Theravance Biopharma Ireland Limited, a Theravance Biopharma subsidiary, and Janssen Biotech have joined forces to develop and commercialize the investigational therapy TD-1473 as a treatment for inflammatory bowel diseases (IBDs) such as Crohn’s disease and ulcerative colitis.
TD-1473 is an orally administered, highly specific inhibitor of the Janus kinase (JAK) family of enzymes, which play a critical role in inflammation.
JAK inhibitors are currently approved to treat rheumatoid arthritis (RA) and myelofibrosis. They have also demonstrated some benefit for patients with ulcerative colitis. However, these products are known to have certain side effects associated with their systemic exposure.
TD-1473 has a specific type of activity that is restricted to the intestinal tract, which prevents the risk of systemic exposure and unwanted side effects.
Under the agreement, Theravance will receive $100 million upfront from Janssen, one the Janssen Pharmaceutical Companies of Johnson & Johnson. And Theravance will be eligible to receive an additional $900 million if Janssen chooses to remain in the collaboration after certain milestones are met.
“Internally, we have been very excited about the potential of TD-1473 to serve as a transformational medicine designed to offer the proven therapeutic activity of JAK inhibitors without the safety concerns associated with systemic JAK exposure. We believe this transaction can accelerate the development of TD-1473 and maximize the potential value of the program to Theravance Biopharma,” Rick E. Winningham, chairman and chief executive officer of the Theravance Biopharma Group, said in a press release.
Theravance is also planning to initiate a Phase 2b/3 adaptive design induction and maintenance study in ulcerative colitis with TD-1473 this year, as well as a Phase 2 study in Crohn’s disease.
Following completion of the Phase 2 Crohn’s trial and the Phase 2b portion of the ulcerative colitis trial, Janssen can choose to pay $200 million to enter another exclusive license agreement. If TD-1473 is approved and commercialized, Theravance will have the option to commercialize together with Janssen in the United States. Janssen will be responsible for the new therapy outside the U.S.
“The opportunity to apply Janssen’s unrivaled expertise in inflammatory bowel disease at this stage of the development of TD-1473 is very exciting,” said Brett Haumann, MD, chief medical officer of the Theravance Biopharma Group. “Janssen has an extremely impressive record in developing therapies using efficient clinical designs and has developed unparalleled biomarker datasets that can inform patient stratification to optimize clinical response to TD-1473.”
The agreement follows the announcement in August 2017 of early data from an ongoing Phase 1b clinical trial (NCT02818686) of TD-1473 in patients with ulcerative colitis, which showed targeted action and effectiveness. The study is still recruiting participants with moderate to severe active ulcerative colitis.
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