Mylan to distribute Gilead's Hepatitis C drugs in India

New York: US-based leading generic drugmaker Mylan Monday said it will sell in India two chronic Hepatitis C drugs of Gilead Sciences.

The drugs would be distributed in India by its Indian subsidiary, Mylan Pharmaceuticals Private Limited, and an agreement has been reached in this regard with Gilead Sciences, Mylan said in a statement.

Mylan has been appointed as the exclusive distributor in India of Sovaldi and Harvoni drugs for the treatment of chronic Hepatitis C.

"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," it added.

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."

The agreement will help 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," he added.

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 versions of Sovaldi and Harvoni, as well as another Hepatitis C of Gilead drug currently under development.

Mylan has also partnered 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.