Generic Companies Join the Medicines Patent Pool

Aurobindo signs on to increase access to HIV medicines

GENEVA, 11 OCTOBER 2011: Aurobindo Pharma Limited, a key producer of generic medicines, has signed an agreement with the Medicines Patent Pool for the manufacture of several antiretroviral medicines. This will speed access to critical HIV medicines in developing countries, in particular to new medicines still in development.

The full text of the agreement is available here [pdf].

Reactions from UNAIDS and UNITAID on the Pool’s first sub-licences:

UNAIDS “strongly encourages other antiretroviral patent holders to establish agreements… [and] generic manufacturers to ultilize the licenses that the Pool can facilitate to expand access to antiretroviral treatment.” Full statement here.

UNITAID says new agreement “will increase the number of manufacturers of new products to treat HIV infections.” Full statement here.

 

The agreement will enable Aurobindo to manufacture products licensed to the Pool by Gilead Sciences in July: emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG), and the fixed-dose combination of these medicines known as the Quad (a combination of FTC, COBI, EVG, and tenofovir). COBI, EVG and the Quad are new products in development. Their uptake by generic manufacturers will help close the gap between the arrival of new medical technology in developed country markets and its often delayed arrival in developing countries.

Aurobindo has chosen to take advantage of a key provision negotiated by the Pool so it can sell tenofovir to a larger number of countries and without paying royalties [see note].

“We are pleased with the rapid uptake of our first licences by generic companies,” said Medicines Patent Pool Executive Director Ellen ’t Hoen. “Generic medicines producers have a key role to play in ensuring the availability of low cost medicines for the treatment of HIV.”

“We are excited about both the public health and business opportunities provided by the Patent Pool licences. Aurobindo looks forward to increasing its manufacture of HIV-related products, and expanding its work to cover promising new treatments, for the millions of people living with HIV across the globe,” said P.V. Ramaprasad Reddy, chairman of Aurobindo.

“UNITAID welcomes this new agreement, which will increase the number of manufacturers of new products to treat HIV infections,” said Denis Broun, executive director of UNITAID. “Competition from generic producers has been one of the most powerful tools to reduce drug prices. This agreement shows that generic manufacturers believe in the Patent Pool, and this is good news for people living with HIV across the developing world who will be able to access affordable, quality medicines.”

The Pool signed its first licence agreement with a pharmaceutical company, Gilead Sciences, in July 2011, securing several public-health related improvements on the status quo for voluntary licences.

Today’s announcement concerns the other critically important part of the Pool’s work — using licences in the Pool to encourage and expand increased generic production of antiretrovirals. Aurobindo has an established record in producing quality generic drugs for HIV, including fixed-dose combinations and pediatric formulations.

Generic producer MedChem has also signed licences with the Pool. MedChem is a new player in the HIV field. Attracting generic producers will help increase production capacity, which is needed to meet treatment goals.

The signature page of the MedChem licence is available here.

The Medicines Patent Pool, founded with the support of UNITAID in 2010, aims to bring down the prices of HIV medicines, and stimulate the development of needed new formulations, through access-oriented voluntary licences. The Pool’s voluntary licences are negotiated to maximise their public health impact, and the full terms and conditions of each licence agreement are made public on the Pool’s website. 


Note for the editor:

The Pool negotiated for its licences with Gilead to be “unbundled” – this means a generic manufacturer can elect to uptake licences on a product-by-product basis. Aurobindo chose to take licences covering emtricitabine, cobicistat, elvitegravir, and the Quad and not to take a licence on tenofovir, on which there is currently no product patent in India. This means that Aurobindo should be able to sell tenofovir to a larger number of countries than it was able to sell to before.

For further information, contact MPP Communications: gro.looptnetapsenicidemnull@sserp

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