Gilead hands rights to make HIV drug candidate to firms in developing countries
Under the agreement – which is contingent on bictegravir being approved by the US Food and Drug Administration (FDA) - MPP can sub-license production to generic drug companies in India, China and South Africa.
Gilead filed bictegravir for FDA review in July, seeking approval for its use in the treatment of HIV-1 infection in combination with other antiviral agents. The firm has said it plans to submit the drug for assessment by the European Medicines Agency (EMA) in the third quarter of 2017.
Bictegravir is the fifth drug Gilead has licensed to the MPP.
Access
The firm has also signed deals allowing Sun Pharmaceutical Industries Limited, Strides Shasun Limited, Mylan Laboratories Limited and SeQuent Scientific Limited to make and distribute the drug and combination therapies including it in 116 counties.
Gilead says such agreements are part of an effort to increase access to its drugs, explaining that licensing to multiple generics manufacturers creates price competition.
According to the California biotech, the strategy has reduced the price of some HIV therapies to $3.50 per patient per month.
News of the deal comes six months after Pharco Pharmaceuticals licensed rights to make ravidasvir – a hepatitis C treatment and potential rival to Gilead’s €400 plus per pill products Sovaldi and Harvoni – to Switzerland-based MPP.
