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.
Patients with Parkinson’s disease (PD) frequently suffer from sleep disorders, in addition to the neurodegenerative processes associated with the disease. These disorders affect both rapid eye movement (REM) and non-REM (NREM) sleep, but the underlying mechanisms in PD patients remain largely unknown.
Nippon Zoki Pharmaceutical Co. Ltd. has discovered alkyne derivatives acting as GABA-A receptor subunit α1β2γ2 positive allosteric modulators. As such, they are believed to be useful for the treatment of sleep disorders.
Weighing in on the marketing exclusivity provided by the Orphan Drug Act, the U.S. Court of Appeals for the District of Columbia Circuit said the FDA didn’t act beyond its statutory authority when it approved Avadel CNS Pharmaceuticals plc’s narcolepsy drug, Lumryz, for marketing during the exclusivity period granted to Jazz Pharmaceuticals plc’s Xywav, even though both drugs contained the same active ingredient, sodium oxybate, and were approved for the same disease or condition.
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., in collaboration with Aexon Labs Inc., has announced new preclinical findings on AEX-2, a non-sulfonamide dual orexin receptor agonist (DOXA) with potential for narcolepsy and related neurological disorders.
Centessa Pharmaceuticals plc recently detailed the discovery and preclinical characterization of a novel potent and selective orexin OX2 receptor agonist, ORX-142.
Patients with multiple sclerosis have an increased prevalence of sleep disorders compared to the general population, with an estimated rate ranging from 25% to 50% and negative impacts on quality of life.
Royal Philips NV agreed with the U.S. FDA to the terms of a consent decree focused on its Respironics business, following the recall of millions of its devices over the last few years. Although the details of the decree are being finalized, Philips said it will halt the sales of new continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) sleep therapy machines as well as other respiratory care devices in the U.S. until the conditions of the decree are met.