Biotech Values

[DewDiligence]

Fast Track does not guarantee Priority Review:

[You already knew that, right? If not, please reread #msg-3041879.]

http://yahoo.reuters.com/financeQuoteCompanyNewsArticle.jhtml?duid=mtfh38598_2004-09-08_20-02-57_n08...

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Adolor stock down-FDA won't expedite drug's review

NEW YORK, Sept 8 (Reuters) - Shares of Adolor Corp. (ADLR.O: Quote, Profile, Research) fell 12 percent on Wednesday after U.S. regulators said they would take longer than expected to review the company's experimental drug to restore bowel function after abdominal surgery.

The Exton, Pennsylvania-based company said the Food and Drug Administration agreed to a standard review of the drug, called Entereg. Adolor said it expects a decision on approval by April 25, 2005, or 10 months from the June submission of its application of the drug it shares with GlaxoSmithKline (GSK.L: Quote, Profile, Research) .

In February, however, the FDA gave Entereg "fast track" status, which is bestowed on products intended to treat serious or life-threatening conditions and/or those with unmet medical needs.

Drugs that receive fast track designation are often reviewed within six months rather than the standard 10-month process. In this case, the FDA decided to forego an expedited review.

Jason Kantor, an analyst for WR Hambrecht, said investors were likely reacting to the extra months it would now take before Entereg could hit the market. "History would say that fast track drugs get expedited review," he said. "In this case, the indication is an important one but it's self-resolving, not life-threatening," Kantor said. [LOL --a typical quote from our man, Jason.]

Entereg treats a condition known as postoperative ileus in which bowel function is impaired following abdominal surgery, often as a side effect of the common use of opioids for pain relief. In clinical trials, Entereg helped reduce hospital stays compared with patients receiving a placebo.

Neither Adolor nor GlaxoSmithKline would speculate on what drove the FDA decision to forego a priority review.

Adolor Chief Executive Bruce Peacock, who in February expressed confidence in the potential for a priority review, on Wednesday said the company was happy to simply have its New Drug Application accepted by the FDA.

GlaxoSmithKline spokeswoman Nancy Leone said there was no cause for concern over the longer review period.

"We feel that April 2005 is still coming up on us pretty quickly," she said.

Adolor shares were down $1.50 at $11.03 on Nasdaq.
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