Toronto (Press Release) - Janssen Inc. announced today that Health Canada has accepted for review the New Drug Submission (NDS) for dara­tu­mu­mab as a treat­ment for patients with multiple myeloma. Health Canada will review the sub­mission with ad­vance con­sid­er­a­tion under the Ministry's Notice of Compliance with Conditions Policy (NOC/c) based on data from the Phase 2 MMY2002 (SIRIUS) mono­therapy study.

Daratumumab is a new class of ther­apy – a human anti-CD38 mono­clonal anti­body. It received Break­through Therapy Desig­na­tion and the Biologics License Application (BLA) was granted priority review and accelerated approval by the U.S. Food and Drug Admin­istra­tion (FDA) on November 16, 2015. In addi­tion, the European Medicines Agency has granted the medication's appli­ca­tion an Accelerated Assessment.

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is char­ac­ter­ized by excess growth and survival of malignant plasma cells.¹ Patients who lapse after treat­ment often have a poor prognosis and few treat­ment options.²

The sub­mission for dara­tu­mu­mab is primarily sup­ported by data from the Phase 2 SIRIUS study announced in May 2015, at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO). The study enrolled patients with multiple myeloma who had received at least three prior lines of ther­apy, in­­clud­ing a pro­te­a­some inhibitor (PI) and an immuno­modu­la­tory agent (IMiD), or were double refractory to a PI and an IMiD.³ The data presented showed dara­tu­mu­mab dem­onstrated a 29 per cent over­all response rate and a tolerable safety profile in these heavily pre-treated patients.⁴

The sub­mission also is sup­ported with data from other studies, in­­clud­ing the multi-centre, two-part open-label Phase 1/2 GEN501 mono­therapy study published in The New England Journal of Medicine in August 2015. This study enrolled patients with multiple myeloma who had a relapse after, or had disease that was refractory to, two or more dif­fer­en­t prior ther­a­pies, in­­clud­ing IMiDs, PIs, chemo­ther­apy, and au­tol­o­gous stem-cell trans­plan­ta­tion. The study showed dara­tu­mu­mab dem­onstrated a tolerable safety profile and a 36 per cent over­all response rate in patients treated with a 16 mg/kg dose, with responses deepening over time.⁵

The NDS was filed under Health Canada's NOC/c policy. The policy aims to provide access to promising new drugs for patients suffering from serious, life-threatening or severely debilitating diseases, or con­di­tions for which no drug is cur­rently mar­keted in Canada, or for which a sig­nif­i­cant in­­crease in efficacy or sig­nif­i­cant de­crease in risk is dem­onstrated in rela­tion­ to existing drugs mar­keted in Canada.⁶

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered a world­wide agree­ment which granted Janssen Biotech, Inc. an exclusive license to develop, manu­fac­ture and com­mer­cial­ize dara­tu­mu­mab. If approved, dara­tu­mu­mab would be com­mer­cial­ized in Canada by Janssen Inc.

About Multiple Myeloma

Multiple myeloma is the most common plasma cell cancer⁷ and is char­ac­ter­ized by an excess proliferation of plasma cells.⁸ In Canada, there will be an esti­mated 2,700 new cases in 2015 and an esti­mated 1,400 deaths asso­ci­ated with the disease.⁹ While some patients with multiple myeloma have no symp­toms at all, most patients are diag­nosed due to symp­toms which can in­clude bone fractures or pain, low blood counts, cal­cium elevation, and kidney problems.¹⁰

About Dara­tu­mu­mab

Daratumumab is a human mono­clonal anti­body (mAb) that binds with high affinity to the CD38 molecule, which is highly ex­pressed on the surface of multiple myeloma cells. It is believed to induce rapid tumor cell death through multiple effects,¹¹ in­­clud­ing direct (apoptosis¹²) and indirect (complement-dependent cyto­tox­icity,¹³ anti­body-dependent cellular phago­cytosis¹⁴ and anti­body-dependent cellular cyto­tox­icity¹⁵) means. 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 lym­phoma.

About Janssen Inc.

Janssen Inc. is one of the Janssen Pharma­ceu­tical Com­panies of Johnson & Johnson, which are dedicated to addressing and solving some of the most im­por­tant unmet medical needs in on­col­ogy, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we bring inno­va­tive prod­ucts, services and solu­tions to people through­out the world. Please visit www.janssen.com for more in­­for­ma­tion.

Cautions Concerning Forward-Looking Statements

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 Inc. and/or Johnson & Johnson. Risks and un­cer­tain­ties in­clude, but are not limited to: chal­lenges and un­cer­tain­ties in­her­ent in new prod­uct devel­op­ment, in­­clud­ing obtaining regu­la­tory approvals; com­pe­ti­tion, in­­clud­ing technological ad­vances, new prod­ucts and patents attained by com­pet­i­tors; 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. American Cancer Society. "Multiple Myeloma Overview" http://www.cancer.net/cancer-types/multiple-myeloma/overview. Accessed May 2015.
2. Kumar, SK et al. Leukemia. 2012 Jan; 26(1):149-57.
3. Johnson & Johnson, "Data Show Daratumumab Achieved a Pronounced Overall Response Rate as a Single-Agent with Tolerable Safety Profile in Heavily Pre-Treated Multiple Myeloma Patients," Available at: http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=915772. Accessed September 2015.
4. Johnson & Johnson, "Data Show Daratumumab Achieved a Pronounced Overall Response Rate as a Single-Agent with Tolerable Safety Profile in Heavily Pre-Treated Multiple Myeloma Patients," Available at: http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=915772. Accessed September 2015.
5. Lokhorst, HM et al. New England Journal of Medicine, "Targeting CD38 with Daratumumab Monotherapy in Multiple Myeloma." August 26, 2015DOI: 10.1056/NEJMoa1506348. Available at: http://www.nejm.org/doi/full/10.1056/NEJMoa1506348. Accessed September 2015.
6. Health Canada. "Guidance Document: Notice of Compliance with Conditions (NOC/c)," Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/compli-conform/noccg_accd-eng.php.Accessed September 2015.
7. Canadian Cancer Society. "Types of Multiple Myeloma," Available at: http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/multiple-myeloma/types-of-multiple-myeloma/?region=on. Accessed September 2015.
8. American Cancer Society. "Multiple Myeloma Overview" http://www.cancer.net/cancer-types/multiple-myeloma/overview. Accessed June 2015.
9. Canadian Cancer Society. "Canadian Cancer Statistics 2015." Available at https://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2015-EN.pdf. Accessed September 2015.
10. Canadian Cancer Society. "Signs and Symptoms of Multiple Myeloma," Available at: http://www.cancer.ca/en/cancer-information/cancer-type/multiple-myeloma/signs-and-symptoms/?region=on. Accessed September 2015.
11. Michael de Weers et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. February 1, 2011vol. 186 no. 3 1840-1848.
12. Jing Yang and Qing Yi. Therapeutic monoclonal antibodies for multiple myeloma: an update and future perspectives. Am J Blood Res. 2011; 1(1): 22–33.
13. Michael de Weers et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. February 1, 2011vol. 186 no. 3 1840-1848.
14. Yulian Khagi and Tomer M Mark. Potential role of daratumumab in the treatment of multiple myeloma. Onco Targets Ther. 2014; 7: 1095–1100.
15. Michael de Weers et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. February 1, 2011vol. 186 no. 3 1840-1848.

Source: Janssen Inc.