Investors sue Biovail over FDA snafu

Just when it looked as if things were calming down at Canada's Biovail, shareholders have filed a new class action suit. Filed in New York, the suit claims that Biovail execs misled the public during the approval process for its antidepressant drug Aplenzin. The company was required to submit a single-dose trial to support FDA approval of Aplenzin, the suit claims, but the company only submitted a trial that used multiple doses. By failing to meet FDA's conditions, the company "materially delayed" Aplenzin's market debut, according to a statement from the shareholders' lawyers.

The company, for its part, says that the "claim is completely without merit" and that it will "defend itself vigorously."

FYI, the FDA approved Aplenzin--a salt formulation of the successful antidepressant Wellbutrin XL--in April, after Biovail turned in additional testing data. This follows a rejection in July 2007, when the FDA said Biovail's data wasn't sufficient [1]. That day, the stock dropped by about one-fifth to $20.03, according to the shareholders' law firm.

- see the plaintiffs' release [2]
- check out the Biovail statement [3]
- read the story [4] in the Financial Post

Related Articles:
Melnyk slams Biovail board, calls for change [5]
Biovail shares sink after FDA schedules review [6]
FDA hands Biovail a non-approval letter [1]