Compound in Development for Multiple Myeloma

Horsham, PA (Press Release) – Janssen Biotech, Inc. ("Janssen"), one of the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson, announced today that it has executed a global license and devel­op­ment agree­ment with the Danish com­pany Genmab A/S for the anti-cancer com­­pound, dara­tu­mu­mab. Dara­tu­mu­mab (HuMax®-CD38) is a human CD38 mono­clonal anti­body cur­rently in Phase I/II studies in re­lapsed, refractory multiple myeloma.

"Janssen was one of the first com­pa­nies to recog­nize the power and promise of mono­clonal anti­bodies and today is a world leader in biologics. We look for­ward to applying that same expertise to dara­tu­mu­mab to help meet the needs of patients with multiple myeloma," said William N. Hait, M.D., Ph.D., head of Janssen Research & Development, LLC. "Dara­tu­mu­mab is an exciting, inno­vative com­pound, and we are delighted to add it to our portfolio."

Under terms of the agree­ment, Genmab will grant Janssen an exclusive world­wide license to develop and com­mer­cial­ize dara­tu­mu­mab as well as a back-up CD38 human anti­body. Janssen has made an up­front pay­ment and will make addi­tional pay­ments based upon the achieve­ment of certain devel­op­ment, regu­la­tory and sales mile­stones. Genmab will be responsible for com­plet­ing the GEN501 and GEN503 Phase I/II trials. Janssen will be responsible for all other develop­ment, clin­i­cal and regu­latory filing activities. In addi­tion, as part of the agree­ment, Johnson & Johnson Development Corpo­ra­tion, an affiliate of Janssen, will make an equity investment in Genmab.

The trans­­action is subject to customary closing con­di­tions, in­­clud­ing approval by the Danish Financial Supervisory Authority and clearance by the U.S. antitrust author­i­ties.

About Dara­tu­mu­mab

Dara­tu­mu­mab is a human mono­clonal anti­body (mAb) with broad spectrum cytotoxic activity. It targets the CD38 molecule, which is highly ex­pressed on the surface of multiple myeloma cells. It is cur­rently in Phase I/II trials for multiple myeloma and has poten­tial applicability against other malig­nan­cies on which CD38 is ex­pressed.

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, intestinal 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 viewer 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; and changes in behavior and spending patterns or financial distress of purchasers of health care prod­ucts and services. 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.