DarzalexTreatment for Multiple Myeloma
Update: Darzalex (daratumumab) Now FDA Approved - November 16, 2015
Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab
HORSHAM, Pa., Aug. 30, 2012 /PRNewswire/ -- 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 DaratumumabDaratumumab 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 & JohnsonThe 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.
CONTACT: Media Inquiries: Kellie McLaughlin, Janssen Global Services, LLC, +1-908-927-7477 or cell, +1-609-468-8356; Investor Relations: Stan Panasewicz, +1-732-524-2524 or Louise Mehrotra, +1-732-524-6491
Posted: August 2012
- FDA Approves Darzalex (daratumumab) Split-Dosing Regimen - February 12, 2019
- Janssen Announces Darzalex (daratumumab) U.S. FDA Approval for Newly Diagnosed Patients with Multiple Myeloma who are Transplant Ineligible - May 7, 2018
- Genmab Announces U.S. FDA Approval of Darzalex (daratumumab) in Combination with Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma - June 16, 2017
- Darzalex (daratumumab) Approved by FDA in Combination with Two Standard of Care Regimens for the Treatment of Patients with Multiple Myeloma Who Have Received At Least One Prior Therapy - November 21, 2016
- FDA Approves Darzalex (daratumumab) for Patients with Previously Treated Multiple Myeloma - November 16, 2015
- U.S. FDA Grants Priority Review to Janssen for Daratumumab as a Treatment for Multiple Myeloma - September 4, 2015
- Janssen Initiates Rolling Submission of BLA for Daratumumab for the Treatment of Multiple Myeloma - June 5, 2015
- Genmab Announces Preliminary Results in Phase II Study of Daratumumab in Double Refractory Multiple Myeloma - February 3, 2015
- Daratumumab Receives Breakthrough Therapy Designation in Double Refractory Multiple Myeloma from U.S. FDA - May 1, 2013
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