Gilead Hands Over Sofosbuvir Distribution in India to Mylan

Gilead Hands Over Sofosbuvir Distribution in India to Mylan

sovaldiThe Indian subsidiary of Mylan Inc. has signed an agreement with biopharmaceutical company Gilead Sciences to receive the rights as exclusive distributor in India of both Sovaldi and Harvoni — therapies designed to treat chronic hepatitis CMylan Pharmaceuticals Private Limited is now the exclusive branded medicine distribution partner of Gilead and is expected to start distributing Sovaldi in the country during the second quarter of the year.

Solvadi (sofosbuvir 400mg tablets), which was approved by the U.S. Food and Drug Administration (FDA) in 2013 and by the European Commission in 2014, was accepted to enter the Indian market last January, making the country the first in Asia to receive the drug treatment. The studies on solvadi revealed the drug’s effectiveness to cure chronic hepatitis C in combination with other medications, and is currently recommended by the World Health Organization as a first treatment option.

Harvoni (ledipasvir 90mg/sofosbuvir 400 mg tablets) is a once-daily single tablet treatment for chronic hepatitis C adult patients carrying the genotype 1 infection, who were not previously treated for the disease, with both cirrhotic and non-cirrhotic infections. It was approved by the FDA in October of the last year, as well as by the European Commission last November, becoming the first drug combination for the treatment of chronic hepatitis C in Europe.

“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,” said the president of Mylan, Rajiv Malik, in a press release. “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.”

The two companies added sovaldi and harvoni to their agreement, which had already been established for licensing and technology transfer, and provided Mylan non-exclusive rights for producing and distributing the generic version of sofosbuvir, ledipasvir/sofosbuvir, as well as the NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir/GS-5816, after receiving approval in 91 developing countries.

Mylan is focused on the Indian market, and is also collaborating with Gilead to provide affordable antiretroviral medication to treat HIV/AIDS in the country. Mylan will add sovaldi to its gastrointestinal program, Hepato Care, which comprises the four segments of Critical Care, HIV Care, Women’s Care and Oncology.

The Indian authorities have also recently rejected a patent application from Gilead to have exclusive access to the sofosbuvir compound, allowing other local drug producers to launch generic versions of the medication at lower prices. Since the Indian patent office enables other parties to participate in the validation process for pending patent applications, Gilead’s application has been contested by both the Indian generic drugmaker Natco Pharma Ltd. and the New York-based Initiative for Medicines, Access & Knowledge (I-MAK).

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