to SC, ST and differentlyabled persons.

The policy makers are clearly trying to achieve multiple targets with this scheme: providing affordable safe medicine as well as employment.

While this is a smart move, will this meet the objectives, is the question.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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12 EXPRESS PHARMA February 1-15, 2017

MARKET PRE EVENTS

Healthcare Sabha 2017: Co-creating a manifesto for a healthy India The event will be held at Visakhapatnam from February 9-12, 2017

W

ith an aim to drive a revolution and facilitate a dialogue in public health, Express Healthcare, a publication from The Indian Express Group, launched Healthcare Sabha – The National Thought Leadership Forum on Public Healthcare.

Healthcare Sabha 2017 will create a blueprint to facilitate evidence-based policy making, augment excellence in healthcare delivery and eliminate barriers to equitable access. Healthcare Sabha 2017 will work toward 'Co-creating a Manifesto for a Healthy India.' The event will be held at Visakhapatnam from February 9-12, 2017.

Key subjects at the forum include: Pillar 1-Tackling talent crunch: Improving capacity and competence ◗ Role of PPPs in training healthcare professionals. ◗ Strategies to attract doctors to public health (especially in rural India). ◗ An assessment of the Skill India Initiative and the way forward. ◗ Creating a large pool of efficient and skilled professionals. ◗ Medical education syllabus in India: In need of a major rehaul.

Pillar 2-Developing sustainable health financing systems ◗ Galvanising healthcare via insurance. ◗ Govt sponsored schemes: Meant for poor, but beyond their reach. ◗ Understanding health economics: A much needed remedy for a healthy India. ◗ Infrastructure essentials:

14

EXPRESS PHARMA

February 1-15, 2017

KEY DECISION MAKERS TO BE PRESENT AT HEALTHCARE SABHA 2017 ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗ ◗

◗ ◗ ◗

◗ ◗ ◗ ◗ ◗ ◗

Manoj Jalani,Joint Secretary, MoH&FW Dr Gajendra Kumar,Advisor, Ministry of Railways, GoI Prof K Srinath Reddy, President, PHFI BD Athani, Special DG, DGHS, MoH&FW, GoI Dr J RadhaKrishnan, Health Secretary, Government of Tamil Nadu Alok Kumar,Adivisor Health & Nutrition, NITI Aayog Dr Anil Dhoke,Additional Director, Central Government Health Scheme Dispensary Dr Atul Kharate, State TB Officer, Madhya Pradesh, GoI Dr HG Koshia, Commissioner, FDCA, Gujarat Dr Suresh Saravdekar, Director, Rural Health & Education Centre, Krishnamurti Foundation India,Varanasi Bhudeb Chakravarti, Honorary President, Centre for Development of Excellence, Hyderabad Dr AVelumani, Promoter, CMD and CEO,Thyrocare Dr Avinash Supe, Dean, KEM and Director, Medical Education-Major Hospitals- Mumbai Dr Prateek Rathi, Fellow member Post Graduate Programme in Public Policy Management, IIM , Bengaluru and ESIC, Government of Maharashtra Prof Mukul Asher, Professorial Fellow, Lee Kuan School of Public Policy, National University of Singapore Prof Dayashankar Maurya, Chairperson, Healthcare Management & International Relations,TA Pai Institute of Management Lokesh Sharma, Director, QuintilesIMS Institute India and Head of Government Solutions in India for QuintilesIMS Health, QuintilesIMS Health Dr Deepak Agrawal, Chairman, Computerisation and IT,AIIMS Dr Suleman Merchant, Dean, Lokmanya Tilak Municipal Medical College and Hospital Dr V Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission, MoH&FW, GoI Gyanesh Pandey, CMD, HSCC Dr Navjot Khosa ,MD, Equipments Procurement, Kerala Medical Services Corporation Prof Arvind Sahay (OR Prof Piyush Kumar Sinha, Professor of Marketing and International Business, Head-India Gold Policy Center, Dean, (Alumni &External Relationships), IIM Ahmedabad

Plan for an affordable healthcare system.

Pillar 3-Ushering good governance in public health ◗ Technology for good governance in public hospitals. ◗ Revisiting our disease control strategies: Successes & failures (NCD, Anti-TB programmes etc.) ◗ Strategies to mitigate health infrastructure deficit. ◗ Uprooting corruption from healthcare: An urgent need.

Pillar 4-Ensuring access to quality health services and essential medicines ◗ Analysis of Mohalla clinics (Studying the efficacy of the model and their replicability). ◗ Universal Immunisation Coverage: Making it Mission Possible. ◗ Medicines for all: Roadmap for better accessibility and affordability. ◗ Sanitation: Is the Swachh Bharat campaign taking us closer to a Swasth Bharat? ◗ Eliminating malnutrition: Taking a multi-pronged approach.

To be held concurrently with Healthcare Sabha, the Express Public Health Awards will honour Champions, Visionaries and Game Changers in Public Healthcare.

The first edition (held from March 4-6, 2016 at Hyderabad Marriott Hotel and Convention Center) brought together significant stakeholders in public health to deliberate on cohesive, unified and innovative ways to achieve the National Health Mission’s Vision pertaining to ‘Universal Access to Equitable, Affordable and Quality Healthcare Services to All’.

BioAsia 2017 to be held in Hyderabad THE FOURTEENTH edition of BioAsia will be held in Hyderabad from February 68, 2017. BioAsia 2017 will be sponsored by Indian Council of Medical Research, OPPI, BIRAC and supported by Department of Pharmaceuticals, Government of India. The event will be organised by Government of Telangana, Pharmexcil and Federation of Asian Biotech Associations.

The state partner is Department of Science and Technology, Rajasthan. Corporate sponsors are SHANTHA and UK Trade and Investment.

The Technology Conferences of BioAsia is a sciencebusiness bridge, that will aim to bring together a trans-disciplinary environment for driving innovation in the life sciences industry. The tech conferences have been structured in order to leverage technology trends for business relationships. While presenting an opportunity to explore partnerships and channels for extending businesses between industry and academia, BioAsia’s tech conferences will cover contemporary developments in research and will assist in building capabilities to break the technology development resistors for smooth flow of technology and collaborations.

The CEO Conclave will discuss opportunities to drive industry’s growth agenda by focussing on key action areas.

On February 7, a roundtable will be held on 'Orphan Drugs - Discovery and Development' will be organised under the leadership of Prof Ramaiah Muthyala, Associate Director, Center for Orphan Drug Development, University of Minnesota and President/CEO, Indian Organization for Rare Diseases.

EP News Bureau

Bengaluru to host India Pharma 2017 The event from February 11-13, 2017, will be an international exhibition and conference on pharma industry INDIA PHARMA 2017 will be held at Bangalore International Exhibition Centre, Bengaluru from February 11-13, 2017. India Pharma 2017, an international exhibition and conference on pharmaceutical industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among

the conference delegates and business visitors provided by the event.

India Pharma 2017 will cover all the sectors of the pharma industry starting from finished formulations, APIs, bio – pharma, fine chemicals and intermediates, natural extracts, excipients and many more.

Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment.

Conferences are scheduled as part of India Pharma 2017 with the theme ‘Make In India -

India Pharma 2017 will cover all the sectors of the pharma industry starting from finished formulations, APIs, bio – pharma, fine chemicals and intermediates, natural extracts, excipients and many more Are We On Track?’. The various sessions planned during the conference would involve

taking stock of the achievements so far and the way forward on the journey of ‘Make

in India’ in pharma and biotech sector. It would be conglomeration of eminent policy makers; national and international leaders from the industry.

Since pharma is a capital intensive sector which requires active involvement/ cooperation of major players of formulations, technology, R&D, product development, etc, the need for much closer and frequent interactions with industry leaders from various parts of the country and the world are of paramount importance.

EP News Bureau

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To subscribe: bpd.subscription@expressindia.com

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EXPRESS PHARMA

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February 1-15, 2017

EVENT BRIEF FEBRUARY TO SEPTEMBER-2017 6

BioAsia 2017

11

BIOASIA 2017 Date: February 6-8, 2017 Venue: Hyderabad International Convention Centre (HICC) Summary: BioAsia 2017 will be supported by Ministry of Science & Technology, Government of India and organised by Federation of Asian Biotech Associations (FABA). There will be participation from 50 countries with 100 speakers, 800 corporates and 1000 partnering meetings.

Technology Conferences of BioAsia is a science-business bridge, that aims to bring together a trans-disciplinary environment for driving innovation in the life sciences industry. The tech conferences have been structured in order to leverage technology trends for business relationships and help to put technology in

16

EXPRESS PHARMA

February 1-15, 2017

India Pharma 2017

11

the development relay across the world through codevelopment opportunities.

BioAsia’s tech conferences will cover contemporary developments in research and will assist in building capabilities to break the technology development resistors for smooth flow of technology and collaborations.

Contact details BioAsia Secretariat 301, Gayathri Nest, Telecom Nagar, Gachibowli, Hyderabad - 500032, Telangana Phone: +91 (40) 23000205/206 Fax: +91 (40) 2300 0207 Email: info@bioasia.in

INDIA PHARMA 2017 Date: February 11-13, 2017 Venue: Bengaluru

PharmaTech Expo 2017

25

International Exhibition Centre, Bengaluru Summary: India Pharma 2017, an international exhibition and conference on pharmaceutical industry is a joint initiative of Department of Pharmaceuticals, Government of India and Federation of Indian Chambers of Commerce & Industry (FICCI). It will provide a common platform where all the participants will get an opportunity to enhance their brand value by displaying their product and the capabilities among the conference delegates and business visitors provided by the event. India Pharma 2017 will cover all the sectors of the pharma industry starting from finished formulations, APIs, bio-pharma, fine chemicals and intermediates, natural extracts, excipients

Respiratory Drug Delivery (RDD) Europe 2017

and many more.

