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.
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
24/7 market commentary from Jim Cramer and 20+ veteran Wall Street gurus. Get access to the latest trading ideas on stocks, options, and ETFs as well as a real-time forum to see the pros exchanging their investment ideas.
- Jim Cramer + 20 Wall Street pros
- Intraday commentary & news
- Real-time trading forum
- Actionable trade ideas
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV