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Standard Review for Gilead's Oncology Candidate

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Gilead Sciences Inc. (NASD:GILD) announced that the U.S. Food and Drug Administration (:FDA) has granted standard review for its new drug application (:NDA) for oncology candidate, Idelalisib. Gilead is looking to get the candidate approved for treating patients suffering from indolent non-Hodgkin’s lymphoma (iNHL).

Gilead had submitted the NDA on Idelalisib to the FDA in Sep 2013. The NDA was submitted on the basis of encouraging data from a phase II study (101-09: n=125) in the iNHL indication. The patients were refractory to both Roche’s (OTC:RHHBY) Rituxan (rituximab) and to chemotherapy inclusive alkylating-agent. A decision from the FDA is expected by Sep 11, 2014.

Apart from iNHL, idelalisib is also being evaluated in other oncology indications, such as chronic lymphocytic leukemia (:CLL). Gilead is also seeking U.S. approval of Idelalisib for treating CLL patients. Management at Gilead is highly optimistic on Idelalisib’s prospects. Approval of the candidate would strengthen Gilead’s already strong product portfolio.

Gilead’s product portfolio was significantly boosted last month with the FDA approving its potential blockbuster drug Sovaldi (sofosbuvir: once daily) as a combination therapy for treating patients suffering from chronic hepatitis C virus (:HCV). Sovaldi, with its high cure rates, a short treatment period and reduction/elimination of the need for interferon injections, has the potential to change the treatment paradigm in the HCV space. The approval has been highly welcomed by HCV patients, many of whom have postponed their treatments waiting for a better therapy like Sovaldi to gain approval. We expect uptake in Sovaldi sales to be rapid, given its broad label and the pent-up demand for new HCV therapies.  

Sovaldi is also approved in Canada while European approval is expected shortly. Approval has also been sought in other countries such as Turkey, Switzerland, Australia and New Zealand. We expect an update on Sovaldi’s initial sales as well as on Gilead’s pipeline on the fourth quarter and full year 2013 earnings conference call.

Gilead, a biopharmaceutical company, carries a Zacks Rank #4 (Sell). High operating expenses due to new product launches are expected to hurt the fourth quarter results.

Some better-ranked stocks in the biopharma space include Actelion Ltd. (OTC:ALIOF) and Medivation, Inc. (NASD:MDVN). Both the stocks carry a Zacks Rank #1 (Strong Buy).

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