) announced that the FDA's Oncologic Drugs Advisory Committee
(ODAC) voted against (11-2) accelerated approval of its oncology
candidate, olaparib. The company is looking to get olaparib
approved as a maintenance treatment for patients suffering from
platinum-sensitive relapsed ovarian cancer with the germline BRCA
mutation, and who are in complete or partial response to
We remind investors that the FDA had granted priority review status
for olaparib's marketing application in Apr 2014. . The regulatory
agency is expected to render a final decision by Oct 3, 2014. We
note that the FDA is not bound to accept the recommendation of the
ODAC panel, but it generally does so while deciding on the fate of
AstraZeneca had submitted the marketing application for olaparib in
Feb 2014 based on a subgroup analysis of data from a phase II
study. The randomized, double-blind, placebo-controlled study
compared the use of olaparib and placebo as maintenance treatment
in platinum-sensitive relapsed serous ovarian cancer patients who
had received previous treatment with at least two platinum regimens
and were in a maintained partial or complete response following
their last platinum regimen. The study met the primary endpoint of
Meanwhile, the company plans to continue to evaluate olaparib in a
phase III study in patients with relapsed BRCA-mutated ovarian
cancer. Data from the study is expected to mature by the end of
2015. AstraZeneca has also initiated a phase III SOLO program to
evaluate the efficacy and safety of olaparib as a maintenance
monotherapy in BRCA-mutated ovarian cancer patients, who are in
complete or partial response following platinum-based chemotherapy
in the relapsed setting.
We are disappointed with the negative recommendation from the FDA
panel. We note that in Dec 2011, AstraZeneca had announced its
decision to stop the development process of olaparib as maintenance
treatment of serous ovarian cancer following an interim analysis of
a phase II study (study 19). Our expectations from the candidate
AstraZeneca's pipeline is currently under severe pressure with
revenues plunging due to generic competition faced by several key
drugs including Seroquel. Additionally, Nexium has also gone
off-patent earlier this year.
AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked
stocks in the health care sector include
Regeneron Pharmaceuticals, Inc.
) While Allergan and Regeneron are Zacks Rank #1 (Strong Buy)
stocks, Affymax holds a Zacks Rank #2 (Buy).
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