PITTSBURGH and HYDERABAD, India — Mylan announced that its subsidiary, Mylan Labs Limited, has signed an agreement with Gilead Science 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 name Sovaldi.
The countries that fall within the terms of the agreement account for more than 100 million people living with hepatitis C. Mylan will receive a technology transfer allowing it to manufacture low-cost versions of the medicines, the company stated.
"Hepatitis C is a growing public health problem in developing countries, with Central and East Asia and North Africa among the regions most affected by this disease," Mylan CEO Heather Bresch said. "Unfortunately, patients in these regions often lack access to critical and effective treatments. This agreement with Gilead will allow Mylan to provide early access to a more affordable version of Sovaldi, helping to meet the unmet medical needs of the millions of patients in developing countries who do not currently have access to this life-saving medicine."
Sofosbuvir was approved by the Food and Drug Administration in December 2013.