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28 Nov 2016

Mylan agrees to produce and market generic version of BMS's Daklimza in developing countries

The license allows Mylan to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of hepatitis C virus.

Mylan 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 Daklinza (daclatasvir) Tablets, 30 mg and 60 mg, for distribution in 112 low and middle income countries.

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 US 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 medicines.

Commenting on today's announcement, Mylan President Rajiv Malik said: "We're committed at Mylan to reducing the burden of hepatitis C on communities around the world by providing access to high quality medicines that treat the disease. We are pleased to work together with the MPP and Bristol-Myers Squibb to help make daclatasvir available to low and middle income countries at affordable prices."

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