Janssen and Johnson & Johnson Innovation Announce License Agreement with Vedanta Biosciences for Microbiome Pharmaceutical Candidate for Inflammatory Bowel Disease

Agreement is first Janssen and Johnson & Johnson Innovation in-licensing of a potential microbiome therapeutic

BOSTON--()--Janssen Biotech, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced a license agreement with Vedanta Biosciences for the company’s lead microbiome pharmaceutical candidate (VE202), which in published preclinical studies has demonstrated efficacy in models of autoimmune disease. Under terms of the agreement, facilitated by the Johnson & Johnson Innovation Center in Boston, Janssen will develop and seek to commercialize the pharmaceutical candidate in inflammatory bowel disease (IBD).

Under the agreement, Vedanta will receive an up-front payment and is eligible to receive development and commercialization milestone payments for an IBD indication up to a potential total of $241 million, plus possible additional consideration related to commercialization. Vedanta may continue to explore other disease indications and Janssen and Vedanta may elect to develop and commercialize within one or more additional indications with terms similar to the IBD indication.

“For us at Janssen, the human microbiome is a strategic area of research and development and we have formed a number of exciting biotech and academic collaborations in this promising scientific space,” said Sue Dillon, Global Therapeutic Area Head, Immunology, Janssen Research & Development, LLC. “Today, we are excited to license a potential microbiome pharmaceutical candidate for inflammatory bowel diseases like Crohn’s disease and ulcerative colitis.”

“Janssen is a leader in the field of inflammatory bowel disease,” said Michael Elliott, Vice President of Immunology Scientific Innovation, Johnson & Johnson Innovation, Boston. “Janssen pioneered the use of anti-TNF antibodies in IBD, and has other medicines in development in this disease area. The new program from Vedanta will complement these efforts, with potential to further improve disease control and treatment for patients in the future.”

The in-licensing agreement with Vedanta Biosciences follows a June 2013 initial investment by Johnson & Johnson Innovation – JJDC, Inc., which formed a close working collaboration to characterize and further advance Vedanta’s lead therapeutic candidate in IBD.

“We are excited by the rapid progress of our collaboration with Vedanta,” said Robert G. Urban, Head, Johnson & Johnson Innovation, Boston. “Johnson & Johnson Innovation is solely focused on novel and highly impactful approaches to help patients. Today’s announcement follows our initial investment and represents Janssen’s first in-licensing of a potential first-in-class microbiome therapeutic; a significant milestone that may lead to exciting new treatment options for people living with IBD.”

About Inflammatory Bowel Disease

The Centers for Disease Control and Prevention describes inflammatory bowel disease (IBD) as conditions with chronic or recurring immune response and inflammation of the gastrointestinal tract, ulcerative colitis and Crohn’s disease being the two most common. Inflammation affects the entire digestive tract in Crohn’s disease and only the large intestine in ulcerative colitis. Both diseases are characterized by an abnormal response to the body’s immune system. According to the Crohn’s and Colitis Foundation of America, IBD impacts nearly 1.4 million in the United States.

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., rheumatoid arthritis, inflammatory bowel disease, psoriasis, and pulmonary diseases including chronic obstructive pulmonary disease and asthma), 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. To learn more, visit www.janssen.com.

About Johnson & Johnson Innovation

Johnson & Johnson Innovation LLC focuses on accelerating early-stage innovation worldwide and forming collaborations between entrepreneurs and Johnson & Johnson’s global healthcare businesses. Johnson & Johnson Innovation provides scientists, entrepreneurs and emerging companies one-stop access to science and technology experts who can facilitate collaborations across the pharmaceutical, medical device and diagnostics and consumer companies of Johnson & Johnson. Johnson & Johnson Innovation includes local deal-making capabilities with the flexibility to adapt deal structures to match early-stage opportunities and establish novel collaborations that speed development of innovations to solve unmet needs in patients. For more information please visit: www.jnjinnovation.com

(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 199 regarding product development. 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 LLC, and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges inherent in new product development, including obtaining regulatory approvals; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes to laws and regulations and domestic and foreign health care reforms; and general industry conditions including trends toward health care cost containment. A further list and description 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 December 29, 2013, including in Exhibit 99 thereto, 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. None of the Janssen Pharmaceutical Companies, Johnson & Johnson Innovation LLC nor Johnson & Johnson undertake to update any forward-looking statement as a result of new information or future events or developments.)

Contacts

Johnson & Johnson Innovation
John Lacey, 781-392-5514
jlacey1@its.jnj.com
or
Janssen
Brian Kenney, 215-628-7010
C: 215-620-0111
bkenney1@its.jnj.com
or
Investor Relations
Lesley Fishman, 732-524-3922
LFishma@its.jnj.com

Contacts

Johnson & Johnson Innovation
John Lacey, 781-392-5514
jlacey1@its.jnj.com
or
Janssen
Brian Kenney, 215-628-7010
C: 215-620-0111
bkenney1@its.jnj.com
or
Investor Relations
Lesley Fishman, 732-524-3922
LFishma@its.jnj.com