Indian generic drugmaker Strides Arcolab recently announced that it has entered a licensing deal to distribute Gilead Sciences’ HIV drug.
The company said that it has entered into a licensing agreement with Gilead, under which Gilead has extended non-exclusive rights to Strides to manufacture and distribute Tenofovir Alafenamide (TAF), both as a single agent product and in combination with other drugs.
TAF is a novel nucleotide reverse transcriptase inhibitor used in human immunodeficiency virus (HIV) patients in the treatment of acquired immunodeficiency syndrome (AIDS). It that has demonstrated high antiviral efficacy at a dose ten times lower than Gilead’s Viread (tenofovir disoproxil fumarate), as well as an improved renal and bone safety profile.
According to Strides, the license being granted extends to 112 countries, which together account for more than 30 million people living with HIV. Under the deal, if the US Food and Drug Administration (FDA) approves TAF, Strides will receive a technology transfer from Gilead, which will allow Strides to manufacture low-cost versions of TAF for developing countries.
Financial terms of the deal were not disclosed.
The announcement follows last week’s rejection of Gilead’s patent application for its drug sofosbuvir by the Indian patent office. Sofosbuvir is Gilead’s hepatitis C drug that is considered a breakthrough therapy. Last September, Gilead signed agreements with seven Indian generic drugmakers licensing them to make sofosbuvir to provide the drug to 90 countries. In the US, sofosbuvir is priced at $84,000 or $1,000 per pill. The effective price for generic version is roughly $900 and a ten percent royalty.
Source: Strides Arcolab