Neuren Pharmaceuticals Ltd.

SAN DIEGO--( BUSINESS WIRE )--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced the closing of the sale of its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million before fees and expenses. As described at the time the agreement to sell was announced on November 5, 2024, Acadia is required to pay Neuren Pharmaceuticals Limited one-third of the net proceeds, pursuant to a license agreement between the companies. Acadia plans to invest proceeds from the sale of the PRV to support its commercial operations, R&D programs in central nervous system and rare disease, and future business development. 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: the use of the proceeds from the transaction. 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: our ability to successfully deploy the proceeds of the transaction as anticipated, our ability to continue to successfully commercialize DAYBUE™, 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.

A few weeks after gaining about $100 million from a priority review voucher, Acadia Pharmaceuticals is putting its money to work by in-licensing an experimental essential tremor medicine. The San Diego drugmaker, which markets two neuro treatments, will pay $28 million upfront and up to $582 million in biobucks to Danish biotech Saniona, the companies said Tuesday post-market. Acadia said it plans to bring Saniona’s GABAa-α3 positive allosteric modulator, dubbed SAN711, into a Phase 2 in essential tremor in 2026. Sage and Biogen’s form of a GABAa receptor positive allosteric modulator failed a Phase 2 essential tremor trial this summer. Jazz Pharmaceuticals’ drug, employing a different mechanism, also flunked a mid-stage test in the neurological condition this summer. “Essential tremor is a condition that has not seen innovation in treatment for decades, creating a compelling opportunity to address a long-overlooked need,” Acadia CEO Catherine Owen Adams said in a press release. Saniona already has partnerships in the neuro field. Boehringer Ingelheim is working with the biotech in schizophrenia, and AstronauTx , a startup that emerged with $61 million last year, has an Alzheimer’s pact with Saniona. Acadia said it will help pay for an ongoing Phase 1 and will take control of further clinical development, regulatory work and commercialization. The biotech has previously in-licensed a drug and then brought it to market, securing FDA approval of Daybue for Rett syndrome in 2023 after licensing it from Neuren Pharmaceuticals in 2018. It also developed Nuplazid, winning an FDA nod in Parkinson’s disease psychosis in 2016, but didn’t snag success in schizophrenia and Alzheimer’s disease psychosis. Acadia is also working on clinical trials in hyperphagia in Prader-Willi syndrome, Alzheimer’s disease psychosis, Rett syndrome and Fragile X syndrome, with more in preclinical stages.

Acadia Pharmaceuticals has sold its priority review voucher for $150 million, the company said Tuesday, but did not disclose the buyer. The FDA granted Acadia the rare pediatric PRV in March 2023 thanks to the approval of Daybue for Rett syndrome. Since Acadia licensed Daybue from Neuren Pharmaceuticals in 2018 as part of a license agreement, Acadia will hand over one-third of the net proceeds from the voucher sale to Neuren. Jefferies analysts forecast Neuren will receive $50 million from the sale. The vouchers, which speed up the FDA’s review of a drug, can be acquired through the approvals of rare pediatric disease or rare tropical disease drugs, and then can be sold or used. According to Acadia, the company will use the influx of cash to “support its commercial operations, R&D programs in central nervous system and rare disease, and future business development.” At the end of June, Acadia had $500.9 million in cash, cash equivalents and investment securities. The company will report its third-quarter earnings Wednesday. The sale of the voucher is one of the highest publicly-announced prices in about eight years. Ipsen sold a PRV for $158 million in August. In 2016, PaxVax Bermuda sold its voucher for $290 million.