Mylan Pharmaceuticals Private Limited, an Indian subsidiary of Mylan Inc. has entered into an agreement with Gilead Sciences, under which Mylan has been appointed as the exclusive distributor of Sovaldi (sofosbuvir 400mg tablets) and Harvoni (ledipasvir 90mg/sofosbuvir 400 mg tablets) for the treatment of chronic hepatitis C, in India.
As Gilead's exclusive branded medicine distribution partner, Mylan expects to begin distribution of Sovaldi in India in Q2 2015. Sovaldi received regulatory approval in India in January 2015 - the first country in Asia to approve the medicine.
Mylan president Rajiv Malik said, "Hepatitis C is a growing public health concern, particularly in developing countries such as India where access to high quality, effective and affordable treatment remains a challenge. Mylan is proud to partner with Gilead to expand access to Sovaldi and Harvoni, life-saving medications that offer an improvement in the standard of care for the 12 million hepatitis C patients in India."
This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead, which grants Mylan the non-exclusive rights to manufacture and distribute generic sofosbuvir, ledipasvir/sofosbuvir and, upon approval, the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries.
Sovaldi is the latest addition to Mylan India's new gastrointestinal segment called Hepato Care. The company also offers four additional unique and innovative segments - critical care, HIV care, women's care and oncology.
Sovaldi was approved by the US Food and Drug Administration (FDA) in December 2013 based on clinical studies that showed, in combination with other agents, the drug achieved very high cure rates with a course of treatment as short as 12 weeks depending on viral genotype. Sovaldi 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).
Harvoni was approved by the US FDA in October 2014 as a once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults.