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Reviewing Cost Effective Solutions to Support Reviewing Cost Effective Solutions to Support Your Biosimilars StrategyYour Biosimilars Strategy
CPhI Worldwide Pre-show Conference
1Paris – Oct 4, 2010
Rahul PadhyeHead, Corporate Development
ContentsContents
1. Biosimilar Development Perspective
2. Strategic Aspects
2
3. Reliance Life Sciences Context
4. Summary
Biopharmaceutical Opportunity Biopharmaceutical Opportunity
� Global pharmaceutical revenues USD 837 billion
� Global biopharmaceutical revenues USD 90 billion
Global Pharmaceutical Industry2009 RevenuesUSD 837 billion
Biopharma, 90
3
Biopharmaceuticals contribute to about 11% of pharmaceutical revenues and is growing at 12-15 % p.a.
revenues USD 90 billion � Pharmaceutical growth rate 5-8%� Biopharmaceutical growth rate 12-
15 % Small Molecule, 747
Source: IMS
8000
10000
12000
14000
$ M
illio
ns
US Europe ROW
Biosimilars OpportunityBiosimilars Opportunity
6,411
11,890
+ 57%
CAGRPercent
47.8
4
0
2000
4000
6000
8000
2008 2009 2010 2011 2012 2013
Year
$ M
illio
ns
The global biosimilars market potential is substantial.
Source: Global Industry Analysts Report (2006), National Coalition on Healthcare, McKinsey
1,255 1,6842,434
3,802
6,411
53.5
60.4
Target identificationGene synthesis
MolecularBiology
Process Development
QualityManagement
Clinical Research
RegulatoryAffairs Manufacture Marketing
Bioprocess devBioanalytical dev.
Pre-clinicalToxicity studiesEfficacy
Quality controlQuality assurance
DossierspreparationRegulatory
UpstreamDownstreamPurification
Product mgmt.SalesMedical affairs
Biosimilar Development Biosimilar Development –– Competencies Competencies
5
An integrated biopharmaceutical initiative requires several competencies working seamlessly across the value chain.
Gene synthesisGene validationElectrophoresisStable cloneClone expression
dev.Stability studiesProcess scale-up
Efficacy studiesAnimal modelsBioassays dev.ClinicalClinical opns.Project mgmt.BiometricsMedical writing
assuranceValidation
Regulatoryinterface Intellectual property
PurificationFill-finishPackagingBioprocesscontrol
Medical affairsPharmaco-VigilanceMarket research
GXP Compliance
Biosimilar Development Biosimilar Development -- Challenges Challenges �Technology
� Extensive product characterization required
� Manufacturing complexity� High capital costs for setting up large-
scale manufacturing facility� Higher cost to prove comparability
�Regulatory
6
Biosimilars are a big opportunity; but is capital intensive with long gestation period.
�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
Biosimilar Development Biosimilar Development --Competitive AdvantagesCompetitive Advantages
� Quality� Precise sequence� Process development� Bioassay specificity and linearity
� Cost� High productivity cell lines � Downstream yields
7
Competitive advantages of quality, cost and timelines are derived from skills, technology and development strategy.
� Downstream yields� Scaled-up process, particularly
for antibodies
� Timelines� In-house development vs.
outsourcing� Clinical development geography
ContentsContents
1. Biosimilar Development Perspective
2. Strategic Aspects
8
3. Reliance Life Sciences Context
4. Summary
Competency GapsCompetency GapsIm
porta
nce H
igh
Mol. Biology
Process Dev
Manufacturing
Marketing & sales
Clinical Development
Regulatory Affairs
Quality Management
9
Competency gaps led biosimilar players to adopt different strategies for product development and commercialization
Competency Gap
Impo
rtanc
e
Low
Low High
Intellectual Property
StrategiesStrategies
Strategies
� Build
� Outsource
� Partner
� Acquire
� Combination of above
10
Biopharmaceutical company can follow several strategies for product development.
