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Genmab Announces Approval of DARZALEX (daratumumab) in Frontline Multiple Myeloma in Japan

Firm Announcement

  • DARZALEX® accredited in mixture with bortezomib, melphalan and prednisone for the remedy of sufferers with newly recognized a number of myeloma ineligible for autologous stem cell transplant in Japan
  • Genmab to receive USD 7 million milestone cost
  • Approval based mostly on knowledge from Part III ALCYONE research

Copenhagen, Denmark; August 22, 2019 – Genmab A/S (Nasdaq: GMAB) announced at this time that the Ministry of Well being, Labor and Welfare (MHLW) in Japan has accepted the use of DARZALEX (daratumumab) in mixture with bortezomib, melphalan and prednisone for the remedy of sufferers with newly recognized a number of myeloma who are ineligible for autologous stem cell transplant (ASCT). DARZALEX is being developed beneath an August 2012 settlement in which Genmab granted Janssen Biotech, Inc. (Janssen) an unique worldwide license to develop, manufacture and commercialize the product. Genmab will obtain a USD 7 million milestone cost from Janssen in connection with the approval and first business sale of DARZALEX beneath the newly expanded label. The approval and associated milestone do not impression the financial steerage issued by Genmab on August 14, 2019.

“Multiple myeloma remains one of the most common forms of blood cancer in Japan and as such, we are encouraged that patients in Japan newly diagnosed with this disease now have the option to receive a DARZALEX containing regimen,” stated Jan van de Winkel, Ph.D., Chief Government Officer of Genmab.

The approval is predicated on knowledge from the Part III ALCYONE research that showed a discount of the danger of illness progression or demise by 50 % in newly recognized ASCT ineligible multiple myeloma sufferers when daratumumab is mixed with bortezomib, melphalan and prednisone. This knowledge was introduced as a Late-Breaking Abstract on the 2017 American Society of Hematology (ASH) Annual Meeting and revealed in The New England Journal of Drugs in December 2017.

Concerning the ALCYONE research
This Part III research (NCT02195479) is a randomized, open-label, multicenter research that included 706 newly recognized sufferers with multiple myeloma who’re ineligible for ASCT. Sufferers have been randomized to obtain 9 cycles of both VMP [bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid)] mixed with daratumumab, or VMP alone. Within the daratumumab remedy arm, patients acquired 16 mg/kg of daratumumab once weekly for six weeks (cycle 1; 1 cycle = 42 days), as soon as every three weeks from cycles 2 to 9, as soon as every 4 weeks from cycle 9 until disease development. The first endpoint of the research is development free survival (PFS).

About a number of myeloma
Multiple myeloma is an incurable blood cancer that begins in the bone marrow and is characterised by an extra proliferation of plasma cells.1 Approximately 6,313 new sufferers have been anticipated to be recognized with multiple myeloma and roughly 4,338 individuals have been anticipated to die from the illness in Japan in 2018.2 Globally, it was estimated that 160,000 individuals have been recognized and 106,000 died from the illness in 2018.3 While some patients with a number of myeloma haven’t any signs at all, most sufferers are recognized on account of signs which may embrace bone problems, low blood counts, calcium elevation, kidney problems or infections.four

About DARZALEX®(daratumumab)
DARZALEX® (daratumumab) intravenous infusion is indicated for the remedy of adult sufferers in the USA:  in mixture with lenalidomide and dexamethasone for the remedy of sufferers with newly recognized a number of myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the remedy of sufferers with newly recognized a number of myeloma who’re ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the remedy of sufferers with a number of myeloma who have acquired at the least one prior therapy; in combination with pomalidomide and dexamethasone for the remedy of patients with a number of myeloma who have acquired a minimum of two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the remedy of patients with a number of myeloma who’ve acquired at the very least three prior strains of remedy, including a PI and an immunomodulatory agent, or who’re double-refractory to a PI and an immunomodulatory agent.5 DARZALEX is the primary monoclonal antibody (mAb) to obtain U.S. Meals and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in mixture with bortezomib, melphalan and prednisone for the remedy of adult sufferers with newly recognized multiple myeloma who are ineligible for autologous stem cell transplant; to be used in mixture with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the remedy of grownup patients with multiple myeloma who’ve acquired at the very least one prior remedy; and as monotherapy for the remedy of grownup sufferers with relapsed and refractory a number of myeloma, whose prior remedy included a PI and an immunomodulatory agent and who have demonstrated illness progression on the last remedy. The choice to split the primary infusion of DARZALEX over two consecutive days has been authorised in each Europe and the U.S. In Japan, DARZALEX is accredited in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the remedy of adults with relapsed or refractory a number of myeloma and in combination with bortezomib, melphalan and prednisone for the remedy of patients with newly recognized a number of myeloma who are ineligible for autologous stem cell transplant. DARZALEX is the primary human CD38 monoclonal antibody to succeed in the market in the United Said, Europe and Japan. For more info, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with excessive affinity to the CD38 molecule, which is very expressed on the surface of a number of myeloma cells. Daratumumab triggers an individual’s personal immune system to assault the most cancers cells, resulting in speedy tumor cell dying via multiple immune-mediated mechanisms of motion and thru immunomodulatory effects, in addition to direct tumor cell dying, by way of apoptosis (programmed cell dying).5,6,7,eight,9