Latest pharma machinery, plants, laboratory equipment, analytical instrument and cleanroom equipment will also be showcased.

Contact details Kamal Bhardwaj Deputy Director Mob: 9899392930 Email: kamal.bhardwaj@ ficci.com Federation of Indian Chambers of Commerce & Industry (FICCI) Federation House, Tansen Marg, New Delhi 110001

3

PharmaTech Expo 2017

international exhibition on pharma machinery, lab and packaging equipment, will see a common platform for suppliers, manufacturers, industrialists, buyers and consultants. This year the focus will be on nutraceutical, food and cosmeceuticals and ayurveda. The event will be concurrently held with LabTec expo 2017.

More than 150 exhibitors from across the country participated in last year’s event and varied kinds of high tech pharma machinery, lab and packaging equipment were on display. With more than 5000 trade visitors took part in last year's event.

PHARMATECH EXPO 2017 Date: April 11-13, 2017 Venue: Parade Ground, Sector – 17, Chandigarh Summary: The 5th Edition of PharmaTech Expo 2017, an

Contact details PharmaTechnologyIndex.com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall,

Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

Income Tax, Ashram Road, Ahmedabad - 380009 P: +91-79-27540493/ +91-79-40306340

RESPIRATORY DRUG DELIVERY (RDD) EUROPE 2017

INDIA LAB EXPO 2017/ANALYTICA ANACON INDIA

Date: April 25-28, 2017 Venue: Palais des Congrès d’Antibes, Nice, France Summary: RDD Online and Aptar Pharma will organise RDD Europe 2017, an event in the Respiratory Drug Delivery field in Europe. It will bring together pulmonary and nasal drug delivery experts from all around the world to exchange scientific knowledge and expertise, and also provide a dynamic forum for expanded opportunities for business networking. RDD Europe 2017 will feature podium sessions and debates, scientific poster sessions, technology exhibition and workshops sessions.

Academics, industrial and regulatory scientists involved in the research, development, investigation will take part in the event.

Date: September 21-23, 2017

Contact details Joanne Peart: info@rddonline.com

PHARMATECH EXPO 2017 Date: August 3-5, 2017 Venue: Gujarat University Convention Centre, Ahmedabad, Gujarat Summary: The 6th Edition of PharmaTech Expo 2017 will be Gujarat’s largest pharma expo and will be concurrently held with ‘Labtec’ & ‘Track & Trace’ Expo 2017. This year, the focus will be on pharma machinery and equipment manufacturing sector and pharma packaging. More than 150 exhibitors from across the country participated in last year’s event and varied kinds of high tech pharma machinery, lab and packaging equipment were on display.

Contact details PharmaTechnologyIndex. com A Division of KNS Group 701 - 702, Corporate House, Opp Dinesh Hall,

EXPRESS PHARMA

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February 1-15, 2017

Venue: Hitex, Hyderabad Summary: India Lab expo, India’s largest exhibition on laboratory, scientific, analytical and biotechnology sector will see international as well as Indian manufacturers and distributors. Decision makers from sectors like hospitals, diagnostic labs, oil

and petroleum, chemical, cosmetics and government departments will meet at the tradeshow. The event will be supported by Ministry of Science & Technology, Government of India.

Contact details MMI India

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

MARKET GROWTH TRACKER

IPM clocks ` 9,321 crores in December 2016 The industry witnessed a drastic drop in the number of new introductions launched in the month of December post de-monetisation THE INDIAN Pharmaceutical Market (IPM) was valued at ` 9,321 crores in the month of December 2016. The Government of India’s well intentioned move to de-monetise currency notes of ` 500 and ` 1000 disrupted the market to a certain extent rendering the growth in December to a mere three per cent over same period last year (SPLY).

On a MAT basis, the industry was valued at ` 112,570 crores and reflected 11 per cent growth with volumes contributing 31 per cent of this growth and new introductions playing an important role with 46 per cent contribution to the overall growth.

Growth across company slabs was sluggish for the month with top 10 companies reflecting a three per cent, 1120 companies reflecting stagnancy and 21-30 companies reflecting three per cent growth respectively.

Among the top 20 companies, Lupin was the only company to reflect a double digit growth for the month (14 per cent) while Sun Pharma (eight per cent), Intas (four per cent), Torrent (eight per cent) and USV (eight per cent) were the only companies to reflect a growth higher than the IPM. Domestic companies continued to dominate the market with a 78 per cent share in December 2016 with a growth of 2.8 per cent. MNCs on the other hand reflected a growth of 1.9 per cent for the month on a SPLY basis. Out of Abbott, GSK, Pfizer and Sanofi which contributed around 66 per cent of the overall MNC turnover in IPM, only Abbott reflected a growth while GSK, Pfizer and Sanofi reflected degrowths.

The demonetisation drive had lesser impact on chronic therapy areas with the category reflecting 7.6 per cent

18

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February 1-15, 2017

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

November Month

Month Growth per cent

MAT November

MAT growth per cent

Global Pharma Mkt

83130

1.8

1057418

4.5

US

34224

2.9

447693

5.8

JAPAN

6808

7.7

80497

10.5

CHINA

6359

6.5

74519

1.2

GERMANY

3427

9.1

40666

3

VENEZUELA

2940

128

20008

63.6

UK

1871

-13.8

24229

-5.1

BRAZIL

1829

29.1

20527

3.3

FRANCE

1748

-31.4

32097

-1.4

CANADA

1666

1.4

19212

-1.6

INDIA

1255

6

15307

6.7

AUSTRALIA

1151

27.4

12916

17.7

RUSSIA

963

-1.7

11906

-5.8

ITALY

952

-58.6

27219

0.9

SPAIN

880

-46.9

20185

-0.2

TABLE 2: INDIAN COMPANIES MARKET SIZE IN THE GLOBAL MARKET All values in Million USD

November Month

Month Growth per cent

MAT November

MAT growth per cent

Indian Pharma market globally

1255

6

15307

6.7

Sun Pharma

104

11.9

1227

5.8

Abbott

81

12.6

963

6

Cipla

64

1.8

793

5.5

Mankind Pharma

47

5.7

584

11.2

Lupin Lab

42

13.8

494

7.5

Zydus Cadila

41

0.3

517

2

Glaxosmithkline

40

-1.8

497

1.3

Macleods

39

3.1

496

10.6

Alkem

37

3.3

477

9.3

Intas

36

7.6

430

7.8

growth over SPLY. Cardiac therapy reflected a six per cent growth while anti-diabetics grew at 14 per cent on a month basis. Among acute

therapy areas, anti-infectives de-grew at 12 per cent while gastrointestinals and respiratory reflected a growth of three per cent and minus two

per cent respectively.

Cardiac replaced anti-infectives to be the largest therapy area for the month for the first time, clocking a revenue

of ` 1149 crores. Rosuvastatin (10per cent), Telmisartan + HCT (16per cent), Amlodipine + Telmisartan (19per cent) were among the fastest

MARKET growing cardiac molecules for the month while Atorvastatin (-14per cent) and Telmisartan (-18per cent) were top molecules which reflected degrowth.

Anti-infectives slipped to the number two spot for the month with top five molecules reflecting de-growth for the month.

Amoxyclav solids (-8 per cent), Meropenem (-1 per cent), Ceftrixone injection (-27 per cent), Cefixime solids (-18 per cent) and Amoxyclav injection (-5 per cent) were among the top molecules reflecting degrowth.

Gastrointestinals continued to be the third largest therapy area for the month garnering a revenue of ` 929 crores with a growth of three per cent over SPLY. Proton Pump Inhibitors (PPIs) and their combination with Domperidone contributed around 18 per cent of the overall therapy area value. While most molecules reflected robust growth over SPLY, average growth of the top 10 molecules in gastrointestinals over SPLY was to the tune of seven per cent. Ranitidine solids (-3 per cent), Omeprazole + Domperidone (-5 per cent) and Antacid + Antiflatulant liquids (-5 per cent) were among the top molecules which reflected degrowth.

Anti-diabetics maintained its fourth position in IPM for December 2016 and emerged as the therapy area to reflect second highest growth on SPLY basis clocking a growth of 14 per cent. Dipeptidyl peptidase-4 (DPP4) inhibitors was the largest drug category in the anti-diabetic space with Teneligliptin contributing 19 per cent of the category by value. Top five categories in the anti-diabetic space which contribute 66 per cent to overall therapy area value reflected a growth in excess of 13 per cent with Glimiperide + Metformin + Voglibose combination and Glimiperide + Metformin combination reflecting 43 per cent and 25 per cent growth respectively.

Dermatology, one of the fastest growing therapy areas in IPM registered the highest growth for the month, clocking growth at 15 per cent

IPM OVERVIEW

IPM was valued at ` 112,570 crores and the retail sector was valued at ` 94,528 crores as of MAT Dec 2016 TSA has grown by 11 per cent at MAT and three per cent at month. Retail sector has grown by 10 per cent at MAT and 3% at month ● ●

Source: QuintilesIMS TSA & SSA, DEC'16

INDIAN / MNC TRENDS

SPLY with a value of ` 704 crores. Anti-fungals, Itraconazole (116 per cent) and Terbinafine (25 per cent) reflected highest growth among top categories with emollients continuing to dominate the therapy area.

Neurology reflected a seven per cent growth for the month over SPLY, Levetiracetam continued to be the largest molecule in the space clocking a value of ` 44 crores with a 14 per cent growth for the month. Sodium Valproate solids reflected a slowdown in growth with only four per cent for the month, down from 14 per cent reflected in November 2016.

