Gilead Sciences, Inc. (GILD) expanded its hepatitis C generic licensing agreements with its partners (based in India) to include an investigational pan-genotypic agent, GS-5816. Under the amended agreement, Gilead’s partners will gain the rights to manufacture GS-5816 and the single-tablet combination of its blockbuster hepatitis C drug Sovaldi and GS-5816 (if approved) for commercialization in 91 developing countries.
We remind investors that in Sep 2014, Gilead announced non-exclusive licensing agreements with several generic pharmaceutical companies (based in India) to expand the commercialization of its chronic hepatitis C drugs in developing countries.
Under these agreements, the company’s partners received a complete technology transfer of the manufacturing process and the rights to produce Sovaldi and Harvoni (single-tablet regimen of ledipasvir/sofosbuvir) for distribution in these countries. Currently, eight Indian generic manufacturers hold licenses to manufacture Gilead’s HCV drugs.
We note that GS-5816 is being evaluated in phase III studies as a part of the single tablet regimen with Sovaldi for the treatment of all six genotypes of hepatitis C virus (HCV). Data from these studies should be out in the second half of 2015. Gilead said that upon approval, the Sovaldi/GS-5816 combination will become the first pan-genotypic, all-oral single-tablet regimen for HCV.
According to Gilead, these developing countries jointly account for 54% of the total number of patients suffering from HCV across the world. Moreover, due to the presence of a diverse mix of hepatitis C genotypes, coupled with the unreliability, unavailability or high cost of genotype testing, a pan-genotypic treatment for HCV is an important therapeutic option in these regions. There is an urgent need for a treatment that can cure HCV, irrespective of the genotype.
Meanwhile, Sovaldi received approval in India in Jan 2015.
Gilead currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Celgene Corp. (CELG), Regado Biosciences, Inc. (RGDO) and Alexion Pharmaceuticals, Inc. (ALXN). All these stocks hold a Zacks Rank #1 (Strong Buy).
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