Nektar Therapeutics (NKTR) and AstraZeneca’s (AZN) Moventig (U.S. trade name: Movantik) gained approval in the EU for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). This makes Moventig the first once-daily oral peripherally-acting mu-opioid receptor antagonist (PAMORA) to gain EU approval for this indication.
EU approval was largely expected as the Committee for Medicinal Products for Human Use (CHMP) had issued a favorable opinion this September.
We note that Movantik was approved by the FDA in September this year for the treatment of OIC in adult patients suffering from chronic non-cancer pain.
Nektar’s association with AstraZeneca goes back to 2009 when the companies had entered into a license agreement for the development and commercialization of Moventig. On its third quarter conference call, Nektar had mentioned that AstraZeneca plans to launch Movantik in both the U.S. and Europe by the end of the first quarter of 2015 or early in the second quarter. Nektar will be eligible to receive a $100 million and $40 million milestone payment upon the launch of Movantik in the U.S. and major EU countries, respectively.
Nektar continues to progress with its pipeline. Last week, partner Baxter (BAX) submitted a biologics license application (BLA) to the FDA for the approval of BAX 855, which is based on ADVATE [Antihemophilic Factor (Recombinant)], for the treatment of patients suffering from hemophilia A.
We expect investor focus to remain on the commercialization and sales ramp up of Movantik.
Nektar currently carries Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Sucampo Pharmaceuticals, Inc. (SCMP) carrying a Zacks Rank #1 (Strong Buy).
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