Mylan Signs Deal With Gilead Sciences On Sovaldi And Ledipasvir/Sofosbuvir

(RTTNews) - Mylan Inc. (MYL) announced that its subsidiary Mylan Laboratories Limited has entered into an agreement with Gilead Sciences Inc. (GILD) under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. Sofosbuvir is marketed by Gilead under the brand name Sovaldi.

The countries within the agreement account for more than 100 million people living with hepatitis C globally representing 54% of the total global infected population.

As per the licensing agreement, Mylan will receive a technology transfer enabling the company to manufacture low-cost versions of the medicines for developing markets.

Sofosbuvir was approved under the trade name Sovaldi by the U.S. Food and Drug Administration (FDA) in December 2013 based on clinical studies that showed sofosbuvir, in combination with other agents, achieved very high cure rates with a course of treatment as short as 12 weeks depending on viral genotype.

Sofosbuvir also was approved by the European Commission in January 2014 and is a recommended treatment option in the World Health Organization's first hepatitis C treatment guidelines (released in April 2014).

The FDA and the European Medicines Agency are currently reviewing Gilead's applications for a single tablet regimen of ledipasvir/sofosbuvir; it is an investigational agent and its safety and efficacy have not been established.