- Johnson & Johnson is teaming up with Theravance Biopharma Inc. to develop and commercialize TD-1473, a pan–Janus kinase (JAK) inhibitor for the treatment of inflammatory intestinal diseases like ulcerative colitis and Crohn's disease.
- J&J's Janssen Biotech will pay $100 million upfront and as much as $900 million in potential milestones should it opt in. Theravance will have co-commercialization rights in the U.S. and J&J will have full ex-U.S. rights. Theravance will receive royalties on international sales.
- In 2018, Theravance plans to initiate two mid-stage studies, including a Phase 2b/3 induction and maintenance study in ulcerative colitis and a study in Crohn's. Once completed, Janssen has the option to continue in the collaboration for a $200 million fee.
While there are already JAK inhibitors on the market and plenty of others in development, Theravance believes TD-1473 has an advantage over the competition — the drug acts directly at the site of inflammation in the intestinal wall in order to limit systemic exposure.
JAK inhibitors have proven to be highly effective in treating conditions like rheumatoid arthritis, but also come with some nasty side effects like severe infections, liver damage, gastrointestinal bleeding, as well as increased blood pressure and cholesterol.
"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 Theravance CEO Rick Winningham in a statement.
"We believe this transaction can accelerate the development of TD-1473 and maximize the potential value of the program to Theravance Biopharma."
The structure of the deal suggests J&J is willing to take a small bet on the safety and efficacy profile of TD-1473. An upfront payment of $100 million is a drop in the bucket for the multi-national conglomerate, and J&J doesn't technically opt in until after Phase 2 results come back. This deal structure also suggests J&J doesn't have a lot of confidence in the drug just yet.
But if TD-1473 pays off, it could be a lucrative market for J&J. The ulcerative colitis market alone was valued at $4.2 billion in 2012 and is expected to grow to $6.6 billion by 2020. The big pharma already has multiple franchises in the therapeutic area including Simponi (golimumab) and Stelara (ustekinemab), as well as the blockbuster Remicade (infliximab), which is already facing competition.
Yet, there are already some heavyweights in the space. Pfizer Inc. got the first ever approval for a JAK inhibitor with the 2012 OK of Xeljanz (tofacitinib). The drug brought in $410 million in 2017 and is a cornerstone of the big pharma's inflammatory portfolio. Pfizer is waiting on an approval in ulcerative colitis, with a decision expected by June.
Eli Lilly & Co. and partner Incyte Corp. received a Complete Response Letter for their JAK inhibitor baricitinib last April, but recently resubmitted the drug for FDA review.
And AbbVie Inc. is thought to have a best-in-class JAK in late-stage development with upadacitinib.