In a move to provide accelerated access to its HIV/AIDS medications at lower prices, Gilead Sciences has expanded its global access program, including new incensing terms for three drugs in late-stage clinical development to four Indian drug makers – Strides Arcolab Ltd., Ranbaxo Laboratories Ltd., Matrix Laboratories, and Hetero drugs Ltd.

Gilead claims to be the first drug company to have a licensing agreement with the Medicines Patent Pool Foundation (The Pool). The Medicines Patent Pool’s goal is to improve access to quality, safe, effective, more appropriate and affordable medicines for people living in low- and middle-income countries. It focuses on HIV/AIDS treatments. The Pool does this by negotiating with patent holders to share their intellectual property – it is then licensed to other manufacturers so that patients in poorer nations can have affordable access to generic medications.

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. We look forward to working together to expand access to much-needed antiretrovirals and fixed-dose combinations for patients in the developing world. Our expectation now is that other companies will follow Gilead’s lead and join the Pool.”

Future rights have been granted to The Pool and the four Indian manufacturers for investigational integrase inhibitor elvitegravir, investigational antiretroviral boosting agent cobicistat, and Gilead’s combination once-daily single-tablet regimen called the “Quad”. Gilead licenced rights to market elvitegravir from JT (Japan Tobacco), which is said to be working to make sure access is widened in poorer nations.

Gregg H. Alton, Gilead’s executive vice president for corporate and medical affairs, said:

“Gilead is proud to engage in innovative partnerships to expand access for patients in the developing world, and we welcome new opportunities to work with Indian manufacturers and the Medicines Patent Pool. 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.”

Gilead says it has established licensing agreements with Indian manufacturers since 2006. One Gilead antiretroviral drug has dropped in price to 21 cents per patient per day ($6.15 per month). Over 1.1 million HIV patients in poorer nations receive Gilead medications produced by Indian manufacturers.

Gilead branded HIV drugs are also available in developing nations at the company’s cost of manufacturing – a considerable discount. Approximately 1.6 million people with HIV in developing nations are receiving either generic or branded Gilead HIV drugs, which the company claims makes up one-quarter of the 6.6 million HIV patients receiving treatment in the developing world.

The initial licensing agreements gave Indian drugmakers non-exclusive rights to manufacture active pharmaceutical ingredients and finished products and market generic versions of Viread (tenofovir disoproxil fumarate, or TDF) and Truvada (emtricitabine/tenofovir disoproxil fumarate) in India and 94 other developing nations.

The latest (expanded) agreements allow Indian drug companies to manufacture and market generic versions of Elvitegravir, cobicistat and the Quad if and when they are approved. The latest agreements also allow the marketing of Truvada and Viread to another 16 countries. Viread will also be allowed to be manufactured and sold for chronic hepatitis B treatment in the expanded territory.

The Indian manufacturers will receive from Gilead a complete technology transfer of its manufacturing process to help their production capacity as well as their efforts to obtain regulatory approval.

Rajiv Malik, Director, Matrix Laboratories Ltd. and COO, Mylan Inc, said:

“India’s pharmaceutical industry has the scientific expertise and large-scale production capacity that are critical for addressing the challenges of the HIV epidemic – both in India and around the world. We are pleased to expand our innovative collaboration with Gilead as we seek to help more individuals living with HIV in resource-limited countries.”

Matrix Laboratories was among the first partners to sign an expanded licensing agreement with Gilead.

The Indian manufacturers will be allowed to set their own prices on the licensed medications – they will pay Gilead a royalty on finished product sales. Royalties on pediatric formulations will be waived, says Gilead.

Written by Christian Nordqvist