Key Developments For Biovail Corporation
Biovail Corporation (BVF.TO) (Toronto Stock Exchange)
Biovail Corporation Declares Quarterly Dividend
Biovail Corporation announced that the Company`s Board of Directors has declared a quarterly cash dividend of $0.09 per share payable on January 4, 2010 to shareholders of record at the close of business December 2, 2009. The ex-dividend date is November 30, 2009.
Biovail Corporation 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.
Biovail Corporation's Biovail Pharmaceuticals To Pay Nearly $25 Million In Kickbacks Case-AP
The Associated Press reported that Biovail Pharmaceuticals Inc. will pay nearly $25 million in criminal and civil fines after pleading guilty to federal charges that it made illegal payments to encourage doctors to prescribe a blood pressure drug. The U.S. attorney's office in Boston announced that Biovail Pharmaceuticals Inc. was sentenced to pay $22.2 million after pleading guilty to conspiracy and kickback charges. The company also will pay a $2.4 million civil penalty. Prosecutors alleged Biovail paid thousands of physicians and others up to $1,000 apiece to induce them to prescribe or recommend Cardizem LA. The company is a subsidiary of Biovail Corporation, which announced in May 2008 it had agreed to plead guilty and pay to settle the case.
Biovail Corporation Announces Results From ACADIA Pharmaceutical Inc.'s Phase III Trial of Pimavanserin In Parkinson's Disease Psychosis
Biovail Corporation announced the top line results from ACADIA Pharmaceutical Inc.'s 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 between the pimavanserin and placebo arms. The primary endpoint of the study was the mean change in SAPS scores at day 42 compared to baseline for each of the two pimavanserin treatment arms versus placebo. Patients showed marked improvements in the SAPS scores across all study arms (mean reductions in SAPS scores were 5.9 points in the placebo arm, 5.8 points in the 10 mg pimavanserin arm, and 6.7 points in the 40 mg pimavanserin arm); however, statistical significance was not achieved in either pimavanserin arm primarily due to the larger than expected improvement in placebo treated patients. 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.
Judge Dismisses Biovail Corporation Suit Against SAC Capital-Reuters
Reuters reported that a New Jersey state judge has dismissed Biovail Corporation's lawsuit accusing hedge fund SAC Capital Advisors of conspiring with other firms to drive down the stock price of the Company. Judge Donald Goldman of the Superior Court of New Jersey dismissed the 2006 suit after finding the court lacked jurisdiction and that Biovail failed to prove that it was entitled to damages. Goldman noted he did not evaluate the merits of Biovail's claims against SAC or research firm Gradient Analytics Inc. The lawsuit said SAC had colluded with independent research firms and Wall Street banks in the spring of 2003 to produce negative reports on Biovail that it knew were false. SAC and other hedge funds would then bet against the Company's shares and profit when the price fell.
