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Kunwar Shailubhai, Ph.D. & M.B.A Executive VP & Head R&D Callisto Pharmaceuticals, Inc. New York, USA Acceleration of technological innovations in pharmaceutical and biotechnology industries through collaborative R&D Callisto Pharmaceuticals, Inc. Oncology Inflammation Bioterrorism A publicly traded biotechnology company A global need for collaborative R&D in Pharmaceutical and biotechnology Industries Why ? Where ? What ? How ? An experience Small World for Biotech Challenges for Pharmaceutical Industry Astronomically high R&D costs - $ 500 to 750 millions - Pricing Control - Increased competition from generics Technological Advances - Genomics - Proteomics - Bioinformatics - Computer Technologies Gene therapy and Personalized Medicine Opportunities for collaborative R&D Bringing a Drug to Market Takes on Average 8-12 Years Drug Discovery 3-5 Years Drug Development FDA Approval 5-8 Years 1-2 Years 100 projects 1-3 Years 1 product 3-5 Years 1-2 Yr • cGMP Manufacturing • Expedited FDA Approval • In-Licensing • Multi-center Clinical Trials • New Technologies • Global Collaboration • New Technologies • CRO’s A high cost high risk business Opportunities for Pharmaceutical/Biotechnology Industries Cancer Bioterrorism A risky but highly rewarding business Alliances between Big and Emerging companies are rising A win-win situation Growth of pharmaceutical industry in India (Rs. Crores) 1965-66 1980-81 1997-98 1998-99 19992000 Capital Investment 140 500 1840 2150 2500 Production : Formulations 150 1200 12068 13878 15960 18 240 2523 3148 3777 Import 8.20 113 2868 3128 3441 Export 3 46 5353 5959 6631 3 15 220 250 320 Bulk Drugs R & D Expenditure India is the 15th largest producer of pharma/biotech products Areas for Collaborative R&D Drug candidates - Custom Synthesis - SAR studies - Combinatorial Synthesis - Biopharmaceuticals cGMP Manufacturing - Chemical compounds - Biologics - Vaccines - Generics Drug Discovery - Target Validation - Animal Studies - Genomics - Biologics Clinical Trials - Safety & Toxicity - Multi-Center Trials - Anti-infectives - CRO’s Primary goal of collaborative R&D is to reduce cost and time Market for generics is growing rapidly Forecasted to grow annually to US$ 263 billion in 2005 Represents 42% of total prescriptions by volume More then 150 brand name patented drugs (US$105 bn) will come off the patents and will be available for generics by 2010. Patent protection laws are changing Consumer awareness for generics is increasing The current US government is supportive of generics to Indian Drugmakers: TIME reduce health care expenditure WTO agreement 2005: Indian firms have to compete globally Indian firms are well-positioned to challenge the BIG pharma of the west Biologics offer business opportunities for Indian firms Human proteins and peptides - Insulin, EPO, Growth hormone etc. - Antagonist peptide (D-form) Enzymes and cytokines - tPA, Streptokinase, GM-SF, Interferon, Interleukins Therapeutic antibodies - Humanized antibodies for cancer - Anti-angiogenesis Abs: AVASTIN Vaccines - Hepatitis, Dengue virus, Smallpox, Anthrax - Tuberculosis, Malaria - Cancer Vaccines, DNA/RNA vaccines Diagnostics Bioterrorism: A new frontier for Pharma/Biotech NIAID Biodefense Strategy Broad-Spectrum Drugs - Peptides, Antibodies - Small compounds Vaccination - Smallpox, Anthrax, SARS - U.S. Govt. Contracts Diagnostic tests for rapid detection - Toxins - Bacteria - Viruses Manufacturing Substantial increase in NIH biodefense budget for grants Novel approaches to develop broad-spectrum drugs and vaccines against deadly bacteria and their toxins Nutraceuticals: The future of prophylactic medicines Genomics and proteomics are paving way for the development of technologies for early detection of the deadly diseases: Prevention and control Nutraceuticals vs Pharmaceuticals Cancer Inflammation Nutraceutica ls Drugs Cardiovascular Diabetes Multiple targets Multiple molecules Low Potency Clinical evaluation ? Single target Single molecule High Potency Clinical validation Synergistic combination of mechanism-based compounds for prevention of diseases Phytonutrients for Cancer Prevention Enzyme Targets Biopharmaceuticals Phase II Inducers (QR & GST) Antioxidants, Polyphenols (EG Ellagic acid & Carbinol Brassinin & Sulforaphane. Cyclooxygenases Resveratrol, CAPE, Curcumin Polyphenols, CLA & Olive extracts. ODC Deguelin, Curcumin, Rotenoids Protein Kinase C DNA Topoisomerase I NF-kB inhibitors. Angoline, Laricirasinol, Betulinic acid Garlic extracts, Curcumin & C Nutraceuticals are getting attentions from public, government and the “Big” pharmaceutical companies Successful strategy for small and emerging biotechnology companies Technical Alliances - Preclinical discovery - Out-Licensing Joint Ventures - Clinical Trials - Manufacturing Generics - Off-patent drugs - Patent loopholes Biologics - Recombinant proteins - Humanized antibodies - Peptide Mimetics Subsidiary in USA - Federal grant money (SBIR/STTR) - NIH resources - Free evaluation of compounds (NCI Program) - Venture Capitalists funds in US - Public listing on the financial markets How did we use collaborative R&D strategy ? NeoCeutix Co-Founded the company with VC money Preclinical discovery through collaborations Developed IP estate Merged NeoCeutix with Synergy Developed lead drug candidates for Hepatitis B & C Funded through VC money & Federal grants Out-Licensed the compound to United Therapeutics Developing a compound for colon cancer (SBIR grants) In-Licensed a compound for multiple myeloma Merged with Callisto, a publicly traded company Collaborations with NCI, M.D. Anderson and Dana Farber Developed IP estate for cancer and inflammation In-Licensed a technology from The Rockefeller University Grant money from NIAID and Army Collaborative R&D is essential for the small and emerging companies