Hyderabad: US drug maker Gilead Sciences Inc. has agreed on new licensing terms with Ranbaxy Laboratories Ltd, India’s biggest pharmaceutical firm by sales, and three other companies to produce generic versions of three HIV/AIDS drugs that are in late-stage clinical development, as part of an effort to provide faster access to its treatments to patients in developing countries.
Besides Ranbaxy, new terms were agreed with Hetero Drugs Ltd, Matrix Laboratories Ltd and Strides Arcolab Ltd, the company said in an announcement in Hyderabad on Tuesday.
“Our goal is to ensure that the new Gilead HIV therapies are developed and approved and make the low-cost versions rapidly accessible in developing countries without delay,” Gregg H. Alton, executive vice president for corporate and medical affairs at the California-based firm, told a news conference.
Gilead’s original licensing agreements provided the Indian drug makers with non-exclusive rights to produce active pharmaceutical ingredients and finished products and sell generic versions of Gilead’s HIV medicines Viread(R) and Truvada(R) in 95 developing countries, including India.
The expanded agreements include future rights to produce and sell generic versions of three HIV therapies, “if and when they are approved,” the company said in a statement.
The three drugs -- Elvitegravir, Cobicistat and the Quad -- are investigational products. The agreements also allow the sale of Viread and Truvada in an additional 16 countries, and also allow Viread to be produced and sold for the treatment of chronic hepatitis B in the expanded territory, Gilead said.
Gilead, which earns 80% of its revenue from HIV/AIDS drugs, also became the first pharmaceutical firm to enter a licensing agreement with the Medicines Patent Pool Foundation, a Geneva-based United Nations body, to allow sales of generic versions of the HIV/AIDS drugs on similar licensing terms as its Indian partners.
”The licensees will receive complete technology transfer of the Gilead manufacturing process to support their efforts to obtain local regulatory approvals and scale up production as soon as possible following US Food and Drug Administration approval of the products,” Gilead said.