Tranzyme Pharma, a clinical-stage biopharmaceutical company, and Norgine B.V., a European specialty pharmaceutical company, announced 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.
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.
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.