Company Announcement
- 3 new Phase III studies of daratumumab planned in multiple myeloma and
amyloidosis
- Studies planned to start between second half 2017 and first quarter 2018
Copenhagen, Denmark; May 17, 2017 – Genmab A/S (Nasdaq
Copenhagen: GEN) announced today that its partner Janssen Biotech, Inc. plans to start four new studies of daratumumab in multiple
myeloma and amyloidosis. The studies described below are currently planned to start between
the second half of 2017 and the first quarter of 2018 and may be subject to change. DARZALEX is being developed under an
August 2012 agreement in which Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and
commercialize the product.
- Phase III study of daratumumab in smoldering multiple myeloma
- Phase III study comparing the subcutaneous and intravenous administration of daratumumab in relapsed and
refractory multiple myeloma
- Phase III study of daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone for
amyloidosis
- Phase II study of subcutaneous daratumumab in combination with standard of care regimens for frontline and
relapsed multiple myeloma
The plans for the new studies were announced at Johnson & Johnson’s Pharmaceutical Business Review
today.
“Janssen’s expansive development plans for daratumumab emphasize the commitment to test daratumumab broadly in
many different clinical settings, which hopefully results in better treatment options for patients,” said Jan van de Winkel, Ph.D.,
Chief Executive Officer of Genmab.
About DARZALEX® (daratumumab)
DARZALEX® (daratumumab) injection for intravenous infusion is indicated in the United States in
combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple
myeloma who have received at least one prior therapy and as a monotherapy 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, or who
are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal
antibody (mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat multiple myeloma. DARZALEX is indicated in Europe in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the
treatment of adult patients with multiple myeloma who have received at least one prior therapy and for use as monotherapy for the
treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an
immunomodulatory agent and who have demonstrated disease progression on the last therapy. For more
information, visit
www.DARZALEX.com.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma
cells. Daratumumab triggers a person’s own immune system to attack
the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through
immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell
death).1,2,3,4,5
Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop,
manufacture and commercialize daratumumab from Genmab. Five Phase III clinical studies with daratumumab in relapsed and frontline
multiple myeloma settings are currently ongoing, and 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, NK/T-cell lymphoma, amyloidosis,
myelodysplastic syndromes and solid tumors. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA,
for multiple myeloma, as both a monotherapy and in combination with other therapies.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of
differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies,
DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab)
for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional
multiple myeloma indications, other blood cancers, and solid tumors. A subcutaneous formulation of ofatumumab is in
development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline.
Genmab's technology base consists of validated and proprietary next generation antibody technologies - the
DuoBody® platform for generation of bispecific antibodies, and the HexaBody® platform which creates effector
function enhanced antibodies. The company intends to leverage these technologies to create opportunities for full or
co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more
information visit
www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com
This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”,
“intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ
materially from any future results or performance expressed or implied by such statements. The important factors that could cause
our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical
development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues,
uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the
competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified
personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated
entities, changes and developments in technology which may render our products obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are
available on www.genmab.com. Genmab does not undertake
any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements in
relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab
logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™;
HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra®
is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.
1 FDA 2015. Daratumumab Prescribing information.
Available at:
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036Orig1s000lbledt.pdf.
Last accessed December 2016.
2 De Weers, M et al. Daratumumab, a Novel Therapeutic
Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology.
2011; 186: 1840-1848.
3 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the
anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.
4 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells,
Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.
5 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis
of myeloma tumor cells via Fc receptor-mediated crosslinking. Blood. 2012;120(21):abstract 2974.
Company Announcement no. 20
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
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http://www.globenewswire.com/NewsRoom/AttachmentNg/41ed360c-63ec-4fc4-a5e3-89ca25383a96