� Combination of above
Factors
� Track record
� Expediency
� Risk appetite
� Profitability aspirations
Outsourcing Outsourcing –– Small molecules vs. Biosimilars Small molecules vs. Biosimilars Aspect Small Molecules Proteins/MAbs
Product development
� Can outsource product development (chemical synthesis) to CROs
� Large no. of CRAM players provide these services on time and materials basis
� Cell lines are key for biosimilar product development and therefore can ideally be developed in-house.
� Very few CROs provide cell line development ability and the fee structure involves licensing fees
Manufacturing � Can outsource � Biosimilars manufacturing is
11
Outsourcing biosimilars development is difficult compared to small molecules.
Manufacturing � Can outsource manufacturing to different manufacturers for drug intermediate, bulk drug and formulated drug product
� Biosimilars manufacturing is vertically integrated up to formulated bulk so one can, at most, outsource fill-finish operations
Clinical Development
� Easy to outsource clinical trials (BA/BE studies) – requires less time and effort
� Need extensive exercise for clinical development , which will include pre-clinical studies, Ph 1 and Ph 3 studies
Outsourcing OptionsOutsourcing Options
MolecularBiology
Process Development
Clinical Research
RegulatoryAffairs Manufacture Marketing
� CRO/CMO � CRO � CMO �CSO
Areas for Outsourcing
Outsourcing Potential
Moderate High Moderate to High Low
12
Emerging markets can provide cost-time advantage for biosimilars development.
� Cell line development� Product
characterization� Process development
� CRO� Clinical research� Regulatory filings
� Process scale-up� Drug substance
mfg.� Fill/finish
�CSO
Where to Outsource?
US/EU US/EU + Emerging Markets?
US/EU + Emerging Markets?
StrategiesStrategiesStrategies
� Build
� Outsource
� Partner
� Acquire
� Combination of above
13
Biopharmaceutical company can follow several strategies for its product development.
� Combination of above
Factors
� Track record
� Expediency
� Risk appetite
� Profitability aspirations
Biosimilars Licensing Biosimilars Licensing –– ObjectivesObjectives� Licensor:
� Non-dilutive funding� Recognition/Validation of product
quality� Opportunity to work with Partner on
additional products/areas� Licensee:
� Adding to internal product pipeline
14
Licensing can help each partner achieve its objectives.
� 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
Biosimilar Licensing Deals (1)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
Territory
Pliva – CEE, US and JP; Mayne –
W. Europe, APAC, MENA
Stada – Germany, Hospira – NA, EU (except Germany)
(Hospira has the first right of refusal for all countries outside US
and EU)
Abraxis– NA, UK, Germany, Spain, Italy, France (Co-
exclusivity in other EU
countries);Biocon – RoW
Apotex – NA & EU; Intas – RoW
Watson –worldwide
rights
15
Generic pharma companies have done outlicensing deals for some of the first generation biosimilars (EPO & GCSF).
and EU) Biocon – RoW
Roles and Responsibility
of Parties
Pliva –Manufacturing;Both parties -joint clinical development
Stada - Complete product development Not Disclosed
Intas –Manufacturing,
Both parties - Co-development
Watson -Complete product
development
Upfront US$ 21 million over 3 years
US$ 21 MillionUS$ 7.5 million
Not disclosed Not disclosed
Milestones US$ 34 Million Not disclosed Not disclosed
Royalty Not Disclosed Not Disclosed Not disclosed Not disclosed Not disclosed
Total US$ 21 mn + Royalties US$ 55 mn + Royalties US$ 7.5 mn +
Royalties Not disclosed Not disclosed
Partners Biocon & Mylan Teva & Lonza Hospira & Celltrion Hikma & Celltrion
Year 2009 2009 2009 2010
Products MAbs MAbs Eight Products (most likely MAbs)
Nine Products (most likely MAbs)
Territory
Mylan – US, Canada, EU, JP, AU,NZ, EU-FTA
countries and co-exclusivity with Biocon for ROW
Global US, EU, Australia, NZ, Canada MENA
Biosimilar Licensing Deals (2)Biosimilar Licensing Deals (2)
16
Partnerships for product pipelines (mostly MAbs) are the ‘flavor of the season’.
