• June 16, 2010
  • North America

Tranzyme Pharma and Norgine Sign License Agreement for Late-Stage Development Product, Ulimorelin (TZP-101), in Europe and Other Select RegionsCompanies to Jointly Initiate Pivotal Phase 3 Studies in 2010

RESEARCH TRIANGLE PARK, NC and AMSTERDAM, NETHERLANDS – June 16, 2010 – Tranzyme Pharma, a clinical-stage biopharmaceutical company, and Norgine B.V., a European specialty pharmaceutical company, announced today that they have entered into a licensing agreement that provides Norgine with the exclusive rights to develop and commercialize Tranzyme’s novel ghrelin agonist, ulimorelin (TZP-101), in Europe, Australia, New Zealand, the Middle East, South Africa and North Africa. Ulimorelin is entering Phase 3 development for the treatment of gastrointestinal dysmotility conditions in acute care settings.

Under the agreement, Norgine will make an upfront payment of $8 million and will also make an equity investment in Tranzyme. Further, Tranzyme is eligible to receive up to approximately $150 million if certain development, regulatory and commercial milestones are achieved. Tranzyme will also receive escalating double-digit royalties on net sales in the licensed territories. The companies will jointly fund further development of ulimorelin and anticipate initiating pivotal Phase 3 studies in the second half of 2010.

“Norgine’s focus on pharmaceutical products that address unmet medical needs, and their development and commercial experience and expertise in European markets, make them an ideal strategic and co-development partner for Tranzyme,” said Vipin K. Garg, PhD, President and CEO of Tranzyme. “This partnership allows us to monetize part of the value of ulimorelin, while still retaining the significant upside of North American and Asian markets”.

Peter Stein, Chairman and CEO of Norgine said, “There is a critical need for a new, safe and effective prokinetic drug for use in acute care settings, as there are no satisfactory treatments on the market. We have been very impressed with the work that Tranzyme have done to take ulimorelin through Phase 2 development and we are excited to be working with them on this innovative therapy, which could bring relief to millions of patients.”

About Ulimorelin
Ulimorelin is an intravenous ghrelin agonist with potent prokinetic properties currently in clinical development for the treatment of gastrointestinal dysmotility disorders in acute care settings. Ulimorelin has been comprehensively studied in the management of severe gastroparesis and postoperative ileus (POI), and has the potential to treat other serious conditions requiring administration of intravenous prokinetic agents. The safety and pharmacokinetic profiles of ulimorelin have been extensively characterized in healthy subjects and patients across multiple dose levels, and the GI prokinetic properties of the compound are well-established. Ulimorelin was discovered using Tranzyme’s proprietary drug discovery technology.

About Norgine
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 2009, Norgine’s net product sales were €253 million, the 23rd year of double-digit growth at constant exchange rates. 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 areas such as gastroenterology, hepatology and pain management. 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 fecal impaction, MOVIPREP® a new generation of bowel cleansing preparation, KLEAN-PREP® for bowel preparation prior to colonoscopy, XIFAXAN® for the treatment of travelers’ diarrhea 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, Wales and Dreux in France. www.norgine.com

About Tranzyme Pharma
Tranzyme Pharma is a clinical-stage drug development company that discovers and develops novel small molecule macrocyclic drugs for both acute care (hospital-based) and chronic indications with significant unmet medical needs. The Company’s pipeline is derived from its proprietary drug discovery (chemistry) technology, MATCH™, and targets products for gastrointestinal motility, metabolic diseases and cancer supportive care.
Tranzyme recently entered into a broad drug discovery partnership with Bristol-Myers Squibb to discover, develop and commercialize novel drug candidates in multiple therapeutic areas. www.tranzyme.com.