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C ph i biosimilar presentation - rahul padhye - reliance

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  • 1. Reviewing Cost Effective Solutions to Support Your Biosimilars Strategy CPhI Worldwide Pre-show Conference Rahul Padhye Head, Corporate Development Paris – Oct 4, 2010 1
  • 2. Contents 1. Biosimilar Development Perspective 2. Strategic Aspects 3. Reliance Life Sciences Context 4. Summary 2
  • 3. Biopharmaceutical Opportunity Global Pharmaceutical Industry 2009 Revenues USD 837 billion Global pharmaceutical revenues USD 837 billion Biopharma, 90 Global biopharmaceutical revenues USD 90 billion Pharmaceutical growth rate 5-8% Biopharmaceutical growth rate 12- 15 % Small Molecule, 747 Source: IMSBiopharmaceuticals contribute to about 11% ofpharmaceutical revenues and is growing at 12-15 % p.a. 3
  • 4. Biosimilars Opportunity US Europe ROW CAGR 14000 Percent 11,890 12000 10000 + 57% 47.8$ Millions 8000 6,411 6000 3,802 53.5 4000 2,434 1,255 1,684 2000 60.4 0 2008 2009 2010 2011 2012 2013 Year Source: Global Industry Analysts Report (2006), National Coalition on Healthcare, McKinsey The global biosimilars market potential is substantial. 4
  • 5. Biosimilar Development – Competencies Molecular Process Quality Clinical Regulatory Manufacture Marketing Biology Development Management Research AffairsTarget Bioprocess dev Quality control Pre-clinical Dossiers Upstream Product mgmt.identification Bioanalytical Quality Toxicity studies preparation Downstream SalesGene synthesis dev. assurance Efficacy Regulatory Purification Medical affairsGene validation Stability Validation studies interface Fill-finish Pharmaco-Electrophoresis studies Animal models Intellectual Packaging VigilanceStable clone Process scale- Bioassays dev. property Bioprocess Market researchClone up Clinical controlexpression Clinical opns. Project mgmt. Biometrics Medical writing GXP Compliance An integrated biopharmaceutical initiative requires several competencies working seamlessly across the value chain. 5
  • 6. Biosimilar Development - Challenges Technology Extensive product characterization required Manufacturing complexity High capital costs for setting up large- scale manufacturing facility Higher cost to prove comparability Regulatory Need clinical trials which are expensive Regulatory pathway in US is still unclear Marketing Limited discounting ability (discounting in the range 25-30%) so ability to compete on price Brand development and promotional effortsBiosimilars are a big opportunity; but is capital intensive withlong gestation period. 6
  • 7. Biosimilar Development -Competitive Advantages Quality Precise sequence Process development Bioassay specificity and linearity Cost High productivity cell lines Downstream yields Scaled-up process, particularly for antibodies Timelines In-house development vs. outsourcing Clinical development geographyCompetitive advantages of quality, cost and timelines arederived from skills, technology and development strategy. 7
  • 8. Contents 1. Biosimilar Development Perspective 2. Strategic Aspects 3. Reliance Life Sciences Context 4. Summary 8
  • 9. Competency Gaps Mol. Biology Regulatory Quality Management Process Dev Affairs High ManufacturingImportance Clinical Development Marketing & sales Low Intellectual Property Low High Competency Gap Competency gaps led biosimilar players to adopt different strategies for product development and commercialization 9
  • 10. StrategiesStrategies Build Outsource Partner Acquire Combination of aboveFactors Track record Expediency Risk appetite Profitability aspirationsBiopharmaceutical company can follow several strategiesfor product development. 10
  • 11. Outsourcing – Small molecules vs. Biosimilars Aspect Small Molecules Proteins/MAbs Product Can outsource product Cell lines are key for biosimilar development development (chemical product development and synthesis) to CROs therefore can ideally be Large no. of CRAM developed in-house. players provide these Very few CROs provide cell line services on time and development ability and the fee materials basis structure involves licensing fees Manufacturing Can outsource Biosimilars manufacturing is manufacturing to vertically integrated up to different manufacturers formulated bulk so one can, at for drug intermediate, most, outsource fill-finish bulk drug and formulated operations drug product Clinical Easy to outsource Need extensive exercise for Development clinical trials (BA/BE clinical development , which will studies) – requires less include pre-clinical studies, Ph 1 time and effort and Ph 3 studiesOutsourcing biosimilars development is difficult compared tosmall molecules. 11
  • 12. Outsourcing Options Areas for OutsourcingMolecular Process Clinical Regulatory Manufacture Marketing Biology Development Research Affairs Outsourcing Potential Moderate High Moderate to High Low CRO/CMO CRO CMO CSO Cell line development Clinical research Process scale-up Product Regulatory filings Drug substance characterization mfg. Process development Fill/finish Where to Outsource? US/EU US/EU + US/EU + Emerging Markets? Emerging Markets? Emerging markets can provide cost-time advantage for biosimilars development. 12
  • 13. StrategiesStrategies Build Outsource Partner Acquire Combination of aboveFactors Track record Expediency Risk appetite Profitability aspirationsBiopharmaceutical company can follow several strategiesfor its product development. 13
