Alkermes plc’s decision to explore separating its commercial-stage neuroscience business from earlier-stage oncology efforts – forming a distinct, publicly traded company to investigate cancer therapies – drove speculation about the launch of the firm’s Lybalvi (olanzapine and samidorphan), approved by the U.S. FDA in the middle of 2021 for schizophrenia and bipolar I disorder.
Alkermes plc’s recent update on sales of the schizophrenia drug Lybalvi (also indicated for bipolar I disorder) along with positive phase III data from Karuna Therapeutics Inc. from tests of Karxt (xanomeline plus trospium) shone more light on the troublesome indication, where Cerevel Therapeutics Holdings Inc. is advancing emraclidine in what could be a registrational phase II study.
Shares of Alkermes plc slipped 15% Nov. 9 on news that longtime partner Janssen Pharmaceutica NV plans to partially terminate two license agreements related to know-how royalties on U.S. sales of paliperidone products using Alkermes’ nanoparticulate technology. While the move is expected to result in only a modest near-term impact on the Dublin-based firm’s bottom line, it took both company management and investors by surprise.
Stock market exuberance, particularly in favor of an innovative industry working to pull the world out of the deadly COVID-19 pandemic, led to drug developers shares surging 30% in 2020. But if one thing is certain, it is this: Markets usually pull back and that is partially why BioWorld’s Drug Developers Index is showing only a 2.06% gain so far this year, in contrast to both the Nasdaq Biotechnology Index and the Dow Jones Industrial Average, which are up 6.28% and 10.96%, respectively.
Alkermes plc worked its way through a complete response letter (CRL) issued in late 2020 as the FDA has approved Lybalvi (olanzapine and samidorphan) for treating adults with schizophrenia and bipolar I disorder. The once-daily, oral antipsychotic treatment, the company’s first, is for maintenance monotherapy or acute treatment of manic or mixed episodes and as a monotherapy or adjunct to lithium or valproate. The therapy had a June 1 PDUFA date.
The latest global regulatory news, changes and updates affecting biopharma, including: Sacklers threatened with House subpoena; DEA proposes de-scheduling Alkermes drug; Marburg MCMs protected under PREP; OPDP: Don’t make risks a P.S.; U.S. Senators sound off on E&M offsets.
The already intriguing IL-2 pathway as a therapeutic target gained still more traction after San Francisco-based Nektar Therapeutics Inc. unveiled melanoma data with bempegaldesleukin (bempeg), its CD122-preferential agent in the class.
Multiple companies have had their FDA reviews put on hold because coronavirus-related travel restrictions at the FDA has kept their manufacturing plants from being inspected.
Even as Alkermes plc works to resolve the complete response letter (CRL) sent by the FDA regarding ALKS-3831, labeling talks are underway for the compound, an oral therapy for schizophrenia and bipolar I disorder in adults. Regulators reviewed manufacturing records and said the Dublin-based firm needs to supply documents related to making the tablet’s coating at the Wilmington, Ohio, facility. No clinical or non-clinical concerns were raised, the firm said, and shares (NASDAQ:ALKS) hardly moved, closing Nov. 17 at $18.30, up 45 cents.
Opioid-related hazards with Alkermes plc’s combo drug ALKS-3831 – specifically, with the samidorphan element – and the significance of weight-gain reduction brought about by the tablet, which also includes olanzapine, became key topics in the joint meeting of the FDA’s Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
