ACADIA Pharmaceuticals Inc., a biopharmaceutical company, focuses on the development and commercialization of medicines to address unmet medical needs in central nervous system disorders. Product Candidates and Programs NUPLAZID (Pimavanserin) The company has a portfolio of product opportunities led by its novel drug candidate, NUPLAZID (pimavanserin), for which the company has reported positive Phase III pivotal trial results in Parkinson’s disease psychosis (PDP) and which has the potential to be the first drug approved in the United States for this condition. NUPLAZID is a selective serotonin inverse agonist preferentially targeting 5-HT2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in PDP in the company’s Phase III pivotal trial and has the potential to avoid many of the debilitating side effects of existing antipsychotics, none of which are approved for use in PDP patients. The company holds worldwide commercialization rights to pimavanserin for all indications and has a patent portfolio, which includes various issued patents in the United States, Europe, and various additional countries. The company is pursuing PDP as its major indication for NUPLAZID. In September 2015, the company submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for NUPLAZID for the treatment of psychosis associated with Parkinson’s disease, which was accepted for priority review by the FDA in October 2015 with a Prescription Drug User Fee Act goal date of May 1, 2016. In 2014, the company announced that the FDA granted Breakthrough Therapy designation for NUPLAZID for the treatment of PDP. The Breakthrough Therapy designation was created to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions. If approved, the company intends to commercialize NUPLAZID for PDP in the United States by establishing a specialty sales force focused primarily on physicians who treat PDP patients, including neurologists, psychiatrists, and long-term care physicians. The company is in Phase II development with pimavanserin as a new treatment for Alzheimer’s disease psychosis. In 2013, the company initiated a Phase II trial, referred to as the -019 Study, to examine the efficacy and safety of pimavanserin as a treatment for Alzheimer’s disease psychosis. The company expects to complete enrollment of this study around mid-year 2016. The company plans to initiate a Phase II study in Alzheimer’s disease agitation and aggression in the first half of 2016. The company is also assessing areas of major unmet need in schizophrenia. Adrenergic and Muscarinic Programs In collaboration with Allergan, the company has discovered small molecule product candidates for the treatment of chronic pain. The company’s novel alpha adrenergic agonists provide pain relief in a range of preclinical models, without the side effects of pain therapies, including sedation and cardiovascular and respiratory effects. Allergan has conducted various 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. Allergan has announced that it is seeking a partner for the further development of this program and for commercialization in areas primarily served by general practitioners. The company discovered small molecule product candidates for the treatment of glaucoma. The company identified a subtype of the muscarinic receptors that controls intraocular pressure and discovered lead compounds that selectively activate this target. In preclinical models, the company’s product candidates have demonstrated a promising preclinical profile, including robust efficacy and a long duration of action. This program has reached Phase I development. Strategy The company’s strategy is to discover, develop and commercialize innovative small molecule drugs that address unmet medical needs in central nervous system disorders.
acadia pharmaceuticals inc
(ACAD:Consolidated Issue Listed on NASDAQ Global Select )
3611 Valley Centre Drive
San Diego, CA 92130
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