SAN-711

SAN711 treats essential tremor, a neurological disorder characterised by involuntary shaking. Credit: CGN089/Shutterstock. Acadia Pharmaceuticals has secured an exclusive global licence from Saniona to develop and commercialise SAN711 for essential tremor, a neurological disorder characterised by involuntary shaking. A new GABA A -α3 positive allosteric modulator, SAN711 will be investigated in a Phase II study for the indication in 2026. Saniona is set to obtain an upfront payment of $28m, with the potential for up to $582m in milestone payments, plus royalties on net sales. Saniona CEO Thomas Feldthus said: “Our collaboration with Acadia leverages their robust expertise in neuroscience development and commercialisation, positioning SAN711 as a promising option for neurological disorders while enabling us to advance several of our other valuable pipeline programs to key inflection points. “Acadia’s commitment aligns with our mission to improve outcomes for those affected by neurological disorders, and together, we aim to expand treatment possibilities for patients in need.” Acadia will lead the clinical development and handle activities related to regulatory submissions along with worldwide commercialisation of the therapy, while offering a financial backup for Saniona’s ongoing Phase I and subsequent Phase II study preparations. Acadia Pharmaceuticals CEO Catherine Owen Adams stated: “Licensing SAN711 to expand our pipeline underscores our unwavering commitment to delivering innovative therapies for patients with central nervous system disorders. “Essential tremor is a condition that has not seen innovation in treatment for decades, creating a compelling opportunity to address a long-overlooked need. Our work with SAN711 will draw on our deep expertise in developing and commercialising cutting-edge treatments for neurological disorders.” In October 2024, Saniona commenced a Phase I multiple ascending dose/biomarker trial, dosing the first patient with SAN711. The trial is pivotal for a clinical proof-of-concept study in children with absence seizures planned for 2025. It is designed to assess SAN711’s safety and tolerability, and pharmacokinetics at higher doses than previously tested.

SAN DIEGO--( BUSINESS WIRE )--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced it has entered into an exclusive worldwide license agreement with Saniona (OMX: SANION) for the development and commercialization of SAN711, a first-in-class, highly selective GABA A -α3 positive allosteric modulator. The first indication the Company plans to pursue is development of SAN711 for essential tremor, a neurological condition that includes shaking or trembling movements in one or more parts of the body. Acadia is planning to initiate a Phase 2 study of SAN711 in essential tremor in 2026. " Licensing SAN711 to expand our pipeline underscores our unwavering commitment to delivering innovative therapies for patients with central nervous system disorders," said Catherine Owen Adams, Chief Executive Officer. " Essential tremor is a condition that has not seen innovation in treatment for decades, creating a compelling opportunity to address a long-overlooked need. Our work with SAN711 will draw on our deep expertise in developing and commercializing cutting-edge treatments for neurological disorders." Under the terms of the License Agreement, Saniona will receive US $28 million upfront plus potential milestone payments of up to US $582 million. In addition, Saniona is eligible to receive tiered royalties of mid-single digits to low double digits on net sales of commercial products that may result from development of SAN711. The potential milestone payments to Saniona consist of up to US $147 million subject to achievement of development and commercial milestones related to potential first and second indications, and up to US $435 million subject to achievement of thresholds of annual net sales of SAN711 worldwide. Acadia will lead further clinical development, regulatory submissions, and global commercialization efforts for SAN711 while also providing financial support for Saniona’s ongoing Phase 1 study and preparations for Phase 2. About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at Acadia.com and follow us on LinkedIn and X . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “intends,” “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i.) the timing of the commencement of a Phase 2 clinical trial evaluating SAN711; (ii.) the likelihood of success of such clinical trial; (iii.) the prospects for FDA approval of SAN711 for essential tremor; and (iv.) the success of any efforts to commercialize SAN711. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties, assumptions and other factors include, but are not limited to: the timing, enrollment and results of ongoing and future clinical trials and our ability to continue to stay in compliance with applicable laws and regulations. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-Q for the period ended September 30, 2024 filed with the Securities and Exchange Commission on November 7, 2024, as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.