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Biotech / Medical : Versicor (VERS) -- Ignore unavailable to you. Want to Upgrade?


To: JOEBT1 who wrote (38)3/17/2003 7:21:05 PM
From: Arthur Radley  Respond to of 83
 
Joe,
The primary endpoint is "okay" IMO....especially when you have a standard of 98% to beat. With that said, I do take pause over the recurrent number in which VERS admits that these are statistically significant results. In the CC, I think they handled this point as best they could... My take is that a large number of the trial patients in South Africa, Thailand and Argentina had no previous exposure to fluconazole and the built-up resistance wasn't as great as for the patients in the United States arm of the trial. Foresure, I think it common knowledge that here in the US we are quickly building up resistance by over prescribing antibiotics.

The after-hours trading is a little disconcerting in that it traded down by over a $1.00...but it was light trading. Tomorrow will be very interesting....



To: JOEBT1 who wrote (38)3/17/2003 7:26:27 PM
From: Arthur Radley  Read Replies (2) | Respond to of 83
 
Joe,
This latest release seems to better speak to this issue.....

"There seems to be confusion about some of the data," said Tom Dietz, an analyst at Pacific Growth Equities, noting that the follow-up segment of the trial showed that anidulafungin failed to sustain its effectiveness.

At the two-week follow up, 64.4 percent of patients in the anidulafungin arm were still infection-free, compared with 89.5 percent of patients in the fluconazole arm.

The company said end-of-therapy response, rather than follow up, is most significant because almost all patients eventually relapse and in a non-trial setting they would be given preventive therapy.

Dietz agreed, noting that Versicor chose to test its drug against esophageal candidiasis mainly because it is a non-fatal, treatable infection. "In practice, these patients would never be taken off of fluconazole. Ultimately they would all relapse," the analyst said.

Anidulafungin belongs to a new class of antifungal agents, called echinocandins, that are seen as less likely to cause drug resistance and have a potentially better safety profile than some treatments. The first product in the class is Merck & Co.'s (NYSE:MRK - News) Cancidas, which was approved in January 2001.

"The esophageal candidiasis indication is more important in the western world where patients have become resistant to existing drugs," said Dov Goldstein, Versicor's chief financial officer. "But the class will mostly be used to treat invasive bloodstream infections."