AstraZeneca (AZN) 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 Nektar Therapeutics (NKTR) in Sep 2009. The acceptance of MAA by the EMA triggered a $25 million milestone payment from AstraZeneca to Nektar Therapeutics.
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 revenues.
AstraZeneca carries a Zacks Rank #3 (Hold). Currently, companies like Roche (RHHBY) and Actelion Ltd. (ALIOF) look well-positioned with both being Zacks Rank #1 (Strong Buy) stocks.