Gilead Goes Ahead With Expanded Generic Sovaldi Licensing in Developing Countries

Gilead has expanded its licensing agreements with eight India-based generic drugmakers to market cheaper copies of its pricey blockbuster hepatitis C therapy Sovaldi in 91 developing countries.

The expansion of the agreement allows the generics makers to produce a version of Sovaldi (sofosbuvir) in combination with an investigational drug; the company says the combo is aimed at treating all six genotypes of hepatitis C.

The investigational therapy, GS-5816, is an NS5A inhibitor. The combo with sofosbuvir is currently undergoing Phase III clinical trials, Gilead said, with data from those studies expected in the second half of this year.

If approved, the investigational combo would be the first tablet regimen for hepatitis C that treats all genotypes, Gilead said, which is especially important for developing countries that often don’t have reliable genotype testing.

Under the terms of the licensing arrangement, the generics firms pay Gilead an undisclosed royalty, although they can set their own prices. The generics makers are Biocon, Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab.

Gilead won approval for Sovaldi in India this month, the company said, though India has denied the drug a patent – a decision the company continues to challenge. — Bryan Koenig