ACADIA Pharmaceuticals and Biovail Announce Completion of Enrollment in First Pivotal Phase III Trial with Pimavanserin in Patients with Parkinson's Disease Psychosis

SAN DIEGO & TORONTO—(BUSINESS WIRE)—May. 6, 2009—ACADIA Pharmaceuticals Inc. (Nasdaq:ACAD) and Biovail Corporation(NYSE:BVF) (TSX:BVF), today announced the completion of enrollment inthe first pivotal Phase III clinical trial of pimavanserin in patientswith Parkinson’s disease psychosis (PDP). Top-line results from thistrial are expected to be announced by the end of the third quarter of2009.

The Phase III trial is a multi-center, double-blind, placebo-controlledstudy designed to evaluate the safety and efficacy of pimavanserin inpatients with PDP. A total of 298 patients were enrolled in the trialand randomized to one of three study arms, including two different dosesof pimavanserin (10 mg or 40 mg daily) and one placebo arm. Patientsreceive oral doses of either pimavanserin or placebo once daily for sixweeks in addition to stable doses of their existing dopamine replacementtherapy.

Patient enrollment in the second pivotal Phase III clinical trial ofpimavanserin in PDP is ongoing. The primary endpoint of each of thePhase III trials is antipsychotic efficacy as measured using the Scalefor the Assessment of Positive Symptoms, or SAPS. Motoric tolerabilityis an important secondary endpoint in the Phase III trials and ismeasured using the Unified Parkinson’s Disease Rating Scale, or UPDRS(Parts II and III).

About Pimavanserin

Pimavanserin is a 5-HT_2A receptor inverse agonist in PhaseIII development as a treatment for Parkinson’s disease psychosis. Thisnew chemical entity, which was discovered by ACADIA, is a small moleculethat can be taken orally as a tablet once-a-day. ACADIA and BiovailLaboratories International SRL, a subsidiary of Biovail, have formed acollaboration to co-develop and commercialize pimavanserin forneurological and psychiatric indications in the United States andCanada. ACADIA retains rights to pimavanserin in the rest of the world.

About Parkinson’s Disease Psychosis (PDP)

According to the National Parkinson Foundation, over 1.5 million peoplein the United States suffer from Parkinson’s disease. Up to 40 percentof patients with Parkinson’s disease may develop psychotic symptoms,commonly consisting of visual hallucinations and delusions. Currentlythere is no therapy in the United States approved to treat PDP. Thedevelopment of psychosis in patients with Parkinson’s disease isassociated with increased caregiver burden, nursing home placement, andincreased mortality.

About ACADIA Pharmaceuticals

ACADIA is a biopharmaceutical company utilizing innovative technology tofuel drug discovery and clinical development of novel treatments forcentral nervous system disorders. ACADIA’s most advanced productcandidates include pimavanserin in Phase III for Parkinson’s diseasepsychosis in collaboration with Biovail Laboratories International SRL,a product candidate in Phase II for chronic pain and a product candidatein Phase I for glaucoma, both in collaboration with Allergan, as well asadditional compounds in IND-track development. All of the productcandidates in ACADIA’s pipeline emanate from discoveries made using itsproprietary drug discovery platform. ACADIA maintains a website at www.acadia-pharm.comto which ACADIA regularly posts copies of its press releases as well asadditional information and through which interested parties cansubscribe to receive email alerts.

About Biovail Corporation

Biovail Corporation is a specialty pharmaceutical company engaged in theformulation, clinical testing, registration, manufacture, andcommercialization of pharmaceutical products. The Company is focused onthe development and commercialization of medicines that address unmetmedical needs in niche specialty central nervous system markets. Formore information about Biovail, visit the Company’s web site at www.biovail.com.

Forward-Looking Statements

Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the progress and timing of drugdiscovery and development programs, including clinical trials and theresults therefrom, and the benefits to be derived from productcandidates, in each case including pimavanserin, and the development andclinical plans for pimavanserin. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differ materiallyfrom those projected in any of such statements due to various factors,including the risks and uncertainties inherent in drug discovery,development, commercialization and collaborations with others, and thefact that past results of clinical trials may not be indicative offurther trial results. For a discussion of these and other factors,please refer to ACADIA’s annual report on Form 10-K for the year endedDecember 31, 2008 as well as ACADIA’s subsequent filings with theSecurities and Exchange Commission and to Biovail’s annual report onForm 20-F for the year ended December 31, 2008. You are cautioned not toplace undue reliance on these forward-looking statements, which speakonly as of the date hereof. This caution is made under the safe harborprovisions of the Private Securities Litigation Reform Act of 1995. Allforward-looking statements are qualified in their entirety by thiscautionary statement and neither ACADIA nor Biovail undertakes anyobligation to revise or update this press release to reflect events orcircumstances after the date hereof, except as required by law.

Source: ACADIA Pharmaceuticals Inc. and Biovail Corporation

ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director,Investor Relations
Thomas H. Aasen, Chief Financial Officer
858-558-2871
or
BiovailCorporation
Nelson F. Isabel, Vice President, InvestorRelations and Corporate Communications
905-286-3000