HORSHAM, Pa., July 6, 2015 /PRNewswire/ -- Janssen Biotech, Inc. (Janssen) announced today the opening of a daratumumab expanded access program (EAP) for eligible U.S. patients. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for people with multiple myeloma. The multicenter, open-label EAP is available to multiple myeloma patients who are refractory to both a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) or who have received three or more prior lines of therapy, including a PI and an IMiD. This is referred to as "double refractory" multiple myeloma, which occurs when a patient's disease has become resistant to at least two of the most commonly utilized and active classes of anti-myeloma agents.

"We understand that heavily pre-treated or double refractory patients are in immediate need of new treatment options," said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Oncology, Janssen. "Through a research collaboration with the Multiple Myeloma Research Foundation, or MMRF, we have broadened our network of sites and sped site activation. Our goal is to provide timely access to daratumumab for multiple myeloma patients who may benefit while its application is under review with the U.S. Food and Drug Administration. MMRF's significant experience in multiple myeloma research and innovation has helped to accelerate our efforts to meet this urgent patient need."

In the U.S., EAPs are conducted as clinical trials and designed to make investigational medicines available for patients with serious or life-threatening illnesses who are ineligible for ongoing interventional trials and have exhausted currently available treatment options.

Up to 40 medical centers in the U.S. will enroll patients in the daratumumab EAP. The MMRF played a key role in identifying sites geographically distributed across the U.S. and opening sites for enrollment.

"While we work urgently each day to find solutions for all who are fighting multiple myeloma, our most critical focus is for those individuals whose multiple myeloma has relapsed and often have few or no active treatment options," said Walter M. Capone, Chief Executive Officer and President of the MMRF. "In collaboration with pharmaceutical and biotech companies, the FDA, leading research institutions both within our wholly-owned subsidiary, the Multiple Myeloma Research Consortium and beyond, the MMRF is relentless in advancing the most promising science and accelerating the development of new, innovative multiple myeloma therapies. Our work together with Janssen on this important EAP is a perfect example of our mission in action, helping patients in every way possible, particularly at times of intense need."

On May 1, 2013, daratumumab received Breakthrough Therapy Designation from the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a PI and an IMiD, the current standards of care, or who are double refractory to a PI and an IMiD. On June 5, 2015, Janssen announced it had initiated the rolling submission of its Biologics License Application (BLA) for daratumumab to the FDA for the treatment of this set of multiple myeloma patients. A rolling submission allows the company to submit portions of the regulatory application to the FDA as they are completed.i The regulatory submission for daratumumab will be primarily supported by data from the Phase 2 MMY2002 (SIRIUS) monotherapy study announced in May 2015 at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), along with additional data from four other studies, including the Phase 1/2 GEN501 monotherapy study.

About the daratumumab Expanded Access Program Protocol

The daratumumab expanded access program (EAP) is for U.S. patients 18 years of age or older who are double refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) or who have received three or more prior lines of therapy, including a PI and an IMiD, who may benefit from treatment with daratumumab prior to its potential U.S. Food and Drug Administration (FDA) approval. The EAP has specific inclusion and exclusion criteria for patients to be considered for enrollment in the program, and patients must not be eligible for another daratumumab study. Interested patients should contact their physician to discuss whether they may be a candidate for daratumumab through the EAP. Additional information about the expanded access protocol can be found on clinicaltrials.gov (NCT02477891).

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.ii Multiple myeloma is the third most common blood cancer in the U.S., following only leukemia and lymphoma.iii Approximately 26,850 new patients will be diagnosed with multiple myeloma, and approximately 11,240 people will die from the disease in the U.S. in 2015.iv Globally, it is estimated that 114,251 people will be diagnosed and 80,019 will die from the disease.v While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.vi

About daratumumab

Daratumumab is an investigational human IgG 1k monoclonal antibody (mAb) that binds with high affinity to the transmembrane ectoenzyme, CD38, on the surface of multiple myeloma cells. It induces rapid tumor cell death through diverse mechanisms of action. Five Phase 3 clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin's lymphoma. In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide agreement which granted Janssen an exclusive license to develop, manufacture and commercialize daratumumab. With the exception of one study sponsored globally by the French multiple myeloma cooperative group, Intergroupe Francophone du Myelome (IFM), Janssen is the global sponsor of all current and future clinical studies for daratumumab.

About Janssen Biotech, Inc.

Janssen Biotech, Inc. redefines the standard of care in immunology, oncology, urology and nephrology. Built upon a rich legacy of innovative firsts, Janssen Biotech has delivered on the promise of new treatments and ways to improve the health of individuals with serious disease. Beyond its innovative medicines, Janssen Biotech is at the forefront of developing education and public policy initiatives to ensure patients and their families, caregivers, advocates and health care professionals have access to the latest treatment information, support services and quality care. For more information on Janssen Biotech, Inc. or its products, visit www.janssenbiotech.com. Follow us on Twitter at www.twitter.com/JanssenUS.

Janssen in Oncology

In oncology, our goal is to fundamentally alter the way cancer is understood, diagnosed and managed, reinforcing our commitment to the patients who inspire us. In looking to find innovative ways to address the cancer challenge, our primary efforts focus on several treatment and prevention solutions. These include a focus on hematologic malignancies, prostate cancer and lung cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized use of our therapies; as well as safe and effective identification and treatment of early changes in the tumor microenvironment. Please visit oncology.janssenrnd.com.

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i U.S. Food and Drug Administration. "Guidance for Industry Expedited Programs for Serious Conditions – Drugs and Biologics." Available at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm358301.pdf. Accessed June 2015.

ii American Cancer Society. "Multiple Myeloma Overview." http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2015.

iii National Cancer Institute. "A Snapshot of Myeloma." Available at www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2015.

iv American Cancer Society. "What are the key statistics about multiple myeloma?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-key-statistics. Accessed June 2015.

v GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed June 2015.

vi American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 2015.

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SOURCE Janssen Biotech, Inc.

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