Gilead Expands Generic Sovaldi Pact to Add Investigational Pill

Gilead Sciences Inc. said it aims to launch Sovaldi, its blockbuster hepatitis C drug, in India by June while expanding the reach of a generic licensing agreement with Indian drugmakers to include an investigational combination pill.

The pill, which combines sofosbuvir, the chemical name for Sovaldi, with GS-5816, a compound in advanced clinical trials in the U.S., could treat six genotypes of hepatitis C if approved by regulators. Gilead will ask India’s health ministry to waive clinical trials and expedite approval for the compound, which eliminates the need for costly genotype tests, Gregg Alton, an executive vice president at the Foster City, California-based company, said in a phone interview.

“In many of the resource limited environments around the world, it’s very difficult, and not feasible to do genotyping,” Alton said. “It’s an expensive diagnostic that’s simply not available many places.”

Gilead’s Sovaldi, which will launch at $900 for a 12-week regimen in India, has drawn criticism from patient advocates in developing countries, who say that its generic licensing agreement doesn’t cover enough of the middle-income countries with high hepatitis C burdens. The investigational fixed dose combination pill that’s been added to the licenses could be a more cost effective way of treating hepatitis C in poor countries, Alton said.

Gilead Sciences has licensed eight India-based generic drugmakers to bring cheaper versions of Sovaldi to 91 mainly low-income countries, including India, Indonesia, Cambodia and many nations in Africa.

The eight manufacturers that hold the license are Biocon Ltd., Cadila Healthcare Ltd., Cipla Ltd., Hetero Labs Ltd., Mylan Laboratories Ltd., Ranbaxy Laboratories Ltd., Sequent Scientific Ltd. and Strides Arcolab Ltd.

India’s drug regulator approved Gilead’s Sovaldi on Jan. 13, the same week that the nation’s patent office rejected claims from Gilead covering an active metabolite of the drug.

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