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Mylan launches Gilead Sciences’ Sovaldi tablets in India

Sovaldi is indicated for the treatment of chronic hepatitis C infection, a blood-borne infectious disease

Mylan’s subsidiary, Mylan Pharmaceuticals, has launched Gilead Sciences’ Sovaldi (sofosbuvir 400mg tablets) in India. Sovaldi is indicated for the treatment of chronic hepatitis C infection, a blood-borne infectious disease, as a component of a combination antiviral treatment regimen. It is estimated that approximately 12 million people are chronically infected with hepatitis C in India.

In February 2015, Gilead appointed Mylan as its exclusive distributor of Sovaldi in India. Rajiv Malik, President, Mylan, commented, “Mylan has a long-standing history of partnering with Gilead to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending our partnership to include hepatitis C treatments. We are proud to continue our work together with the launch of Sovaldi as it supports our joint commitment to meeting the unmet medical needs of patients in India.”

“We are pleased to bring this important therapeutic advance to patients living with hepatitis C in India. Today marks an important milestone in Gilead’s ongoing effort to make its hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible,” said Gregg Alton, Executive Vice President, Corporate and Medical Affairs, Gilead Sciences.

Sovaldi is sold by Mylan’s dedicated sales force as part of its Hepato Care segment.

Additional hepatitis C arrangements with Gilead include:

  1. A licensing and technology transfer agreement that grants Mylan the non-exclusive rights to manufacture and distribute generic sofosbuvir and generic ledipasvir/sofosbuvir and, upon FDA approval, the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816 in 91 developing countries
  2. An exclusivity for distribution of Gilead’s brand Harvoni (ledipasvir 90mg/sofosbuvir 400 mg tablets) in India

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