Champs & Chumps ..........Stock Market Winners & Losers

Friday, September 29, 2006

Stock Market Chumps..........9-29-06

Labopharm Inc. (DDSS)
Last Trade:5.69
Trade Time:2:22PM ET
Change:Down 1.62 (22.14%)


Labopharm Inc.'s chief executive said on Friday he was "pretty confident" the company's once-daily version of the pain-killer tramadol would receive U.S. approval despite a letter from the U.S. Food and Drug Administration that said some issues still must be resolved.

"We're pretty confident. You're not done until you're done," James Howard-Tripp, Labopharm president and CEO, told Reuters.

"We have got it approved in other jurisdictions. We believe it's a good product. We believe in our data package, so we would be pretty optimistic."

Labopharm shares dropped almost 25 percent on Friday after the company said it had received an approvable letter from the U.S. Food and Drug Administration for its version of the tramadol pain killer, but that the FDA said there are some unresolved issues.

The shares were down C$1.69, or 20.8 percent, at C$6.42 on the Toronto Stock Exchange, after dropping as low as C$6.09 earlier in the day. On Nasdaq, the shares were off $1.56, or 21.3 percent, at $5.75 after earlier falling as low as $5.42.

Howard-Tripp said the company plans to discuss the letter with the FDA "fairly rapidly" and believes it can address the issues raised without the need for additional data.

Howard-Tripp refused to say what issues were flagged.

"We are not trying to be deliberately obscure. We need to fully understand quite what it is they want, and until we fully understand, we obviously can't tell the marketplace what it is," he said.

"If we can't understand it, it doesn't make sense to try to put information out."

Analysts said the news was a setback for the company and raised doubts that it would meet its earlier targeted approval date.

"I think this is more of a setback in timing, but the problem is, we don't know for how long," said Laurence Terrisse-Rulleau, a biotechnology analyst at Blackmont Capital in Montreal.

"I'm still confident in the product. I'm still confident that they will get approved, I just don't know when."

Terrisse-Rulleau said it is unlikely that the company will meet the approval target of first quarter 2007. She said it will now "most likely" be in the third quarter of 2007.

"The problem is it depends if the FDA is going to take 50 days or six months," she said. "And it is going to take weeks before we find out."

Labopharm's new drug application for tramadol was submitted to the FDA in November 2005.

Once-daily tramadol, Labopharm's key product, has received regulatory approval in 22 European countries and commercial launch of the product across Europe is under way.

Corcept Therapeutics Inc. (CORT)
Last Trade:0.91
Trade Time:2:25PM ET
Change:Down 0.40 (30.53%)
Corcept Therapeutics Shares Hit All-Time Low After 2nd Corlux Clinical Trial Fails

Shares of Corcept Therapeutics Inc. took another hit Friday and sunk to an all-time low after the drug developer said the second of three clinical trials for its Corlux depression drug had failed.

Corcept shares dropped 54 cents, or 41.2 percent, to 77 cents in midday trading on the Nasdaq at more than double their average volume. The stock, which went public at $12 in April 2004, hit a new all-time low of 75 cents earlier in the session.

On Aug. 25, the stock shed 56 percent of its value in one day, trading at hundreds of times its average volume, to close at $1.54 on the Nasdaq after the company announced that the first of three Corlux trials had failed.

In the second study, researchers found no significant difference between Psychotic Major Depression patients who were given Corlux or a placebo and then assessed using a psychiatric rating scale.

As in the first study, the company noted there was an unusually high placebo response rate in the second study. After 56 days, about 95 percent of those taking Corlux or a placebo had responded by improving their scores on the rating scale by 50 percent, the study's primary endpoint.

The company said it has about $17.5 million in cash and securities, enough to complete the third clinical trial. Results of the third study are expected early next year.

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