Nektar Therapeutics (NKTR) and AstraZeneca’s (AZN) Moventig is one step closer to receiving EU approval after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive opinion on the approval of the drug.
The companies are looking to get Moventig approved for the treatment of opioid-induced constipation (OIC) in adults whose response to laxatives has been inadequate. Nektar has a worldwide license agreement with AstraZeneca for Moventig.
The CHMP’s opinion on the approval of Moventig will be reviewed by the European Commission, which will render a final decision on the same. We note that though the European Commission is not bound to follow the CHMP’s decision, it generally does so. Moventig’s approval in the EU will be the first approval of a once-daily oral PAMORA class of drug indicated for the treatment of OIC in adults whose response to laxative(s) has been inadequate.
The favorable CHMP opinion came close on the heels of the U.S. approval of the drug. Moventig was approved in the U.S. earlier this month, under the trade name Movantik, for use in adults with chronic non-cancer pain suffering from OIC. The drug is expected to be available in the U.S. from the first half of 2015 (read more: AstraZeneca's Constipation Drug Movantik Gets FDA Nod).
Our Take
We are encouraged by the positive regulatory decisions regarding Moventig. Nektar’s progress with its pipeline and partnership programs in the recent past has been significant. The company is expecting several pipeline related news in the coming quarters. We expect investor focus to stay on these updates.
Nektar presently carries a Zacks Rank #3 (Hold). Gilead Sciences (GILD) and Medivation (MDVN) are better-ranked stocks in the healthcare sector carrying a Zacks Rank #1 (Strong Buy).
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