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Reviewing Cost Effective Solutions to Support
         Your Biosimilars Strategy
           CPhI Worldwide Pre-show Conference




                      Rahul Padhye
               Head, Corporate Development
                    Paris – Oct 4, 2010
                                                1
Contents



      1. Biosimilar Development Perspective

      2. Strategic Aspects

      3. Reliance Life Sciences Context

      4. Summary




                                              2
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: IMS

Biopharmaceuticals contribute to about 11% of
pharmaceutical revenues and is growing at 12-15 % p.a.
                                                                               3
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
Biosimilar Development – Competencies

  Molecular         Process          Quality          Clinical          Regulatory
                                                                                        Manufacture      Marketing
   Biology        Development      Management        Research            Affairs



Target            Bioprocess dev   Quality control   Pre-clinical        Dossiers       Upstream       Product mgmt.
identification    Bioanalytical    Quality           Toxicity studies    preparation    Downstream     Sales
Gene synthesis    dev.             assurance         Efficacy            Regulatory     Purification   Medical affairs
Gene validation   Stability        Validation        studies             interface      Fill-finish    Pharmaco-
Electrophoresis   studies                            Animal models       Intellectual   Packaging      Vigilance
Stable clone      Process scale-                     Bioassays dev.      property       Bioprocess     Market research
Clone             up                                 Clinical                           control
expression                                           Clinical opns.
                                                     Project mgmt.
                                                     Biometrics
                                                     Medical writing

                                                 GXP Compliance

       An integrated biopharmaceutical initiative requires several
       competencies working seamlessly across the value chain.
                                                                                                                     5
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
      efforts
Biosimilars are a big opportunity; but is capital intensive with
long gestation period.
                                                                   6
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 geography


Competitive advantages of quality, cost and timelines are
derived from skills, technology and development strategy.
                                                            7
Contents



      1. Biosimilar Development Perspective

      2. Strategic Aspects

      3. Reliance Life Sciences Context

      4. Summary




                                              8
Competency Gaps

                                                                   Mol. Biology
                    Regulatory      Quality
                                    Management                   Process Dev
                    Affairs
             High



                                                             Manufacturing
Importance




                                       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
Strategies
Strategies
   Build
   Outsource
   Partner
   Acquire
   Combination of above
Factors
   Track record
   Expediency
   Risk appetite
   Profitability aspirations

Biopharmaceutical company can follow several strategies
for product development.
                                                          10
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 studies

Outsourcing biosimilars development is difficult compared to
small molecules.
                                                                                 11
Outsourcing Options
                             Areas for Outsourcing
Molecular     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
Strategies
Strategies
   Build
   Outsource
   Partner
   Acquire
   Combination of above
Factors
   Track record
   Expediency
   Risk appetite
   Profitability aspirations
Biopharmaceutical company can follow several strategies
for its product development.
                                                          13
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
      capabilities

Licensing can help each partner achieve its objectives.
                                                          14
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,       Complete
Responsibility   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
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 to
Responsibility                                            supply; Co-
                 by both the parties    by both the                              market the
  of Parties                                             marketing of
                                          parties                                 products
                                                          products by
                                                                             exclusively under
                                                            partners
                                                                             own brand name

Deal Structure     Profit Sharing      Joint Venture        Alliance              Alliance


Partnerships for product pipelines (mostly MAbs) are the
‘flavor of the season’.
                                                                                                  16
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 stage
There is no single strategy for licensing. It depends on the
needs of both partners.
                                                               17
Contents


      1. Biosimilar Development Perspective

      2. Challenges

      3. Strategic Aspects

      4. Reliance Life Sciences Context

      5. Summary




                                              18
Reliance Life Sciences Initiatives
                                      Clinical
     Bio-                                                             Regenerative    Molecular          Plant      Industrial
                Pharmaceuticals      Research           Biofuels
pharmaceuticals                                                        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
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 Factors



Reliance Life Sciences is developing and bringing to market a
range of biosimilars.
                                                                  20
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
        GeneMedix

Reliance Life Sciences has adopted a multi-pronged strategy
in developing an integrated biopharmaceutical play.
                                                          21
Contents


      1. Biosimilar Development Perspective

      2. Challenges

      3. Strategic Aspects

      4. Reliance Life Sciences Context

      5. Summary




                                              22
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 context


Developing biosimilars in cost-effective manner in emerging
markets is challenging, but is doable.
                                                              23
Thank You



            24

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C ph i biosimilar presentation - rahul padhye - reliance

  • 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: IMS Biopharmaceuticals contribute to about 11% of pharmaceutical 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 Affairs Target Bioprocess dev Quality control Pre-clinical Dossiers Upstream Product mgmt. identification Bioanalytical Quality Toxicity studies preparation Downstream Sales Gene synthesis dev. assurance Efficacy Regulatory Purification Medical affairs Gene validation Stability Validation studies interface Fill-finish Pharmaco- Electrophoresis studies Animal models Intellectual Packaging Vigilance Stable clone Process scale- Bioassays dev. property Bioprocess Market research Clone up Clinical control expression 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 efforts Biosimilars are a big opportunity; but is capital intensive with long 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 geography Competitive advantages of quality, cost and timelines are derived 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 Manufacturing Importance 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. Strategies Strategies Build Outsource Partner Acquire Combination of above Factors Track record Expediency Risk appetite Profitability aspirations Biopharmaceutical company can follow several strategies for 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 studies Outsourcing biosimilars development is difficult compared to small molecules. 11
  • 12. Outsourcing Options Areas for Outsourcing Molecular 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. Strategies Strategies Build Outsource Partner Acquire Combination of above Factors Track record Expediency Risk appetite Profitability aspirations Biopharmaceutical company can follow several strategies for 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 capabilities Licensing 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, Complete Responsibility 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 to Responsibility supply; Co- by both the parties by both the market the of Parties marketing of parties products products by exclusively under partners own brand name Deal Structure Profit Sharing Joint Venture Alliance Alliance Partnerships 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 stage There is no single strategy for licensing. It depends on the needs 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 Biofuels pharmaceuticals 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 Factors Reliance Life Sciences is developing and bringing to market a range 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 GeneMedix Reliance Life Sciences has adopted a multi-pronged strategy in 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 context Developing biosimilars in cost-effective manner in emerging markets is challenging, but is doable. 23
  • 24. Thank You 24