C ph i biosimilar presentation - rahul padhye - reliance

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



8


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.


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


13

Biopharmaceutical company can follow several strategies for its product development.


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


2. Challenges


18



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

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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


2. Challenges


22



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

Documents

C ph i biosimilar presentation - rahul padhye - reliance