In terms of new introductions, the industry witnessed a drastic drop in number of new introductions launched in the month of December post demonetisation.

Global (November 2016)

● ●

Indian companies registered growth of 2.8 per cent during the month and continue to dominate IPM in value terms Indian companies constitutes around 78 per cent of IPM during the month and MAT basis

Source: QuintilesIMS TSA & SSA, DEC 2016

ACUTE / CHRONIC TRENDS

● ●

Acute therapies continue to dominate the market constituting 64 per cent of the IPM The top TC4 in the IPM is DPP4 Inhibitor & Comb with a value growth of 15 per cent

Source: QuintilesIMS TSA & SSA, DEC'16

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The global pharma market is valued at $1057 billion growing at 4.5 per cent. The US continues to dominate the market with 42 per cent market share with growth of 5.8 per cent.

Amongst the top market, India has moved three positions down and is ranked 10th in November 2016. The markets which have shown value growth more than 10 per cent in the month of November globally is Venezuela, Australia and Brazil. Critical observation to be made in the month of November is, four of the Top EU5 markets have de-grown.

Indian companies hold 1.5 per cent share in the global market and growing faster than the global market as per November 2016 data. For the month of November 2016, the IPM showed growth and the Top 10 companies showed positive growth just leaving aside GSK. Sun Pharma, Abbott and Mankind Pharma showed double digit growth in November 2016.

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

EXPRESS PHARMA

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February 1-15, 2017

cover )

RESURRECTING

BRAND AP Visakhapatnam and Nellore to play pivotal roles in rebuilding Andhra Pradesh's reputation as a leading pharma hub

BY PRATHIBA RAJU

A

ndhra Pradesh, gearing to enter a new orbit of growth, is set to revive its IT and pharma sectors which took a hit post bifurcation. A major chunk of the pharma industry’s base remained in Hyderabad and its surrounding districts of Ranga Reddy, Mahabubnagar, Medak and Nalgonda which became a part of Telangana.

The state has plans to become to regain its position as a major pharma hub and is beckoning investors Now,

20 EXPRESS PHARMA February 1-15, 2017

the Andhra Pradesh government is contemplating to set up two big pharma clusters, one in Visakhapatnam and the second one in Nellore district of the state. These upcoming new clusters are expected to be crucial connecting points for the East and Far Eastern countries.

Located in the middle of coastal Andhra with well-developed infrastructure, an international airport and good rail connectivity, among other advantages, Visakhapatnam is well positioned to take on a pivotal role in

further progress in the pharma sector.

Lured by the incentives offered by Chief Minister of Andhra Pradesh, Nara Chandra Babu Naidu, multinationals such as Mylan, Eisai, Johnson & Johnson, Hospira have set to make significants investments in the state.

Major domestic players such as Dr Reddy’s Laboratories, Aurobindo Pharma, Hetero Drugs, Divis Laboratories, SMS Pharmaceuticals, Cipla, Ranbaxy, Laurus Labs, Lee Pharma, Sionc Pharma, Pharmazell, Raks Pharma, Natco, Granules, Neuland

(

Laboratories have also made inroads in the state.

Thus, the industry too is keen to leverage the opportunities being offered by Andhra Pradesh.

Teeming with opportunities The US-India Business Council, during a meeting with the Chief Minister, had discussed investment plans worth around $5 billion by Mylan,

which has four facilities in Visakhapatnam.

Citing that the sunrise industry has a bright future in AP, SV Krishna Prasad, CEO and Director, Cito Healthcare says, “The Andhra Pradesh government is taking proactive steps to develop the pharma industry in the state. In the recent bifurcation, the state had lost a major chunk of pharma industry to Telangana. So, the state government has taken

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measures to expand the pharma industry’s base in AP. As of today, the North Andhra region of pharma industry is worth nearly $2 billion.”

Adding to the state's advantage is the Jawaharlal Nehru Pharma City (JNPC) built over 2,200 acres at Parawada near Visakhapatnam, has 600 acres under SEZ. This has attracted major investments from Hospira, Mylan, Eisai, Reddy’s Lab and Aurobindo Pharma. Apart

THE MAIN FOCUS

from these, major companies such as Hetero Drugs which has a huge plant near Nakkapalli and Divis Pharma also have their expansion plans charted out for the state.

Also, Lupin Pharma has plans to invest nearly `500 crores while Biocon also plans to revive its Parawada facility. Johnson & Johnson has shown interest in setting up a greenfield project, So, these indicate that Andhra Pradesh is

striving to be a preferred destination for the pharma sector.”

“In the coming years, exports are expected to have a quantum jump, as the state government is adding another cluster in the JNPC region.

This would give a double boost to the new investors as most of the ancillary units required will be in the same vicinity.

With this, VisakHAPAtnam will have two pharma clusters, one at Parawada and the other

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February 1-15, 2017

cover ) which is yet to be finalised in the nearby vicinity to the existing one,” adds Prasad.

Creating coastal clusters

AP needs support of the central government for growth of the pharma sector, especially in the formation of a bulk drug policy. It would have specific measures to make India self sufficient in bulk drugs and APIs, thereby and reducing dependence on China Sasikant Misra Management Consultant and Ex-Team Member CII, Drugs and Pharma Sector

The state government should link investments with incentives and IT benefits should be given so that the investors are attracted to special sector specific zones and bio parks Sanjit Singh Lamba President and MD Eisai Pharmatechnology and Manufacturing

22 EXPRESS PHARMA February 1-15, 2017

Visakhapatnam’s 900 km sea coast is one of the most advantageous aspects for the development of the bulk drug industry. It is proposed to be one of the major logistics hub in the country, while Nellore located in the banks of Penna river, is also luring investors from the pharma sector.

According to experts, Andhra Pradesh is strong in manufacturing of bulk drugs and third in formulations in the country. The bulk drug segment will open a vista of opportunities for coastal regions in the state. It will emerge as bulk drug manufacturing hubs, against the traditional bulk drug hub Hyderabad. The districts that could stand to gain from the split include Visakhapatnam, Ongole, Nellore and Krishna.

Dr Lal Krishna, CEO, Ramky Pharma City (India), Visakhapatnam outlines, “The pharma business has a good opportunity for growth in Andhra Pradesh , particularly in Visakhaptnam and Nellore. The state government is mulling over to build one more Pharma City similar to JNPC, for which discussions are on. The second pharma industrial park is said to be bigger one. The sector-specific pharma industrial estate is a highly successful business model; the operating cost is low, and competitive advantages are also there for the sector.”

“At present, the JPNC pharma city has 611 acres under SEZ and 1531 acres are non-SEZ. The state government has a plan to build another bigger pharma city at Parawada near Visakhapatnam under public/private partnership. The Pharma City will have world-class infrastructure on an area covering 2,200 acres with stateof-the art environmental protection measures. This will facilitate the local industry to expand its manufacturing facilities and it is a positive signal for the pharma and biotechnology investors in the state,” Krishna adds.

Not just Nellore, Visakhapatnam, with its coastal line, will provide cheap maritime transportation of pharma products which can easily be exported or imported through ports, opines Prasad.

“Post bifurcation, Visakhapatnam is the next largest centre for pharma sector. The state government is taking

measures towards setting up clusters along the coastline with the ports such as Krishnapatnam, Machilipatnam and Kakinada. Apart from strengthening its ports, they are also increasing connectivity via road, particularly the Visakhapatnam-Chennai Industrial Corridor (VCIC), which will boost logistics and help the region to be a crucial connect point as well as logistics, manufacturing and bulk drug hub of the country,” he adds.

Fast-forward mode The state is also girding up for higher growth in pharma and biotech sectors and transforming itself from just a bulk drug manufacturing base. The state government is setting up three mini life sciences parks, which will be coming in the next three years. Plans are also to set up Life Sciences Knowledge Centres across the state through the PPP model.

In the coming years, exports are expected to have a quantum jump in the state with expansion plans of the existing companies inside and outside JNPC, along with a proposed life sciences park.

“The state government has planned to develop a mega Life Sciences Park at Visakhapatnam in 200 acres of land and also plans to develop a skill development and training centre to cater to the need of skill for the workforce employed in the industry and to generate new employment prospects in the sector. The state being a major contributor to the country’s exports in the category of bulk drugs/APIs needs the support of the Central Government for growth of the sector especially in the formation of a bulk drug policy, which would have specific measures taken on making India self sufficient in the bulk drugs/API segment and reducing the dependence on China,” says Sasikant Misra, Management Consultant and Ex-Team Member CII, Drugs and Pharma Sector.

“The new measures like Life Science Park and Knowledge Centers are great initiatives by the AP government. There is a good climate for investment when it comes to pharma sector,” comments Sanjit Singh Lamba, President and MD, Eisai Pharmatechnology and Manufacturing.

Thus, the industry is very optimistic about growth however, it is not without challenges. Lamba recommends certain measures to overcome them.

He suggests, “The state is con-

The Andhra Pradesh government is taking proactive steps to develop the pharma industry in the state.

As of today, the North Andhra region of pharma industry is worth nearly $2 billion SV Krishna Prasad CEO and Director, Cito Healthcare

The state government is mulling about building one more pharma city similar to JNPC. The sectorspecific pharma industrial estate is a highly successful business model; the operating cost is low with competitive advantages Dr Lal Krishna CEO, Ramky Pharma City (India), Visakhapatnam

( ducive for the sunrise industry due to factors such as plenty of land, good government policies, an established pharma industry, a growing medical devices industry and the upcoming bio pharma research park being set up in Visakhapatnam.

