Key Developments For ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc. (ACAD.O) (Consolidated Issue listed on NASDAQ Global Market)
Biovail Corporation And ACADIA Pharmaceuticals Inc Provides Update On Pimavanserin Collaborative Development Program
Biovail Corporation announced an update on its Phase III program with pimavanserin for Parkinson`s disease psychosis (PDP), which is being pursued in collaboration with ACADIA Pharmaceuticals Inc (ACADIA). ACADIA has conducted a substantial portion of the analysis of the data from its first Phase III PDP trial with pimavanserin (-012 Study). While the -012 Study did not meet its primary endpoint of antipsychotic efficacy and had a larger than expected placebo response, signals of antipsychotic efficacy were observed in the pimavanserin 40 mg study arm. These findings relate to dose selection, the method and application of ratings, and other study design elements. ACADIA and Biovail have agreed on a development strategy for PDP that involves using the findings from the -012 Study together with those from the second, ongoing Phase III trial (-014 Study), which is testing 10 mg and 20 mg doses of pimavanserin, to arrive at an enhanced study design that may be used in new Phase III trials. Accordingly, the ongoing -014 Study will be concluded at its current enrollment level (about 120 patients) to allow for the analysis of data as soon as practicable. Meanwhile, the parties will begin planning for a new Phase III PDP trial using a 40 mg dose of pimavanserin. This study is expected to start in the first half of 2010.
ACADIA Pharmaceuticals Announces Results From Phase III Trial of Pimavanserin In Parkinson's Disease Psychosis
ACADIA Pharmaceuticals announced top line results from the first pivotal Phase III trial with pimavanserin in patients with Parkinson's disease psychosis, or PDP. The study did not meet its primary endpoint of antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Pimavanserin met the key secondary endpoint of motoric tolerability as measured using the Unified Parkinson's Disease Rating Scale, or UPDRS. Pimavanserin was safe and well tolerated, with the frequency of adverse events generally similar in the pimavanserin and placebo arms. The Phase III trial was a multi center, double blind, placebo controlled study designed to evaluate the safety and efficacy of pimavanserin in patients with PDP. A total of 298 patients were enrolled in the trial and randomized to one of three study arms, including two different doses of pimavanserin (10 mg or 40 mg) and placebo. Patients received oral doses of either pimavanserin or placebo once daily for six weeks. Patients remained on stable doses of their existing anti-Parkinson's therapy throughout the study. The primary endpoint was antipsychotic efficacy as measured using the hallucinations and delusions domains of the SAPS. The key secondary endpoint was motoric tolerability as measured using Parts II and III of the UPDRS.
ACADIA Pharmaceuticals Says Likely To Co-Market Psychosis Drug-Reuters
Reuters reported that Acadia Pharmaceuticals said it is likely to exercise an option to co-market its psychosis drug in the United States, and that the experimental product has strong sales potential. Acadia in May announced a deal under which Biovail Corp will help develop its drug, pimavanserin, and sell it in North America, with Acadia having an option to co-market the product in the same market.
ACADIA Pharmaceuticals And Biovail Corporation Announces Completion of Enrollment In First Pivotal Phase III Trial With Pimavanserin In Patients With Parkinson's Disease Psychosis
ACADIA Pharmaceuticals and Biovail Corporation announced the completion of enrollment in the first pivotal Phase III clinical trial of pimavanserin in patients with Parkinson's disease psychosis (PDP). Top line results from this trial are expected to be announced by the end of the third quarter of 2009. The Phase III trial is a multi center, double blind, placebo controlled study designed to evaluate the safety and efficacy of pimavanserin in patients with PDP. A total of 298 patients were enrolled in the trial and randomized to one of three study arms, including two different doses of pimavanserin (10 mg or 40 mg daily) and one placebo arm. Patients receive oral doses of either pimavanserin or placebo once daily for six weeks in addition to stable doses of their existing dopamine replacement therapy. Patient enrollment in the second pivotal Phase III clinical trial of pimavanserin in PDP is ongoing. The primary endpoint of each of the Phase III trials is antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Motoric tolerability is an important secondary endpoint in the Phase III trials and is measured using the Unified Parkinson's Disease Rating Scale, or UPDRS (Parts II and III).
ACADIA Pharmaceuticals Announces Collaboration And License Agreement With Biovail Corporation's Biovail Laboratories International SRL
Biovail Corporation announced that its subsidiary, Biovail Laboratories International SRL (BLS), has entered into a collaboration and license agreement with ACADIA Pharmaceuticals Inc. BLS has acquired the U.S. and Canadian rights to develop, manufacture and commercialize pimavanserin tartrate (a selective 5-HT2A inverse agonist) in a number of neurological and psychiatric conditions, including Parkinson`s disease psychosis (PDP) and Alzheimer`s disease psychosis (ADP). Pimavanserin is a new chemical entity (NCE) currently in Phase III clinical development for the treatment of PDP. Under the terms of the agreement, Biovail has paid an upfront fee of $30 million, and will pay up to $160 million in potential development milestones associated with the successful completion of clinical trials, regulatory submissions and approvals for pimavanserin in the PDP and ADP indications.
