Janssen, Theravance ink GI pact worth up to $1B

Theravance and Janssen have the option to co-commercialize TD-1473 in the U.S., while Janssen will be responsible for ex-U.S. marketing. (pasja1000)

Janssen and Theravance Biopharma are teaming up to develop a JAK inhibitor for inflammatory bowel disease. Theravance will pick up $100 million up front, with the potential to earn another $900 million in milestone payments and royalties.

Under the agreement, Theravance will conduct a phase 2 study of the candidate, TD-1473, in Crohn’s disease, as well as a phase 2b/3 induction and maintenance study in ulcerative colitis, both slated to start this year. If all goes well, Janssen may pull the trigger on an exclusive license agreement for the program and take the lead on developing the drug in Crohn’s, according to a statement.

If the drug is approved, Janssen will be responsible for ex-U.S. marketing, with Theravance receiving tiered royalties, while the pair has the option of co-commercializing within the U.S. They will also split profits in the U.S., as well as development costs, with Janssen picking up 67% of the tab.

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TD-1473 is in a class of drugs designed to block JAK enzymes to regulate the activity of inflammatory cytokines. While they have been shown to be useful in treating ulcerative colitis, JAK inhibitors do cause side effects because they act so broadly.

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Theravance hopes to avoid these side effects with TD-1473, which is designed to act only at sites of inflammation in the intestinal wall, the company 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,” said Rick Winningham, chairman and CEO of Theravance, in the statement.

"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,” Winningham said.

JAK inhibitors started 2018 strong, with Celgene splashing out $1.1 billion for tiny startup Impact Biomedicines and its JAK2 inhibitor, fedratinib. AbbVie and tandem Eli Lilly and Incyte have high hopes for their respective programs.

AbbVie’s JAK1 drug is slated to enter phase 3 in atopic dermatitis this year, but analysts have noted that its $3.5 billion peak sales estimate may be too low if it manages to snag approvals in other indications, such as rheumatoid arthritis and IBD. Lilly and Incyte are teeing up for an FDA approval for their arthritis candidate the second time around, possibly by midyear.