Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for oral interleukin-23 receptor antagonist drug candidate for the treatment of inflammatory bowel disease.
Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced it has entered into a worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. (Protagonist) to develop, manufacture and commercialize PTG-200, a first-in-class, oral interleukin-23 receptor (IL-23R) antagonist drug candidate in development for the treatment of Crohn’s disease and ulcerative colitis (UC).
Under the terms of the agreement and subject to the termination or expiration of any applicable waiting periods under the Hart-Scott-Rodino Act, Protagonist will receive an upfront payment and is eligible to receive development and commercialization milestone payments. If PTG-200 is commercialized, Protagonist would be eligible to receive royalties on net sales and will also have the option to co-detail in the U.S.
The agreement stems from a long-standing collaboration fostered through a series of equity investments by Johnson & Johnson Innovation–JJDC, Inc. in Protagonist to study and advance oral peptide-based therapeutics.
Inflammatory bowel disease (IBD), which includes Crohn’s disease and UC, affects five million people globally and the incidence is growing with a near three-time increase in the U.S. as recently reported by the Centers for Disease Control and Prevention.1,2 In addition, many patients who receive treatment today do not achieve remission and up to 80 percent of patients with Crohn’s disease and 30 percent of patients with UC will progress to surgery.3
“The addition of PTG-200 to the Janssen Immunology portfolio builds upon our expertise and leadership in the IL-23 pathway and we look forward to advancing this novel oral IL-23R antagonist into clinical development,” said Susan B. Dillon, Ph.D., global therapeutic area head, immunology, Janssen. “Together with Johnson & Johnson Innovation, we have forged a strong relationship with the Protagonist Therapeutics team over the course of several years. We look forward to continuing a strong and productive collaboration in progressing this novel oral candidate for the treatment of inflammatory bowel disease.”
PTG-200, a potential first-in-class oral IL-23R antagonist, is currently in Investigational New Drug (IND) enabling studies and the initiation of a Phase 1 clinical trial is planned in 2017.
“We look to continue to pioneer the science of inflammatory bowel disease and advance novel therapeutics like PTG-200, an oral therapy that targets a validated pathway and acts locally in the gut at the site of disease,” said Scott E. Plevy, M.D., vice president, disease area leader, inflammatory bowel disease, Janssen. “We’re particularly excited to add an oral peptide-based therapy to our robust portfolio as we aim to address the increasing incidence of inflammatory bowel disease and the growing needs of people living with Crohn’s disease and ulcerative colitis around the world.”
The transaction is expected to close in the third quarter of 2017.
___________________________________________________
References:
1 World IBD Associations. World IBD Day. Available at https://worldibdday.org/. Accessed May 26, 2017.
2 Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of Inflammatory Bowel Disease Among Adults Aged ≥18 Years — United States, 2015. MMWR Morb Mortal Wkly Rep 2016;65:1166–1169. Available at: https://dx.doi.org/10.15585/mmwr.mm6542a3. Accessed May 26, 2017.
3 Loftus EV. Progress in the Diagnosis and Treatment of Inflammatory Bowel Disease. Gastroenterology & Hepatology. 2011;7(2 Suppl 3):3-16.
(Source: PR Newswire)
Filed Under: Drug Discovery
