Actavis Gets Accelerated Review in Namenda Appeal

A federal appeals court is expected to rule next month in a dispute over Actavis’ plan to pull an older formulation of its blockbuster Alzheimer’s drug Namenda from the market and replace it with a newer version.

Actavis confirmed last week that the U.S. Court of Appeals for the Second Circuit would expedite its appeal of a district court’s ruling that temporarily mandated Namenda IR (memantine) stay on the shelves. The drugmaker said it had sought a ruling by Feb. 16.

The company also expressed confidence that the appellate court would overturn the Southern District of New York judge’s temporary ruling in the case, which stemmed from Actavis and subsidiary Forest Laboratories’ bid to switch patients to extended-release Namenda XR.

New York state Attorney General Eric Schneiderman sued Actavis in September claiming the switch was designed solely to prolong market exclusivity through the newer, patent-protected version. Actavis has countered that the XR version is superior because it needs to be administered just once a day compared with twice daily for the older formulation. — Bryan Koenig