Takeda Pharmaceutical will develop Theravance Biopharma’s Phase II drug candidate for gastrointestinal motility disorders, including enteral feeding intolerance (EFI), the companies said today, in a collaboration that could generate up to $125 million-plus for Theravance.

The companies said they reached a global license, development, and commercialization agreement for TD-8954, a selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist. TD-8954 is being developed for short-term use with EFI to achieve early nutritional adequacy in critically ill patients at high nutritional risk. The compound has received the FDA’s Fast Track Designation in that indication.

“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,” Asit Parikh, M.D., Ph.D., head of Takeda’s Gastroenterology Therapeutic Area Unit, said in a statement. “We believe that TD-8954 has the potential to deliver therapeutic benefit to patients with gastrointestinal motility disorders, including EFI.”

Takeda’s therapeutic areas include gastrointestinal as well as “general medicine,” including oncology, cardiovascular and metabolic, central nervous system, respiratory, and immunology, and vaccines. In January, Takeda agreed to use enGene’s “gene pill” gene delivery platform to develop new therapies for gastrointestinal disease.

Gastrointestinal is also one of Theravance’s therapeutic areas, along with cardiovascular, infectious disease, and respiratory.

Theravance has 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.

“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,” added Theravance Chairman and CEO Rick E. Winningham.

Takeda has agreed to pay Theravance $15 million cash upfront, plus payments tied to achieving development and sales milestones—of which the first $110 million would be associated with development, regulatory, and commercial launch milestones for EFI or other intravenously dosed indications.

In addition, Takeda agreed to pay Theravance double-digit royalties on worldwide net sales.

The licensing agreement is expected to close during the second quarter, subject to customary closing conditions and clearance under the Hart–Scott–Rodino Antitrust Improvements Act.

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