Gilead's Sofosbuvir under European Review

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Gilead Sciences Inc. (GILD) recently announced that its Marketing Authorisation Application (MAA) for HCV candidate sofosbuvir (formerly GS-7977), submitted to the European Medicines Agency (:EMA) on Apr 17, 2013, has been validated and is under review.

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 MAA 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 MAA on the basis of encouraging data from four phase III studies (NEUTRINO, FISSION, POSITRON and FUSION). 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.

The EMA granted Gilead’s request for accelerated assessment of the company’s Marketing Authorization Application for sofosbuvir. The acceptance of the request is expected to bring down EMA’s review time of the application by two months. Gilead also intends to seek sofosbuvir approval in other countries. Gilead expects sofosbuvir to be available in the EU by the first half of 2014, assuming approval. Gilead is also seeking US approval for sofosbuvir.

Approval of sofosbuvir would bring down the duration of HCV therapy to 12-16 weeks. Currently, HCV therapy includes 24-48 weeks of treatment with injectable peg-IFN. Moreover, the current standard of care comes with several side effects which make it difficult for patients to remain on treatment.

Approval of sofosbuvir would not only boost Gilead’s top line but would also strengthen its position in the lucrative HCV market. A sizeable population suffers from HCV throughout the world. However, the treated population is much lower. This leaves the field open for new treatments. We note that companies such as Johnson & Johnson (JNJ) and Bristol-Myers Squibb (BMY) are also developing therapies to combat HCV.

Gilead, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Celgene Corporation (CELG) appears to be more attractive in the biopharma space with a Zacks Rank #2 (Buy).

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