Gilead Sciences, Inc in pact with four Indian pharma firms for 3 anti-HIV drugs

Gilead Sciences, Inc, a biopharmaceutical company, has entered into an in-licensing agreement  with four India-based drug manufacturers - Ranbaxy Laboratories Ltd, Strides Arcolab Ltd, Hetero Drugs Ltd and Mylan-owned Matrix Laboratories Ltd, for three drugs that are currently in late-stage clinical development.

Gilead said in a statement that it plans a global access programme expansion in an effort to provide accelerated access to Gilead medicines for the treatment of HIV / AIDS.
Gilead is the first pharmaceutical company to enter a licensing agreement with the Medicines Patent Pool Foundation.

The Indian companies will have the rights under license to manufacture and sell generic versions of these drugs in India and other developing countries, after getting necessary regulatory approvals.

The India firms will also have the rights to manufacture and market generic equivalents of new products, Elvitegravir, an investigational integrase inhibitor, Cobicistat, an investigational antiretroviral boosting agent and Quad, which combines four Gilead HIV medicines in a once-daily, single-tablet regimen.

The India companies will receive complete technology transfer of the Gilead manufacturing process, will be allowed to establish their own price and will pay a royalty on sale of finished products.

Elvitegravir, cobicistat and the Quad are investigational products and have not yet been determined safe or efficacious in humans.