Delaware District Court Rules in Favor of Acadia on Formulation Patent Construction (Markman) Claims Regarding NUPLAZID® (pimavanserin)

- This is the second patent ruling issued today from the Court in favor of Acadia

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. District Court for the District of Delaware has issued a Claim Construction Order in favor of Acadia regarding its ‘721 formulation patent for NUPLAZID^® (pimavanserin), Acadia’s drug for the treatment of Parkinson’s Disease Psychosis. In today’s Order, the Court ruled in favor of Acadia on all of the disputed claim construction points.

In the Order, the Court adopted Acadia’s interpretation of key disputed terms of the patent. Acadia believes that the Court’s interpretations affirm the strength of the patent. As a result of today’s order, a claims construction hearing (also referred to as a “Markman” hearing), which had been scheduled for December 19, 2023, has been cancelled by the Court. The case remains scheduled for trial in December 2024.

This was the second ruling issued today by the Court pertaining to Acadia’s patents covering NUPLAZID. Earlier today, in a separate litigation, the Court granted summary judgment to Acadia, confirming validity of Acadia’s ‘740 composition of matter patent.

“We are pleased to announce a second positive ruling today from the U.S. District Court for the District of Delaware, both of which underscore the strength of our NUPLAZID patent estate, including patents running into 2038,” said Steve Davis, President and Chief Executive Officer. “Establishing claims construction is an important milestone in patent litigation. We look forward to proceeding with the remainder of our formulation patent case.”

The formulation patent that is the subject of today’s claims construction ruling is scheduled to expire in 2038. In addition, Acadia has a method of use patent on the 10mg tablet of NUPLAZID that runs to 2037 and a NUPLAZID composition of matter patent, which was the subject of today’s earlier ruling, that runs to 2030.

About NUPLAZID^® (pimavanserin)

Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID. In addition, Acadia is developing pimavanserin as a potential treatment for the negative symptoms of schizophrenia.

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. For 30 years 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 approved therapies for hallucinations and delusions associated with Parkinson’s disease psychosis and for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on treating the negative symptoms of schizophrenia, Prader-Willi syndrome, Alzheimer’s disease psychosis and neuropsychiatric symptoms in central nervous system disorders. For more information, visit us at www.acadia.com and follow us on LinkedIn and Twitter.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements regarding the timing of future events. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval and commercialization. For a discussion of these and other factors, please refer to Acadia’s annual report on Form 10-K for the year ended December 31, 2022, as well as Acadia’s subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Acadia undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.

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