  • 14. Biosimilars Licensing – Objectives Licensor: Non-dilutive funding Recognition/Validation of product quality Opportunity to work with Partner on additional products/areas Licensee: Adding to internal product pipeline Timing – faster to market compared to internal development Better product – higher cell line productivity Accessing cost competitive product development and manufacturing capabilitiesLicensing can help each partner achieve its objectives. 14
  • 15. Biosimilar Licensing Deals (1) Year 2005 2006 2007 2008/2009 2010 Licensor Pliva Stada Biocon Intas Watson Licensee Mayne Pharma Hospira Abraxis Apotex Itero Products EPO and GCSF EPO GCSF GCSF, PEG-GCSF FSH Stada – Germany, Abraxis– NA, UK, Hospira – NA, EU Germany, Spain, Pliva – CEE, US (except Germany) Italy, France (Co- Watson – and JP; Mayne – Apotex – NA & EU; Territory (Hospira has the first exclusivity in worldwide W. Europe, Intas – RoW right of refusal for all other EU rights APAC, MENA countries outside US countries); and EU) Biocon – RoW Pliva – Intas – Watson - Roles and Manufacturing; Stada - Complete Manufacturing, CompleteResponsibility Both parties - Not Disclosed product development Both parties - Co- product of Parties joint clinical development development development Upfront US$ 21 million US$ 21 Million Not disclosed Not disclosed US$ 7.5 million Milestones over 3 years US$ 34 Million Not disclosed Not disclosed Royalty Not Disclosed Not Disclosed Not disclosed Not disclosed Not disclosed US$ 21 mn + US$ 7.5 mn + Total US$ 55 mn + Royalties Not disclosed Not disclosed Royalties Royalties Generic pharma companies have done outlicensing deals for some of the first generation biosimilars (EPO & GCSF). 15
  • 16. Biosimilar Licensing Deals (2) Partners Biocon & Mylan Teva & Lonza Hospira & Celltrion Hikma & Celltrion Year 2009 2009 2009 2010 Eight Products Nine Products Products MAbs MAbs (most likely MAbs) (most likely MAbs) Mylan – US, Canada, EU, JP, AU,NZ, EU-FTA US, EU, Australia, Territory Global MENA countries and co- NZ, Canada exclusivity with Biocon for ROW Celltrion would be Celltrion would be responsible for responsible for Joint manufacturing & Roles and manufacturing & Joint development development supply; Hikma toResponsibility supply; Co- by both the parties by both the market the of Parties marketing of parties products products by exclusively under partners own brand nameDeal Structure Profit Sharing Joint Venture Alliance AlliancePartnerships for product pipelines (mostly MAbs) are the‘flavor of the season’. 16
  • 17. Biosimilars Licensing - Strategies Pipeline deal with one partner Deal management is simple No flexibility and high risk if partner is unable to deliver Licensing deal with multiple partners Risk is diversified Alliance management is difficult Selective partnering – products / geographies Risk is diversified Deal management complex Timing Early stage Late stageThere is no single strategy for licensing. It depends on theneeds of both partners. 17
  • 18. Contents 1. Biosimilar Development Perspective 2. Challenges 3. Strategic Aspects 4. Reliance Life Sciences Context 5. Summary 18
  • 19. Reliance Life Sciences Initiatives Clinical Bio- Regenerative Molecular Plant Industrial Pharmaceuticals Research Biofuelspharmaceuticals Medicine Medicine Biotechnology Biotechnology Services Plasma Pre-clinical Embryonic Molecular Plant Tissue API Agronomy Biopolymers Proteins Studies Stem Cells Diagnostics Culture BA/BE Farm Hematopoietic Plant Metabolic Biosimilars Formulations Genetics Biochemicals Studies Advocacy Stem Cells Engineering Monoclonal Phase 1 Plant Metabolic Ocular Predictive Plant Antibodies Studies Engineering Stem Cells Diagnostics Products Phase 2/3/4 Plant Tissue Skin and Studies Culture Tissue Engg. Novel Data Mgmt. Cord Blood Enzymology Repository Therapeutics & Biostatistics Trans- QTc Studies Esterification Fusion Proteins siRNA Molecules Reliance Life Sciences is building one of the most diverse and integrated life sciences initiatives in the world. 19
  • 20. Biosimilars Product Pipeline Products in Indian market Erythropoietin (ReliPoietin™) GCSF (ReliGrast™) Interferon (ReliFeron™) Reteplase TPA (MIRel™) FSH (FostiRel ™) Products under development Cytokines Interferons Hormones Monoclonal antibodies Blood FactorsReliance Life Sciences is developing and bringing to market arange of biosimilars. 20
  • 21. Biosimilars Strategy Build Entire value chain Institutionalized competency development Outsource/Access Product characterization High-expression cell lines Cell line development Clinical development in EU Partner Clinical development (inbound) Contract manufacturing (inbound and outbound) RNA Delivery technologies Acquire GeneMedixReliance Life Sciences has adopted a multi-pronged strategyin developing an integrated biopharmaceutical play. 21
  • 22. Contents 1. Biosimilar Development Perspective 2. Challenges 3. Strategic Aspects 4. Reliance Life Sciences Context 5. Summary 22
  • 23. Summary The biopharmaceutical opportunity is compelling Challenges are formidable Strategic considerations and responses are critical to developing biosimilars in a cost-effective manner Emerging markets can provide time-cost advantage for developing biosimilars Reliance Life Sciences is a notable example in contextDeveloping biosimilars in cost-effective manner in emergingmarkets is challenging, but is doable. 23
  • 24. Thank You 24