Delaware Federal District Court Rules in Favor of Acadia Pharmaceuticals in NUPLAZID® (pimavanserin) Patent Litigation

- Court ruled in favor of Acadia on all grounds

SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. District Court for the District of Delaware has granted summary judgment to Acadia, confirming validity of the NUPLAZID^® (pimavanserin) '740 composition of matter patent. The court ruled in favor of Acadia on all grounds. The ruling came in Acadia’s litigation against MSN Laboratories Pvt. Ltd., MSN Pharmaceuticals, Inc. and other ANDA (Abbreviated New Drug Application) filers and concludes this litigation in the District Court.

“We are very pleased that the Court has made its final decision on this matter, ruling strongly in favor of Acadia. We advanced two legal arguments to support our position and, while we only needed to win on one, the Court ruled in our favor on both arguments,” said Steve Davis, President and Chief Executive Officer of Acadia Pharmaceuticals. “This outcome demonstrates Acadia’s commitment to protecting our innovations in new treatments for disorders with high unmet need.”

The ‘740 composition of matter patent protects NUPLAZID into 2030. Acadia markets two forms of NUPLAZID, a 34mg capsule and a 10mg tablet. In addition to the ‘740 patent, Acadia has an issued method of use patent that protects the 10mg tablet to 2037 and multiple issued formulation patents that protect the 34mg capsule into 2038.

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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Media Contact:

Acadia Pharmaceuticals Inc.

Deb Kazenelson

(818) 395-3043

media@acadia-pharm.com

Investor Contact:

Acadia Pharmaceuticals Inc.

Al Kildani

(858) 261-2872

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Acadia Pharmaceuticals Inc.

Jessica Tieszen

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Source: Acadia Pharmaceuticals Inc.