Pharma Business Development & Licensing Service

Pharma Regulatory & licensing Service Business. A.Vikram Sathish

Indian companies have recently focused a lot on R&D in the pharmaceutical sector. •Many companies now spend 8% or more of revenues on research. •Many pharma companies are now actively targeting international companies for contract research and manufacturing (CRAM) deals. •Medicinal chemistry, custom synthesis, and clinical studies are some areas in which Indian firms

The global pharmaceutical outsourcing market was worth

USD57.2 billion in 2007. It is expected to grow at a CAGR of

10% to

reach USD76 billion by 2010. Global market for Contract Research and Manufacturing Services

(CRAMS) bn.

in 2007

is

USD55.48

Out of the total global CRAMS market,

Contract research w a s

USD16.58 bn, growing at a CAGR of

13.8% and

Contract manufacturing was USD38.89 bn accounting for the

major share

Indian pharma outsourcing market

USD1.27m in 2007 and is expected to reach USD3.33 bn by 2010, growing at a was valued at

CAGR of

37.6%.

USD1.21 bn in 2007, and is estimated to reach USD3.16 bn by 2010. The Indian CRAMS market stood at

SCOPE • Pharmaceutical companies increasingly outsource to third parties to save money, speed up processes and get products into the market quicker. • Outsourcing allows companies to focus on their core competency areas and expedite the entire process. • In Asia pacific, large biopharmaceutical companies outsource to their local and regional partners. • CRO's (Contract Research Organizations) move up the value chain with the desire to serve only few global customers rather than diversify in different areas. • Additionally, they are slowly converting into SMO's (Site Management Organizations), where protocol development and monitoring takes place in addition to R&D.

Outsourcing Business Space Range of Services

From Clinical quantities to Commercial scale

Business Space

BIG PHARMA

EMERGING PHARMA

Discovery Chemistry Process R& D Pipeline Intermediates Matured Intermediates Pipeline API’s Matured API’s Dosage Development Commercial Drug Product Discovery Chemistry Process R& D Pipeline Intermediates Matured Intermediates Pipeline API’s Dosage Development

FINE CHEMICAL COMPANIES

Pipeline & Matured Intermediates

Global Pharmaceutical Outsourcing Estimated Potential Market:

Pharmaceutical R&D

Drug Substance Supply

Formulated Drug Supply

30-35

~50

60-80 (in $ bn)

Current share of outsourcing in defined Contract R&D/Manufacturing space is around ~$35 bn Source: Dow Report, AD Little, Cardinal Health

Changing Face of Industry Declining R&D output & high costs  continue to pose challenges to  profitability Blockbuster drug launches expected  to drop from 14 in ’03 to 4 in ’08 Drug Product Withdrawls (Vioxx)  and safety concerns (Crestor) By ’08 patent expirations will  Leading account for $ 72 bn in current sales to

Global Outsourcing DRIVERS B. Cost C. Increase Productivity D. Speed up New product Development D. Expand skills & Source: AT Kearney Report

Changing Face of Industry Declining R&D output & high costs  continue to pose challenges to  profitability Blockbuster drug launches expected  to drop from 14 in ’03 to 4 in ’08 Drug Product Withdrawls (Vioxx)  and safety concerns (Crestor) By ’08 patent expirations will  Leading account for $ 72 bn in current sales to

Global Outsourcing DRIVERS B. Cost C. Increase Productivity D. Speed up New product Development D. Expand skills & Source: AT Kearney Report

Facts & Figures - INDIA Highest number of FDA approved plants outside USA Largely English speaking workforce IT capital of the world Democracy of 1 billion TRIP compliant UK based legal system Structured and reasonably transparent financial markets & banking system • Dependent on oil for energy • Well entrenched entrepreneurial culture & developed private sector • Superior education level • • • • • • •

• Infra-structure in need of development • Largest market-share in generic API production • Export & Western oriented

Changed IP Scenario in India Global standards followed on IPM CDAs, MoUs, Non-Use Agreements, etc – routinely implemented Work ethics & “Need-to-know” work practices Employee Contracts & Employee retention mechanisms Legal provisions & remedies available Cheap Source of intermediates

