Janssen begins global collaboration with Theravance Biopharma for an oral inhibitor drug candidate Pan-JAK for the treatment of inflammatory bowel disease


HORSHAM, Pennsylvania., Feb. 7, 2018 / PRNewswire / – Pharmaceutical companies Janssen of Johnson & Johnson announced today that they have entered a global collaboration with a subsidiary of Theravance Biopharma, Inc. to develop TD-1473, an oral, gastrointestinal ( GI) restricted first class. -Janus kinase inhibitor (JAK) 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 study 2b/ 3 induction and maintenance study in the CPU, scheduled to start in 2018. Following the availability of phase 2 data from both studies, Janssen Biotech, Inc. (Janssen) may choose to enter into an agreement to exclusive license for the program and would then assume a leading role in the further development of TD-1473 in Crohn’s disease. Theravance Biopharma will continue to lead the development of TD-1473 in UC until the conclusion of the phase 2b/ 3 program. If TD-1473 is marketed, Theravance Biopharma has the option of co-marketing in the United States, and Janssen would have exclusive marketing responsibilities outside of the United States. As part of the agreement, Theravance Biopharma will receive an upfront payment and will be eligible to receive amounts if Janssen chooses to remain in the collaboration after the completion of Phase 2 activities.

IBD affects five million people worldwide and its incidence is increasing.1.2 A great unmet need remains as many patients who receive treatment today do not achieve remission and up to 80 percent of Crohn’s disease patients and 30 percent of UC patients ultimately progress to surgery.3

“The addition of TD-1473 to Janssen Immunology’s portfolio reinforces our commitment to transform patient outcomes with the potential to deliver a first-class topical and oral pan-JAK inhibitor with wide use in inflammatory related diseases. to the gastrointestinal tract, ”said Scott E. Plevy, MD, vice president, head of disease, 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 oral restricted topical inhibitor of pan-JAK and topical action for IBD, is specifically designed to act directly at the site of inflammation in the intestinal wall in order to limit through following systemic exposure. The compound has already been tested in a phase 1a study and completed an initial cohort in phase 1b, which support the advancement of TD-1473 in a phase 2 study in Crohn’s disease and a phase study 2b/ 3 study in UC in 2018.

About Janssen Pharmaceutical Companies
At Janssen Pharmaceutical Companies of Johnson & Johnson, we work 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. Find out more at www.janssen.com. follow us on 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 Regarding Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, regarding a new licensing 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 the underlying assumptions prove to be incorrect or if known or unknown risks or uncertainties materialize, actual results could differ 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 of collaboration may not materialize or take longer to materialize than expected; the challenges and uncertainties inherent in research and product development, including the uncertainty of clinical success and obtaining regulatory approvals; the uncertainty of the commercial success of new products; competition, including technological advances, new products and patents obtained by competitors; patent challenges; manufacturing difficulties or delays; product efficacy or safety issues resulting in product recalls or regulatory action; changes in applicable laws and regulations, including global healthcare reforms; and trends in the containment of health care costs. A list and additional descriptions of these risks, uncertainties and other factors are available in Johnson & Johnson’s annual report on Form 10-K for the year ended. January 1, 2017, including under “Article 1A. Risk Factors ”, its latest Quarterly Report filed on Form 10-Q, including under“ Caution Regarding Forward-Looking Statements ”and the Company’s subsequent filings with the Securities and Exchange Commission. Copies of these documents are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither tJanssen pharmaceutical companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

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1 World IBD Associations. World IBD Day. Available at http://worldibdday.org/. Accessed Jan. 30, 2018.
2 Dahlhamer JM, Zammitti EP, Ward BW, Wheaton AG, Croft JB. Prevalence of inflammatory bowel disease in 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 Jan. 30, 2018.
3 Loftus EV. Advances in the diagnosis and treatment of inflammatory bowel disease. Gastroenterology & Hepatology. 2011; 7 (2 Suppl 3): 3-16.

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