RESEARCH TRIANGLE PARK, N.C.—Tranzyme Pharma, aclinical-stage biopharmaceutical company focusing on therapeutics forgastrointestinal disorders, and Amsterdam, Netherlands-based Norgine B.V. haveannounced the completion of patient enrollment in ULISES 008, the second of twoPhase III trials of ulimorelin for the acceleration of gastrointestinalrecovery in patients undergoing abdominal surgery. The first Phase III trial,ULISES 007, completed enrollment in December 2011.
"We are very pleased with the timely completion ofenrollment in our second Phase 3 trial and expect to release top-line resultsof both trials in the first half of 2012. Further, we are focusing our effortson preparing the ulimorelin NDA," Franck S. Rousseau, M.D., Chief MedicalOfficer of Tranzyme, said in a press release. "Assuming positive data, we planto submit to the U.S. FDA by year-end."
Ulimorelin is an intravenous ghrelin agonist discoveredthrough use of Tranzyme's proprietary technology. The intravenous form of thedrug is indicated for patients in acute (hospital-based) settings, and it isalso being developed as an oral drug, TZP-102, for chronic conditions. The drugcandidate is being developed in partnership with Norgine.
The Phase III program for ulimorelin consists of tworandomized, double-blind, placebo-controlled studies, and for each study,approximately 330 bowel surgery patients were enrolled at sites across theUnited States and Europe. The studies will serve to determine the efficacy andsafety of daily 160 and 480µg/kg doses of ulimorelin compared to a placebo arm.The primary endpoint for both studies is the time to recovery ofgastrointestinal function.
It is estimated that up to 1 million patients in the UnitedStates are at high risk each year for delayed gastrointestinal recoveryfollowing surgery, a figure that includes the roughly 340,000 bowel resectionsurgeries that are performed in the country each year. Delayed gastrointestinalrecovery is also a possible complication for those who have undergonegynecological surgery, extraperitoneal surgery, joint replacement andcardiovascular surgery. According to Tranzyme's website, approximately 20percent of adults worldwide are affected by upper gastrointestinal motilitydisorders, conditions in which the normal movement of food through thegastrointestinal tract is disrupted. Despite the prevalence, limited treatmentoptions exist for patients.
The partnership with Norgine was established in June 2010,when the two companies entered into a license agreement centered on ulimorelin.Per the agreement, Norgine holds commercial rights for the drug in Europe,Australia, New Zealand, the Middle East, North Africa and South Africa, whileTranzyme retains commercial rights in all other territories, including NorthAmerica, South America and the entirety of Asia. The two companies areco-managing the Phase III development campaign, with Norgine sharing the costof the Phase III trials as well as clinical manufacturing supply costs.Tranzyme received an upfront license fee of $8 million in accordance with theagreement, and Norgine also purchased $2 million equity upon execution of thelicense. Tranzyme also stands to receive up to approximately $150 million ifdevelopment, regulatory and sales milestones are met over the course of thelicense. Norgine will also pay royalties on product sales in sales-based tiersbetween the low teens to the high twenties.