[Ip-health] Hetero Joins Patent Pool; Signing Licence to Produce Low-Cost HIV Medicines

Kaitlin Mara kmara at medicinespatentpool.org
Thu Aug 2 08:51:36 PDT 2012



WASHINGTON, DC, 25 JULY 2012: Hyderabad-based Hetero Labs has signed a
licence agreement with the Medicines Patent Pool that will allow it to
produce key HIV medicines for a number of developing countries.

The agreement will allow Hetero to produce four key medicines originally
developed by Gilead Sciences ­ emtricitabine, cobicistat, and
elvitegravir, and a combination of these medicines plus a fourth drug,
tenofovir, in a single pill known as the "Quad" ­ in 100-112 countries.
These medicines were licensed to the Pool by Gilead Sciences in July 2011.

"The terms and conditions that the Pool was able to negotiate represent an
improvement on previous licences and this will enable us to make
affordable drugs available faster to more people," said Mr M. Srinivas
Reddy of Hetero. Hetero is a major supplier of HIV medicines in the
developing world, with more than 25 products approved by the US Food and
Drug Administration/World Health Organization in Geneva, and many in the
pipeline. Hetero currently produces antiretroviral treatment for over 2
million people living with HIV in more than 100 countries.

Hetero has also chosen to take advantage of a key flexibility in the
Pool's agreement that enables it to sell tenofovir to a large number of
countries where it is not under patent.

Cobicistat, elvitegravir and the Quad are new drugs in development; being
licensed through the Pool should help speed their availability in
developing countries soon after they receive regulatory approval; this is
a significant step forward as there is often a several years-long delay
for new medicines to reach resource-limited markets.

"Hetero's joining the Pool will help expand access to tenofovir in more
countries. We are also excited at the prospect of a leading HIV
manufacturer such as Hetero being able to launch promising new therapies
soon after they are approved in developed countries," said Chan Park,
Interim Executive Director of the Medicines Patent Pool.

Hetero is the fourth generic company to take a licence from the Pool. The
more companies take licences from the Pool, the more robust will be
generic competition on HIV medicines, and the more affordable those
medicines will become for people who need them.

"UNITAID helped create the Pool because it believed in its potential to
help bring affordable, necessary medicines to market. Every new
sub-licensee takes the Pool one step closer to that goal," said Denis
Broun, Executive Director of UNITAID.

The Medicines Patent Pool is in negotiations with patent holders
Boehringer-Ingelheim, Bristol-Myers Squibb, F. Hoffman La Roche, and ViiV
Healthcare [a joint venture of GlaxoSmithKline and Pfizer], as well as
with several generic companies, to reach licence agreements that will help
reduce the prices on several additional key HIV medicines.

For further information on the Medicines Patent Pool, see its website
at:www.medicinespatentpool.org, or contact Communications Manager Kaitlin
Mara at kmara at medicinespatentpool.org.


The Medicines Patent Pool, founded with the support of UNITAID in July
2010, is a mechanism seeking to lower the price of medicines for HIV in
developing countries by facilitating generic competition. Patents can
drive up prices for drugs; licences allow low-cost generic versions to be
made even where patents exist. The Pool negotiates with the patent holders
of critically important HIV medicines for licences; it then sub-licenses
these to generic manufacturers, freeing them up to develop, produce and
sell affordable medicines in agreed countries under strict quality

UNITAID is a global health initiative established to increase access to
quality-assured treatments for HIV/AIDS, malaria and tuberculosis through
sustainable financing and market interventions. In less than five years
since its inception, UNITAID has committed US$ 800 million for AIDS
treatment in 52 low- and middle-income countries. UNITAID developed the
concept of the Medicines Patent Pool as part of its market strategy, which
is to stimulate market competition, ramp up production and increase
availability of newer and better medicines at affordable prices. In
December 2009, the UNITAID Executive Board voted in principle to create
the Medicines Patent Pool, which became a separate legal entity in July

More information about the Ip-health mailing list