Mylan to produce and market a generic version of Bristol-Myers Squibb's DAKLINZA™ (daclatasvir) for low and middle income countries

Mylan Signs Sub-license Agreement with the Medicines Patent Pool to Increase Access to Hepatitis C Treatment in Developing Countries

HERTFORDSHIRE, England and BENGALURU, India, Nov. 28, 2016 /PRNewswire/ -- Mylan N.V. (NASDAQ, TASE: MYL) today announced that the company 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 U.S. 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.

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."

Globally, 130 to 150 million people have chronic hepatitis C infection² and the vast majority live in low and middle income countries³

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