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June 8, 2016updated 25 Nov 2021 10:49am

Takeda signs licensing deal for Theravance’s TD-8954 to treat gastrointestinal motility disorders

Japanese-based Takeda Pharmaceutical and US firm Theravance Biopharma have entered into global licence, development and commercialisation agreement for TD-8954.

By Lopamudra Roy

Japanese-based Takeda Pharmaceutical and US firm Theravance Biopharma have entered into global licence, development and commercialisation agreement for TD-8954.

Theravance’s TD-8954 is a selective 5-HT4 receptor agonist that can be used to treat gastrointestinal motility disorders, including enteral feeding intolerance (EFI).

Under the deal, Theravance Biopharma will receive an upfront cash payment of $15m and will also be eligible to receive success based development and sales milestone payments, as well as double digit royalties on net sales across the world by Takeda.

The transaction is slated to close during the second quarter of this year.

“We believe that TD-8954 has the potential to deliver therapeutic benefit to patients with gastrointestinal motility disorders, including EFI.”

Takeda gastroenterology therapeutic area unit head Asit Parikh said: “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.

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“Today EFI impacts approximately one million Americans and there are currently no FDA-approved treatment options available.”

The two companies are developing TD-8954 for its short-term use with EFI, with an aim to attain early nutritional adequacy in critically ill patients at high nutritional risk.

The compound TD-8954 received the US Food and Drug Administration (FDA) Fast Track Designation.

Theravance recently completed a study that assessed the safety and tolerability, as well as pharmacodynamics of a single dose of the compound that is administered intravenously compared to the use of metoclopramide in seriously affected patients with EFI.

Theravance Biopharma chairman and CEO Rick E. Winningham said: “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.”

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