2014

Janssen Announces Worldwide Agreement To Develop And Commercialize JAK Inhibitor For Immunological Diseases Orally Administered Investigational Therapy Expands Global Immunology Portfolio

HORSHAM, Pa., Oct. 1, 2012 /PRNewswire/ -- Janssen Biotech, Inc. ("Janssen") announced today that it has entered into a license agreement with Astellas Pharma Inc. ("Astellas") for the worldwide development and commercialization, except in Japan, of ASP015K, an oral, small molecule Janus Kinase (JAK) inhibitor. ASP015K is currently in Phase 2b development as a once-daily oral treatment for moderate-to-severe rheumatoid arthritis (RA), following a successful Phase 2a study demonstrating its potential in the treatment of moderate-to-severe plaque psoriasis. Rheumatoid arthritis affects between one and two percent of the world's population and results in pain and inflammation, and in some cases, joint destruction and disability. Psoriasis, a chronic inflammatory disease that results from the overproduction of skin cells, affects 125 million people worldwide and can range from mild to severe and disabling. 

"Janssen has a heritage of innovation and delivering transformative medicines to address unmet needs in immunologic diseases," said Susan Dillon, Ph.D., Global Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. "We are committed to expanding the portfolio of new treatments for patients with serious immune-mediated diseases and are excited to add Astellas' ASP015K to our pipeline."

Under the terms of the agreement, Janssen gains exclusive worldwide rights to develop and commercialize ASP015K, except in Japan, as an oral treatment for immune-mediated inflammatory diseases. In addition to an upfront payment, Janssen and Astellas have agreed to future milestone and royalty payments if certain development and commercialization milestones are achieved.  Astellas will be responsible for completing the ongoing Phase 2b studies. Janssen will be responsible for all other development, clinical and regulatory filing activities in its territories. Astellas will continue development and commercialization of ASP015K in Japan. 

About ASP015K
ASP105K is an oral, small molecule Janus Kinase (JAK) inhibitor, which blocks critical components of signaling mechanisms used by a number of inflammatory cytokines, including those that are believed to be important to mediating disease in people with immune-mediated inflammatory diseases. ASP015K is currently in Phase 2b studies evaluating the efficacy and safety of once-daily oral dosing in the treatment of moderate-to-severe RA. A Phase 2a study in the treatment of moderate-to-severe plaque psoriasis has been completed.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology (e.g., multiple myeloma and prostate cancer), immunology (e.g., RA, inflammatory bowel disease (IBD) and psoriasis), neuroscience (e.g., schizophrenia, dementia and pain), infectious disease (e.g., HIV/AIDS, Hepatitis C and tuberculosis), and cardiovascular and metabolic diseases (e.g., diabetes).

Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995.  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 unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Biotech, Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; impact of business combinations; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; increased scrutiny of the health care industry by government agencies; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; financial instability of international economies; and disruptions due to natural disasters.  A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 1, 2012.  Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson.  Neither Janssen Biotech, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

SOURCE Janssen Biotech, Inc.




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