These factors are attracting many US and Europe companies to invest in Andhra Pradesh. However, though the state has immense potential, it does lag behind in providing world-class infrastructure, regulatory clearances are slow, and the pace of infrastructure development needs to accelerate. The state government should link investments with incentives and IT benefits should be given so that they investors are attracted to sector specific zones, bio parks etc. ” “In order to develop the skill set and train the local workforce and equip them to pharma, bio park and medical devices industry a research institute similar to National Institute of Pharma Education and Research in Hyderabad, should be set up in Visakhapatnam as well,” he further states.

Highlighting the need for more incentives from the government to boos the pharma sector in the state, he states, “Already burdened with Minimum Alternative Tax by the central government since 2011, we have not achieved much despite huge potential due to tax restrictions. The companies in SEZs are burdened with heavy tax like the custom duty even when they supply it to their own subsidiary in the Indian market. People have their own facilities but they can't supply to their own market because it is treated as import. If we invite a company to come and set up a facility in the SEZ here, it takes three to four years to set up the facility and get approvals. Until then the companies should be allowed to supply in the domestic tariff area, with some rationalisation in tax by the state government as it will help attract investors.”

Lamba urged the Andhra Pradesh government to give around three to four percent

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incentives based on their exports. “Such incentives can attract more investors, be it SEZ and non SEZ. China, Singapore, Philippines, Indonesia and Thailand are giving such

incentives,” he adds.

Both the newly formed states of Telangana and Andhra Pradesh have a competitive edge when it comes to the pharma sector,

THE MAIN FOCUS

but the former also has good infrastructure in place. Andhra Pradesh too should work at creating better infrastructure and a speedy approval system as these would be pivotal to its

growth as a pharma hub. However, with the port cities in its kitty, the future is bright for Andhra Pradesh in the sunrise industry. prathiba.raju@expressindia.com

MANAGEMENT REPORTS

US regulations hit global PMB M&As Mergermarket in the global Pharma, Medical & Biotech (PMB) sector report for Q1 –Q4 2016, highlights that total deal values for the sector fell 27.8 per cent in 2016 to their third highest values on Mergermarket record (since 2001), $283.4 bn, from 2015’s record-breaking $392.4 bn

G

lobal Pharma, Medical & Biotech (PMB) M&A felt the heat for the first time since 2014 from US regulations targeting tax inversion deals for the third year in a row, though still managed to take advantage of the need for consolidation in an environment of cheap financing. Total deal values for the sector fell 27.8 per cent in 2016 to their third highest values on Mergermarket record (since 2001), $283.4 bn, from 2015’s record-breaking $392.4 bn. Volume, despite dropping by 52, finished the year with 1,439 deals, the second highest number of transactions on record after the previous year’s 1,491. Government regulations also appeared to have an effect on cross-border activity.

2016 saw 468 such deals worth $126.5 bn, a 21.8 per cent decrease in value with 38 fewer deals compared to 2015’s 506 deals worth a total of $161.7 bn.

2016 also saw a 51.5 per cent decrease in value with 26 more deals compared to 2014 (442 deals, $260.9 bn). Mergermarket highlights the last two years, as 2014 hit highs for deal values and then saw a drop off that paralleled regulation roll-outs.

The US was once again the most targeted region for PMB M&A activity, with 528 deals worth $176.7 bn. This figure is a 40.8 per cent decrease with 74 fewer deals compared to the 2015 values ($298.4 bn, 602 deals). 2016 also saw the US’s global market share decrease from 76 to 62.4 per cent. Chinese inbound activity for the US reached all-time highs in 2016, a trend that can also be seen in the PMB sector. The year saw China’s highest investment values in US PMB assets ever with $1.5 bn and eight deals, also notable as the first time that Chinese inbound

24 EXPRESS PHARMA February 1-15, 2017

deals into the US’s PMB sector surpassed a billion dollars. With Chinese regulatory bodies looking to significantly reduce the outflow of capital from its borders, such a trend may not continue in 2017.

Europe’s share in global PMB M&A values jumped the most this year, rising from 8.4 per cent in 2015 to 20 per cent, recording 461 deals worth a total of $56.6 bn, a 71.8 per cent increase with 23 fewer deals com-

pared to 2015 ($33 bn, 484 deals). The two largest transactions, Boehringer Ingelheim’s $12.6 bn acquisition of Merial SAS. and Mylan NV’s $9.9 bn acquisition of Meda, both had bidders and targets based in

Europe. Both were also pharmaceuticals transactions.

Although the pharma subsector had four of five of the largest valued deals, it was not the top sub-sector for 2016, seeing 348 deals worth a total of $127.7 bn and the largest decrease in value (40.3 per cent) with 40 fewer deals from 2015’s 388 deals worth a total of $214 bn. Medical was the largest sub-sector in 2016, with 926 deals worth a total of $133.6 bn, down 16.9 per cent with 29 fewer deals from 2015’s $160.7 bn, 955 deals. The medical sub-sector was highlighted by medical device transactions seeing a large increase in activity. In 2016, medical device transactions saw 94 deals worth $58.5 bn in value, which is 43.8 per cent of total medical deal value for the year. 2016’s medical device performance is even more impressive considering it was a 198.5 per cent and 143.8 per cent increase from 2015 and 2014 figures, respectively, which were not only record years for M&A, but also for PMB M&A. Lastly, biotechnology saw 165 deals worth $22 bn, up 24.5 per cent with 17 more deals than 2015 ($17.7 bn, 148 deals).

Despite regulatory issues resulting in the collapse of high profile deals such as Pfizer’s $183.7 bn bid for Allergan in 2016, global PMB deal activity still managed to finish the year strongly. Anticipation over president-elect Donald Trump’s proposed tax holiday for companies to repatriate cash could also lead to more activity next year.

However, other Trump proposals such as trade and immigration restrictions could also cause problems for companies’ growth strategies, leaving 2017 a difficult year to predict.

APAC COPD market set to hit $7.3 bn by 2022 According to GBI Research, the prevalence of COPD is expected to increase significantly across the APAC markets as the smoking population increases THE CHRONIC obstructive pulmonary disease (COPD) market in the Asia-Pacific (APAC) is forecast to almost double from $3.7 billion in 2015 to $7.3 billion by 2022, representing a compound annual growth rate of 10.2 per cent, according to business intelligence provider GBI Research.

The company’s latest report states that the prevalence of COPD is expected to increase significantly across the APAC markets as the smoking population increases. The rising prevalence population, together with better diagnostic techniques, improving health awareness, and increasing health insurance coverage and

In terms of upcoming products, the latestage pipeline contains promising targeted and triple combination therapies with the potential for approval and launch by 2022

affordability, will increase diagnosis and the treatment-receiving population, driving demand and contributing to market growth.

Vinod Makthal, Analyst, GBI Research, explains, “Despite the substantial growth rate, there are a number of significant unmet needs in the COPD market.

Existing therapies are aimed at managing the frequency and severity of the symptoms, and none have been shown to modify

long-term disease progression.”

“Roflumilast, which is the only targeted therapy available in the APAC COPD market, has significant anti-inflammatory effects. However, the dosing of roflumilast is limited due to its side effects, which means that the therapeutic benefit is marginal. In this way, there is an unmet need for safe and effective disease-modifying therapies that can target inflammation and arrest the decline in lung function, as well as reducing the frequency of exacerbations in COPD.” In terms of upcoming products, the late-stage pipeline contains promising targeted and triple combination therapies with the potential for approval and launch by 2022. Following the anticipated launch of novel targeted interleukin-5 (IL-5) inhibitors and long-acting beta agonists/long-acting muscarinic antagonist/inhaled corticosteroids triple combination therapies over the forecast period, GBI Research believes the COPD space is likely to undergo rapid expansion.

Novel targeted therapies include GlaxoSmithKline’s mepolizumab and AstraZeneca’s benralizumab, which are IL5 inhibitors and both currently in Phase III development in Australia, Japan and South Korea. The late-stage triple combination therapies are PT010 and fluticasone/umeclidinium/vilatnerol. PT010 is currently undergoing Phase III development in China and Japan, while the latter is in Phase III development in China, Australia, South Korea and Japan.

Makthal continues, “The most important driver of growth in the COPD market will be the transition from bronchodilator agents to targeted therapies.

Mepolizumab and benralizumab are expected to launch in the forecast period, and to capture significant market share.

As both products are monoclonal antibodies, they are likely to be more costly than small molecule therapies, and therefore could generate significant revenues if approved.”

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EP News Bureau

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February 1-15, 2017

RESEARCH UPDATES

Alcobra to stop testing sole drug for ADHD after study fails The drug, MDX, did not induce a statistically significant benefit over a placebo in the 283-patient ‘MEASURE’ trial

A

lcobra said it would abandon evaluating its only experimental drug to treat attention deficit hyperactivity disorder (ADHD), after a failed latestage study, wiping away more than half the company's value before the bell. The Israeli drug developer is evaluating assets, both internal and external, and will present its strategic direction to shareholders in the coming weeks, CEO, Dr Yaron Daniely said. ADHD, a cognitive disorder characterised by inattention and/or hyperactivity-impulsivity that interferes with functioning or development, affects about four to five per cent of adults globally, according to Alcobra. At first, it was believed to only affect children, but ADHD is now known to persist into adolescence and adulthood.

The drug, MDX, did not induce a statistically significant benefit over a placebo

in the 283-patient ‘MEASURE’ trial, the company said. The drug has a checkered

past. The US Food and Drug Administration earlier recommended Alcobra con-

duct an extra six-month MDX trial to expel safety concerns emanating from preclinical data. The regulator had placed a clinical hold on the long-acting therapy in September in light of this data. About 80 patients discontinued treatment in the MEASURE study after the imposition of the hold, Daniely said. In 2014, Alcobra said it was encouraged by MDX's impact versus a placebo in a prior late-stage adult ADHD trial, only after excluding four patients from the analysis, citing "extreme placebo responses." In 2015, the drug failed a mid-stage study in Fragile X syndrome, a rare genetic condition that causes a range of developmental problems. Alcobra will continue to explore the promise of MDX in other conditions, including Fragile X syndrome, potentially with a partner in Europe, Daniely added.

