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Furiex Pharmaceuticals, Inc. (NASDAQ: FURX) today announced dosing of the first patient in its Phase III randomized, double-blind, placebo-controlled studies evaluating efficacy, safety and tolerability of MuDelta (JNJ-27018966) in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Furiex is conducting two simultaneous Phase III trials, one with a 52-week treatment period and one with a 30-week treatment period, in study centers in the United States, Canada and United Kingdom. Combined, the trials are expected to enroll approximately 2,250 patients.
Furiex previously announced the successful completion and outcome of its Phase II study to assess the safety and efficacy of an oral formulation of MuDelta in patients with IBS-D. The study achieved statistically and clinically significant results for its primary as well as a number of key secondary endpoints, and demonstrated durable efficacy through the 12-week treatment period.
“MuDelta is a first-in-class compound and we are extremely pleased that the Phase III trials have commenced and look forward to further advancing the development plan for this important therapeutic candidate,” said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex.
Added Fred Eshelman, Pharm.D., chairman of Furiex, “We believe MuDelta will fill an unmet need for an IBS-D treatment that has efficacy in both pain and diarrhea, a good safety profile and a convenient dosing schedule. It has the potential to create significant value as we progress its development.”
In November 2011, we acquired full exclusive license rights to develop and commercialize MuDelta under our existing development and license agreement with Janssen Pharmaceutica, N.V., or Janssen. Under the terms of our agreement Janssen will be eligible to receive a $5 million milestone payment upon dosing of the fifth patient in the Phase III trial, up to $45 million in regulatory milestone payments and, if approved for marketing, up to $75 million in sales-based milestone payments and sales-based royalties increasing from the mid to upper single digit percentages as sales volume increases. Royalties are to be paid for a period of ten years after the first commercial sale or, if later, the expiration of the last valid patent claim or the expiration of patent exclusivity.