Panacea Biotec is a proactive customer centric company and lays emphasis on innovation and quality.

Transcription

1

2 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.

3 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

4 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.

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

6 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

7 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

8 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.

9 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

10 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 Japanese Encephalitis Virus Vaccine, Cholera vaccine, Dengue Fever etc. in collaboration with reputed institutes / universities.

11 - 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

12 - 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

13 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

14 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

15 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

16 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

17 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.

18 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

19 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

20 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.

21 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

22 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.

23 - 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

24 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.

25 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.

26 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] For more information, please visit our website at