Saniona AB. (11/26/24). "Press Release: Saniona Announces Licensing Agreement with Acadia Pharmaceuticals for SAN711 in Neurological Diseases".

	Region	ALL
	Organisation	Saniona AB (OMX: SANION)
	Organisation 2	Acadia Pharmaceuticals Inc. (Nasdaq: ACAD)
	Group	Acadia (Group)
	Product	SAN711 (Saniona / Acadia)
	Product 2	drug development
	Index term	Acadia–Saniona: GABAA-a3 positive allosteric modulator, 202411– license ww excl to SAN711 $28m upfront + $582m milestones + royalties
	Person	Feldthus, Thomas (Saniona 201705 CFO before Symphogen –201103 CFO + Co-founder LEFT 3/12)

Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces a partnership with Acadia Pharmaceuticals (Acadia) for the development and commercialization of SAN711 in neurological diseases. Saniona will receive up to US $610 million, including a US $28 million upfront payment and up to US $582 million in development, regulatory, and commercial milestone payments, along with tiered royalties from mid single digits to low double digits on global net sales of SAN711. In addition, Acadia will provide financial support for Saniona’s ongoing Phase 1 clinical study and preparation for the Phase 2 clinical study.

“Our collaboration with Acadia leverages their robust expertise in neuroscience development and commercialization, 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,” said Thomas Feldthus, CEO of Saniona. “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.”

As a first indication, Acadia plans to pursue 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. Acadia will lead and finance further clinical development, regulatory submissions, and global commercialization efforts for SAN711. Saniona will continue overseeing the ongoing Phase 1 study and provide support for Phase 2 preparation.

Under the terms of the License Agreement, Saniona will receive US $28 million in upfront plus potential milestone payments of up to US $582 million, of which the first milestone payment of US $10 million will be payable upon initiation of the first Phase 2 study. 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 regulatory/commercialization 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.

For more information, please contact

Thomas Feldthus, CEO, +45 22109957; [email protected]

About Saniona

Saniona (OMX: SANION) is a clinical-stage biopharmaceutical company leading the way in ion channel modulation for the treatment of epilepsy and other neurological disorders. Saniona’s epilepsy pipeline includes SAN2219, targeting acute repetitive seizures; and SAN2355, addressing refractory focal onset seizures. Beyond epilepsy, Saniona oversees four clinical programs poised for collaboration. Tesofensine for obesity is Saniona’s most advanced candidate and is out licensed to Medix in Mexico and Argentina. Tesomet™ is ready for Phase 2b, targeting rare eating disorders, while SAN903 is ready for Phase 1 for inflammatory bowel disease and SAN2465 is set for preclinical development for major depressive disorder. Saniona partners include Acadia Pharmaceuticals, Boehringer Ingelheim GmbH, Productos Medix S.A de S.V, AstronauTx Limited, and Cephagenix ApS. Saniona is based in Copenhagen and listed on Nasdaq Stockholm Main Market.

For more information, visit www.saniona.com.

Record changed: 2024-12-27