visivastudio /
29 January 2015Americas

Gilead and Mylan expand hepatitis C licensing agreement

Drug companies Gilead and Mylan are expanding their licensing agreement covering hepatitis C treatment to include two new products.

Mylan will be granted a non-exclusive right to manufacture and distribute the investigational NS5A inhibitor GS-5816 and a single tablet regimen that combines Sovaldi (sofosbuvir) and GS-5816.

NS5A is a protein that plays a role in the development of hepatitis C.

The drugs will be manufactured in Mylan’s Indian plants and distributed in 91 developing countries, which, according to Gilead, account for 54% of the total worldwide population of individuals infected with the hepatitis C virus.

The single tablet combination of sofosbuvir and GS-5816 to treat all six genotypes of hepatitis C is undergoing clinical studies. Data from the trials are expected in the second half of this year.

If approved, it is thought it will be the first all-oral single tablet regimen for all hepatitis C genotypes.

Gregg Alton, executive vice president of corporate and medical affairs at Gilead, said: “Developing countries are home to a diverse mix of hepatitis C genotypes, and the development of a medicine that has the potential to cure any patient, regardless of genotype, could help accelerate access to treatment.”

President of Mylan, Rajiv Malik, added: “We are proud to partner with Gilead, once again, in our joint effort to quickly expand access to high quality, affordable medications to the more than 100 million people living with hepatitis C in developing countries.”

Mylan signed an agreement with Gilead last September that granted it the non-exclusive rights to make and distribute sofosbuvir and ledipasvir/sofosbuvir (harvoni) in 91 developing countries. Eight India-based generic drug makers now hold licences to manufacture Gilead’s hepatitis C medicines.

Earlier this month, the Indian Patent Office refused Gilead’s application for a patent protecting Sovaldi, which in the US costs $1,000 per pill, or $84,000 for a 12-week treatment course.

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