Reuters

Stimulant boosts function in patients recovering from depression Researchers at Britain’s Cambridge University found the drug prompted significant improvements in memory and higher scores in a test PEOPLE RECOVERING from depression but struggling with its effect on memory, concentration and cognitive function may benefit from the stimulant modafinil, according to results of a small study published. Modafinil is a generic drug usually prescribed for sleep disorders such as narcolepsy. But in a trial of modafinil versus placebo in patients recovering from depression, researchers at Britain's Cambridge University found

26 EXPRESS PHARMA February 1-15, 2017

the drug prompted significant improvements in memory and higher scores in a test. Describing the results as promising, Muzaffer Kaser from Cambridge's psychiatry department explained how the effects of depression on brain performance in everyday life are often sidelined as both patients and doctors focus on improving mood.

"Cognitive dysfunction is an unmet need in the treatment of depression," he said.

"(Family doctors) or psychiatrists often hear complaints of concentration or memory difficulties from patients with depression. Our study demonstrated that modafinil may be a feasible option." Depression is one of the world's leading causes of disability, affecting 350 million people globally, according to the World Health Organization.

Almost all people with depression have problems with attention, concentration and

memory. This cognitive impairment tends to persist even as they start to recover from depression and can make it tough for patients to get back to work or to a fully functioning life - also increasing the risk of relapse. To test whether modafinil might help, Kaser's team asked 60 people previously diagnosed with depression to complete computerised memory, attention and planning tasks after receiving either modafinil or placebo. The

results showed that those on modafinil made fewer errors in two specific types of memory, episodic memory and working memory, both of which are important in day-to-day activities. Barbara Sahakian, who co-led the study, said longer term studies were now needed to see if modafinil can have a positive effect in terms of people successfully returning to work following depression.

Reuters

Egalet painkiller wins FDAapproval but label disappoints Egalet plans to launch Arymo ER, approved in three dosage strengths: 15 mg, 30 mg and 60 mg, in the US in the first quarter of 2017 THE US Food and Drug Administration has approved Egalet Corp's long-acting opioid painkiller, Arymo ER, and will allow the company to claim it deters abuse by those seeking to dissolve and inject it.

However, investors had hoped the company would also be allowed to claim the drug deters abuse by those seeking to snort or chew it.

The FDA’s decision ran counter to a recommendation by its advisory panel, which in August voted 18-1 in favour of approval. The panel recommended the drug be labelled as an abuse-deterrent product via all three routes: oral, nasal and intravenous. The FDA typically follows the advice of its advisory panels but is not obliged to do so. Arymo ER is a long-acting variation of morphine that is intended to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment. The FDA said in a statement that an extended-release morphine product made by Daiichi Sankyo, MorphaBond, has market exclusivity on the ability to claim it deters snorting. The company is exclusively allowed to make that claim until October 2, 2018.

The FDA did not say whether it will allow Egalet to make the snorting-deterrence claim when Daiichi's exclusivity runs out, but it will be able to do so if it wishes. The FDA did not approve a claim that the drug deters abuse via the oral route. The abuse of opioids, a class of drugs that includes heroin and prescription pain-killers, has reached epidemic proportions in the US. The Centers for Disease Control and Prevention estimates that 78 Americans die every day from an opioid overdose.

Egalet plans to launch Arymo ER, approved in three dosage strengths: 15 mg, 30 mg and 60 mg, in the US in the first quarter of 2017.

The same advisory panel

that recommended Egalet's drug also recommended the FDA approve a long-acting opi-

oid made by Teva Pharmaceutical Industries, Vantrela ER. It also recommended approval of

a long-acting, abuse-deterrent opioid made by Pfizer, Troxyca ER, although it had reserva-

tions about the drug's ability to curb all forms of abuse.

Reuters

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RESEARCH

Inotek’s eye drug fails late-stage study Inotek blamed the study failure on an unexpected high placebo response compared to that observed in mid-stage data INOTEK'S LEAD drug, trabodenoson, did not confer a statistically significant benefit over a placebo in reducing fluid pressure inside the eye in patients with the most common form of glaucoma and those with higher-than-normal ocular pressure. There is no cure for glaucoma, the second-leading cause of blindness in the world, according to the World Health Organization. Fluid pressure is a key indicator of glaucoma risk. Three doses of the drug were tested against a placebo over a three-month period in the trial, with data collected on days 28, 42 and 84 and at four time points during each of these days.

Only the highest dose of trabodenoson came close but still missed the main goal, data showed. Inotek blamed the study failure on an unexpected high placebo response compared to that observed in mid-

stage data. Piper Jaffray’s Joshua Schimmer said that while it may be tempting to hold out hope, he lacked confidence given the multiple study arms as well as the disconnect in findings versus the mid-stage trials. Additional data on the drug is expected later this quarter, and will determine Inotek’s next steps, the company

said. Aerie Pharmaceuticals, which is developing similar drug Rhopressa, is expected to resubmit an application to market the treatment at the end of the first quarter.

These new eye treatments promise to improve outcomes and reduce side effects associated with current glaucoma medicines, exploiting a dearth

of innovative new products for the disease. Aerie and Inotek’s drugs are the first to target the trabecular network, the main drain through which fluid flows out of the eye, though they do so in different ways. No new class of medicine has been introduced since Pfizer’s Xalatan, known generically as latanoprost, in 1996. Inotek is also testing a combination of trabodenoson with latanoprost.

Aerie also has another drug in development called Roclatan, which combines Rhopressa and latanoprost. Ocular Therapeutix is taking another approach.

Its device, which can be inserted into the eye to deliver regular glaucoma medication, is in mid-stage development.

Prostaglandins are the most widely prescribed glaucoma drugs, but can cause eye redness and changes to eye pigmentation and eyelash length.

Reuters

Life-extending capacity of new cancer drugs varies widely A third of the drugs lacked evidence to suggest they increased survival when compared to alternative treatments DRUGS RECENTLY approved around the world to fight cancer increased patients' overall survival, but benefits vary depending on the drug, a new study shows. Researchers looked at the 62 cancer drugs approved in the US and Europe between 2003 and 2013 and found they extended survival by an average of about 3.5 months. But nearly a third of the drugs lacked evidence to suggest they increased survival when compared to alternative treatments.

"Our results point to the notion that new cancer treatments may not always provide patients with greater clinical benefits, or lower risks, over existing treatments," wrote senior re-

28 EXPRESS PHARMA February 1-15, 2017

searcher Dr Elias Mossialos, of the London School of Economics and Political Science. The risk-benefit ratio of new drugs is especially important if people are concerned, for example, about whether the cost of a drug would make it difficult for a person to complete the treatment regimen.

Writing in JAMA Oncology, Mossialos and colleagues point to growing questions about the value of new cancer medicines.

While the drugs' high costs may be a barrier to access, they note, some people argue the high prices are justified if the treatments offer large benefits. A lack of solid data on new drugs' benefits and risks makes it dif-

ficult to evaluating their value.

For the 62 medicines they wanted to study, the researchers found data from England, France and Australia evaluating 53 drugs. Nearly 80 per cent were tied to improvements in survival, quality of life or safety.

The drugs increased survival - with or without recurrence - by about 3.5 months on average, compared to other treatments available in 2003. 23 drugs were individually tied to an increase in survival of three months or more. Six drugs extended survival by less than three months. Eight drugs increased survival by an unknown amount. And for 16 of the ap-

proved drugs, there was no evidence to suggest they were better than alternative treatments at extending survival. The researchers point out that overall survival benefits differed by the type of drug. For example, drugs for thyroid cancer were tied to no increase in overall survival, while drugs to treat breast cancer were linked to an average increase of about 8.5 months. 22 of the drugs were tied to an improved quality of life, but 24 were linked to worse patient safety, which include side effects and whether a person could tolerate the treatment.

Reuters Health

Heron drug for post-surgery pain succeeds in midstage trial HERON THERAPEUTICS said its experimental combination drug for post-operative pain led to significant reductions in pain intensity and the need for opioids, according to initial data from a midstage trial.

The pain drug, HTX-011, which combines a long-acting version of the anaesthetic bupivacaine with the anti-inflammatory meloxicam, produced a statistically significant 36.6 per cent reduction in pain versus placebo through 96 hours following abdominoplasty, a cosmetic procedure commonly known as a tummy tuck. Statistically significant reductions in pain were reported between 24 and 48 hours, 48 to 72 hours, and 72 to 96 hours compared with placebo after a single administration of HTX-011, the company said. HTX-011 also led to statistically significant reductions in the need for opioid medication, which could make it an important alternative if approved. Postsurgical use of opioids can cause severe constipation and lead to future abuse of the highly addictive pain drugs.

Following discussions with US health regulators, Heron said it expects to begin larger Phase III studies this year with an eye toward seeking approval in 2018.

Heron said its combination pain therapy could be used following a wide range of surgical procedures involving small to very large incisions, such as with abdominoplasty. The drug, which is applied directly to the incision site, has previously been tested in bunionectomy and hernia repair.

Reuters

RESEARCH

Synthetic Biologics' C. difficile mid-stage study meets main goal C. difficile is most often spread through hospital surfaces and human contact and typically affects the elderly SYNTHETIC BIOLOGICS said its experimental treatment designed to reduce antibiotic-resistant ‘superbug’ infections, notably life-threatening C. difficile, outperformed a placebo in a trial.

