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QLT to appeal injunction against Eligard sales

By Craig Wong, Canadian Press
The Toronto Star, February 28, 2006 

VANCOUVER — Drug developer QLT Inc. (TSX: QLT) plans to appeal a U.S. court decision that has placed an injunction on production and sales of its Eligard treatment for prostate cancer.

QLT CEO Bob Butchofsky said the company hoped to file an ``emergency" appeal that would be heard quickly by the United States Court of Appeals for the Federal Circuit.

"I think we can probably get the appeal resolved and we're hoping that that takes place within the week, but obviously to some degree it is out of our control," Butchofsky said Tuesday.

The ruling Monday by the U.S. District Court for the Northern District of Illinois Eastern Division granted an injunction that stops QLT and partner Sanofi-Aventis from promoting, manufacturing and selling Eligard until May 1.

In addition, the court ordered the recall of any Eligard products still owned by the companies and a voluntary recall program to allow doctors, wholesalers or distributors to return it for a refund.

However the injunction has been stayed for seven days to give QLT time to file its appeal.

The court order was requested by U.S.-based TAP Pharmaceutical Products Inc., which is suing QLT and its partner, a unit of Sanofi-Aventis Group of France, alleging Eligard infringes on a TAP patent.

A U.S. court issued a decision earlier this year that denied an assertion by QLT and its partner, a unit of France's Sanofi-Aventis Group (NYSE: SNY), that the TAP patent was unenforceable.

In December, a jury also ruled the patent was valid.

Butchofsky said there would be some costs associated with the voluntary recall program, but suggested they would likely be inconsequential. He also suggested that because most of QLT's business from Eligard comes from the six-month formulation there would be relatively few patients that would be coming back for injections over the next six or seven weeks.

"It's difficult to say, but we don't think there will be substantial loss of market share," Butchofsky said.

UBS analyst Dimi Ntantoulis had estimated 2006 Eligard sales of $104.5 million (U.S.), of which $34.8 million would go to QLT.

"Should QLT and Sanofi be forced to remove Eligard from the market until May 1, we estimate end user sales during this period at $18 million (U.S.) with $6 million (U.S.) to QLT," Ntantoulis wrote.

Shares of QLT have been under pressure for months amid positive test results of a rival to eye drug Visudyne and difficulty in following up its initial success with Eligard acquired when QLT bought Atrix Laboratories Inc. in 2004.

In its outlook, QLT said it expects 2006 revenue from its key Visudyne product will come in between $370 million and $400 million (U.S.), down from the $483.8 million it booked for the full year of 2005. The Vancouver-based company reports in U.S. dollars.

QLT lost $325.4 million or $3.51 per share on revenue of $242 million last year, compared with a loss of $165.7 million or $2.26 per share on revenue of $186.1 million a year earlier.

At Dec. 31, the company had cash and cash equivalents of $345.8 million.

Its shares were up nine cents at $8.20 on the Toronto Stock Exchange on Tuesday.
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