Gilead Sciences said today it will expand access to its chronic hepatitis C medicines in developing countries through non-exclusive licensing agreements signed with seven India-based generic pharmaceutical manufacturers.
The agreements will allow the seven—Cadila Healthcare, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy Laboratories, Sequent Scientific and Strides Arcolab—to manufacture Gilead’s Sovaldi® (sofosbuvir) and an investigational single tablet combination regimen of sofosbuvir and another Gilead hepatitis treatment, ledipasvir, for distribution in 91 developing countries. Those countries account for more than 100 million people living with hepatitis C, representing 54% of the world’s total infected population.
“In developing countries, large-volume generic manufacturing and distribution is widely regarded as a key component in expanding access to medicines. These agreements are essential to advancing the goals of our humanitarian program in these countries,” Gregg H. Alton, Gilead’s evp, corporate and medical affairs, said in a statement.
The FDA and the European Medicines Agency are currently reviewing Gilead’s applications for the single tablet ledipasvir/Sovaldi combination. Ledipasvir is an inhibitor of the NS5A protein, while Sovaldi is a once-daily oral nucleotide analog polymerase inhibitor of the NS5B protein. The combination is designed to interfere with HCV replication and be used as a treatment for hepatitis patients with genotypes 1a or 1b without PEG-interferon.
Sovaldi was approved in December 2013 for chronic hepatitis C, as part of a combination treatment regimen which, depending on the patient’s type of infection, could combine the drug with ribavirin (RBV; genotypes 2 and 3), or with ribavirin and peginterferon-alfa (RBV + peg-IFN; genotypes 1, 4, 5, and 6). Sovaldi was the first drug that had shown the safety and efficacy to treat certain types of HCV infection without the need for injection of interferon at the same time.
However, Sovaldi and Gilead found themselves at the center of controversy earlier this year after three top Democrats in the Republican-majority House of Representatives—later echoed by the World Health Organization and pharmacy benefit manager Express Scripts—complained about Sovaldi’s price of $84,000 per 12-week treatment. Gilead has countered that the cost of the drug is lower than the cost of complications associated with hepatitis C treatment, such as liver damage or liver failure.
The seven Indian companies will receive a complete technology transfer of the Gilead manufacturing process, intended to help them scale up production as quickly as possible. Licensees will set their own prices for the generic product they produce, paying a royalty on sales to Gilead to support product registrations, medical education and training, safety monitoring and other business activities. The licenses also allow production of Sovaldi or ledipasvir in combination with other chronic hepatitis C medicines, Gilead said.