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Next Up for Celgene's Crohn's Pill: A Snapshot Inside Patients' Colons (Updated)

Note: This story was first published on July 14. It's been updated and republished with additional information about investor expectations for the GED-0301 study results, which Celgene is likely to announce in early September.

Celgene (CELG) will use a medical meeting this fall to address a lingering investor concern about GED-0301, an experimental pill for Crohn's disease and one of the most important drugs in the company's research pipeline.

GED-0301 is one of three drugs -- Otezla and ozanimod are the others -- which form the core of Celgene's burgeoning immunology and inflammation franchise. Today, Celgene's blood cancer drugs, mainly the multiple myeloma drug Revlimid, account for a majority of the company's revenue and profit. But in the next four to five years, Celgene is counting on "I&I" drugs like GED-0301 to diversify and extend the company's prodigious growth projections.

At the medical meeting, (Celgene isn't being any more specific about which meeting) results will be presented from a small phase II study in which doctors use an endoscope to peer into the gastrointestinal tract of Crohn's patients treated with GED-0301.

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The "endoscopy data" assess the ability of GED-0301 to reduce the size and severity of ulcers in the colon and bowel. These ulcers -- a hallmark of Crohn's disease -- occur when a patient's own immune system mistakes the gastrointestinal tract as a foreign body needing to be eliminated.

Investors were first excited about the blockbuster potential of GED-0301 in March 2015, when a mid-stage study of GED-0301 demonstrated high rates of clinical remission in Crohn's patients. Data from this study were called "unprecedented" by a physician in an editorial published in the New England Journal of Medicine. However, the physician also raised a concern that enrolled patients may have had more moderate Crohn's disease, making it easier for GED-0301 to show an outsized treatment effect.

In that study, Celgene defined remission as a...


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