Epilepsy

Eisai said Friday that it agreed to sell Japanese rights for the vertigo treatment Merislon (betahistine mesilate) and the antispasmodic drug Myonal (eperisone hydrochloride) to Kaken Pharmaceutical.The drugs have long been used by patients in Japan since their respective launches there decades ago, according to the Eisai. "Divesting rights for these products to Kaken, which has strengths in the products' disease areas, is the most optimal choice to ensure them to continue contributing to a greater number of patients," it added.Eisai will receive JPY 3.8 billion ($25 million) under the deal, and will proceed with the transfer of marketing capabilities by March 2025, followed by the transfer of manufacturing and marketing approval.Towards the end of 2022, the drugmaker agreed to offload US rights to its epilepsy drug Fycompa (perampanel) to Catalyst Pharmaceuticals for an upfront payment of $160 million.The company said it doesn't anticipate any changes to its consolidated financial forecast for the period ending March 31, 2024, as a result of the latest deal.

CORAL GABLES, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst") (Nasdaq: CPRX), a commercial-stage, patient-centric biopharmaceutical company focused on in-licensing, developing, and commercializing novel high-quality medicines for patients living with rare and difficult-to-treat diseases, today announced its endorsement of the inaugural Lambert-Eaton myasthenic syndrome ("LEMS") Awareness Day. This landmark event, now officially observed annually on March 30th, signifies a meaningful milestone for the LEMS community. The chosen date holds profound historical significance, coinciding with the publication of Dr. Edward Lambert and Dr. Lee Eaton's pioneering research on LEMS, which has greatly advanced the understanding and treatment of this rare neuromuscular disorder. "Creating an awareness day for LEMS is a huge win for our community," said Price Wooldridge, Founder and Board Member of the LEMS Family Association. "This brings us one step closer to our goal, improving the awareness of our rare condition in the larger population. We couldn't be more thrilled to celebrate the milestone of this first LEMS Awareness Day together." "In the realm of rare diseases, awareness is the key that unlocks paths to diagnosis and treatment. By shedding light on LEMS, we pave the way for better support, understanding, and care for those who need it most," stated Richard J. Daly, CEO of Catalyst. "At Catalyst, we are proud to stand alongside the LEMS Family Association in honoring this pivotal event. Together, we forge pathways of support and understanding for those affected by rare diseases, illuminating a brighter future for all." LEMS is a rare neuromuscular disease that affects at least 3,600 and potentially up to 5,400 LEMS patients in the United States. For more information, please visit www.lemsfamily.org and www.lemsaware.com. About Catalyst Pharmaceuticals, Inc.With exceptional patient focus, Catalyst is committed to developing and commercializing innovative first-in-class medicines that address rare and difficult-to-treat diseases. Catalyst's flagship U.S. commercial product is FIRDAPSE® (amifampridine) Tablets 10 mg, approved for the treatment of Lambert-Eaton myasthenic syndrome ("LEMS") for adults and for children ages six to seventeen. In January 2023, Catalyst acquired the U.S. commercial rights to FYCOMPA® (perampanel) CIII, a prescription medicine approved in people with epilepsy aged four and older alone or with other medicines to treat partial-onset seizures with or without secondarily generalized seizures and with other medicines to treat primary generalized tonic-clonic seizures for people with epilepsy aged 12 and older. Further, Canada's national healthcare regulatory agency, Health Canada, has approved the use of FIRDAPSE for the treatment of adult patients in Canada with LEMS. On July 18th, 2023, Catalyst acquired an exclusive license for North America for AGAMREE® (vamorolone) oral suspension 40 mg/mL, a novel corticosteroid treatment for Duchenne Muscular Dystrophy. AGAMREE previously received FDA Orphan Drug and Fast Track designations and was approved by the FDA for commercialization in the U.S. on October 26th, 2023. AGAMREE became available in the U.S. by prescription on March 13th, 2024. For more information about Catalyst Pharmaceuticals, Inc., visit the Company's website at www.catalystpharma.com. For Full Prescribing and Safety Information for FIRDAPSE®, visit www.firdapse.com. For Full Prescribing Information, including Boxed WARNING for FYCOMPA®, please visit www.fycompa.com. For Full Prescribing Information for AGAMREE®, please visit https://www.agamree.com. Forward-Looking StatementsThis press release contains forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including those factors described in Catalyst's Annual Report on Form 10-K for the fiscal year 2023 and its other filings with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect Catalyst. Copies of Catalyst's filings with the SEC are available from the SEC, may be found on Catalyst's website, or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date. Source: Catalyst Pharmaceuticals, Inc.

Aeovian Pharmaceuticals raised $50 million to fuel clinical trials of its lead candidate, AV078, to treat a rare, genetic form of epilepsy. The round, which was led by Hevolution, comes as Aeovian dosed the first participant in a Phase I trial assessing the safety of AV078 in healthy volunteers. The compound is a central nervous system-penetrant selective mTORC1 inhibitor in development for tuberous sclerosis complex (TSC) epilepsy. "TSC is a genetic disorder of mTORC1 hyperactivation,” CEO Allison Hulme said. “AV078 has the potential to be transformative for patients with TSC refractory epilepsy, a patient population in need of therapeutic options with better efficacy and tolerability.”The financing – which saw participation from existing investors Apollo Health Ventures, Sofinnova Investments, venBio, Evotec and b2venture – is expected to provide Aeovian enough runway to finish the Phase I study and prepare for a Phase II trial in adult and paediatric patients with TSC refractory epilepsy.Aeovian also welcomed new faces to its executive team on Thursday. Hevolution’s William Greene joined the board along with Justin Gover, former CEO of GW Pharmaceuticals. Additionally, Micah Zajic was named as chief financial officer; he previously served as chief business officer of Lexeo Therapeutics.