ACADIA Pharmaceuticals Inc., a biopharmaceutical company, focuses on the development and commercialization of medicines that address unmet medical needs in neurological and related central nervous system disorders. Pimavanserin is a new chemical entity that the company discovered and that has completed Phase III development. Pimavanserin is drug approved in the United States for the treatment of Parkinson’s disease psychosis. The company holds worldwide commercialization rights to NUPLAZID (pimavanserin) for all indications and has established a patent portfolio, which includes various issued patents in the United States, Europe, and various additional countries. The company holds worldwide commercialization rights to pimavanserin. The company is in Phase II development with pimavanserin as a potential new treatment for Alzheimer’s disease psychosis. The company completed a Phase II study of pimavanserin in the treatment of schizophrenia where it observed significant anti-psychotic effects when pimavanserin was co-administered with a low dose of risperidone, a generic drug approved for the treatment of schizophrenia. The company reported positive Phase III pivotal trial results in Parkinson’s disease psychosis. The company is completing a new drug application, for NUPLAZID for the treatment of Parkinson’s disease psychosis and related preparations to support a review of the new drug application by the U.S. Food and Drug Administration (FDA). Strategy The key elements of the company’s strategy include developing and commercializing its priarmy product candidate, NUPLAZID, for Parkinson’s disease psychosis; leveraging the commercial potential of pimavanserin by expanding to additional neurological and psychiatric disorders; seeking to in-license or acquire complementary products or product candidates; and continuing to develop its other product candidates for the treatment of central nervous system and related disorders. Intellectual Property The company holds 49 issued U.S. patents and 244 issued foreign patents. All of these patents originated from discoveries made by the company. In addition, the company has 15 provisional and utility U.S. patent applications and 52 foreign patent applications. Pimavanserin: 20 U.S. patents have been issued to the company that provide protection for pimavanserin, including 2 that cover the compound generically and 12 that specifically cover pimavanserin, polymorphs thereof, the use thereof for treating Parkinson’s disease psychosis, Alzheimer’s disease psychosis, schizophrenia, bipolar disorder, Lewy body disease, sleep disorders, and other methods of treatment. The pimavanserin-specific patent and the Parkinson’s disease psychosis treatment patent provide protection until June 2027 and 2026, respectively. The patent that covers polymorphs of pimavanserin provides protection until June 2028. The patents that cover pimavanserin generically expire in 2021. The company has 56 issued foreign patents that specifically cover pimavanserin, including patents in 38 European countries, Australia, Canada, China, Hong Kong, India, Japan, Mexico, New Zealand, Russia, Singapore and South Africa, which provide patent protection until 2024. The company also has 48 issued foreign patents that cover polymorphs of pimavanserin and provide patent protection until 2025. Muscarinic Program: The company has two U.S. patents that have been issued to it providing coverage for the compounds covered by its collaboration with Allergan, Inc. for the treatment of glaucoma. These U.S. patents would expire in 2023. The company has 48 issued foreign patents and 14 pending foreign applications that cover these compounds. The issued foreign patents for this program would expire in 2022 and 2025. Trademarks The company owns or has rights to various trademarks, copyrights and tradenames used in its business, including ACADIA and NUPLAZID. Collaboration Agreements The company has a collaboration agreement with Allergan, Inc. focused primarily on the discovery and development of new therapeutics for pain and ophthalmic indications. Research and Development Expenses For the year ended December 31, 2014, the company’s research and development expenses were $60.6 million. Government Regulation Before marketing in the United States, any new drug developed by the company must undergo rigorous preclinical testing, clinical trials and an extensive regulatory clearance process implemented by the FDA under the federal Food, Drug, and Cosmetic Act, as amended. Before commencing clinical investigations in humans, the company or its collaborators must submit an investigational new drug application to the FDA. If the product is approved, the company must also comply with post-marketing requirements, including compliance with advertising and promotion regulations enforced by various government agencies, including the FDA’s Office of Prescription Drug Promotion, through such laws as the Prescription Drug Marketing Act, federal and state anti-fraud and abuse laws, including anti-kickback and false claims laws, healthcare information privacy and security laws, post-marketing safety surveillance, and disclosure of payments or other transfers of value to healthcare professionals and entities. History ACADIA Pharmaceuticals Inc. was founded in 1993. The company was incorporated in Vermont in 1993. The company was reincorporated in Delaware in 1997.
acadia pharmaceuticals inc
(ACAD:Consolidated Issue Listed on NASDAQ Global Select )
3611 Valley Centre Drive
San Diego, CA 92130
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