Gilead Sciences Inc. aims to launch Sovaldi, the hepatitis C drug, in India by June and to expand the reach of a generic licensing agreement with Indian drug-makers to include an investigational combination pill.
The pill could treat six genotypes of hepatitis C if approved by regulators and is a combination of sofosbuvir, the chemical name for Sovaldi, with GS-5816, a compound in advanced clinical trials in the U.S.
Gregg Alton, an executive vice president at the Foster City, California-based company, said, "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".
"In many of the resource limited environments around the world, it's very difficult, and not feasible to do genotyping. It's an expensive diagnostic that's simply not available many places" Alton said.
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.