Takeda Pharmaceutical Co. Ltd. is to pay $15m upfront to acquire global development and commercialization rights to a Phase II stage Theravance Biopharma Inc. product candidate for gastrointestinal motility disorders, including enteral feeding intolerance (EFI).

The deal, expected to close in the second quarter, will add the serotonin 5-HT4 receptor agonist TD-8954 to the Japanese firm's pipeline in the GI area, which it has positioned as one of three core therapeutic fields of focus along with oncology and CNS disorders under a corporate turn-around effort ([A#28160511003]).

Takeda has signed a string of deals over the past year or so to exit non-core areas and assets, and this week alone has announced two new agreements to bolster its rare disease research ([A#28160607003]) and to spin off an oral GnRH antagonist asset ([A#28160606003]).

The latest tie-up with Nasdaq-listed Theravance will see the Ireland-based firm eligible for milestones, the first $110m of which are linked to development, regulatory and launch progress for EFI or other indications that use an intravenous dose. Takeda will also pay undisclosed sales milestones and double-digit royalties on its worldwide net sales of the product. [See Deal]

‘Early Confidence’

TD-8954 is being investigated for possible short-term use in EFI to improve nutrition in critically ill patients in intensive care, a setting for which US fast track designation has already been granted. Delayed gastric emptying time in such patients can complicate normal feeding and nutritional status, delaying recovery.

EFI affects around one million people in the US and there are currently no FDA-approved treatments, noted Dr. Asit Parikh, Takeda's gastroenterology unit head.

Theravance has already completed a Phase I/II trial in Australia that compared a single intravenous dose of TD-8954 with metoclopramide in critically ill patients with EFI. Clinical results so far have "provided early confidence in the potential for TD-8954 to improve gastric emptying time," Theravance chairman and CEO Rick Winningham said in a statement.

The company says it is in dialog with the US FDA over designs for further studies in EFI patients.

Informa's Biomedtracker currently gives the drug a 24% likelihood of US approval, the same as average. Other companies working in the 5-HT4 field include Shire PLC with SHP555 for chronic idiopathic constipation (Phase III), while Theravance's own velusetraq (TD-5108) is in Phase IIb for gastroparesis with partner Alfa Wassermann SPA.

Building A Presence

Takeda's strategic effort to build up its GI presence centers around the potential blockbuster Entyvio (vedolizumab), an alpha4 beta7 integrin-targeting antibody first launched in 2014 for ulcerative colitis and Crohn's disease. The company expects the drug to hit $2bn in global sales by 2018.

Takeda also markets the motility agent Amitiza (lubiprostone) chronic idiopathic constipation and irritable bowel syndrome with constipation, and opioid-induced constipation.

Its current GI clinical pipeline includes lubiprostone for pediatric functional constipation (Phase III in the US) and the oral RORyt inverse agonist TAK-828 for Crohn's (Phase I).

Takeda Adds Theravance GI Candidate In Deal Flurry

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