J&J and Theravance Biopharma in deal worth up to $1 billion

Janssen Biotech, one of the pharmaceutical companies of Johnson & Johnson, has formed a global co-development and commercialization pact with Theravance Biopharma, a South San Francisco, California-headquartered biopharmaceutical company, for a Phase II compound (TD-1473) and related back-up compounds from Theravance for treating inflammatory intestinal diseases, in a deal worth up to $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. Theravance Biopharma and Janssen plan to jointly develop and commercialize TD-1473 in inflammatory intestinal diseases with the two companies sharing profits in the US and expenses related to a potential Phase III program (67% to Janssen; 33% to Theravance Biopharma). Theravance Biopharma would receive double-digit tiered royalties on ex-US sales.

TD-1473 is an orally administered and intestinally restricted pan-Janus kinase (JAK) inhibitor in clinical development with the potential to treat a range of inflammatory intestinal diseases. TD-1473 is specifically designed to act directly at the site of inflammation in the intestinal wall and thereby limit systemic exposure, according to information from Theravance.

Theravance Biopharma plans to initiate in 2018 a large, Phase IIb/III adaptive design induction and maintenance study in ulcerative colitis with TD-1473. The company is also planning to initiate a Phase II study in Crohn’s disease in 2018. Following completion of the Phase II Crohn’s study and the Phase IIb 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 II, 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 IIb/III 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 US. Theravance Biopharma would be eligible to receive up to an additional $700 million in development and commercialization milestone payments.