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Dive Brief:Axsome Therapeutics gained more than $1 billion in market value Monday, after the brain drug developer disclosed a patent settlement with Teva Pharmaceuticals that will keep a generic copy of Axsomes top drug at bay in the U.S. until at least 2038.Axsome had sued Teva for patent infringement when the generic drugmaker filed for approval of a knock-off version of Auvelity, a medicine for major depressive disorder that last year earned Axsome some $290 million in net sales.Per the settlement struck by the two companies, Teva will gain a license to sell generic Auvelity on or after March 31, 2039, should Axsome gain regulatory exclusivity for pediatric use of the drug. If Axsome doesnt, Teva can enter the U.S. market with its copy on Sept. 30, 2038.Dive Insight:Auvelity is one of three drugs Axsome sells and by far the companys top product.Auvelity combines a form of dextromethorphan, which is used as a cough suppressant in drugs like Robitussin, and bupropion, an antidepressant compound that on its own was previously marketed as Wellbutrin.The New York-based biotechnology company also markets Sunosi, a treatment to improve wakefulness in people with narcolepsy or obstructive sleep apnea, and Symbravo, a migraine medicine that U.S. regulators approved last month.The patent settlement with Teva will ensure Auvelity remains a contributor to Axsomes business for years to come, and removes the threat of Teva entering the market earlier. The biotech has a large tranche of Auvelity patents that expire in 2034, which would have been the next line of defense if Teva had succeeded in challenging Axsomes later-dated patentsThe settlement also provides for the termination of all litigation between Axsome and Teva over Auvelity patents that was pending in the New Jersey district court. The companies will submit their agreement to the Federal Trade Commission and the Department of Justice for review.We see this as a material win for Axsome, wrote Myles Minter, an analyst at William Blair, in a client note. Graig Suvannavejh, an analyst at Mizuho Securites, took a similar view, calling the settlement a significant positive for the company.Investors seemed to agree, pushing Axsome shares up by 23% through mid-morning Monday. Part of those gains may be expectations the settlement will put Axsome higher on pharmaceutical companies lists of deal targets.Staying generic entry with this settlement favorably positions the company if there is a potential M&A buyer for Axsome, in our view, wrote Minter.Theres some recent precedent for this line of thinking. Intra-Cellular Therapies patent settlement with Sandoz for its drug Caplyta was one item Johnson & Johnson reviewed before finalizing a $14.6 billion buyout of Intra-Cellular, recently filed regulatory documents show. '

NEW YORK, Feb. 10, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Teva Pharmaceuticals, Inc. (Teva) resolving all patent litigation related to Axsome’s AUVELITY® (dextromethorphan HBr – bupropion HCl) product. The litigation resulted from submission by Teva of an Abbreviated New Drug Application to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of AUVELITY in the United States prior to the expiration of applicable Axsome patents. Under the terms of the settlement agreement, Axsome will grant Teva a license to sell its generic version of AUVELITY beginning on or after March 31, 2039, if pediatric exclusivity is granted for AUVELITY, or on or after September 30, 2038, if no pediatric exclusivity is granted, subject to FDA approval and conditions and exceptions customary for agreements of this type. In accordance with the agreement, the parties will terminate all ongoing litigation between Axsome and Teva regarding AUVELITY patents pending in the U.S. District Court for the District of New Jersey. The settlement agreement resolves all outstanding patent litigation relating to AUVELITY. “Axsome is proud of its commitment to innovating treatments aimed at improving the lives of the millions of patients living with central nervous system disorders. The resolution of this patent litigation underscores the value of that innovation as it relates to AUVELITY, and more broadly reflects the strength of Axsome’s intellectual property portfolio,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome Therapeutics. “With our industry-leading neuroscience pipeline addressing difficult-to-treat conditions, we look forward to continuing to serve our patient communities through innovation and delivery of differentiated new medicines.” As required by law, Axsome and Teva will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. About Axsome Therapeutics Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder and excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit the Company’s website at www.axsome.com. Forward Looking Statements Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s Sunosi®, Auvelity®, and Symbravo® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of Sunosi, Auvelity, and Symbravo and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. Investors: Mark Jacobson Chief Operating Officer (212) 332-3243 mjacobson@axsome.com Media: Darren Opland Director, Corporate Communications (929) 837-1065 dopland@axsome.com Source: Axsome Therapeutics, Inc.