J&J and Theravance in $1-Billion Deal for Inflammatory Bowel Disease

On Feb. 7, 2018, the Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) announced that they have entered into a worldwide collaboration with Theravance Biopharma Ireland, a subsidiary of Theravance Biopharma, to develop TD-1473, an oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor, and related back-up compounds for treating inflammatory bowel diseases (IBD), including Crohn's disease and ulcerative colitis (UC). The deal is potentially worth approximately $1 billion.

Under 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 II activities. The companies will jointly develop and commercialize TD-1473 in inflammatory intestinal diseases and will share profits in the United States. The companies will also share in the expenses related to a potential Phase III program, with Janssen accounting for 67% of expenses and Theravance Biopharma accounting for 33%. Theravance Biopharma would receive double-digit tiered royalties on ex-US sales.

Theravance Biopharma will complete a Phase II study in Crohn's disease and a Phase IIb/III induction and maintenance study in UC, which it plans to start in 2018. When Phase II data is available 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 the drug candidate in Crohn's disease. Theravance Biopharma will continue to conduct development in UC through the conclusion of the Phase IIb/III program.

"Adding TD-1473 to the Janssen Immunology portfolio reinforces our commitment to transforming patient outcomes with the potential to offer a first-in-class oral, local acting pan-JAK inhibitor with broad use across GI-related inflammatory disease," said Scott E. Plevy, MD, vice president, disease area leader, Inflammatory Bowel Disease, Janssen Research & Development, in a company press release. "We look forward to advancing this promising, oral, drug candidate through clinical development as we continue to address the significant unmet needs of people living with Crohn's disease and UC around the world."

"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 CEO of the Theravance Biopharma group, in a company press release. "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."

Source: Johnson & Johnson, Theravance Biopharma