Biovail said Tuesday it received Canadian approval for its once-daily, extended-release formulation of its tramadol pain treatment, giving the stock a much-needed dose of positive news.
The product, which will be marketed under the Ralivia trademark, is identical to Biovail's once-daily formulation of tramadol that received approval from the United States Food and Drug Administration in September 2005.
Investors lauded the news, sending Biovail's stock up 41 Canadian cents, or 2.2 percent, to C$19.03 in midday trading on the Toronto Stock Exchange, after earlier climbing as high as C$19.47.
The country's biggest publicly traded drugmaker said it would release the version soon, in 100mg, 200mg and 300mg strengths. The product will compete in the Canadian market where pain product sales totaled C$872.2 million ($828 million) in the year through June.
Biovail's stock has languished recently, losing 28 percent of its value since late July, when the FDA rejected its new drug application for the once-daily salt version of its anti-depressant bupropion.
John Maletic, a biotechnology analyst at Scotia Capital, acknowledged the latest development was encouraging for Biovail, which has been hurt by the FDA rejection and competition from copy-cat drugs, but wasn't convinced it would help the stock regain its former glory.
"This is positive stuff for Biovail in Canada, but nothing that is going to take this company back to where it was," Maletic said.
"Something has to happen in the U.S. for that to really take effect and everyone is waiting for what they have in the pipeline. That, essentially, is what is going to move the stock going forward."
Last month, the company's founder and former chairman, Eugene Melnyk, said Biovail's strong product pipeline was key to protecting its stream of revenue. It has 10 new drugs and another four approaching New Drug Application.