Gilead expands generic drug deals to include NS5A inhibitor GS-5816

Gilead Sciences said Monday that it will expand existing agreements and allow eight companies to manufacture the experimental hepatitis C drug GS-5816, as well as a single tablet regimen combining the NS5A inhibitor with Sovaldi (sofosbuvir), once approved, for distribution in 91 developing countries.

GS-5816 is currently being investigated in late-stage studies as part of a single tablet regimen with Sovaldi for the treatment of all six genotypes of hepatitis C, with data expected in the second half of the year. Gilead noted that if authorised, the combination "would become the first pan-genotypic, all-oral single tablet regimen" for hepatitis C, which the company indicated would be "particularly important for developing countries, where genotype testing is often unreliable or not readily available."

Gregg Alton, Gilead's executive vice president of corporate and medical affairs, commented "this compound will offer over 90 percent cure rate for all genotypes, with one pill a day for 12 weeks." Alton said the company will ask India's health ministry to waive clinical trials and expedite approval for the combination therapy. "In many of the resource limited environments around the world, it's very difficult, and not feasible to do genotyping," Alton remarked, adding "it's an expensive diagnostic that's simply not available many places."

In September last year, Gilead granted non-exclusive licensing agreements allowing seven drugmakers to manufacture Sovaldi for distribution in 91 developing countries. The deals also allow the companies to produce Harvoni, a single tablet regimen combining Sovaldi with ledipasvir. According to Gilead, eight Indian-based generic manufacturers now hold licenses to manufacture the company's hepatitis C medicines: Biocon, Cadila Healthcare, Cipla, Hetero Labs, Mylan, Ranbaxy, Sequent Scientific and Strides Arcolab.

Sovaldi was approved by the FDA in December 2013 and gained clearance from the European Commission in January 2014. The drug was authorised in India in January this year, while Gilead noted that regulatory submissions have been completed in additional countries, including Pakistan, Thailand, Brazil, Uganda, South Africa and Nigeria.

Earlier this month, India's patent office rejected one of the patents on Sovaldi, with Gilead later indicating that it will appeal the ruling. "We believe there were procedural mistakes and don't believe it was a proper decision," Alton said.

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