Gilead Sciences Inc.
) 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.
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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
) Rituxan (rituximab) and to chemotherapy inclusive
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
Gilead, a biopharmaceutical company, carries a Zacks Rank #3
(Hold). Biopharma stocks such as
Vanda Pharmaceuticals, Inc.
) are better ranked. While Actelion carries a Zacks Rank #1
(Strong Buy), Vanda holds a Zacks Rank #2 (Buy).