The company's oral enzyme, ribaxamase, met the main goal of significantly reducing Clostridium difficile infection, the most common cause of hospital-associated infectious diarrhoea. Ribaxamase, tested against a placebo in a 412-patient mid-stage study, is being developed to protect trillions of ‘good’ bacteria living in the digestive system from the unintended effects of intravenous antibiotic use.

These bacteria are believed to play a role in everything from obesity to depression. Seven cases of C. difficile infection were reported in the placebo group, compared to two in the ribaxamase group, a preliminary analysis showed. As the antibiotics typically used to treat C. difficile kill good bacte-

ria, it becomes more difficult for the body to fend off the C. difficile germ, creating a vicious cycle.

C. difficile is most often spread through hospital surfaces and human contact and typically affects the elderly. Switzerland's Nestle SA, the world's largest food company, said in September it was looking into socalled microbiome therapy, a concept that includes faecal transplants, to cure C. difficile.

This therapy can cure patients by replenishing the good bacteria in their gut by transplanting bacteria from a healthy person's stool, delivered through a nasal or rectal tube. Antibiotic-resistant infections are a grave threat to public health. A Reuters investigation has found that infectionrelated deaths are going uncounted, hindering the ability of the US to fight the scourge.

Reuters

FDA speeds up review of Roche’s Tecentriq to treat another bladder cancer ROCHE SAID that US regulators agreed to priority review of its Tecentriq immunotherapy for an additional type of bladder cancer, a boost to the Swiss drugmaker's bid to expand indications for the drug. Under the accelerated review, the Food and Drug Administration will make a decision within six months on Roche's application for Tecentriq's use in patients with metastatic urothelial carcinoma who are ineligible for cisplatin chemotherapy and who are either previously untreated or have disease progression at least 12 months after receiving chemotherapy before or after surgery.

Tecentriq was approved last year for another group of patients with locally advanced or metastatic urothelial carcinoma as well as non-small cell lung cancer, the most-common form of lung cancer.

Reuters

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February 1-15, 2017

LOGISTICS SPECIAL I N T E R V I E W

‘Locus aims to be a market leader in the healthcare services domain’ Locus, a machine learning start-up, is helping companies across sectors automate their intra-city scheduled and on-demand delivery, thereby ushering a new paradigm in logistics solutions. Nishith Rastogi, Co-Founder and CEO, Locus, talks about the differentiators that his company offers, the challenges it seeks to address and changing trends in pharma logistics, in an interview with Lakshmipriya Nair Excerpts As a logistics solutions company, how are you different from your counterparts? What are the three major differentiators that you have brought to the table?

Locus is a highly intelligent platform that focusses on decision making. We are not just a software developer but a squad with an ability of solving complicated operational challenges on ground. It is the first automatic dispatch engine to work on the ground and scale as per the industry's wants.

Our routing technology is easily adaptable to several verticals and use cases, right from moving people to packages. From cement to FMCG and the pharma industry where time is of essence, our platform can easily be scaled for crossindustry disruption.

Locus’ planning engine concocts highly optimised routing while it envisages constraints like time, volume, etc., taking into account several variables, including real-time gridlock conditions.

What are the most pressing challenges that you seek to overcome in the logistics arena through your solutions?

Let’s categorise these challenges to decipher them better. Productivity vs time is a major challenge that needs

30 EXPRESS PHARMA February 1-15, 2017

to be addressed in logistics.

The key current issue is underutilisation of space and resources. Dependency on human resources makes the entire operation sub-optimal.

Inefficient logistics leads to increase in overhead and resource costs, which is an alarming sign. The product margins get squeezed and this can make organisations noncompetitive in the market.

We must aim to impress the consumers during the last mile delivery to help create customer loyalty.

Customer experience is a key lever for Locus.

There is a huge reliance on humans for decision making (the question that the operations head always asks is - Manoj kahaan hai?) and hence issues with consistency are very big. Analytics and reporting day-to-day operations remain unanswered. Locus helps in addressing these challenges.

Why is automation the need of the hour in logistics?

Let's take the planning process as an example. Even now, a large number of traditional companies use excel sheets and paper-pen to plan their routes. Also, in order to keep up with customer requirements, the approach they use is to deploy an over-supply of resources.

One small change in the direction of automation holds

the potential to reduce costs and dependence on labour as well as make operations quick and accurate, regardless of the volume being processed.

The era of ‘one size fits all’ type of service has ended.

Nowadays, logistics solutions must be tailored to suit each customer. Full transparency of orders, visibility from raw material stage to final goods sale, and reverse logistics have almost become standards in this space.

One small change in the direction of automation holds the potential to reduce costs and dependence on labour

How are you geared to serve the healthcare sector which has very peculiar demands when it comes to logistics?

When it’s healthcare, time is the most critical factor that is stressed upon by the industry.

In services like diagnostic sample collections and delivery of medicines at patients’ doorstep, time sensitivity play a vital role.

The underlying prescription for today's advanced healthcare supply chain approaches—regardless of the healthcare organisation's scope and scale—is technology, with a strong dose of data and analytics. We enhance these service levels and ensure that the customer is catered to on-demand and on-the-go.

At Locus, we help our customers increase the serviceability quotient by increasing the utilisation of

current resources on ground and continuously tapping their ability to provide additional offerings to their end customers.

You have recently signed a deal with 1mg, an online pharma player. Can you share more details about it? Are there any more deals in the pipeline as far as the pharma sector is concerned?

Locus helps 1mg in delivering medicines to the patient's doorstep. Primarily, we help them optimise their deliveries by enabling efficient automation and optimisation using our route planning engine. The average distance travelled per rider for every task completed was reduced by 50 per cent by following the routes planned by Locus’ optimisation engine.

We are at various stages of discussions and pilots with some of India's largest diagnostics labs and other medicine delivery companies.

What are your growth plans for the sector this year?

The healthcare industry has realised that it's time to bridge the gap between technology, data, and analytics to truly transform supply chain into a strategic business asset.

Various companies have now Continued on Page 32

I N T E R V I E W

‘Pluss is today working with all major pharma and vaccine manufacturers in India to educate and grow its market share’ Samit Jain, MD, Pluss Advanced Technologies, talks about the company’s innovative product offerings for pharma logistics, in conversation with Mansha Gagneja The vision of PLUSS is creating innovations, how have you been strategising to achieve it and what are your plans for the future?

Creating Impactful Innovations – is how we define our vision. It is simple and straightforward thereby easy to remember for each one in our team. To successfully create innovative products, we need to first ensure that the entire team is in sync with our vision – we work hard on developing the person and helping the R&D team members work collaboratively with the Marketing team members to create what the customer needs and incorporate design thinking into our processes. In today's age, distractions are easy and that is the biggest hindrance to thinking and innovation – we guide our team members to overcome this and focus on thinking to be able to find innovative and low cost solutions. We hope to create one new product each year that would try and address the challenges that countries like India face with a focus on clean energy and access to energy.

Could you brief us about the new launch CELSURE? Vaccine delivery is a challenge. WHO data says that over 30 per cent of vaccines and pharma products are often wasted because of the lack of temperature control. Infact people don’t realise that vaccines should never 0 go below 2 C – and the industry today conveniently uses ice packs to transport – especially the last mile delivery. It should not cross 8o C either.

Insulin, when open should be stored between 15o C and 25o C and when closed should be between 2 and 8o C. There are no laws to enforce this and ignorance of the consumer is the saviour for the industry. At PLUSS, we recently launched two products – CELSURE for the pharma and logistics companies that can use our box and transport these products at the right temperature for 96 hours and beyond at the tropical temperatures that countries like India, South East Asia and Africa have. PronGO was launched for the insulin segment for home use. It allows the consumer to keep the Insulin at the right temperature for 8 to 15 hours.

Elaborate on the application of Phase Change Materials in the pharma industry and how are you

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LOGISTICS SPECIAL I N T E R V I E W

‘We recorded a growth of around 15% last fiscal’ Sunil Saraf, Director, REMI Group, speaks about his company's offerings for the pharma sector and its growth plans, in an interaction with Express Pharma Give us an overview about REMI Laboratory Instruments and its growth REMI is a well-known brand with the scientific and healthcare community in India for more than 50 years.

It is a pioneer in supplying innovative products that are import substitutes thereby helping the nation save precious foreign exchange. We were the first in India to manufacture table top centrifuges, laboratory and magnetic stirrers, high speed (20000 RPM) centrifuges, refrigerated centrifuges, blood bank centrifuge for component separation, CE marking for table top centrifuges, mixers and shakers and biggest top entry agitator in India for fluid mixing.

REMI has been exporting its products to more than 50 countries globally. We participate in international exhibitions and trade shows to increase our presence and keep ourselves abreast with the changing technology, customer requirements and new product introductions.

How has REMI Laboratory Instruments contributed in the growth/success story of the Indian pharma industry?

The Indian pharma sector is expected to reach $20 billion in 2015 -2016, In order to facilitate such an exponential growth, the pharma sector needs constant supply of state of the art products which are technologically advanced and quality driven. REMI has been

and efficiently.

catering to the pharma industry for over 50 years; we always strive to be at par with global standards with respect to technology, ingenuity and innovation. Whether it be testing, storing, freezing or mixing, our products are reliable and help pharma companies go about their daily operations smoothly

What are the advantages of your products? How good are they in comparison with your competitors?

REMI are pioneers in the laboratory and healthcare industry. Our products are reliable, safe, user friendly and performance oriented.

We, at REMI, believe in our core values of providing quality products to our customers, we leave no stone unturned in designing, manufacturing and delivering quality products to our customers.

How much revenue did your company generate in the last fiscal? What percentage of your revenue came from the Indian market?

REMI is constantly growing and improving year by year.

We recorded a growth of around 15 per cent last fiscal and we expect to grow even more next year. Our habit of improving our products without compromising on quality is what sets us apart and helps us increase our revenue.

