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Gilead Seeks FDA Approval

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Gilead Sciences (GILD) recently submitted a New Drug Application (:NDA) to the US Food and Drug Administration (:FDA) seeking approval to market its hepatitis C Virus (:HCV) candidate sofosbuvir (formerly GS-7977).

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 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.

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) and Bristol-Myers Squibb (BMY) are also developing therapies to combat HCV.

Approval of sofosbuvir would not only bring down the duration of HCV therapy to 12-16 weeks but also eliminate/reduce the duration of peg-IFN injections depending on the genotype of the disease. 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.

Gilead intends to seek EU approval for sofosbuvir in the second quarter of 2013. The European Medicines Agency (:EMA) has already granted Gilead’s request for accelerated assessment of the company’s Marketing Authorization Application for sofosbuvir. The acceptance of the request can bring down EMA’s review time of the application by two months. Gilead also intends to seek sofosbuvir approval in other countries.

Gilead, a biopharmaceutical company, carries a Zacks Rank #2 (Buy). Array BioPharma, Inc. (ARRY) is another favorably placed stock in the biopharma space with a similar rank.

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