Company Announcement
- Net sales of DARZALEX in the second quarter of 2017 totaled USD 299 million
- Genmab will receive royalties on worldwide net sales from Janssen Biotech, Inc.
Copenhagen, Denmark; July 18, 2017 – Genmab A/S (Nasdaq
Copenhagen: GEN) announced today that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 299
million in the second quarter of 2017. Net sales were USD 212 million in the U.S. and USD 87
million in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive
worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.
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; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple
myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a
monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including
a 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 for use 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 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. DARZALEX is the first human CD38 monoclonal antibody approved in
Europe. 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, NKT-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
Company Announcement no. 25
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/76a61460-a122-4859-bf97-f8e0080a9b0c
