Mylan sub-licensed to market generic hepatitis C drug

Netherlands-incorporated Mylan (Nasdaq: MYL) has signed an agreement with the Medicines Patent Pool (MPP) to expand access to chronic hepatitis C medicines in developing countries.

The agreement licenses Mylan to produce and market a generic version of Bristol-Myers Squibb's (NYSE: BMY) Daklinza (daclatasvir) Tablets, 30mg and 60mg, for distribution in 112 low and middle income countries. This adds to the deal with Gilead Sciences (Nasdaq: GILD), to distribute the latter’s Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) hepatitis C drugs in India.

Daclatasvir Tablets, 30 mg and 60 mg, are indicated for use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 or genotype 3 infection in the USA and genotype 1, 3 and 4 in Europe. The license allows Mylan to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of HCV. Earlier this year, the World Health Organization added several new hepatitis C treatments, including daclatasvir, to its essential medicines list, highlighting the urgent need to promote equitable access to innovative medicines1.