Shares of drug manufacturer Adolor went into freefall yesterday, dropping 56%, after Glaxosmithkline and Adolor announced they are suspending their development program for bowel drug alvimopan (Entereg/Entrareg[R]) while long-term safety study findings are evaluated. Entereg is Adolor's most advanced experimental drug. Adolor's shares lost $4.87 to $3.90 while Glaxo's gained $0.06 to $56.18. Late-stage clinical trial results unexpectedly indicated a "numerical imbalance" in the number of cardiovascular side effects and tumors among patients taking Entereg versus those taking a placebo, though the total number of "serious adverse events" was comparable (Entereg 13%; placebo 11%). The trial involved 805 patients suffering from opioid-induced bowel dysfunction [OBD] who take painkillers for chronic, non-cancer pain.
Glaxo has halted an application for another Entereg clinical trial as well as a smaller study of cancer patients on strong painkillers, while Adolor has halted a separate Entereg study of patients who take painkillers after rotator cuff surgery.
Sources: MarketWatch (I, II, III)
Commentary: GlaxoSmithKline: Why This Year Will Be the Healthiest Yet • Top Six Socially Responsible Healthcare and Pharmaceutical Firms • Does Adolor’s Announcement of Positive Entereg Data Assure FDA Approval?
Stocks/ETFs to watch: Glaxosmithkline plc (GSK), Adolor Corp. (ADLR). Competitors: Endo Pharmaceuticals Holdings Inc. (ENDP), Pain Therapeutics Inc. (PTIE), Novartis AG (NVS), Pfizer Inc. (PFE), Sanofi-Aventis (SNY). ETFs: Europe 2001 HOLDRs (EKH), BLDRS Europe 100 ADR Index (ADRU), BLDRS Developed Markets 100 ADR Index (ADRD)
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