) recently announced that the European Medicines Agency (EMA) has
accepted the Marketing Authorisation Application (MAA) for two of
its candidates - olaparib and naloxegol.
AstraZeneca is looking to get olaparib approved as a maintenance
therapy in BRCA mutated relapsed serous ovarian cancer patients,
who have shown response to platinum-based chemotherapy in the EU.
The MAA for olaparib was submitted on the basis of a phase II
study. The phase II study compared the efficacy and safety of
olaparib versus placebo in patients suffering from
platinum-sensitive, relapsed, high grade serous ovarian cancer.
The patients had already been treated with two or more
platinum-based regimens and exhibited a partial or complete
response to the last platinum-based treatment regimen. A subgroup
analysis revealed that olaparib significantly improved
progression-free survival as compared to placebo.
Meanwhile, AstraZeneca is also seeking to market Naloxegol in the
EU for the treatment of opioid-induced constipation in adults.
The MAA for Naloxegol was submitted on the basis of encouraging
data from the phase III KODIAC program. AstraZeneca had licensed
the candidate from
) in Sep 2009. The acceptance of MAA by the EMA triggered a $25
million milestone payment from AstraZeneca to Nektar
AstraZeneca's pipeline is currently under severe pressure with
revenues plunging due to generic competition faced by several key
drugs including Seroquel. We believe that approval of these
candidates would provide a much needed boost to AstraZeneca's
AstraZeneca carries a Zacks Rank #3 (Hold). Currently, companies
) look well-positioned with both being Zacks Rank #1 (Strong Buy)
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