Scope and Opportunities of Contract Research Services in India

Transcription

1 Scope and Opportunities of Contract Research Services in India Vijay Dahiya Sr.Business Manager New Initiatives (R&D) Panacea Biotec Ltd., New Delhi, INDIA

2 Introduction The Indian Drugs & Pharmaceuticals industry has made rapid strides in both National and international markets India offers both Cost and Value arbitrage Skill base, knowledge, innovative capacity, reduced timelines & costs are only a few of the advantages.

3 Drug Discovery - Issues Blockbusters pipeline getting dried up About 90% of drugs sell less than $150M per year About 30% drugs in the above mentioned category can t recover the cost in their life time It is widely believed that most of the low hanging fruits are already picked up Drug approving authorities are tightening the rules every year All these attributes to the phenomenal cost of discovery

4 What s already there 370 Biotech medicines to treat 200 diseases are in the development pipeline from 144 companies 178 for cancer, 47 for infectious diseases, 26 for autoimmune diseases, 21 for HIV/AIDS Of every 5000 compounds only 5 make it to clinical trials In spite of sluggish economy R&D spending is on the rise For the first 8 pharma companies there is 6.8% increase in the R&D spending. Approx. $8B spent on R&D in 2002 Contrary to popular perception FDA approval time has come down from 2.4 to 1.9 years from 60s to 99 Merck introduced 16 new drugs in 7 years

5 Research Strategy In the past companies out-sourced only minor components or some thing completely outside of their domain Once VP, Merck stated that outsourcing research is next to give away the company strategy Research efforts has to be more intense to be in the business How can a company maximize the research efforts without assuming tremendous liability otherwise?

6 Growth of Global Chemistry Services Market (US$ Billions) Value Year

7 Working with CROs Risk/Benefit Review Expected Benefit Reduced time to discovery and development Access to new technologies and expertise Access to focused, flexible infrastructure Lower capital investment, higher ROI Lower total cost Perceived Risks Loss of control Atrophy of critical discovery and developmental skill Regulatory risk Leaking Intellectual Property Mismatch of work culture leading to incompatibility Dishonoring exclusivity

8 Working with CROs Issues to consider Technical ability, reputation, experience Communication skill Knowledge of specification/regulatory requirements Quality systems, Accreditation Track record of honoring IPRs Adherence to timelines Price/Cost Long-term partnership To achieve the desired goals with minimum resource input

9 Outsourcing Process Speed Cost Science & Quality C x S x SQ = Productivity Indian Weakness: Raw material resourcing Private courier regulations Customs trappings

10 CROs in the developing countries QUALITY COMES FIRST CROs in the developing countries lose credibility very fast on this account Accurate Certificate Of Analysis report must accompany the deliverables Prior clear understanding with the clients on the parameters of QC. TIMELY delivery is very important but not at the expense of QUALITY

11 CROs in the developing countries COMMUNICATION India has a distinct advantage over its competitors and it s of prime importance Telecom revolution has helped enormously Cultural acquaintance may be helpful (like BPO?)

12 INDIAN ADVANTAGE Communication Documentation Good analytical set up cgmp compliance (if necessary - more credibility required) Consistency Long term commitment Strong legal system (Better than our competitors) Straight forward pricing

13 Current Gloom Prevailing in the Biotech World NEARLY 40% BIOTECH COMPANIES HAVE STOCK VALUES BELOW $2.00 PER SHARE, AND 20% HAVE VALUES BELOW $1.00 AND FACE DELISTING. SOME 25% OF COMPANIES ARE TRADING AT A VALUE LESS THAN THEIR AVAILABLE CASH PER SHARE. AND MANY HAVE LESS THAN A YEAR S WORTH OF MONEY TO FUND OPERATION CHEMICAL & ENGINEERING NEWS, JAN. 27, 2003, PP.41

14 WHAT S INDIAN CROs PROSPECT IN THIS BACK DROP? The discovery companies will rely more on sophisticated technologies currently not available in India In spite of that business will not be seriously affected as this constitutes a miniscule fraction of the total cost but we will not see the great surge till the market improves More companies will be willing to work if they can pay by stock swapping etc. - Introducing cash substitute CROs should change gear and be prepared for short term projects - intense marketing effort required to bring in more customers - not merely using as a backend hub Credible Value Addition will determine a CROs future

