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[e-drug] Hetero joins the Patent Pool; Licences Low-Cost HIV Medicines

E-DRUG: Hetero joins the Patent Pool; Licences Low-Cost HIV Medicines


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 

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@medicinespatentpool.org or +41 79 825 4786.

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 assurance.

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 2010.

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