Takeda Licenses Global Rights to Theravance Biopharma's TD-8954, a Novel 5-HT4 Agonist and Motility Agent for Gastrointestinal Motility Disorders

DUBLIN, IRELAND and OSAKA, JAPAN--(Marketwired - Jun 8, 2016) - Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") today announced that the companies have entered into a global license, development and commercialization agreement for TD-8954, a selective 5-HT4 receptor agonist being investigated for potential use in the treatment of gastrointestinal motility disorders, including enteral feeding intolerance ("EFI"). 

TD-8954 is being developed for the short-term use with EFI to achieve early nutritional adequacy in critically ill patients at high nutritional risk, an indication for which the compound received U.S. Food and Drug Administration (FDA) Fast Track Designation. Theravance Biopharma has most recently completed a study evaluating the safety, tolerability and pharmacodynamics of a single dose of the compound administered intravenously compared to metoclopramide in critically ill patients with EFI.

"The addition of TD-8954 to our portfolio highlights Takeda's commitment to the development of treatments to improve the health of patients with gastroenterological disorders," said Asit Parikh, M.D., Ph.D., Head, Gastroenterology Therapeutic Area Unit, Takeda. "As a leader in gastroenterology, Takeda has a history of bringing innovative treatments to patients where there is significant unmet need. We believe that TD-8954 has the potential to deliver therapeutic benefit to patients with gastrointestinal motility disorders, including EFI. Today EFI impacts approximately one million Americans and there are currently no FDA-approved treatment options available."

"This is an important licensing deal for Theravance Biopharma as it provides a path forward for the development of this much-needed treatment option. Our single-dose study of TD-8954 in critically ill patients with EFI provided early confidence in the potential for TD-8954 to improve gastric emptying time. This is important as delayed gastric emptying makes it more difficult to feed patients in the ICU, slowing their recovery time, extending their stay in the ICU and increasing the risk of ICU-related complications," said Rick E. Winningham, Chairman and Chief Executive Officer of Theravance Biopharma. "Takeda is an industry leader in the development of treatments for gastrointestinal disorders, which we believe makes the company an ideal partner to drive the continued advancement of TD-8954."