15 CONCLUSION Contract Research Services holds lots of promise for India. Communication - India has a distinct advantage. IT - Strength for the the bioinformatics applications. The best R&D companies have already setup operations in India. Ability to provide ICH GCP compliant clinical research studies. Clinical research that accounts for majority of drug development costs,could be immensely controlled by outsourcing from India. The diverse population and genetic pool available offers wide ranging opportunities for Clinical research. A large no. of research labs, universities and other academic institutions can provide cost effective interdisciplinary research. Spare capacity can offer long term facility /resource commitment to projects. India has the second largest no. of cgmp facilities outside of US. Change of legislation, understanding of the urgency, realization of the fierce competition from the neighborhood will facilitate growth. Availability of quality research capacity and the ability to meet the research objectives at very economical terms on committed timelines makes India the destination for outsourcing Drug development and clinical research.

16 Innovation has to be continuous and has to better every single time Panacea Biotec addresses another strategic. need few of the endorsements.20th Oct 2004 High hopes for fridge-free jabs British Scientists Develop New Vaccine Scientists develop fridge-free vaccine A new technology developed in the UK could Technology WEDNESDAY, OCTOBER 20, 2004 : A leading Indian revolutionise vaccine delivery by eliminating the LONDON (Reuters) - British scientists have taken tips from bio-tech firm is on the cusp of manufacturing a need for refrigeration. Mother Nature to develop a new technology that could... revolutionary new, UK-developed vaccine... read more... read more... read more... Panacea Biotec to manufacture CBL s revolutionary vaccine Wednesday, October 20, 2004 : A new technology, based on processes that are two billion years old, promises to revolutionise... Forget The Fridge, wait for vaccine in sugarbox NEW DELHI, OCTOBER 19: A low-cost child vaccine that can be transported and stored in the most remote villages without need for refrigeration will be out in a couple of years. Press Release - 9th OCT DFID BOOST FOR NEW VACCINE TECHNOLOGY WHICH COULD PROTECT 10 MILLION MORE CHILDREN FROM KILLER.. read more... read more... read more...

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18 Introduction Panacea Biotec is one of the leading and fastest growing health companies, involved in research, production and marketing of ethical pharmaceuticals, vaccines, and biopharmaceuticals products. Panacea Biotec is a proactive customer centric company and lays emphasis on innovation and quality.

19 Core Competencies 3 State-of-the-art Research & Development Centers with over 155 Scientists Collaborative Research & Development Programme Joint Ventures & Product Licensing Arrangements 3 Production Facilities Meeting cgmp Norms Established Brand Equity In Many Therapeutic Areas Dedicated Sales and Marketing team of more than 1000 professionals. BestOnhealth.com Health Portal

20 Ranking Panacea Biotec is ranked 43rd in terms of retail sales audit (IMS-ORG April 2004, MAT) and 38th in prescription audit (CMARC, Nov 03- Feb 04). Panacea Biotec is ranked 2nd amongst 200 biotechnology companies in India.(Biospectrum, Vol. 1, Issue 7, September 2003). Panacea Biotec also features in first 250 companies in the D&B s annual report India s top 500 companies.

21 Panacea Biotec is among India s most valuable companies. Achievements India s biggest wealth creators (The BT-Stern ranking of companies - Business Today, 11 April 2004).

22 Research & Development Core Research Areas: - Drug Delivery - Natural Products - Drug Discovery - Vaccines - Biopharmaceuticals Supporting Functions: - Analytical / Bio-analytical - Process Chemistry - Information Science - Intellectual Property Rights - Documentation & Regulatory Affairs - Pre-Clinical & Clinical Research

23 Pharmaceuticals A state-of-the-art 30,000 sq.ft. research facility with 110 scientists dedicated for Pharmaceutical Research. Panacea Biotec has extensive research capabilities on the following areas : - Self Microemulsifying Drug Delivery Systems (SMEDDS) - Mucoadhesive / Bioadhesive formulations - Specialized tablets (inlay / bilayer / tablet in tablet) - Gastroretentive Systems - Targeted Drug Delivery - Hydrophillic Matrix Systems - Nanoparticles - Taste Masking - Mouth Dissolving / Dispersion Systems -Transdermal Drug Delivery - Particle coating / Beads

24 Facilities Include Pharmaceutical - Sophisticated Drug Delivery Labs equipped with Lyophilizer, Zetasizer, Particle Size Analyzer, High Pressure Homogenizer, Differential Scanning Calorimeter, Fluidized Bed Processor, Spray Drier, Multilayer/Tablet-in-Tablet Machines etc. - Pilot Plant Facility for Clinical Trial Batches - Sophisticated Analytical & Bio-analytical Labs equipped with an array of HPLCs, Gas Chromatography equipment, FTIR, LC-MS/MS etc.