Daratumumab is being developed by Janssen Biotech, Inc. underneath an unique worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A complete medical improvement program for daratumumab is ongoing, including multiple Part III studies in smoldering, relapsed and refractory and frontline a number of myeloma settings. Further studies are ongoing or deliberate to evaluate the potential of daratumumab in other malignant and pre-malignant illnesses in which CD38 is expressed, akin to amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has acquired two Breakthrough Remedy Designations from the U.S. FDA for sure indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line remedy of multiple myeloma.

About Genmab
Genmab is a publicly traded, worldwide biotechnology firm specializing in the creation and improvement of differentiated antibody therapeutics for the remedy of cancer. Based in 1999, the company has two accepted antibodies, DARZALEX® (daratumumab) for the remedy of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the remedy of sure persistent lymphocytic leukemia indications. Daratumumab is in medical improvement for extra multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in improvement for relapsing multiple sclerosis. Genmab also has a broad medical and pre-clinical product pipeline. Genmab’s know-how base consists of validated and proprietary next era antibody technologies – the DuoBody® platform for era of bispecific antibodies, the HexaBody® platform, which creates effector perform enhanced antibodies, the HexElect® platform, which mixes two co-dependently appearing HexaBody molecules to introduce selectivity while maximizing therapeutic efficiency and the DuoHexaBody® platform, which reinforces the potential efficiency of bispecific antibodies by way of hexamerization. The corporate intends to leverage these technologies to create opportunities for full or co-ownership of future merchandise. Genmab has alliances with prime tier pharmaceutical and biotechnology corporations. Genmab is headquartered in Copenhagen, Denmark with core websites in Utrecht, the Netherlands and Princeton, New Jersey, U.S.

Contact:          
Marisol Peron, Company Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: acn@genmab.com

This Firm Announcement incorporates forward wanting statements. The phrases “believe”, “expect”, “anticipate”, “intend” and “plan” and comparable expressions determine ahead wanting statements. Precise results or efficiency might differ materially from any future results or efficiency expressed or implied by such statements. The necessary elements that would trigger our precise outcomes or efficiency to differ materially embrace, among others, dangers associated with pre-clinical and medical improvement of merchandise, uncertainties associated to the result and conduct of medical trials together with unforeseen questions of safety, uncertainties associated to product manufacturing, the shortage of market acceptance of our products, our lack of ability to manage progress, the competitive surroundings in relation to our business area and markets, our incapability to attract and retain suitably certified personnel, the unenforceability or lack of safety of our patents and proprietary rights, our relationships with affiliated entities, modifications and developments in know-how which can render our merchandise or technologies out of date, and other elements. For an extra discussion of these dangers, please seek advice from the danger administration sections in Genmab’s most up-to-date monetary studies, which can be found on www.genmab.com and the danger elements included in Genmab’s ultimate prospectus for our U.S. public offering and itemizing and different filings with the U.S. Securities and Trade Commission (SEC), which are available at www.sec.gov. Genmab doesn’t undertake any obligation to update or revise forward wanting statements in this Company Announcement nor to verify such statements to mirror subsequent occasions or circumstances after the date made or in relation to precise outcomes, until required by regulation.

Genmab A/S and/or its subsidiaries personal the following logos: Genmab®; the Y-shaped Genmab emblem®; Genmab in combination with the Y-shaped Genmab emblem®; HuMax®; DuoBody®; DuoBody in mixture with the DuoBody emblem®; HexaBody®; HexaBody in mixture with the HexaBody emblem®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® is a trademark of Novartis AG or its associates. DARZALEX® is a trademark of Janssen Pharmaceutica NV.

1 American Cancer Society. “Multiple Myeloma Overview.” Obtainable at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.
2 Globocan 2018. Japan Reality sheet. Obtainable at http://gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf Accessed March 2019
three  Globocan 2018. World Reality Sheet. Obtainable at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.
four  American Most cancers Society. “How is Multiple Myeloma Diagnosed?” http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 2016.
5 DARZALEX Prescribing info, July 2019. Obtainable at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s019lbl.pdf Final accessed July 2019
6 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Different Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.
7 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor exercise of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.
8 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Enlargement, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.
9 Jansen, JH  et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells by way of Fc receptor-mediated crosslinking. Blood. 2012; 120(21): abstract 2974.

 

 

Company Announcement no. 42
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

  • 190822_CA_42_ALCYONE Japan approval

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