ACADIA Pharmaceuticals Inc., a biopharmaceutical company, focuses on the development and commercialization of small molecule drugs for the treatment of central nervous system disorders. The company has four product candidates in clinical development led by pimavanserin, which is in Phase III development as a potential first-in-class treatment for Parkinson’s disease psychosis. It holds worldwide commercialization rights to pimavanserin. In addition, the company has a product candidate in Phase II development for chronic pain and a product candidate in Phase I development for glaucoma, both in collaboration with Allergan, Inc. (Allergan), and a product candidate in Phase I development for schizophrenia in collaboration with Meiji Seika Pharma Co., Ltd. (Meiji Seika). Product Candidates Pimavanserin: Pimavanserin is a new chemical entity that the company discovered and has advanced to Phase III development as a potential first-in-class treatment for Parkinson’s disease psychosis. The company is conducting various studies in its Phase III program with pimavanserin for Parkinson’s disease psychosis, including a Phase III efficacy, tolerability and safety trial, and open-label safety extension studies. The company has completed a Phase II trial with pimavanserin as a co-therapy in schizophrenia and have established plans for a future Phase II feasibility study to explore the use of pimavanserin as a treatment for Alzheimer’s disease psychosis. Alpha Adrenergic Agonists: In collaboration with Allergan, the company has discovered and is in the process of developing small molecule product candidates for the treatment of chronic pain. Its alpha adrenergic agonists provide pain relief in a range of preclinical models, without the side effects of current pain therapies, including sedation and cardiovascular and respiratory effects. Allergan has conducted several Phase II trials in this program and has reported preliminary results, including positive proof-of-concept in a visceral pain trial in patients that had hypersensitivity of the esophagus, and efficacy signals in two chronic pain trials in the areas of fibromyalgia and irritable bowel syndrome. Muscarinic Agonist: The company has discovered and, in collaboration with Allergan, and is in the process of developing a small molecule product candidate for the treatment of glaucoma. Using its proprietary drug discovery platform, the company identified a subtype of the muscarinic receptors that controls intraocular pressure and discovered lead compounds that selectively activate this target. This program has reached Phase I development. AM-831: The company has discovered and, in collaboration with Meiji Seika Pharma, is in the process of developing AM-831, a small molecule product candidate for the treatment of schizophrenia. AM-831 is a novel and orally available small molecule that combines muscarinic m1 partial agonism with both dopamine D2 and serotonin 5-HT2A receptor antagonism. AM-831 has reached Phase I development. Intellectual Property The company holds 48 issued U.S. patents and 236 issued foreign patents. In addition, it has 20 provisional and utility U.S. patent applications and 98 foreign patent applications. Research and Development The company’s research and development expenses were $17.3 million in 2011. Regulation Before marketing in the United States, any new drug developed by the company must undergo preclinical testing, clinical trials and a regulatory clearance process implemented by the U.S. Food and Drug Administration (FDA) under the federal Food, Drug, and Cosmetic Act. The FDA regulates the development, testing, manufacture, safety, efficacy, record keeping, labeling, storage, approval, advertising, promotion, sale and distribution of biopharmaceutical products. The company and its collaborators and contract manufacturers also are required to comply with the applicable FDA current good manufacturing practice regulations. Good manufacturing practice regulations include requirements relating to quality control and quality assurance, as well as the corresponding maintenance of records and documentation. If the product is approved, the company must also comply with post-marketing requirements, including compliance with advertising and promotion regulations enforced by FDA’s Office of Prescription Drug Promotion, the Prescription Drug Marketing Act, anti-fraud and abuse laws, healthcare information privacy laws, post-marketing safety surveillance, and disclosure of payments or transfers of value to healthcare professionsals. History ACADIA Pharmaceuticals Inc. was founded in 1993.
acadia pharmaceuticals inc
3911 Sorrento Valley Boulevard
San Diego, CA 92121
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