Gilead Licenses Hepatitis C Drug

Gilead Sciences has agreed to license to seven Indian generic pharmaceutical firms the rights to sell its multi-billion-dollar hepatitis C drug Sovaldi in poor countries. The Indian companies will also have the right to ledipasvir, another hepatitis C treatment, still at the experimental stage, that is intended to be administered with Sovaldi.

Approved by FDA in 2013 and on track to be a $10 billion-per-year drug, Sovaldi (sofosbuvir) sells in the U.S. for about $1,000 per pill, or $85,000 for a full course of treatment. The Indian companies will likely sell the medication at a far lower price.

Under the terms of the agreement, the Indian firms will pay a 7% royalty to Gilead, which in turn will provide technical support to help them develop their manufacturing processes. The Indian firms will have the right to sell the drug in 91 low-income countries, including India and South Africa. But they will not enjoy sales rights in major middle-income countries such as China, Brazil, and Thailand.

Leading generics producer Cipla is notable among the Indian licensees of sofosbuvir and ledipasvir. In the past, Cipla has contested the validity of patents covering other Gilead drugs, in particular the HIV drug Viread. Cipla was not part of a 2006 licensing deal that Gilead signed with eight Indian firms for Viread.

In a statement, Cipla praised Sovaldi “as a breakthrough in the treatment of hepatitis C.” The other companies in the licensing agreement are Cadila Healthcare, Hetero Drugs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific, and Strides Arcolab.

Doctors Without Borders, a charity that campaigns for affordable pharmaceuticals, is criticizing the pact between Gilead and the seven Indian firms. The group argues that more people suffer from hepatitis C in middle-income countries than in the poorer ones covered by the deal. “People living with chronic hepatitis C in these [middle income] countries often come from poor and marginalized communities with little ability to pay for expensive medicines,” the group says.