Marks a critical step for­ward for the inves­ti­ga­tional human mono­clonal anti­body (mAb)

Raritan, NJ (Press Release) – Janssen Research & Development, LLC (Janssen) has ini­ti­ated the rolling sub­mission of its Biologic License Application (BLA) for dara­tu­mu­mab to the U.S. Food and Drug Admin­is­tra­tion (FDA) for the treat­ment of patients with multiple myeloma who have received at least three prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or who are double refractory to a PI and an IMiD. Dara­tu­mu­mab – an inves­ti­ga­tional human anti-CD38 mono­clonal anti­body – received Break­through Therapy Desig­na­tion by the FDA for this set of patients in May 2013. A rolling sub­mission allows the com­pany to submit portions of the regu­la­tory appli­ca­tion to the FDA as they are com­pleted.¹

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into an agree­ment which granted Janssen a world­wide 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.

Multiple myeloma is an incurable blood cancer.² 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 2015.³ Patients who relapse after treat­ment with standard ther­a­pies, in­­clud­ing PIs or IMiDs, have poor prognoses and few treat­ment options.⁴

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.

"Despite thera­peutic ad­vances over the last 10 years, multiple myeloma remains an incurable disease, and many people eventually relapse or grow resistant to avail­able ther­a­pies, which has underscored the need for newer med­i­cines with novel mech­a­nisms of action," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. "We are proud of the Break­through Therapy Desig­na­tion dara­tu­mu­mab received and look for­ward to work­ing in close col­lab­o­ra­tion with the FDA during its review."

Daratumumab is the second med­i­cine in the Janssen on­col­ogy portfolio to receive Break­through Therapy Desig­na­tion, which is in­tended to expedite the devel­op­ment and review time for a poten­tial new med­i­cine. If approved, dara­tu­mu­mab would be com­mer­cial­ized in the U.S. by Janssen Biotech, Inc.

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.⁵ Multiple myeloma is the third most common blood cancer in the U.S., fol­low­ing only leukemia and lym­phoma.⁶ Globally, it is esti­mated that 114,251 people will be diag­nosed and 80,019 will die from the disease.⁷ 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.⁸

About Dara­tu­mu­mab

Daratumumab is an inves­ti­ga­tional human IgG1k 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.9 Five Phase 3 clin­i­cal studies with dara­tu­mu­mab in re­lapsed and frontline settings are cur­rently ongoing. Additional studies are planned or underway 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.

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most im­por­tant unmet medical needs of our time in on­col­ogy, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop inno­va­tive prod­ucts, services and health­care solu­tions to help people through­out the world. Please visit http://www.janssenrnd.com for more in­­for­ma­tion.

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 Research & Development, LLC and Janssen Biotech, Inc. are part of the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson.

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 www.oncology.janssenrnd.com.

This press release con­tains "forward-looking state­ments" as defined in the Private Se­cu­ri­ties Lit­i­ga­tion Reform Act of 1995 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 Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and un­cer­tain­ties in­clude, but are not limited to: chal­lenges and un­cer­tain­ties in­her­ent in new prod­uct devel­op­ment, in­­clud­ing the uncertainty of clin­i­cal success and of obtaining regu­la­tory approvals; com­pe­ti­tion, in­­clud­ing technological ad­vances, new prod­ucts and patents attained by com­pet­i­tors; chal­lenges to patents; changes to appli­­cable laws and reg­u­la­tions, in­­clud­ing global health care reforms; and 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 28, 2014, 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 or Johnson & Johnson under­takes to update any for­ward-looking state­ment as a result of new in­­for­ma­tion or future events or devel­op­ments.

References

¹ 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.
² American Cancer Society. "Multiple Myeloma Overview." http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2015.
³ 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.
⁴ Kumar, SK et al. Leukemia. 2012 Jan;26(1):149-57.
⁵ American Cancer Society. "Multiple Myeloma Overview." http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma. Accessed June 2015.
⁶ National Cancer Institute. "A Snapshot of Myeloma." Available at www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2015.
⁷ GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx. Accessed June 2015.
⁸ American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 2015.
⁹ Jansen JH, et al. Blood. 2012; 120.2974

Source: Janssen.