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

HORSHAM, Pa., May 30, 2017 /PRNewswire/ -- Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced today 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.

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.

About Johnson & Johnson Innovation
Johnson & Johnson Innovation is working to accelerate scientific innovation at all stages of development worldwide to deliver cutting-edge solutions that solve unmet needs for patients. Johnson & Johnson Innovation provides scientists, entrepreneurs and emerging companies with one-stop access to the broad resources of the Johnson & Johnson Family of Companies across the Pharmaceutical, Medical Devices and Consumer healthcare segments. This includes access to dealmakers, through the innovation centers located in global life science hot spots and Johnson & Johnson Innovation, Janssen Business Development; venture investment, through Johnson & Johnson Innovation-JJDC, Inc.; company incubation, through Johnson & Johnson Innovation, JLABS; as well as R&D, manufacturing and commercialization expertise across all three segments. For more information, visit www.jnjinnovation.com or follow @JNJInnovation.

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 development, manufacture and commercialization of a new drug candidate. 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, Johnson & Johnson Innovation – JJDC, Inc. 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. The Janssen Pharmaceutical Companies, Johnson & Johnson Innovation – JJDC, Inc. and Johnson & Johnson do not undertake to update any forward-looking statement as a result of new information or future events or developments.

^[1] World IBD Associations. World IBD Day. Available at http://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: http://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 Janssen Pharmaceutical Companies

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