Tranzyme Pharma Inc. picked up $8 million now and possibly $150 million on the backend of a deal that gives Norgine BV exclusive rights to develop and commercialize Tranzyme's ghrelin agonist, ulimorelin (TZP-101) in several ex-U.S. regions.

Norgine, of Amsterdam, the Netherlands, gains rights to the Phase III compound, being developed in gastrointestinal dysmotility conditions in acute care settings, in Europe, Australia, New Zealand, the Middle East, South Africa and North Africa. Tranzyme retains development rights in the U.S. and Asian countries.

Norgine also will make an undisclosed equity investment in Tranzyme.

The $150 million possible down the road for Tranzyme is based on the compound achieving development, regulatory and commercial milestones. Tranzyme also will receive escalating double-digit royalties on net sales in the licensed territories. The companies will jointly fund further development of ulimorelin and expect to begin pivotal Phase III studies in the second half of this year.

TZP-101, Tranzyme's intravenous ghrelin agonist, is a product developed from the company's internal research and is being evaluated clinically for the treatment of postoperative ileus (POI). A multinational, double-blind, placebo-controlled Phase IIb trial for POI designed to assess the time to recovery of gastrointestinal function - defined by the time to first bowel movement - showed that TZP-101 was both safe and effective in reducing the duration of ileus following surgery in patients undergoing open bowel resection. For the primary endpoint, TZP-101 was superior to placebo at all doses tested, with the two most effective doses showing a statistically significant difference.

Statistical significance also was achieved in the most effective doses in the secondary endpoint of time to recovery of GI function as defined by the later of the first bowel movement and first solid food intake.

Further back in the pipeline, Tranzyme is developing an oral ghrelin agonist, TZP-102, for chronic gastrointestinal disorders. It currently is in a multinational Phase II study. It also has a ghrelin antagonist, TZP-301, for the treatment of obesity and metabolic syndrome.

Aside from its ghrelin agonists, the Research Triangle Park, N.C.-based company has a motilin antagonist, TZP-201, in preclinical development for various forms of moderate-to-severe diarrhea.

Vipin K. Garg, president and CEO of Tranzyme, said Norgine's focus on products that address unmet medical needs and its expertise in European markets "make them an ideal strategic and co-development partner." And the partnership, he noted, allows Transzyme to monetize part of the value of ulimorelin while retaining the upside of North American and Asian markets.

Norgine, a specialty pharma, has been around for more than 100 years with an extensive product line that weighs heavy in the gastroenterology field, including Movicol for the treatment of constipation and fecal impaction, the Moviprep bowel cleansing preparation, Klean-Prep for bowel preparation prior to colonoscopy and Xifaxan for the treatment of travelers' diarrhea.

The Tranzyme-Norgine deal follows two other signings this year involving ghrelin programs. In January, Alize Pharma SAS and Eli Lilly and Co. inked a research and licensing collaboration for Alize's AZP-01 program focused on development of unacylated ghrelin agonists for the treatment of Type II diabetes, and in March Ipsen SA, of Paris, licensed its melanocortin and ghrelin programs for obesity, metabolic diseases and gastrointestinal disorders to Boston-based start-up Rhythm Pharmaceuticals in exchange for a 17 percent equity stake in Rhythm and up to $80 million in milestone payments as well as royalties.