On January 13, Adolor/NASDAQ: ADLR released top-line results of its Phase III clinical study 308 of Entereg in the treatment of postoperative ileus (POI), an obstruction of the small bowel after an operation. Adolor and its partner, GlaxoSmithKline said Entereg failed to show a clear statistical at doses of either 6 mg or 12 mg. Nonetheless, Adolor plans to submit an NDA in the late half of 2004 to the FDA, as the drug does appear to facilitate gastrointestinal recovery more quickly as compared to placebo.
In the company’s conference call, Adolor defended Entereg’s clinical data and believes that it has the data needed to meet the requirement for an NDA filing which they plan to file in the U.S. in the late first half of 2004. The bigger question is whether the data is sufficient to get FDA approval. Adolor and GlaxoSmithKline will provide 308 data that shows a positive trend and this combined with the other three studies, 302, 313 and 306, makes a strong case for the drug’s therapeutic ability in safety and efficacy to the FDA.
There are several scenarios that can happen with Entereg. Worst case, once the NDA is filed, the FDA does not approve the drug. The companies could conduct additional Phase III trials to strengthen the data, which would further delay Entereg’s entrance to the market.
Okay case, FDA approves Entereg, but with covenants.
Best case, FDA approves Entereg for marketing.
How the FDA will react is difficult to predict. Given that there is no FDA approved drug for POI available and Adolor and GSK have generated data that shows benefits in treatment of this condition, Entereg has value as a treatment that can facilitate patient recovery and reduce health care costs.
The market reacted negatively to the news. We believe that once Wall Street’s emotions have subsided, Adolor’s share price can recover back into the high teens.Nadine Wong
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