Biopharma Ireland Limited, a subsidiary of Theravance Biopharma, has entered into a global co-development and commercialization agreement with Janssen Biotech, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for TD-1473 and related back-up compounds for inflammatory intestinal diseases, including ulcerative colitis and Crohn’s disease. Under the terms of the agreement, Theravance Biopharma will receive an upfront payment of $100 million and will be eligible to receive up to an additional $900 million in potential payments, if Janssen elects to remain in the collaboration following the completion of certain Phase 2 activities. Theravance Biopharma together with Janssen will jointly develop and commercialize TD-1473 in inflammatory intestinal diseases, with the two companies sharing profits in the U.S. and expenses related to a potential Phase 3 program (67% to Janssen; 33% to Theravance Biopharma). Theravance Biopharma would receive double-digit tiered royalties on ex-U.S. sales.

TD-1473 is a novel, potent, orally administered and intestinally restricted pan-Janus kinase (JAK) inhibitor in clinical development, with the potential to treat a range of inflammatory intestinal diseases. In contrast to other oral JAK inhibitors under development for inflammatory bowel disease, TD-1473 is specifically designed to act directly at the site of inflammation in the intestinal wall thereby limiting systemic exposure.

“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,” said Rick E Winningham, chairman and chief executive officer, Theravance Biopharma. “Janssen’s expertise and experience from multiple clinical development programs in both ulcerative colitis and Crohn’s disease, across a range of mechanisms of action, will be important in the development, regulatory, and commercial path forward for this program.”

In 2018, Theravance Biopharma plans to initiate a large, Phase 2b/3 adaptive design induction and maintenance study in ulcerative colitis with TD-1473. The company is also now planning to initiate a Phase 2 study in Crohn’s disease in 2018. Following completion of the Phase 2 Crohn’s study and the Phase 2b induction portion of the ulcerative colitis study, Janssen can elect to enter into an exclusive license arrangement by paying Theravance Biopharma a fee of $200 million. After Phase 2, Janssen would lead subsequent development of TD-1473 in Crohn’s disease. Theravance Biopharma will lead development of TD-1473 in ulcerative colitis through completion of the Phase 2b/3 program. 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 U.S.. Theravance Biopharma would be eligible to receive up to an additional $700 million in development and commercialization milestone payments.  

“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, chief medical officer, Theravance Biopharma. “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. We look forward to collaborating together with the team at Janssen to successfully develop this promising treatment for patients with ulcerative colitis, Crohn’s disease, and other intestinal inflammatory diseases.”