MORRISVILLE, N.C. (June 19, 2012) - 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.
For more details about these trials, please visit www.clinicaltrials.gov.
MuDelta is a novel, orally active, Phase III investigational agent with combined mu opioid receptor agonist and delta opioid receptor antagonist activity which acts locally in the gut and has very low oral bioavailability, diminishing sedating side effects. This dual opioid activity is designed to treat diarrhea and pain symptoms of IBS-D, without causing the constipating side effects that can occur with mu opioid agonists.
Diarrhea-predominant irritable bowel syndrome is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 12 million Americans. Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gut and nervous system interact. IBS-D can be extremely debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.
Furiex Pharmaceuticals is a drug development collaboration company that uses innovative clinical development design to accelerate and increase value of drug development programs by advancing them through the drug discovery and development process in a cost-efficient manner. Our drug development programs are designed and driven by a core team with extensive drug development experience. The company collaborates with pharmaceutical and biotechnology companies and has a strong, diversified product portfolio and pipeline with multiple therapeutic candidates, including one Phase III-ready asset, two compounds in Phase III development, one of which is with a partner and two products on the market. The company's mission is to develop innovative medicines faster and at a lower cost, thereby improving profitability and accelerating time to market while providing life-improving therapies for patients. For more information, visit www.furiex.com.
Except for historical information, all of the statements, expectations and assumptions contained in this news release are forward-looking statements that involve a number of risks and uncertainties. Although Furiex attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors which could cause actual results to differ materially include the following: not completing enrollment for the Phase III studies; terminating the Phase III studies due to changes in the safety profile; potential Food and Drug Administration changes to its regulatory guidance applicable to approval of irritable bowel syndrome drugs; time and cost required to complete trials and gain regulatory approval, and related risks, including that we might not get approval; the need to find collaborators to help develop and commercialize MuDelta; continuing losses and our potential need for additional financing; and the other risk factors set forth from time to time in the SEC filings for Furiex, copies of which can be found on our website.