Company Announcement
- Net sales of
DARZALEX® in 2020 totaled USD 4,190 million
- Genmab
receives royalties on worldwide net sales from Janssen Biotech,
Inc.
Copenhagen, Denmark; January 26, 2021 –
Genmab A/S (Nasdaq: GMAB) announced today that worldwide
net trade sales of DARZALEX® (daratumumab), including sales of the
subcutaneous formulation (sold under the tradename DARZALEX
FASPRO® in the U.S.), as reported by Johnson & Johnson
were USD 4,190 million in 2020. Net trade sales were USD
2,232 million in the U.S. and USD 1,958 million in the rest of the
world. Genmab receives royalties on the worldwide net sales of
DARZALEX and DARZALEX FASPRO under the exclusive worldwide license
to Janssen Biotech, Inc. to develop, manufacture and commercialize
daratumumab. As previously announced, Janssen is reducing its
royalty payments to Genmab by what it claims to be Genmab’s share
of Janssen’s royalty payments to Halozyme, cf. company announcement
No. 39 of September 22, 2020.
About DARZALEX®
(daratumumab)DARZALEX® (daratumumab) has become a
backbone therapy in the treatment of multiple myeloma. DARZALEX
intravenous infusion is indicated for the treatment of adult
patients in the United States: in combination with carfilzomib and
dexamethasone for the treatment of patients with
relapsed/refractory multiple myeloma who have received one to three
previous lines of therapy; in combination with bortezomib,
thalidomide and dexamethasone as treatment for patients newly
diagnosed with multiple myeloma who are eligible for autologous
stem cell transplant; in combination with lenalidomide and
dexamethasone for the treatment of patients with newly diagnosed
multiple myeloma who are ineligible for autologous stem cell
transplant; in combination with bortezomib, melphalan and
prednisone for the treatment of patients with newly diagnosed
multiple myeloma who are ineligible for autologous stem cell
transplant; 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 (U.S. FDA) approval to treat multiple
myeloma.
DARZALEX is indicated for the treatment of adult patients in
Europe via intravenous infusion or subcutaneous administration: in
combination with bortezomib, thalidomide and dexamethasone as
treatment for patients newly diagnosed with multiple myeloma who
are eligible for autologous stem cell transplant; in combination
with lenalidomide and dexamethasone for the treatment of patients
with newly diagnosed multiple myeloma who are ineligible for
autologous stem cell transplant; in combination with bortezomib,
melphalan and prednisone for the treatment of adult patients with
newly diagnosed multiple myeloma who are ineligible for autologous
stem cell transplant; 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 therapy2. Daratumumab
is the first subcutaneous CD38 antibody approved in Europe for the
treatment of multiple myeloma. The option to split the first
infusion of DARZALEX over two consecutive days has been approved in
both Europe and the U.S.
In Japan, DARZALEX intravenous infusion is approved for the
treatment of adult patients: in combination with lenalidomide and
dexamethasone for the treatment of patients with newly diagnosed
multiple myeloma who are ineligible for autologous stem cell
transplant; in combination with bortezomib, melphalan and
prednisone for the treatment of patients with newly diagnosed
multiple myeloma who are ineligible for autologous stem cell
transplant; in combination with lenalidomide and dexamethasone, or
bortezomib and dexamethasone for the treatment of relapsed or
refractory multiple myeloma. DARZALEX is the first human CD38
monoclonal antibody to reach the market in the United States,
Europe and Japan. For more information, visit www.DARZALEX.com.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), a
subcutaneous formulation of daratumumab, is approved in the United
States for the treatment of adult patients with newly diagnosed
light-chain (AL) amyloidosis in combination with bortezomib,
cyclophosphamide, and dexamethasone. It is also approved in the
U.S. for the treatment of adult patients with multiple myeloma: in
combination with bortezomib, thalidomide, and dexamethasone in
newly diagnosed patients who are eligible for ASCT; in combination
with bortezomib, melphalan and prednisone in newly diagnosed
patients who are ineligible for ASCT; in combination with
lenalidomide and dexamethasone in newly diagnosed patients who are
ineligible for ASCT and in patients with relapsed or refractory
multiple myeloma who have received at least one prior therapy; in
combination with bortezomib and dexamethasone in patients who have
received at least one prior therapy; and as monotherapy, in
patients 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.3 DARZALEX
FASPRO is co-formulated with recombinant human hyaluronidase PH20
(rHuPH20), Halozyme's ENHANZE® drug delivery technology. .DARZALEX
FASPRO is the first subcutaneous CD38 antibody approved in the U.S.
for the treatment of multiple myeloma and the first and only
approved treatment for patients with AL amyloidosis in the U.S.
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).1,4,5,6,7
Daratumumab is being developed by Janssen Biotech, Inc. under an
exclusive worldwide license to develop, manufacture and
commercialize daratumumab from Genmab. A comprehensive clinical
development program for daratumumab is ongoing, including multiple
Phase III studies in smoldering, relapsed and refractory and
frontline multiple myeloma settings. Additional studies are ongoing
or planned to assess the potential of daratumumab in other
malignant and pre-malignant diseases in which CD38 is expressed,
such as amyloidosis and T-cell acute lymphocytic leukemia (ALL).
Daratumumab has received two Breakthrough Therapy Designations from
the U.S. FDA for certain indications of multiple myeloma, including
as a monotherapy for heavily pretreated multiple myeloma and in
combination with certain other therapies for second-line treatment
of multiple myeloma.
About Genmab Genmab is an international
biotechnology company with a core purpose to improve the lives of
patients with cancer. Founded in 1999, Genmab is the creator of
multiple approved antibody therapeutics that are marketed by its
partners. The company aims to create, develop and commercialize
differentiated therapies by leveraging next-generation antibody
technologies, expertise in antibody biology, translational research
and data sciences and strategic partnerships. To create novel
therapies, Genmab utilizes its next-generation antibody
technologies, which are the result of its collaborative company
culture and a deep passion for innovation. Genmab’s proprietary
pipeline consists of modified antibody candidates, including
bispecific T-cell engagers and next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates. The company is headquartered in Copenhagen, Denmark
with locations in Utrecht, the Netherlands, Princeton, New Jersey,
U.S. and Tokyo, Japan. For more information, please visit
Genmab.com.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations
& CommunicationsT: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Head of Investor RelationsT: +45 3377 9558; E:
acn@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 or technologies 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 and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission (SEC), which are
available at www.sec.gov. Genmab does not undertake any obligation
to update or revise forward looking statements in this Company
Announcement nor to confirm such statements to reflect subsequent
events or circumstances after the date made or in relation to
actual results, unless required by law. Genmab A/S and/or its
subsidiaries own the following trademarks: Genmab®; the Y-shaped
Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®;
HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®;
HexaBody®; HexaBody in combination with the HexaBody logo®;
DuoHexaBody®; HexElect®; and UniBody®. DARZALEX® and DARZALEX
FASPRO® are trademarks of Janssen Pharmaceutica NV.
1 DARZALEX Prescribing information, August 2020
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s029lbl.pdf
Last accessed August 20202 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed June 20203 DARZALEX FASPRO Prescribing information,
January 2021. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761145s002lbl.pdf
Last accessed January 20214 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: 1840-1848.5Overdijk, 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: 311-21.6 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: 384-94.7 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. 04CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 260121_CA04_DARZALEX 2020 Sales
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