Gilead extends licensing deals with Indian generics firms


Also signs first pact with Medicines Patent Pool Foundation

US biopharmaceutical firm Gilead Sciences is licensing four medicines for HIV/AIDS to generic drugmakers to give developing countries access to cheaper HIV/AIDS treatments.

The company has widened its licensing deals with four India-based drug manufacturers – Hetero Drugs, Matrix Laboratories, Ranbaxy Laboratories and Strides Arcolab – for three drugs currently in late-stage clinical development.

Gilead has also entered a licensing agreement with the Medicines Patent Pool Foundation (the Pool).

The agreement allows the Indian manufacturers and the Pool to market the generic HIV/AIDS medicines Viread (tenofovir disoproxil fumarate, or TDF) and Truvada (emtricitabine/tenofovir disoproxil fumarate), as well elvitegravir and cobicistat.

Also included in the agreements is the ‘Quad’, which combines four Gilead HIV medicines in a once-daily, single-tablet.

The Pool, established in 2010 with the support of UNITAID, aims to partner a number of pharmaceutical companies to expand global access to low cost HIV/AIDS drugs.

Gilead is the first pharmaceutical company to sign a licensing agreement with the Pool.

Ellen \'t Hoen, executive director, Medicines Patent Pool Foundation, said: ‘The Medicines Patent Pool is a creative new approach for increasing access to treatment by facilitating access to IP on essential medicines, and we appreciate Gilead\'s willingness to be engaged and involved with us from the beginning. Our expectation now is that other companies will follow Gilead\'s lead.’

Under the expanded agreement the Indian manufacturers will sell Viread and Truvada in an additional 16 countries.

They can also produce and sell Viread in the expanded territory for the treatment of chronic hepatitis B.

Licensees are allowed to establish their own price and will pay a royalty to Gilead on sales.

Gregg Alton, Gilead\'s executive vice president for corporate and medical affairs, said: ‘Our goal is to ensure that as new Gilead HIV therapies are developed and approved, low-cost versions will be rapidly accessible in developing countries without delay.’

To accelerate the development of paediatric formulations of HIV/AIDS medicines, Gilead will waive royalty payments on any paediatric formulations of Viread, Truvada or pipeline products that are successfully developed and brought to market.