Presented By:-

Arvind Kumar (02) Manoj Gupta (05)

Dharmender (07)

Rohit Kumar (31)

Gaurav Shah (39)1

OUTLINE

Agreement structuremodel

2

WHY COLLABORATION

3

COLLABORATIVE R &D

4

A. Research Alliance

Horizon will apply its genome editing technology GENESIS to develop human isogenic disease model cell lines according to Boehringer’s specifications

5

B. Co - Development

The different parties agree to combine their knowledge to create new innovative productsThere are mainly two forms of co development deals

1. Either the two partners agree on a certain division of ownership2. They decide that one party gets the rights to commercialise the drug in a certain geographical area, and the other side gets the other geographical rights

Eg. Eli-Lily with Genentech to develop recombinant human insulin

6

C. Licensing

• In the R&D many products, especially pharmaceuticals, the costs can be get extremely high, causing companies to have second thoughts about the possibility of drug development• To achieve these goals, a growing number of pharmaceutical companies are licensing proprietary compounds or drug discovery related technologies from other companies to bolster their internal R&D efforts.Lipitor - Pfizer’s blockbuster molecule that crossed $12 billion sales in 2005 (used by over 45 millionPeople) was in-licensed by Yamanouchi

• In the R&D many products, especially pharmaceuticals, the costs can be get extremely high, causing companies to have second thoughts about the possibility of drug development• To achieve these goals, a growing number of pharmaceutical companies are licensing proprietary compounds or drug discovery related technologies from other companies to bolster their internal R&D efforts.Lipitor - Pfizer’s blockbuster molecule that crossed $12 billion sales in 2005 (used by over 45 millionPeople) was in-licensed by Yamanouchi

Collaboration

• Merck-Advinus(2006)- Novel drug discovery & clinical development collaboration in metabolic disorders,late stage clinical studies.

• Eli- Li-ly-Shashun Chemicals(2002)-Agreement for mfg of anti-TB drug to meet global demand,5 years contract, growth changes from 10-43%.

• Dr Reddy’s –Merck Serono(2012)-To co-develop a portfolio in oncology segment of Bio-similar molecule for multiple markets .

Collaboration

• Nicholas Piramal-Pfizer(2006)-7-year agreement relating to R&D services under which Nicholas Piramal will provide process development and scale up services to Pfi zer’s animal health division from the latter’s facilities in India

• Sanofi-aventis-Harvard University (2010)- biomedical research in multiple therapeutic areas such as cancer, diabetes and inflammation

Goal-adv. Knowledge in area of human health through basic and applied research & to promote scientific exchange.

Numbers denote number of articles (thousands) in each subject area in 2008

12

International collaboration is field-dependent

13

AGREEMENTS IN RESEARCH AND DEVELOPMENT

• Research financing agreements• Collaboration agreements• Invention ownership agreements• Confidentiality agreements• Commercialization agreements

– Option– License or technology transfer– Trade

• Agreements to settle disputes

14

15

PROS

16

– Collaborator's level of information security, risk awareness and risk management is not adequate

– Communications issues/problems due to differences in corporate and national cultures.

– Could lead to higher price of the technology by reducing competition in the market

– There are risks involved in relying too heavily on one collaborator, especially in strategic R&D.

– There is a possibility of communications issues/problems due to differences in corporate and national cultures.

– Planning , checkpoints and evaluation at every step is

critical success parameter

CONS

17

• Domestic and international strategies and policies (science, technology, innovation, entrepreneurship, nationwide, regional, etc).

• International and domestic competition.• Business decisions, investors.• Political decisions.• Human, financial and raw material resources; manpower and

salaries.• Education, knowledge, know-how, skills.• International agreements, legislation.• Environment.

18

19

• GSK and HSCI did a collaborative agreement for 5 years in 2008.

• It was a project of $25 Million plus in stem cell science to hasten the development of treatments and cures for a range of diseases.

Objective

20

• HSCI, a network of 700 scientists based at Harvard University and its affiliated hospitals, claims to have the world largest concentration of stem cell researchers. For GSK

• The GSK collaboration will help to keep it ahead of California’s fast-growing stem cell centres, which are benefiting from a huge infusion of state funds. For HSCI

21

• GSK will fund an annual grant in HSCI’s “seed grant” program, which supports early stage innovative research. For HSCI

• The collaboration will integrate HSCI’s world-class stem cellexpertise with GSK’s pharmaceutical capabilities to drive advances indrug discovery research.

• This will include, for example, a staff exchange program where HSCI and GSK researchers will spend up to several months in each other’s laboratories.

22

Bristol-Myers Squibb and AstraZeneca Collaboration

Deal Structure

• BMS and AstraZeneca has acquired Amylin.• Development of anti-diabetic products-

Exenatide • Profits and losses will be shared equally.• AstraZeneca has rights over key strategic and

financial decisions.• AstraZeneca will make a payment USD 3.4

billion in cash

Why Deal Extension ?

• Strengthens alliance leadership position in diabetes

• Adds approved and marketed products for Type 1 and 2 diabetes

• Combined development, regulatory and commercial strengths of partners is expected to unlock the potential of Amylin’s therapies for the benefit of patients worldwide

26