We have upgraded our product range this year with new and innovative products.

We have also recently launched REMI Healthcare Division. The healthcare division will primarily focus on providing quality products to diagnostics centres, pathology labs, blood banks hospitals, clinical and medical research institutions etc.

EP News Bureau

Continued from Page 31

Continued from Page 30

Pluss is today working with all major...

'Locus aims...

facilitating it?

Pharma products typically require three temperature ranges for storage and transport: -15 to -25o C 2 to 8o C +15 to + 25o C. In the negative temperature range, the standard method is to use dry ice; in the two to eight range companies resort to ice packs and for 15 to 25 the solution is found using cold water or a combination of cold water and ice. Each of these methods have the biggest drawback that the temperatures are not precisely maintained in the range. Phase Change Materials (PCM) are materials that store energy at a particular temperature. So,

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February 1-15, 2017

we have a -23oC PCM that melts above -23oC (say around -20oC) and thereby maintains the temperature in the range of -15 to -25o. Similarly a +21o PCM is used to maintain the controlled room temperature of +15o C to +25o C. PCMs provide better control on the temperature thereby preventing medicine spoilage.

Pluss today is supplying its PCMs to European and American pharma industry and logistics players to create solutions using its savE Advanced PCM range.

What are the other products your company offers for pharma industry?

At PLUSS, we recently launched two products — CELSURE for the pharma and

logistics companies that can use our box and transport these products at the right temperature for 96 hours and beyond at the tropical temperatures that countries like India, SE Asia and Africa have. PronGO was launched for the insulin segment for home use. It allows the consumer to keep insulin at the right temperature for eight to 15 hours.

Today, Pluss supplies its PCMs to the European and American pharma industries and logistics players to create solutions using its savE Advanced PCM range.

Who are your clientele and which products are they using?

The Celsure box has been

approved by logistics players such as Blue Dart and DHL for pharma transport. Pluss is today working with all major pharma and vaccine manufacturers in India to educate and grow its market share. Outside India, Pluss is supplying to pharma players in the US and France currently for manufacturing boxes that can guarantee the right temperature.

In the retail segment, we have listed our PronGO bag for insulin on Amazon and we see good traction there.

Individuals now have access to the right technology to ensure their insulin transport and storage is at the right temperature!

started emphasising on the fact that customer requests have become very diverse and hence, timely customer service is the need of the hour.

Healthcare companies require a comprehensive fleet management solution to cater to these requests without increasing their operational expenditure and fleet size.

This means that there is a need to increase the productivity of the service agents on ground.

The healthcare sector currently contributes to 15 per cent of our top line and by the end of the year, as per our projections, this will grow to 20 - 22 per cent.

Locus aims to be the market leader in the healthcare services domain.

manshagagneja@gmail.com

lakshmipriya.nair@expressindia.com

LOGISTICS SPECIAL PRODUCTS

OVEN Industries offers low cost temperature controller that operates with thermoelectric modules ACCESSORIES AVAILABLE are digital display, keypad, sensors and cable.

This open board temperature controller is specifically designed with a proportional integral control algorithm to provide the most precise control to thermoelectric (Peltier effect) modules at the most economical price. The controller can be set up for heat or cool and can run ramp and soak profile. Pulse

OI also carries a full line of standard products, purchasable online, including temperature controllers and sensors, power supplies, heat sinks, thermistors and thermocouples. OI supplies precision electronic devices that serve an array of clients not limited to these industries; aerospace, automotive, biomedical, defense markets, medical and semiconductor.With a superior de-

width modulation controls the power level in the thermoelectric module at a base frequency of 2.5 KHz, output stage is high resolution.

Oven Industries, (OI) was founded in 1964 and specialises in the development of custom electronic temperature controllers and sensors along with extensive turnkey contract manufacturing capabilities and international Sourcing.

sign engineering staff and complete production facilities, the company is a leading technology and development company.

Contact details Rose Wescott 717-766-0721 r.wescott@ovenind.com visit www.ovenind.com

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LOGISTICS SPECIAL

Newtronic Lifecare Equipment introduces CO2 incubators NEWTRONIC LIFECARE Equipment, an ISO 9001:2008 certified company has launched CO2 incubators.

with heater in duct with circulating fan providing a superior uniformity. ◗ Fan-assisted air circulation for rapid recovery airflow patterns are specifically designed for superior distribution of critical environmental conditions (temperature, gas exchange and humidity). ◗ Efficient circulation minimises variation between cultures, while preventing desiccation - no matter where your cultures are located in the incubator.

Standard equipment ◗ Auto-sterilisation with hot air at 1800 C ◗ Humidification system with condensation protection ◗ CO2 gas-mixing with air circulation in chamber ◗ CO 2 sensor with infrared technology ◗ Tightly sealed inner door made of tempered safety glass ◗ Inner and outer chamber is constructed of 304 stainless steel. ◗ Perforated shelves, stainless steel ◗ Units are stackable ◗ Troubleshooting system with visual and acoustic alarms.

High temperature decontamination (1800 C)

Accurate control ◗ PLC-based touch screen display controller, infrared (IR) sensor control CO2 levels within the chamber. ◗ Temperature and humidity

sensors give accurate measurements of conditions in the chamber. ◗ Advanced design provides very stable controls.

Uniformity ◗ A table top design (100 litres) has more useable space with a small foot print. ◗ Chamber is directly heated

◗ Incubatorcan be conveniently cleaned using high temperatures and eliminate the need for separate autoclaving and re-assembly of components. ◗ Automatically radiates heat uniformly to all interior surfaces, requiring no post-cycle cleanup, and returns quickly to your selected operating conditions. ◗ Proven technique to eradicate biological contaminants

with certainty ◗ Avoids physical constraints and variation of ultraviolet germicidal lamps ◗ No sensors (CO2, temp., humidity) to remove during decontamination cycle makes all sensor sterilisation ◗ Eliminates the need for storage, handling and disposal of potentially toxic gemicidal chemical agents.

Key features ◗ PLC-based control system ◗ Touch screen display ◗ Password protected sterilisation ◗ Sterilsation cycle over in 7.5 hours. ◗ No sensor to remove during the decontamination cycle ◗ Easy to clean ◗ User-friendly operating ◗ Uniform growth conditions ◗ Absolute sterility of inner chamber.

Contact details 108-ABCD, Kandivli Co-op Ind Estate Charkop, Kandivali (W), Mumbai-400 067

Goodwill Retails launches FiberFix in India FIBERFIX HAS been introduced in India by Goodwill Retails. It can fix an array of problems ranging from fixing pipes to broken hardware. As the name suggests, FiberFix uses industrial grade fibre and resin to repair and fix products from mixed media that will bond to almost anything, hardens like steel, and provides a permanent fix. It is also more than a 100x stronger than duct tape.

A number of industries, including pharmaceutical industry, can benefit from its usage

34 EXPRESS PHARMA February 1-15, 2017

as it fixes motor pipes, water pipes, high pressure pipes, vehicle parts, breaks in machine parts, garner hoses, etc. It can drastically reduce down time in industrial settings, not only saving money, but also resulting in better productivity and efficiency.

FiberFix being self-adhesive, requires no other products in the process which takes about two to five minutes. It is waterproof and heat resistant.

It comes in two variants- the wrap and the patch. The wrap

is available in four sizes –1”x12”, 1”x40”, 2”x50”, 4”x60”.The patch comes in three sizes3”x3”, 2”x8” and 5”x5”.

Apart from India, the product is also available in over 24 countries.

Contact details HK Jain, Director GoodWill Retails 9619997115/3115 fiberfixindia@hotmail.com goodwillretailspvtltd@ hotmail.com

LOGISTICS SPECIAL

Clean room high speed doors by Gandhi Automations a necessity

CLEAN ROOMS have become integral part of pharma manufacturing facilities. One of the most important aspects of cleanrooms is the doors chosen for cleanroom facility. Time for which door is open will play a critical factor in avoiding dust, outside temperature, humidity etc. Opening and closure of door has to be quick enough to isolate the outside environment and internal facility.

Gandhi Automations provide clean room high speed doors specifically designed for above purpose. The clean room high speed doors are best suited for facilities which need controlled environment. The opening and closing of door is quick enough to separate outside environment and internal facility.

High speed clean room doors designed by Gandhi Automation are engineered carefully with the following features:◗ Concept of low air permeability in pressurised rooms with positive and

negative air pressure ◗ Designed to fit inside the columns ◗ Self-supporting construction ◗ Minimises air leakage ◗ Can be equipped with transparent PVC horizontal sections or vision windows ◗ Special side guides to tightly integrate the curtain ◗ High leak tightness due to the close filling curtain in the guide rails ◗ High door efficiency with and low permeability values, EN 12426 EN 12427: < 12 m3/m2 h Δ 50 PA. ◗ Control device enclosure in stainless steel SS 316 Contact details Gandhi Automations Chawda Commercial Centre, Link Road, Malad (West), Mumbai - 400064 +91-22-66720200 / 66720300 (200 lines) Visit: www.geapl.co.in SMS: 'GANDHI' to 58888 Email: sales@geapl.co.in

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LOGISTICS SPECIAL VALUE ADD

Instrumental advancements LABOMED brings high-end microscopes and diagonstic medical devices designed with the help of 3D printing HELPING SCIENTISTS shed new light on the microscopic world around us is at the centre of what LABOMED does.

Based in India, LABOMED’s research and development team creates a wide range of high-end professionals Stereo Microscope, Slit Lamp, Surgical Microscope and Colposcopes for biomedical, ophthalmology and gynaecology. Since its establishment in 2006, LABOMED’s high-quality products have made it among top 10 brand in medical diagnostic devices globally.

