Intravenous ghrelin agonist is poised to start in Phase III trials against GI motility disorders during this year.

Tranzyme Pharma will receive $8 million cash up front and an equity investment from Norgine as part of a deal covering the latter’s Phase III candidate for gastrointestinal dysmotility disorders. Tranzyme gains exclusive rights to develop and commercialize ulimorelin, an intravenous ghrelin agonist, in multiple territories outside the U.S., including Europe, Australia, New Zealand, the Middle East, South Africa, and North Africa. 

Tranzyme could earn up to about $150 million in development, regulatory, and commercial milestones plus double-digit sales royalties. The firms will jointly fund further development of the drug, which is expected to start in pivotal Phase III studies during the latter half of this year.

Norgine represents an “ideal strategic and co-development partner for Tranzyme,” claims Tranzyme CEO Vipin K. Garg, Ph.D. “This partnership allows us to monetize part of the value of ulimorelin while still retaining the significant upside of North American and Asian markets.”

Tranzyme is developing ulimorelin for the potential treatment of gastric dysmotility conditions including postoperative ileus and acute severe gastroparesis. The firm is also developing an oral ghrelin agonist, TZP-102, for the treatment of chronic gastrointestinal disorders. The molecule is currently undergoing a multinational Phase II study.

Tranzyme’s preclinical pipeline includes a motilin antagonist TZP-201 for the treatment of various forms of moderate-to-severe diarrhea and a ghrelin antagonist TZP-301 for the treatment of obesity and metabolic syndrome.

In December 2009, the firm signed a $10 million up-front collaboration agreement with Bristol-Myers Squibb (BMS), which is focused on the discovery, development, and commercialization of novel macrocyclic compounds against multiple targets of interest to BMS. The collaboration will exploit Tranzyme’s MATCH™ (macrocyclic template chemistry) drug discovery technology to identify and develop new candidates for multiple BMS targets in diverse therapeutic areas.

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