25 Animal House Species available mice, rats, guinea pigs, hamsters and rabbits. Breeding facility - mice, rats, guinea pigs and rabbits. Approved by Govt. of India and monitored by Institutional Animal Ethics Committee. Facilitates research relating to -Evaluation of conventional & newer vaccines -Respiratory Pharmacology -Nociception / Inflammopharmacology -Neuropharmacology -Gastrointestinal permeability studies -Pharmacodynamic studies -Biochemical and Hematology studies -Pre-clinical and toxicity studies -Newer animal models

26 Vaccine & Biologicals Research Centered on the knowledge-base of over 45 scientists, the division has delivered two products in the market: ENIVAC HB in Uniject and Quadruple (DTwP-HB) vaccine. The novel combination vaccine Liquid Pentavalent (DTwP-HB-HIB) is scheduled to be launched by Dec The division is focussed on the following areas of development: Cell - culture based viral vaccines Bacterial Vaccines The division also plans to carry out research on J.E.V.Vaccine, Cholera vaccine, Dengue Fever etc. in collaboration with reputed institutes / universities.

27 - Confidential - Vaccines Product Pentavalent Vaccine (DTP-Hb-Hib) Manufacturing & Analytical Validation Developmental stages Mfg & Analytical Standardisation Pre- Clinical Completed Completed Completed Clinical trial Phase I Clinical trial Phase II/III Final Mfg Completed Completed In Progress Tetravalent Vaccine Completed Completed Completed Completed Completed In Progress Recombinant Anthrax Vaccine Sabin based Inactivated Polio Vaccine Completed Completed In Initiated Progress Completed Under Completion Initiated Hib Conjugate Vaccine Under Completion Under Completion Initiated Recombinant HIV Vaccine In Progress In Progress Japanese Encephalitis Vaccine In Progress In Progress

28 - Confidential - Vaccines Product Manufacturing & Analytical Validation Developmental stages Manufacturing & Analytical Standardisation Pre-Clinical Clinical trial phase I Clinical trial phase II/III Tetanus Toxoid in Uniject Completed Completed Completed To Be Initiated Varicella Vaccine, Live Attenuated In Progress In Progress In Progress To Be Initiated Hepatitis A Vaccine In Progress In Progress Typhoid Vaccine In Progress In Progress Hexavalent Vaccine Meningococcal Conjugate Vaccine Pneumococcal Vaccine In Progress In Progress Initiated In Progress

29 Clinical Research The Clinical Research Department successfully coordinated Clinical Trials on: - Enivac HB (Recombinant Hepatitis B vaccine) Phase III - Ecovac 4 (DTP-HB vaccine) Phase III - Pentavalent Vaccine (DTP-HB-Hib) Phase III - Tetravalent Vaccine (DTP-Hib) Phase III - Recombinant Anthrax Vaccine Phase I - Nimulid Safeinject Phase II, Phase III - Manyana Phase III - ThankGod Phase II - Routine Phase III & bioequivalence studies are carried out for a large number of products. Publications - Scientific Papers : 25 - Poster Presentations : 8 - Book Chapters : 3

30 Intellectual Property With a pragmatic approach towards Research and Development, Panacea Biotec has been able to develop some of the most exclusive products, XEED (Antitubercular FDC with innovative Drug Delivery for optimum bioavailability of all drugs) Nimulid SafeInject (Parenteral formulation of Nimesulide based on co-solvent technique) Panimun Bioral (Cyclosporine formulation based on SEDDS technology) ThankGod (Euphorbia prostrata extract for the comprehensive management of Haemorrohoids) Nimulid MD (Nimesulide tablets based on Fast Mouth Dissolving Technology) Willgo (Nimesulide controlled release formulation) Nimulid Transgel (Nimesulide Transdermal Gel) NIMCET (Synergistic combination of Nimesulide Long Acting + Cetirizine) Manyana (Antispasmodic agent) Total no. of International Patents granted : 110

