(Adds stock price, analyst comment)
TORONTO Nov 21 Labopharm Inc DDS.TO said on
Wednesday the U.S. Food and Drug Administration responded to
its appeal of the approvable letter for its once-daily
tramadol, and that the agency will not overturn the letter,
which was issued in May.
The Canadian biotechnology company said it plans to appeal
the matter to the FDA's next supervisory level in the coming
In response, Labopharm stock shed 17 Canadian cents, or
15.2 percent, to 95 Canadian cents on the Toronto Stock
The shares plunged more than 50 percent after the FDA
issued its approvable letter in May; since then, they have
gradually declined more than 70 percent.
Last month, Labopharm formally appealed the agency's
decision on the painkiller, which stated the once-daily formula
would not be approved until certain conditions were met.
The Montreal-based firm said it was possible the agency
would require additional data before the drug could be
approved. It is not clear where, exactly, the dispute lies.
The company said on Wednesday its appeal process "may
continue through the agency's chain of command, through the
centers to the commissioner of food and drugs."
Douglas Loe, an analyst at Versant Partners, said the FDA's
response is "obviously not positive, but certainly predictable
and we will be surprised if the formal dispute resolution
process does not proceed through one or two more layers of
Loe noted the FDA's office of drug evaluation is currently
headed by an acting director, Curtis Rosebraugh, who is
unlikely to "act boldly" on the tramadol file.
(Reporting by Jonathan Spicer)