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Susan P. Sharpe
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Julie Hornby Winfield
Global Corporate Communications Manager
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Tranzyme Pharma and Norgine Complete Enrollment in First of Two Pivotal Phase 3 Trials of Ulimorelin
RESEARCH TRIANGLE PARK, NC - December 7, 2011 - Tranzyme Pharma and Norgine B.V. today announced completion of patient enrollment in ULISES 007, the first of two Phase 3 pivotal trials of ulimorelin for the acceleration of gastrointestinal (GI) recovery in patients undergoing partial bowel resection. There are an estimated 1 million patients in the U.S. at high risk each year for delayed GI recovery after surgery, including approximately 385,000 bowel resection surgeries.
“Completing enrollment in ULISES 007 is an exciting milestone for our ulimorelin program. We expect to report top-line results from this trial in the spring of 2012,” said Vipin K. Garg, Ph.D., President and CEO of Tranzyme Pharma. “In addition, we remain on track to complete enrollment and announce data from our second Phase 3 trial, ULISES 008, by the end of the first half of 2012.”
The ulimorelin Phase 3 program includes two randomized, double-blind, placebo-controlled studies. Approximately 300 bowel surgery patients are being enrolled at sites across the U.S. and Europe in each of the ULISES 007 and ULISES 008 trials. The objective is to evaluate the efficacy and safety of daily 160 and 480µg/kg doses versus a placebo arm, with the primary endpoint of time to GI recovery defined as the time to the latest of first bowel movement and tolerance of solid food.
Ulimorelin is an intravenous ghrelin agonist discovered by Tranzyme using its proprietary drug discovery technology. Ulimorelin is being developed in partnership with Norgine B.V. based in the Netherlands. Norgine holds the commercial rights for ulimorelin in Europe, Australia, New Zealand, Middle East, and North and South Africa.
Norgine is an independent, successful European specialty pharmaceutical company that has been established for over 100 years and has a presence in all major European markets. In 2010, Norgine’s net product sales were €258 million. The Company employs over 1,200 people.
Norgine’s focus is the development and marketing of pharmaceutical products that address significant unmet clinical needs in therapeutic areas such as gastroenterology, hepatology and supportive care. The Company currently markets a range of products in various markets in its key therapeutic areas e.g., MOVICOL® for the treatment of constipation and faecal impaction, MOVIPREP® a bowel cleansing preparation, KLEAN-PREP® for bowel preparation prior to colonoscopy, XIFAXAN® for the treatment of travellers diarrhoea and ORAMORPH® for the treatment of moderate to severe pain associated with cancer.
Norgine is active in research and development and currently has products in various stages of clinical development. Norgine manufactures most of its own products in Hengoed, UK and Dreux, France. For more information: www.norgine.com
About Tranzyme Pharma
Tranzyme Pharma is a late-stage biopharmaceutical company focused on discovering, developing and commercializing novel, mechanism-based therapeutics for the treatment of upper gastrointestinal (GI) motility disorders. While approximately 20 percent of adults worldwide are affected by these persistent and recurring conditions which disrupt the normal movement of food throughout the GI tract, currently there are a limited number of safe and effective treatment options. Tranzyme is developing an intravenous drug, ulimorelin, for patients in acute (hospital-based) settings, as well as an oral drug, TZP-102, for chronic conditions. Ulimorelin is currently in Phase 3 clinical trials and TZP-102 is currently in Phase 2b clinical trials. Together these product candidates target a significant underserved market. By leveraging its proprietary drug discovery technology, Tranzyme is committed to pursuing first-in-class medicines to address areas of significant unmet medical needs.
Statements in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, which are usually identified by the use of words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "seeks," "should," "will," and variations of such words or similar expressions. We intend these forward-looking statements, including without limitation, those statements relating to expected patient enrollment numbers, geography and dosages and the expected release date for clinical trial data, to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies and prospects, which are based on the information currently available to us and on assumptions we have made. Although we believe that our plans, intentions, expectations, strategies and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control including, without limitation, risks related to enrollment and successful completion of our trials, risk of unforeseen side effects, risks related to our collaborations and risks related to regulatory approval of new drug candidates. Further information on these and other factors that could affect the company's financial results is contained in our public filings with the Securities and Exchange Commission (SEC) from time to time, including our Form 10-Q which was filed with the SEC on November 10, 2011, and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.