Horsham, Pa., February 7, 2018 ― The Janssen Pharmaceutical Companies of Johnson & Johnson announced today their entry into a worldwide collaboration with an affiliate of Theravance Biopharma, Inc. to develop TD-1473, a first-in-class oral, gastrointestinal (GI) restricted pan-Janus kinase (JAK) inhibitor for the treatment of inflammatory bowel disease (IBD), which includes Crohn’s disease and ulcerative colitis (UC).
Under the terms of the agreement, Theravance Biopharma will complete a Phase 2 study in Crohn’s disease and a Phase 2b/3 induction and maintenance study in UC, planned to start in 2018. Following availability of Phase 2 data from both studies, Janssen Biotech, Inc. (Janssen) may elect to enter into an exclusive license arrangement for the program and would then assume a lead role in the subsequent development of TD-1473 in Crohn’s disease. Theravance Biopharma will continue to conduct TD-1473 development in UC through the conclusion of the Phase 2b/3 program. If TD-1473 is commercialized, Theravance Biopharma has the option to co-commercialize in the U.S., and Janssen would have sole commercialization responsibilities outside the U.S. As part of the agreement, Theravance Biopharma will receive an upfront payment and will be eligible to receive additional amounts if Janssen elects to remain in the collaboration following the completion of the Phase 2 activities.
IBD affects five million people worldwide and the incidence is growing., A great unmet need remains as 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 eventually progress to surgery.
“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,” said Scott E. Plevy, M.D., Vice President, Disease Area Leader, Inflammatory Bowel Disease, Janssen Research & Development, LLC. “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.”
TD-1473, a potential first-in-class oral, local acting GI restricted pan-JAK inhibitor for IBD, is specifically designed to act directly at the inflammation site in the intestinal wall to subsequently limit systemic exposure. The compound has previously been tested in a Phase 1a study and completed an initial cohort in Phase 1b, which support advancing TD-1473 into a Phase 2 study in Crohn’s disease and a Phase 2b/3 study in UC in 2018.
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.
We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at Twitter.com/JanssenGlobal and www.twitter.com/JanssenUS. Janssen Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995, regarding a new license and collaboration agreement and the continued development of a new drug candidate and its potential addition to the Janssen Immunology portfolio. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Biotech, Inc., Janssen Research & Development, LLC and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success for new products; competition, including technological advances, new products and patents attained by competitors; challenges to patents; manufacturing difficulties or delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
 World IBD Associations. World IBD Day. Available at http://worldibdday.org/. Accessed January 30, 2018.
 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: http://dx.doi.org/10.15585/mmwr.mm6542a3. Accessed January 30, 2018.
 Loftus EV. Progress in the Diagnosis and Treatment of Inflammatory Bowel Disease. Gastroenterology & Hepatology. 2011;7(2 Suppl 3):3-16.
Joseph J. Wolk
Johnson & Johnson
Johnson & Johnson