Qualified API source And Efficient Process R&D Resource

India is now being looked at as a reliable source across the value chain in

India Advantage / Disadvantage Advantag es Cost

Flexibility

Speed

Ø Language Ø Chemistry, Engineering, Regulatory & QA experience, Dosage expertise Ø Manufacturing Infrastructure Disadvantag es ØCapability in Niche Segments (Ex. Controlled Substances) ØCommunication ØEmotional blocks (Ex. Compliance, Generic Challenges etc)

Operational Issues & Focus Medicinal Chemistry

IP Security Skill Technologies Communicatio n

CMC Development

Scope for scale-up Analytical Sourcing Lead times Stick to timing cGMP

Formulation & Development

Track record Expertise QESH Compliance Capacity Commercial

Causes for negative experiences Provider specific issues: Environmental issues; license to operate Asset reliability Quality issues

“Yes” means, I will do whatever I can, “No” is culturally impolite Communication Issues

Key Elements for Pharma Business PRODUCT INDUSTRY DIFFERENTIATORS ØInnovation Market

First to

ØCost ØQuality ØGeographical Reach

SERVICE INDUSTRY DIFFERENTIATORS Speed ØDelivery Quality Cost Frequency ØCommunication Transparency Quality ØTrustworthiness ØFlexibility ØCustomer Delight

.. Favor India as destination

Choosing the Right Partner in India; a Selection Model

Global Interests Ownership pattern Regulatory Compliance Financial Stability Understanding IP Reporting compliant Capability & Infrastructure

DIFFERENTIATORS Speed Costs Communication Project Management Track Record Understanding the West

Final Partner

QUALIFIERS

Changing Paradigm

Range of Services

From Clinical quantities to Commercial scale

Outsourcing services +

In License the product for Indian & Asian Markets

India’s Conclusion of Strengths…

Speed Competitiv e Pricing Full cGMP

…combining the best of both worlds

Chan nel Partn

Advt’s

Consulti ng Partner’

Growth = More

Business Development Consulting Our consulting activities consist of: - Support in business development - Organizing meetings - Developing the commercial approach for a new product or company - Co-founding new business based on promising new technology

Regulatory Services consulting •Complete database for dossier requirements •Quick dossier compilation •Draft pre-formulation, BMR, MFR, process validation, method validation, dissolution and stability studies documents •Clinical and non-clinical overviews •Justification for fixed dose combination •Prepare Summary of product (SmPC) and Pack Information Leaflet (PIL) •Prepare label and carton contents  •Reply to MOH queries •Product registration assistance •Product development assistance •Global Patent Information •Literature for patented product •Non-infringing process

Regulatory Complaiance services •CGMP / Quality System Auditing •Internal GMP Audit •Analytical Laboratory Audit •Quality System Design & Management •Stability Program Design / Implementation

•Regulatory Submission Preparation for Drug Master File (DMF) in CTD Certificate of Suitability (COS) Dossiers in CTD •Standard Operating Procedure (SOP) Development •Revised Schedule 'M' , WHO - GMP, USFDA,UK-MHRA , Australia - TGA , PIC/s etc. implementation

Regulatory Affairs services we offer the following services: •Technical Data Package for APIs and Intermediates •Drug Master Files for APIs and Intermediates in CTD format or Country specific Requirements •COS/CEP Filing •Drug Product Dossiers •Site Accreditation •Site Registration •Product Registration •Check List for Regulatory Audits

Product Registration & Audit •CGMP / Quality System Auditing •Internal GMP Audit •Analytical Laboratory Audit •Quality System Design & Management •Stability Program Design / Implementation •Regulatory Submission Preparation (Product Dossier) for the following : •European Union (EU) - EMEA Guidelines •Ministry of Health - Cambodia •Ministry of Health - Ghana •Ministry of Health - Myanmar •Ministry of Health - Nigeria •Ministry of Health - Slovakia •Ministry of Health - Sudan •Ministry of Health - Ukraine •Ministry of Health - Vietnam       and many more........ •Standard Operating Procedure (SOP) Development Revised Schedule 'M' , WHO - GMP , PIC/s , TGA etc. Implementation .

