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Gilead’s Tech Transfer Partnerships and IP in India

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1 Gilead’s Tech Transfer Partnerships and IP in India
Swami Swaminathan Vice President, Structural Chemistry Gilead Sciences February 15, 2010

2 About Gilead Sciences Worldwide presence 4,000 employees
25 offices on 3 continents 13 marketed drugs Primary therapeutic focus in HIV/AIDS, liver disease and serious cardiovascular and respiratory conditions Seven successful acquisitions Expanding company’s therapeutic reach 2

3 Viread Enormously important anti-HIV medication – saving and improving lives worldwide One pill, once a day Long-term studies providing efficacy, safety and resistance data Low rate of resistance development Most widely prescribed molecule for the treatment of HIV in the developed world Standard of care for HIV infected individuals 3

4 Indian Pharmaceutical Partnerships
Goal is to advance maximum accessibility and affordability in low-income markets Licensing and technology transfer agreements with 13 local pharmaceutical companies began in 2006 – at the time, only 30,00 patients in low-income countries had access to Viread Ability to manufacture API for use in India – no royalty charged Ability to manufacture finished product for sale in India and 94 other low-income countries No price controls WHO or FDA quality requirements 5% royalty due to Gilead on sales of finished product 4

5 A Highly Successful Tech Transfer Licensing Model
Today, the licensees offer generic Viread in India and many low-income markets at the lowest price In 2010, 1 million patients in low-income markets will have access to Viread and licensees will distribute generic Viread to the overwhelming majority of these patients Licensees do profit from sales and utilize profits to pursue development and market expansion activities Gilead complements low-cost manufacturing and distribution capabilities of the licensees by supporting product registrations Regulatory filings rely on more than a decade worth of clinical data and internal expertise With regulatory approvals in place, licensees can access new markets and increase distribution capacity 5

6 Multiple Partners Can Serve More Patients At the Lowest Price
Lowest generic price/month # patients reached 6

7 Tenofovir DF - An Oral Prodrug of Tenofovir
Tenofovir (PMPA) Orally bioavailable Converted to tenofovir by serum/tissue esterases Selectively loads PBMC’s Nucleotide analog of adenosine monophosphate Inhibitor of HIV RT Not orally bioavailable Shaw et al., Pharm Res, 1997 7 Balzarini et al., Antimicrob Agents Chemother ,1993

8 Lee & Martin, Antiviral Research, 2006
In dogs, PMBC/plasma tenofovir exposure is 4x after tenofovir DF oral dose vs. 1.4x after tenofovir s.c. dose Lee & Martin, Antiviral Research, 2006 8

9 Enhanced Efficacy of Tenofovir Disoproxil as Compared to Tenofovir Human Clinical Trial Results

10 Viread Meets Section 3(d) Standard
TDF is the first and only approved drug in its class for the treatment of HIV Viread, or tenofovir disoproxil fumarate (TDF), shows a fifty fold difference in efficacy compared to tenofovir TDF made the tenofovir molecule a bioavailable product, allowing for oral administration in a pill form that can be taken once-per-day The Viread patent applications and pending case before the Appellate Board do not present a challenge to Section 3(d), and is consistent with the recent High Court ruling on Gleevec 10

11 Conclusions Gilead’s licensing model is distinctive and can serve as an important precedent Indian companies profit, and gain technology and market expansion opportunity Improves worldwide public health in low-income countries since essential medicines reach patients faster and at lowest price However, this level of tech transfer and business partnership is only possible when all parties benefit from, and uphold the licenses The licensing model is at risk, and the decisions by the Appellate Board will send a powerful signal about prospects for tech transfer partnerships with Indian companies 11

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