31 Intellectual Property Patent applications filed for a number of products, to name a few: 0202 (Novel peptide for the treatment of Diabetes) 2 Good (Amoxicillin once daily) Odipep (Synergistic combination of Prokinetic agent and PPI) Niacin Extended Release Recombinant Anthrax Vaccine Injectable Polio Vaccine Sabin Strain Novel Compositions for topical delivery Pending Patent Applications : 114

32 Production Facilities Panacea Biotec has three cgmp certified production units equipped with state of the art facilities for Pharmaceuticals, Biopharmaceuticals and Vaccines. Panacea Biotec is a WHO Prequalified Supplier for Oral Polio Vaccine (OPV) and Diethyl Carbamazine (DEC) tablets

33 Biological Manufacturing Facilities Panacea Biotec commissioned and validated large scale manufacturing facilities for Recombinant Vaccines (e.g. Hepatitis B vaccine). Facilities include fermentors, harvesting and large scale purification equipments based on chromatography, MPLC etc. Automated system for formulating vaccines using adjuvants. Quality Control facilities for vaccines: immunochemistry, physico-chemical, microbiological and animal testing methods. An independent Quality Control / Quality Assurance unit.

34 Marketing Panacea Biotec has countrywide marketing setup represented by a strong marketing team of more than 1000 professionals synergizing their efforts to transform the company s brands to winning brands in the marketplace. The marketing team is positioned in multiple SBUs, so as to have appropriate focus in the concerned therapeutic segments. DIACAR Critical Care SBUs PRO GROW BOH

35 Brands Panacea Biotec has pioneered the launch of various technology driven pharmaceutical specialities in numerous therapeutic segments including : Pain Management Diabetes Management Organ Transplantation Immunization Respiratory Diseases Gastrointestinal Diseases Osteoporosis

36 Panacea Biotec plans Research Facilities One new dedicated R&D center for Drug Discovery One R&D center for Biopharmaceuticals and increase the no. of Scientists to ~ 500 over next two years. Future Plans Production Facilities A new production facility for Pharmaceuticals in North of India conforming to the cgmp norms of USFDA,E.U and other regulatory agencies is expected to be functional by Jan Panacea Biotec plans to build a state of art manufacturing facility for bacterial and cell based vaccines.

37 Drug Discovery The upcoming ultra-modern Drug Discovery Center having more than 35,000 sq.ft. of lab-space, will be manned by 150 scientists focusing on infectious diseases, cancer and metabolic disorders. The facility will specialize in: - Chemical synthesis - Medium Throughput Screening - Complete pre-clinical profiling - ADME studies - Development of Humanized Antibodies - Development of Antibody-Drug conjugates

38 Biological Manufacturing : Future Plans - Panacea Biotec plans: - To build state of art manufacturing facility for bacterial and cell based vaccines. - To augment vaccine filling unit. - Newer vaccines will be developed in house or through in-licensed technology.

39 - Confidential - Strategic Tie-ups Panacea Biotec has entered into synergistic tie-ups with a number of research oriented organizations & institutions, including: - Chiron Corporation, USA - Cambridge Biostability, UK - Center for Genetic Engineering & Biotechnology, Cuba - Biopharma Pte., Indonesia - Solvay, Netherlands - National Institute of Immunology, India - National Research & Development Corp., India - Jawaharlal Nehru University, India - Institute of Himalayan Bio-resources & Technology, India

40 Strategic Tie-ups Joint Ventures Joint venture with Center for Genetic Engineering & Biotechnology, Cuba for the production of recombinant proteins in India. Joint venture with Chiron Corporation for vaccines in India. Collaborations Research collaboration with Solvay, Netherlands for the development of Drug Delivery System for NCE SLV 306. Panacea Biotec is developing thermostable vaccines under collaboration with Cambridge Biostability, UK with grants from DFID.

41 Objectives of the visit In Licensing / joint development : Preventive and Therapeutic vaccines for infectious diseases Human or humanized monoclonal antibodies for therapeutic applications for the management of : Post Organ Transplant Complications Rheumatoid Arthritis Asthma & Allergy Psoriasis New drug interventions for Infectious diseases (Respiratory Diseases ),Diabetes Management,, Pain management and for the management of Post Organ Transplant Complications.

42 For more information, please visit our website at Panacea Biotec Ltd. B-1 1 Ext./G-3, Mohan Co-op. op. Indl.. Estate, Mathura Road, New Delhi , INDIA Phone : /8000, Fax : , [email protected] [email protected]