Product & Process Development •Formulation Development •Excipient / Ingredient Selection •Analytical Methods Development •Product Development Report Writing •Manufacturing Process Development & Assessment •Process Optimization and Validation •Manufacturing Scale - Up •SOP Development •Technical Report Writing •All work is done at reasonable cost

Technical dossier Prepartaion our own databank & sources to compile ,edit and create technical dossier on various new and old Bulk drugs & Drug intermediates. Each technical dossier consists of the following details : •Drug details : CAS No., ATC Code, Chemical name, Molecular formula, Chemical structure, Nomenclature(s), Licensor, Indication(s), Action , Therapeutic class. •Synthesis scheme. •Drug characterisation (by UV,FTIR,NMR, DSC etc.) •Physico-chemical properties. •Analytical methodology. •Impurity Profile. •Patent abstract details.

Quality Assurance services •WSite Master File Preparation •Validation e offer the following services: •Master Plan Preparation •Quality Manual Preparation •Facility Validation •Process Equipment Qualification •HVAC/AHU System Validation •Water System Validation •Blending Validation •Micronisation Validation •Process Validation •Cleaning Validation •Standard Operating Procedures •Documentation as per GMP regulations •GMP Audits •Check lists for Regulatory Audits •Annual Product Review •GMP Training Programmes •Preparation of Product Manuals

Quality Control services We offer following services: •Quality Control Department Establishment as per GMP requirement •Specification and Analytical Procedure Development •Standard Operating Procedures •Instrument Logbook as per GMP requirements •Instrument Qualification •Stability Study Protocols •Preparation of Calibration Planner •Preparation Stability Study Schedule •Documentation as per GMP regulations •Test Protocols as per GMP requirements

Partnering Search Our Partnering Search offers advanced and enhanced partnering support. Actively working for you, our service enables you to utilize our knowledge and expertise. A fully comprehensive solution designed to complement your existing business developement activities. As part of the service: Based on your brief, our partnering experts will search for partners on your behalf and provide a fully qualified list of target companies (Prospect List) On your instruction they will contact

Company profiles

Our profiling service maximizes your potential of finding the most suitable partner for your opportunities by targeting our focused global business development and licensing audience. Pharma licensing Service provides potential partners from all around the world. Whether you are looking to inor out-license, your profile allows interested parties to contact you directly with solutions that match your needs. post detailed information about company and its business development strategy,In- or outlicensing opportunities, or services, Fully categorised listings by sector,

Partner Identification comprehensive consultancy services to support your partnering activities. Our unique service provides you with all of the elements of the licensing process whilst also enabling you to minimize the time and costs associated with it. Fitting around your timescale and needs, we work with you as you move through the individual elements of licensing at your own pace.This flexible approach ensures you remain in control as you progress from initial groundwork, through partner identification, to negotiating and closing the deal.

Partner Introduction

Our partner introduction service helps you to progress from a list of companies into active discussions. Following initial review we will, where necessary, work with you to write or improve your non-confidential dossier. This then forms the basis of our initial approach and presentation to potential partners. Building on these initial approaches we arrange meetings for you to take negotiations further. We work predominantly on a success fee basis; however the initial upfront fee will vary depending on the status of your non-confidential dossier at initial approach. It is vital that we represent you with the best possible offering to potential partners and will work closely with you to ensure this.

Partnership for

Due Diligence Execution

with Panel team partnership We are proud to offer comprehensive Service for Due Diligence Execution. For the first online research company and has access to a global network of professionals experienced in assessing Intellectual Property ,product, Process & Facility acquisition for clients including top tier pharmaceutical and biotechnology companies. .

Representation & Deal Closure We provide you with a named industry expert who is on hand to support and guide you at any time as you move forward with your deal negotiations. Offering you as much or as little assistance as you require, we bring experience of many successful deals to the table to guide your negotiations as they move through to closure. All work is to pre-agreed contractual terms, which are heavily biased towards success payments.

Thank You Vikram Sathish.A Director -Marketing &