ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Files An 8-K Other Events

ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD) Files An 8-K Other Events
Item 8.01 Other Events.

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On March5, 2019, ACADIA Pharmaceuticals Inc. (the Company) submitted an update to the data available through the Centers for Medicare and Medicaid Services (CMS) Open Payments database to reclassify certain categorization information regarding general payments provided to physicians. The update will be reflected in the publicly available data posted on on June30, 2019. The individual transaction amounts, as well as the aggregate figures previously submitted for 2016 and 2017, were and remain accurate, subject to minor changes throughout the year to reflect information that became available after the reporting deadline, such as changes made directly by healthcare professionals in the Open Payments system.

For the Company, the mean general payment amount was approximately $380 for physicians in the United States in 2016, out of approximately 1,580physicians reported, and approximately $1,225 for physicians in the United States in 2017, out of approximately 7,060physicians reported.

The Company was subject to the reporting requirements for only a portion of 2016 because its first Medicare/Medicaid-covered product, NUPLAZID (pimavanserin), was approved in April 2016 and launched in June 2016. The Companys update relates to categorization details, and the tables below summarize those details as updated. These amounts may be subject to minor changes post-submission as a result of routine, ongoing validation by CMS within the Open Payments system.

2016 (for the period from November22 to December 31)

2017 (full year)

NUPLAZID is the first and only FDA-approved treatment for hallucinations and delusions associated with Parkinsons disease psychosis. During 2017, the first full year of launch activities, the Company focused on educating physicians and other healthcare professionals regarding Parkinsons disease psychosis, the importance of identifying symptoms, and the benefits, risks, and appropriate use of NUPLAZID. These early launch activities play a critical role in advancing patient care and ensuring that NUPLAZID is used in a safe and effective manner. In calendar year 2018, the second full year of marketing NUPLAZID, the Companys aggregate general payments to physicians decreased to approximately $4,700,000. The Company will submit payment information for 2018 to the Open Payments system by the annual deadline of March31, 2019.

The Company has policies, procedures, training, and compliance monitoring in place to foster compliance with laws, regulations, and the Voluntary Compliance Program Guidance for Pharmaceutical Manufacturers developed by the Office of Inspector General (OIG) of the Department of Health and Human Services, including the provisions covering relationships with physicians, as well as with the provisions of the PhRMA Code governing speaker programs.

About ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD)

ACADIA Pharmaceuticals Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of medicines for central nervous system disorders. The Company’s lead drug candidate, NUPLAZID (pimavanserin), is under development for the treatment of Parkinson’s disease psychosis (PDP). NUPLAZID is a selective serotonin inverse agonist (SSIA), targeting 5-HT2A receptors. The Company’s Pimavanserin is a chemical entity, which has completed Phase III development, and is indicated for the treatment of Parkinson’s disease psychosis. NUPLAZID (pimavanserin) is a selective serotonin inverse agonist preferentially targeting the 5-HT2A receptor, a key serotonin receptor that plays a role in psychosis. Through this mechanism, NUPLAZID has demonstrated efficacy in Parkinson’s disease psychosis in its Phase III pivotal trial and avoids the side effects of existing antipsychotics.

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