Focussed on creating flawless products, founder Neeraj Jain and the LABOMED team looked to 3D printing to help improve design quality, quicken the product development cycle and keep up with growing demand.

3D Printing

Time per Part

Cost per Part

Outsourced

28 days

$383.00

In-House

Less than 1 day

$180.00

Savings

27 days

$203.00

3D printed ring light painted red

Magnifying innovation LABOMED initially relied on China-based service bureaus for 3D printed prototypes to verify concepts and functionality. However, outsourcing was time-consuming and difficult due to communication with vendors. Also, working with strict validation schedules did not allow enough flexibility during the design review process.

“It was a Catch-22 for the team because it seemed that we had to forgo innovation to make time for quality. There was no room for any rough designs or ideation when we outsourced our prototyping because we had to meet tight production and launch schedules,” said Jain.

Outsourcing 3D printed prototypes was not only time-consuming, but it amounted to substantial costs with less than desirable results. Ordering one prototype could take as long as one month and cost ` 25,000

36 EXPRESS PHARMA February 1-15, 2017

3D printed binocular body cover of the LABOMED Binocular Microscope

($ 383). Plus, prototypes created by vendors using powderbased 3D printing were breakable and in-accurate. In-house 3D printing allowed for validation earlier in the design, helping avoid the costly need for changes at the end of the design process.

To save time and money, LABOMED acquired their own 3D printer from Stratasys.

With 3D printing in-house, the R&D team conceptualises ideas and creates mock-ups as soon as their CAD files are ready. Engineers no longer need to wait one month to hold printed models in their hands. Prototypes are ready within two to three hours, and cost around ` 12,000 ($180), giving designers the freedom to test and iterate innovative designs.

Bringing success into focus

The 3D printed binocular body cover painted white on the left side

One of the most-printed components is the body covers for the LABOMED Surgical Zoom Microscope, which enhance the focusing mechanism of the binoculars on the instrument. To finalise the design of the cover, designers and engineers print prototypes to test the assemblies, living hinges and fit prior

to mass manufacturing. The printed body cover prototypes are tested for cracks or leaks before painting, and patterns are added for look-and-feel assessment.

“It would have taken us months to come up with the final binocular body cover design through a service bureau, but using the uPrint 3D Printer has streamlined the prototyping process, a huge benefit for us,” said Jain.

With the drastic reduction in time and cost spent on prototyping, LABOMED’s designers and engineers now focus on researching and generating new designs without worrying about meeting tight deadlines.

“The uPrint has resolved our design problems and has been one of the key elements that transformed our operations process,” said Jain. “We can now observe finer details in printed parts, identify design errors earlier on and ensure best-in-class products for our customers, all achieved in half the time and cost. Even our sales and marketing staff is ready to take on challenges and showcase new products and concepts with the highly precise 3D models.”

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

Reverse Laminar Air Flow (Dispensing & Sampling Booth)

Clean Room

Horizontal LAF Unit

Air Showers

Dynamic Pass Box

Static Pass Box

Garment Cubicle

The leading air management solution provider...

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

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

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

EXPERTS IN HVAC & CLEAN ROOM SOLUTIONS 502 & 503, 5th Floor, Satellite Silver, Andheri - Kurla Road, Marol Naka, Andheri (East), Mumbai – 400 059.

Tel:+91 9322218023 / +91 9324644630 /+91 9699626434 /+912228592275 E-mail : sales@airtechsys.in, sunil.airtech@gmail.com • Website : www.airtechsys.in

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s which lidation service Airtech offers Va otocols pr PQ , IQ, OQ & comply with DQ rnational te In ng wi llo fo conforming to Field Projects) : Standards (Green

•WHO cGMP •US FDA •UK MHRA •AUS TGA •South Africa MCC

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VISIT US @ B-126 Hall #1

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

Imavac™ - Silicone Hose reinforced with SS 316 helical wire

Imawrap™ - Silicone Hose reinforced with Polyester Fabric & SS 316 helical wire

Imaprene™ - Thermoplastic Elastomer Tube (TPE)

Imavacfit™ - Silicone hose reinforced with Polyester Braiding and SS 316 helical wire

Silicone Inflatable Seals & Gaskets

TM

Ami Polymer Pvt. Ltd. “Sealing Expert in Silicone”

An ISO 9001:2008/14001:2004/18001:2007 & Clean Room Certified Co. DMF #26201 accredited by USFDA

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CORPORATE OFFICE : 319, Mahesh Indl. Estate, Opp. Silver Park, Mira‐Bhayander Rd., Mira Road (E), Thane ‐ 401104. Maharashtra. INDIA. Tel.: +91‐22‐28555 107/631/914. Cell : +91‐9223 411 447 / 9223 290 931 / 43.

www.amipolymer.com

info@amipolymer.com

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PACKAGING PRODUCTS FOR HEALTH CARE

RUBBER STOPPERS

RUBBER WADS

DROPPER ASSEMBLY

BEAK TYPE DROPPER, OPVD DROPPER & BUILT IN DROPPER

DIFFERENT SIZE CAPS

DOSING SYRINGE WITH ADAPTOR

RUBBER DISCS WITH EUROHEAD CAPS AND FLASH BLUB

DIAGNOSTIC PACKAGING

PLASTIC MEASURING CUPS/SPOONS (FOR LIQUIDS & DRY POWDERS)/ PLASTIC CAPS (ROPP)

RUBBER DISCS & PLUNGER FOR DENTAL CARTRIDGES

TABLET & GELL APPLICATOR

EYE / EAR DROP BOTTLES (CONTROLLED DROP SYSTEM)

SYRUP SPOON

SCOOPS

LIDS FOR TIN CONTAINERS

30ML, 60ML & 100ML DRY SYRUP BOTTLE WITH CAP & MEASUGINC CUP

SINGLE & DOUBLE SIDED FEEDING SPOON

BHARAT RUBBER WORKS PVT LTD.

B-46, Girikunj Industrial Estate, Off. Mahakali Caves Road, Andheri (East), Mumbai - 400 003. INDIA. Tel.: +91-22-2687 5361 - 64 l Fax: +91-22-2687 5221 / 22 Email: marketing@brworksindia. com l Website: www.bharatrubberworks.com

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EXPRESS PHARMA Group Companies:

KILITCH HEALTHCARE LLP

NBZ

NBZ PHARMA LTD.

Manufacturing Facilities Accrediation: n n n

WHO GMP Approved ISO-9001:2015, 14001:2015 Certified OHSAS-18001:2007 Certified

Manufacturing Sections: n n n n

Small volume parenterals (Ampoule, Vials) Three Piece Ophthalmic Preservative Free Ophthalmic filling Prefilled Syring

Divisions: n n

Ophthalmic Division Export Division

Head Office: Kilitch Healthcare LLP, 902/B Godrej Colesium, Behind Everad Nagar, Near Priyadarshani Cirlce, Sion (East), Mumbai â&#x20AC;&#x201C; 400022.

Tel. : 022 6137 2222 Mr. Divya Mehta : +91 9819724957

Factory: NBZ Pharma Ltd. R-905, T.T.C. Indl. Area, M.I.D.C, Rabale, Navi Mumbai - 400 701.

Tel. : 022 2769 9174, 6516 2146 Mr. Krishnakant Yajurvedi : +91 7710040409

www.kilitchhealthcare.com

www.eyekarekilitch.com

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info@kilitchhealthcare.com

info@ekl.kilitchhealthcare.com

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EXPRESS PHARMA PHOTON CLEANTECH INC. Manufacturer and Supplier of Modular Operation Room, Cleanroom Turnkey Projects & Cleanroom Equipments

ISO 9001:2015 Certified Company

Ceiling Suspended LAF

Operation Room

Dispensing Booth

Air Shower

Bio Safety Cabinet

Cleanroom Panel

Doors

DY PB

Garment Cabinet

Fore more info contact:

PHOTON CLEANTECH INC. Survey No. 106 A/3, Office No. A-6, Surya Lok Nagari, Pune - 411028, MS, India.

Mobile: +91 8805060111 l Email: photoncleantech@gmail.com l Website: www.photoncleantech.com

1st Indian Company to launch “CE” approaved equipment.

1st Indian Company to launch “PLC Based” Control System.

21CFR Part 11 Compliant Software

GSM Technology: SMS Mobile Alert.

“Best Service in its Class”. Acclaimed by our Proud Customers.

Our World Class & World Renowned Equipment n

Walk-In Humidity Chambers.

n

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n

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n

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n

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Mack Pharmatech Pvt Ltd. B-48, Malegaon MIDC, Sinnar, Dist. Nashik, Pin - 422 113, Maharashtra, India

+91 2551230877

+91 2551230877

sales@mackpharmatech.com

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www.mackpharmatech.com

service@mackpharmatech.com

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LABORATORY EQUIPMENTS Laboratory Centrifuges

Laboratory Stirrers

Bench Top Orbital Shaking Incubator

Magnetic Coupling

Humidity Chamber with TFT Display

Ultra Low Frezeer Gerber Centrifuge

Neya Centrifuges

UTC Freezer

Multi Vortexer

Medico Plus

Walk in Chamber

REMI SALES & ENGINEERING LTD.

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

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OSMOMETER 3250

Milk Cryoscopes Available

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

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

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Wiper Type Sight Glass

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Our other product details

Manhole Pressure Type

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To Advertise in

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Mumbai: Rajesh Bhatkal

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Reduces handling & seed train expansion step for therapeutic production Contact Details: Wadala Shree Ram Indl. Estate, Unit No. C-32, 3rd Floor, G. D. Ambekar Marg, Wadala, Mumbai - 400 031, Maharashtra India.

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

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REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2016 – 18,PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001