ACADIA Pharmaceuticals Inc., a biopharmaceutical company, focuses on the development and commercialization of small molecule drugs that address unmet medical needs in neurological and related central nervous system disorders. Product Candidates The company has a pipeline of product candidates led by pimavanserin, which is in Phase III development as a treatment for Parkinson’s disease psychosis. It has completed a pivotal Phase III trial with pimavanserin in patients with Parkinson’s disease psychosis and is planning to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for this indication near the end of 2014. Pimavanserin is also in Phase II development for Alzheimer’s disease psychosis and has completed a Phase II trial as a co-therapy for schizophrenia. The company’s pipeline also includes clinical-stage programs for chronic pain and glaucoma in collaboration with Allergan, Inc., and two advanced preclinical programs directed at Parkinson’s disease and other neurological disorders. All of its product candidates and programs emanate from internal discoveries. Its pipeline consists of the following product candidates and programs: Pimavanserin Pimavanserin is a new chemical entity that the company discovered and has advanced to Phase III development, positioning it to be the first drug approved in the United States for the treatment of Parkinson’s disease psychosis. The company holds worldwide commercialization rights to pimavanserin and has established a patent portfolio, which includes various issued patents covering this product candidate in the United States, Europe, and various additional countries. The company is pursuing Parkinson’s disease psychosis as its lead indication for pimavanserin. The company intends to use its Phase III Parkinson’s disease psychosis program as a foundation to develop and commercialize pimavanserin for additional neurological and psychiatric indications, including Alzheimer’s disease psychosis and schizophrenia, which are underserved by marketed antipsychotic drugs. The company is conducting a Phase II trial to examine the efficacy and safety of pimavanserin as a treatment for patients with Alzheimer’s disease psychosis. It has completed a Phase II trial that demonstrated various advantages of co-therapy with pimavanserin and a low, sub-therapeutic dose of risperidone, a commonly prescribed antipsychotic drug. Alpha Adrenergic Program: In collaboration with Allergan, the company has discovered small molecule product candidates for the treatment of chronic pain. Allergan has conducted various Phase II trials in this program and has reported preliminary results, including positive proof-of-concept in a human visceral pain trial and efficacy signals in two chronic pain trials in the areas of fibromyalgia and irritable bowel syndrome. Muscarinic Program: The company has discovered, and in collaboration with Allergan, is developing small molecule product candidates for the treatment of glaucoma. Glaucoma is a chronic eye disease and is the second leading cause of blindness in the world. Its selective muscarinic agonists have demonstrated a promising preclinical profile, including robust efficacy and a long duration of action. This program has reached Phase I development. ER-Beta Program: The company has discovered a compound that exhibits anti-inflammatory and neuroprotective properties in preclinical models and might have the ability to slow down the progression of Parkinson’s disease. This compound also might address symptoms of chronic, inflammatory and neuropathic pain, and might serve as a new approach to the treatment of neurodegeneration associated with multiple sclerosis. The company is pursuing research and development in this program pursuant to a grant from the National Institute of Neurological Disorders and Stroke, a division of the National Institutes of Health, and through funding from Fast Forward, LLC, and EMD Serono, a subsidiary of Merck KGaA. Nurr-1 Program: The company has discovered that low doses of a marketed drug, which is used in the treatment of cancer, activate Nurr1-RXR complexes and promote viability of dopamine-containing neurons in preclinical models. It has conducted studies to examine the effect of this compound on neuroprotection and neurodegeneration in preclinical models of Parkinson’s disease pursuant to a grant from The Michael J. Fox Foundation. Strategy Major elements of the company’s strategy are to develop and commercialize its lead product candidate, pimavanserin, for Parkinson’s disease psychosis; improve the commercial potential of pimavanserin by expanding to additional neurological and psychiatric disorders; continue to develop its other product candidates for the treatment of central nervous system and related disorders; and seek to in-license or acquire complementary products or product candidates. Intellectual Property ACADIA and R-SAT are the company’s registered trademarks. Its logos and trademarks are the property of the company. 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 to the FDA an Investigational NDA. 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 professionals. Research and Development Expenses The company’s research and development expenses were $26.7 million in 2013. 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
11085 Torreyana Road
San Diego, CA 92121
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