Gilead rains manufacturing deals on India's generic firms

By Gregory Roumeliotis

- Last updated on GMT

Related tags: Antiretroviral drug, Gilead

Under pressure to respond to the spread of HIV in the developing
world, Gilead has signed non-exclusive licence agreements with
eight Indian generic companies for the manufacture of Viread
(tenofovir disoproxil fumarate), its popular antiretroviral.

The agreements allow the companies to produce and distribute generic versions of Viread to 95 low-income countries around the world, including India.

With more than 40m people living with HIV worldwide, Viread is a well established therapy for second-line treatment of HIV/AIDS and has recently been endorsed by the World Health Organisation (WHO) for first-line treatment as well.

The eight companies awarded the licences are Alkem Laboratories, Aurobindo Pharma, FDC, JB Chemicals & Pharmaceuticals, Matrix Laboratories, Medchem International, Ranbaxy Laboratories and Shasun Chemicals & Drugs.

The licence agreements require that the generic firms meet certain national and international regulatory standards and include a technology transfer to enable expeditious production of large volumes of high-quality generic versions of Viread, Gilead said.

Moreover, these agreements allow the manufacture of commercial quantities of both active pharmaceutical ingredient (API) and finished product.

In August, Gilead announced similar agreements with India-based Emcure Pharmaceuticals, Hetero Drugs and Strides Arcolab.

"We are pleased to have established agreements with eight additional India-based manufacturers, further expanding capacity for production and distribution in India and in other developing world countries,"​ said Gilead CEO John Martin.

"We hope that these agreements will expedite access to therapy for patients in resource-limited parts of the world where the HIV epidemic has hit the hardest."

One of the authorised manufacturers, Shasun, said it expects to commercialise the technology received from Gilead within the next 12 months and file for regulatory approvals.

The drugmaker already manufactures at its UK plant and commercially supplies key intermediates S-propylene carbonate and diethyl paratoluene sulfonyloxymethyl phosphonate (DESMP).

Roche shares Fortovase manufacturing know-how

In a related development, Roche has announced it will provide three African companies free of charge with the technical expertise to manufacture a generic version of its HIV protease inhibitor Fortovase (saquinavir).

These agreements with South Africa's Aspen Pharmacare and Kenya's Cosmos and Universal Corporation are the first in a series of planned technology transfers announced in January 2006, allowing the firms to produce saquinavir for supply throughout Kenya and South Africa in addition to any country within sub-Saharan Africa or defined as least developed by the United Nations, encompassing 64 per cent of all people living with HIV globally.

Manufacturers in sub-Saharan Africa and least developed countries wishing to produce generic saquinavir for use in these regions will not be required to apply for a voluntary licence, as Roche has committed not to enforce patents on HIV antiretroviral medicines within these countries.

As far as technology transfers are concerned, the initial announcement has generated interest from 25 companies from 14 countries, including Kenya, Ghana, Zimbabwe and Nigeria, so Roche is working with these applicants to assess production over the coming weeks.

Related topics: Regulatory & Safety

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