13 February 2018 - - Horsham, Pennsylvania-based pharmaceutical company Janssen Biotech, Inc., a segment of US-based global healthcare company Johnson and Johnson, has entered into a worldwide collaboration with an affiliate of Dublin, Ireland-based biopharmaceutical company Theravance Biopharma, Inc. (NASDAQ: TBPH) to develop TD-1473, a first-in-class oral, gastrointestinal restricted pan-Janus kinase inhibitor for the treatment of inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis (UC), the company said.
Under the terms of the agreement, Theravance Biopharma will complete a Phase 2 study in Crohn's disease and a Phase 2b/3 induction and maintenance study in UC, planned to start in 2018.
Following availability of Phase 2 data from both studies, Janssen Biotech may elect to enter into an exclusive license arrangement for the program and would then assume a lead role in the subsequent development of TD-1473 in Crohn's disease.
Theravance Biopharma will continue to conduct TD-1473 development in UC through the conclusion of the Phase 2b/3 programme.
If TD-1473 is commercialized, Theravance Biopharma has the option to co-commercialize in the US, and Janssen would have sole commercialization responsibilities outside the US.
As part of the agreement, Theravance Biopharma will receive an upfront payment and will be eligible to receive additional amounts if Janssen elects to remain in the collaboration following the completion of the Phase 2 activities.
TD-1473 is specifically designed to act directly at the inflammation site in the intestinal wall to subsequently limit systemic exposure.
The compound has previously been tested in a Phase 1a study and completed an initial cohort in Phase 1b, which support advancing TD-1473 into a Phase 2 study in Crohn's disease and a Phase 2b/3 study in UC in 2018.
The Janssen Pharmaceutical Companies of Johnson and Johnson (NYSE: JNJ) work to find new and better ways to prevent, intercept, treat, and cure disease. The pharmaceutical segment offers various products in the areas of immunology, infectious diseases and vaccines, neuroscience, oncology, and cardiovascular and metabolic diseases.