Eli Lilly and Co. plans to buy Centessa Pharmaceuticals plc for $6.3 billion in up-front cash and another potential $1.5 billion through contingent value rights, gaining access to a pipeline of orexin receptor 2 agonists for sleep disorders. The Indianapolis-based pharma is re-entering a field that has multibillion-dollar potential and one that could emulate the success seen with its obesity program. Centessa, of Boston and London, has a lead candidate, cleminorexton (formerly ORX-750), with positive phase IIa data in narcolepsy types 1 and 2 and idiopathic hypersomnia.
Finding that a lower court went too far with an injunction that ignores the Hatch-Waxman safe harbor protections for drug development, the U.S. Court of Appeals for the Federal Circuit handed Avadel CNS Pharmaceuticals LLC a win of sorts.
NLS Pharmaceutics Ltd. has entered into an exclusive worldwide license agreement with Aexon Labs Inc. granting NLS the opportunity to acquire global development and commercialization rights to Aexon’s next-generation nonsulfonamide dual orexin receptor agonists platform.
Why U.S. FDA-approved Wakix (pitolisant) has worked to treat excessive daytime sleepiness (EDS) in narcolepsy but not in idiopathic hypersomnia (IH) patients is the question that lies before Harmony Biosciences Holdings Inc., and one that the U.S. FDA will take up at a future sit-down.
Harmony Biosciences Holdings Inc.’s plan disclosed at the start of last December to launch a phase III study with Wakix (pitolisant) for idiopathic hypersomnia (IH) during the first half of this year brought renewed attention to the sleep space, where a handful of players are jostling for position.
With generic competition on the horizon for its older sleep disorder drug Xyrem, Jazz Pharmaceuticals plc gained an added indication for its GABA B receptor agonist Xywav as the FDA approved it for idiopathic hypersomnia.
Dublin-based Jazz Pharmaceuticals plc’s phase III top-line win with Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution in adults with idiopathic hypersomnia (IH) provides the company with a needed foothold there as generics threaten its other sleep disorder drug, Xyrem (sodium oxybate).
