Canadian drug developer Biovail Corp. said Thursday it is being sued by investors who allege it made misleading statements during the approval process for the depression drug Aplenzin.
The lawsuit, filed in U.S. District Court for the Southern District of New York, was filed on behalf of investors buying Biovail shares between Dec. 14, 2006, and July 19, 2007. Biovail said it believes lawsuit's claims are without merit.
In a separate statement, the law firm representing the plaintiffs said the lawsuit charges that the company made false and misleading statements about Aplenzin. Specifically, Coughlin Stoia Geller Rudman & Robbins LLP said Biovail failed to disclose that the Food and Drug Administration required a single-dose study of the drug when the company had submitted a multiple-dose study in the regulatory application.
"Thus, defendants' FDA application for BVF-033 (Aplenzin) failed to meet the requirements set forth by the FDA such that approval was likely to be materially delayed."
The FDA asked for additional data on the drug in July of 2007 before considering the application. Aplenzin was approved in April of 2008. The company said in August it was still in talks for a U.S. marketing partner.
Shares of Biovail closed at $8.73 Wednesday.
The lawsuit, filed in U.S. District Court for the Southern District of New York, was filed on behalf of investors buying Biovail shares between Dec. 14, 2006, and July 19, 2007. Biovail said it believes lawsuit's claims are without merit.
In a separate statement, the law firm representing the plaintiffs said the lawsuit charges that the company made false and misleading statements about Aplenzin. Specifically, Coughlin Stoia Geller Rudman & Robbins LLP said Biovail failed to disclose that the Food and Drug Administration required a single-dose study of the drug when the company had submitted a multiple-dose study in the regulatory application.
"Thus, defendants' FDA application for BVF-033 (Aplenzin) failed to meet the requirements set forth by the FDA such that approval was likely to be materially delayed."
The FDA asked for additional data on the drug in July of 2007 before considering the application. Aplenzin was approved in April of 2008. The company said in August it was still in talks for a U.S. marketing partner.
Shares of Biovail closed at $8.73 Wednesday.
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