Standard Review for Gilead's Oncology Candidate - Analyst Blog
14 Janeiro 2014 - 2:50PM
Zacks
Gilead Sciences
Inc. (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 (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. (ALIOF) and Medivation,
Inc. (MDVN). Both the stocks carry a Zacks Rank #1 (Strong
Buy).
ACTELION LTD (ALIOF): Get Free Report
GILEAD SCIENCES (GILD): Free Stock Analysis Report
MEDIVATION INC (MDVN): Free Stock Analysis Report
ROCHE HLDG LTD (RHHBY): Get Free Report
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