ACADIA Pharmaceuticals Announces Presentation of Data on Pimavanserin Co-Therapy at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders
New Data Demonstrate Less Increase in Serum Glucose Levels With Pimavanserin Co-Therapy
SAN DIEGO, Feb 05, 2008 (BUSINESS WIRE) — ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced that Murray Rosenthal, D.O., a Fellow of the American Psychiatric Association, will present data from ACADIA’s pimavanserin Phase II schizophrenia co-therapy trial at the 14th Biennial Winter Workshop on Schizophrenia and Bipolar Disorders in Montreux, Switzerland on February 5, 2008. Dr. Rosenthal was one of the lead investigators in ACADIA’s Phase II co-therapy clinical trial with pimavanserin and has extensive experience conducting clinical studies for patients with schizophrenia.
In an oral presentation titled “Co-Therapy with Pimavanserin and Risperidone 2 mg Provides an Improved Clinical Profile,” Dr. Rosenthal will discuss data from the Phase II trial demonstrating several advantages of co-therapy with pimavanserin, which include an enhanced efficacy, a faster onset of antipsychotic action, and an improved side effect profile, including less weight gain. Dr. Rosenthal also will present new data from this study showing that patients in the co-therapy arm combining pimavanserin with risperidone (2 mg) had significantly less increase from baseline in serum glucose levels after treatment compared to patients in the risperidone (6 mg) plus placebo arm (p=0.024). Taken together, the reductions in weight gain and glucose increase seen after effective antipsychotic treatment with pimavanserin and a sub-maximal dose of risperidone suggest that this co-therapy approach has the potential to reduce the metabolic problems commonly associated with atypical antipsychotics.
Schizophrenia is a chronic, debilitating mental illness characterized by disturbances in thinking, emotional reaction, and behavior. Approximately one percent of the population develops schizophrenia during their lifetime and more than two million people in the United States suffer from this disease. Disturbances in schizophrenia may include positive symptoms, such as hallucinations and delusions, and a range of negative symptoms, including loss of interest, emotional withdrawal and cognitive disturbances.
Pimavanserin is a novel, potent and selective 5-HT2A inverse agonist that ACADIA discovered and is developing as a co-therapy for patients with schizophrenia. ACADIA announced positive results in 2007 from its Phase II schizophrenia co-therapy trial, demonstrating several advantages of pimavanserin when combined with a sub-maximal dose of risperidone, including enhanced efficacy, a faster onset of antipsychotic action, and an improved side-effect profile. ACADIA also is in Phase III development with pimavanserin for the treatment of Parkinson’s disease psychosis.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. ACADIA currently has five mid-to-late stage clinical programs as well as a portfolio of preclinical and discovery assets directed at diseases with large unmet medical needs, including schizophrenia, Parkinson’s disease psychosis, sleep maintenance insomnia, and neuropathic pain. All of the drug candidates in ACADIA’s product pipeline emanate from discoveries made using its proprietary drug discovery platform. ACADIA’s corporate headquarters is located in San Diego, California and it maintains research and development operations in both San Diego and Malmo, Sweden.
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements include but are not limited to statements related to benefits to be derived from ACADIA’s drug development programs, including the potential advantages of the use of pimavanserin as a co-therapy for schizophrenia with risperidone or other antipsychotics. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in clinical trials, and drug development and commercialization, including the uncertainty of whether results in testing of pimavanserin to date will be predictive of results in later stages of development. For a discussion of these and other factors, please refer to ACADIA’s annual report on Form 10-K for the year ended December 31, 2006 as well as other subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Uli Hacksell, Ph.D., Chief Executive Officer