PBR Staff Writer Published 08 February 2018
Janssen Biotech will co-develop Theravance’s TD-1473 and associated backup compounds for inflammatory intestinal diseases, including ulcerative colitis and Crohn’s disease, through an agreement that is potentially worth about $1bn.
The companies have signed a global co-development and commercialization agreement that could generate up to $1bn for Theravance.
Theravance’s TD-1473 is an internally-discovered Janus kinase (JAK) inhibitor that has demonstrated a high affinity for each of the JAK family of enzymes.
TD-1473, which is currently under clinical development, is specifically designed to work directly at the site of inflammation in the intestinal wall to limit systemic exposure. It has the capacity to treat a range of inflammatory intestinal diseases,
This year, Theravance intends to begin a Phase 2b/3 adaptive design induction and maintenance study in ulcerative colitis with TD-1473.
The firm is also planning to start a phase 2 study in Crohn’s disease during the same year
As per terms of the deal, Theravance will secure an upfront payment of $100m. It is also eligible to receive up to an additional $900m in potential payments, if Janssen decides to continue partnership following the completion of certain Phase 2 activities.
Both firms will jointly develop and commercialize TD-1473 in inflammatory intestinal diseases, while share profits in the US and expenses related to a potential Phase 3 program.
Theravance will also secure double-digit tiered royalties on ex-US sales.
Janssen can enter into an exclusive license arrangement by paying Theravance $200m, following completion of the phase 2 Crohn’s study and the phase 2b induction portion of the ulcerative colitis study.
Theravance Biopharma chairman and CEO Rick Winningham said: “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.”