Company Announcement
- Net sales of DARZALEX in 2016 totaled USD 572 million
- Genmab will receive royalties on worldwide sales from Janssen Biotech, Inc.
Copenhagen, Denmark; January 24, 2017 – Genmab A/S (Nasdaq
Copenhagen: GEN) announced today that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 572
million in 2016. Net sales were USD 471 million in the U.S. and net sales in the rest of the
world were USD 101 million. 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.
DARZALEX was approved in the U.S. in November 2015 and in Europe in May 2016. Net sales of DARZALEX in
the U.S. in 2015 were USD 20 million, resulting in royalty income of DKK 16 million to 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 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, non-Hodgkin’s lymphoma, 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
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. 02
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark
Attachments:
http://www.globenewswire.com/NewsRoom/AttachmentNg/b3e1bd0e-bdb4-46da-8ca7-2e6d89f24db8
