Gilead Sciences, Inc. (GILD - Free Report) recently announced detailed results from four phase III studies (NEUTRINO, FISSION, POSITRON and FUSION) which evaluated its candidate sofosbuvir (formerly GS-7977) as a combination therapy in patients suffering from various genotypes of the chronic hepatitis C virus (HCV).
The studies evaluated approximately 1,000 HCV patients. Findings were published in the New England Journal of Medicine. Gilead intends to present the data at the 48th annual meeting of the European Association for the Study of the Liver in the Netherlands shortly.
We note that earlier in the month Gilead had submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval to market sofosbuvir.
Gilead is looking to get the candidate approved in combination with ribavirin (RBV) as an all-oral therapy for treating patients affected with genotypes 2 and 3 of the disease. The NDA also includes data backing the use of sofosbuvir in combination with RBV and pegylated interferon (peg-IFN) as a first-line therapy in patients suffering from the genotypes 1, 4, 5 and 6 of the virus.
Gilead submitted the NDA on the basis of data from the NEUTRINO, FISSION, POSITRON and FUSION studies. Data from the studies revealed that sofosbuvir-based therapy for 12 or 16 weeks was either superior or non-inferior to currently available HCV treatment options. Gilead intends to seek EU approval for sofosbuvir by Jun 30, 2013.
Approval of sofosbuvir would not only boost Gilead’s top line but also strengthen its position in the lucrative HCV market. A sizeable population suffers from HCV the world over. However, the treated population is much lower. This leaves the field open for new treatments. We note that companies such as Johnson & Johnson (JNJ - Free Report) and Bristol-Myers Squibb Company (BMY - Free Report) are also developing therapies to combat HCV.
Gilead, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Celgene Corporation (CELG - Free Report) appears to be more favorably placed in the biopharma space with a Zacks Rank #2 (Buy).