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Gilead's Pipeline Encourages

Zacks Equity Research

Gilead Sciences Inc. (GILD) boasts of a robust pipeline. The candidates targeting various indications are in different phases of development. Successful development and subsequent commercialization of the pipeline candidates would boost Gilead’s top line further.

One of the most interesting candidates at Gilead is idelalisib (formerly GS-1101). The candidate, added to Gilead’s pipeline through its acquisition of Calistoga Pharmaceuticals in 2011, is being developed for multiple indications. At the annual meeting of the American Society of Hematology (ASH), Gilead presented encouraging data on the candidate from a phase II study (101-09: n=125) in the indolent non-Hodgkin’s lymphoma (iNHL) indication. The patients were refractory to both Roche’s (RHHBY) Rituxan (rituximab) and to chemotherapy inclusive alkylating-agent.

Data from the study revealed that idelalisib treatment resulted in an overall response rate of 57% and a median duration of response of 12.5 months in the evaluated patients. We remind investors that Gilead had filed for the U.S. approval of idelalisib in the above indication earlier this year.

Gilead also intends to seek approval for idelalisib in the chronic lymphocytic leukemia (:CLL) indication and is in discussions with the U.S. Food and Drug Administration (:FDA) regarding the same. Idelalisib is under review in the EU in the CLL as well as iNHL indications. With the acceptance of Gilead’s request for accelerated assessment by the European Medicines Agency’s (:EMA) Committee for Medicinal Products for Human Use (CHMP), idelalisib is expected to be available in the EU in the latter half of 2014 (assuming approval). Idelalisib on approval will augment Gilead’s top line further.

Another promising candidate in Gilead’s pipeline is GS-9973. Encouraging interim data on the candidate from a phase II study were also presented at the ASH in patients with relapsed or refractory CLL or NHL. The product portfolio at Gilead, which was boosted by the U.S. approval of Sovaldi (hepatitis C virus) a few days ago, will be strengthened further in the event of the pipeline delivering.

Gilead, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Biopharma stocks such as Actelion Ltd. (ALIOF) and Vanda Pharmaceuticals, Inc. (VNDA) are better ranked. While Actelion carries a Zacks Rank #1 (Strong Buy), Vanda holds a Zacks Rank #2 (Buy).

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