Biocon for ROW
Roles and Responsibility
of Parties
Joint development by both the parties
Joint development by both the
parties
Celltrion would be responsible for
manufacturing & supply; Co-marketing of products by
partners
Celltrion would be responsible for
manufacturing & supply; Hikma to
market the products
exclusively under own brand name
Deal Structure Profit Sharing Joint Venture Alliance Alliance
Biosimilars Licensing Biosimilars Licensing -- StrategiesStrategies� 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
17
There is no single strategy for licensing. It depends on the needs of both partners.
� Alliance management is difficult� Selective partnering – products /
geographies� Risk is diversified� Deal management complex
� Timing� Early stage� Late stage
ContentsContents
1. Biosimilar Development Perspective
2. Challenges
3. Strategic Aspects
18
3. Strategic Aspects
4. Reliance Life Sciences Context
5. Summary
Reliance Life Sciences InitiativesReliance Life Sciences Initiatives
Bio-pharmaceuticals
ClinicalResearchServices
Biofuels MolecularMedicine
Biopolymers
IndustrialBiotechnology
Biochemicals
Plant TissueCulture
PlantBiotechnology
Plant MetabolicEngineering
Plant Products
EmbryonicStem Cells
RegenerativeMedicine
HematopoieticStem Cells
MolecularDiagnostics
Genetics
Agronomy
Plant MetabolicEngineering
FarmAdvocacy
Pre-clinicalStudies
BA/BEStudies
Phase 1Studies
Biosimilars
MonoclonalAntibodies
PlasmaProteins
Pharmaceuticals
API
Formulations
PredictiveDiagnostics
OcularStem Cells
19
Products
Cord BloodRepository
Skin andTissue Engg.
Plant TissueCulture
Engineering
Trans-Esterification
Studies
Phase 2/3/4Studies
Data Mgmt.& Biostatistics
FusionProteins
Antibodies
siRNAMolecules
Enzymology
Diagnostics
QTc Studies
NovelTherapeutics
Stem Cells
Reliance Life Sciences is building one of the most diverse and integrated life sciences initiatives in the world.
Biosimilars Product PipelineBiosimilars Product Pipeline
� Products in Indian market� Erythropoietin (ReliPoietin™)
� GCSF (ReliGrast™)
� Interferon � (ReliFeron™)
� Reteplase TPA (MIRel™)
� FSH (FostiRel ™)
20
Reliance Life Sciences is developing and bringing to market a range of biosimilars.
� Products under development� Cytokines
� Interferons
� Hormones
� Monoclonal antibodies
� Blood Factors
Biosimilars StrategyBiosimilars Strategy� Build
� Entire value chain� Institutionalized competency
development� Outsource/Access
� Product characterization� High-expression cell lines� Cell line development� Clinical development in EU
21
Reliance Life Sciences has adopted a multi-pronged strategy in developing an integrated biopharmaceutical play.
� Clinical development in EU� Partner
� Clinical development (inbound)
� Contract manufacturing (inbound and outbound)
� RNA Delivery technologies� Acquire
� GeneMedix
ContentsContents
1. Biosimilar Development Perspective
2. Challenges
3. Strategic Aspects
22
3. Strategic Aspects
4. Reliance Life Sciences Context
5. Summary
SummarySummary
� The biopharmaceutical opportunity is compelling
� Challenges are formidable
� Strategic considerations and responses are critical to developing biosimilars in a cost-effective manner
23
Developing biosimilars in cost-effective manner in emerging markets is challenging, but is doable.
cost-effective manner
� Emerging markets can provide time-cost advantage for developing biosimilars
� Reliance Life Sciences is a notable example in context
Thank You
24
Thank You
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