Transcript GS-98-437 A RANDOMIZED, DOUBLE

Gilead’s Tech Transfer Partnerships and IP in India
Swami Swaminathan
Vice President, Structural Chemistry
Gilead Sciences
February 15, 2010
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
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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
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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
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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
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Multiple Partners Can Serve More Patients At the Lowest Price
$18
800,000
$17.00
702,911
700,000
600,000
$14
508,103
$12.42
500,000
$12.00
$12
400,000
$10
300,000
$8.25
$8
200,000
$6
31,000
100,000
129,279
$4
0
2006
2007
Price
2008
Patients
6
2009
# patients reached
Lowest generic price/month
$16
Tenofovir DF An Oral Prodrug of Tenofovir
NH2
N
O
O
O
O
O
P
O
O
N
O
O
NH2
N
N
N
Plasma
Tissues
O
N
N
N
HO
P
O
HO
O
Tenofovir DF
• Orally bioavailable
• Converted to tenofovir by
serum/tissue esterases
• Selectively loads PBMC’s
Shaw et al., Pharm Res, 1997
Tenofovir (PMPA)
• Nucleotide analog of adenosine
monophosphate
• Inhibitor of HIV RT
• Not orally bioavailable
7 Balzarini et al., Antimicrob Agents Chemother ,1993
In dogs, PMBC/plasma tenofovir exposure is 4x after tenofovir
DF oral dose vs. 1.4x after tenofovir s.c. dose
Tenofovir AUC0-24 (g.hr/mL)
35
30
Plasma
PBMC
25
20
15
10
5
0
Subcutaneous
Tenofovir
Oral
Viread
Lee & Martin, Antiviral
Research, 2006
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Enhanced Efficacy of Tenofovir Disoproxil as
Compared to Tenofovir
Human Clinical Trial Results
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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
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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
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