Johnson & Johnson’s Janssen Pharmaceutical Companies has entered a worldwide partnership with Theravance Biopharma’s affiliate to co-develop an oral drug candidate for inflammatory bowel disease (IBD) treatment.
The firms will work on a gastrointestinal (GI) restricted, pan-Janus kinase (JAK) inhibitor called TD-1473.
Under the agreement, a Phase II clinical trial in Crohn’s disease patients and a Phase IIb/III induction and maintenance study for ulcerative colitis (UC) will be conducted by Theravance this year.
After Phase II data is obtained from both these studies, Janssen Biotech has the option to sign an exclusive licence arrangement for the programme and take over the further development of the drug candidate for treating Crohn’s disease.
Theravance will, however, continue to be responsible for TD-1473 development in UC through the completion of the Phase IIb/III programme.
As part of the agreement, Janssen will pay $100m upfront, and Theravance is eligible for up to additional $900m in potential payments if the firms remain in alliance following the conclusion of select Phase II activities.
Janssen Research & Development vice-president Scott Plevy said: “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.
“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.”
If TD-1473 reaches commercialisation stage, Theravance holds the option to co-commercialise the drug candidate in the US, while Janssen will have exclusive commercialisation rights for ex-US markets.