Company Announcement
- Net sales of
DARZALEX® in the third quarter of 2020 totaled USD 1,099
million
- Genmab
receives royalties on worldwide net sales from Janssen Biotech,
Inc.
Copenhagen, Denmark; October 13, 2020 –
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
FASPROTM in the U.S.), as reported by Johnson & Johnson
were USD 1,099 million in the third quarter of 2020. Net
trade sales were USD 585 million in the U.S. and USD 514 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 has
started 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 multiple myeloma:
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 the first subcutaneous CD38 antibody approved in the U.S.
for the treatment of multiple myeloma.
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 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 is the creator of
the following approved antibodies: DARZALEX® (daratumumab, under
agreement with Janssen Biotech, Inc.) for the treatment of certain
multiple myeloma indications in territories including the U.S.,
Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under
agreement with Novartis AG), for the treatment of adults with
relapsing forms of multiple sclerosis in the U.S. and TEPEZZA®
(teprotumumab, under agreement with Roche granting sublicense to
Horizon Therapeutics plc) for the treatment of thyroid eye disease
in the U.S. A subcutaneous formulation of daratumumab, known as
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S.,
has been approved in the U.S. and Europe for the treatment of adult
patients with certain multiple myeloma indications. The first
approved Genmab created therapy, Arzerra® (ofatumumab, under
agreement with Novartis AG), approved for the treatment of certain
chronic lymphocytic leukemia indications, is available in Japan and
is also available in other territories via compassionate use or
oncology access programs. Daratumumab is in clinical development by
Janssen for the treatment of additional multiple myeloma
indications, other blood cancers and amyloidosis. 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, the HexaBody® platform, which
creates effector function enhanced antibodies, the HexElect®
platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic
potency and the DuoHexaBody® platform, which enhances the potential
potency of bispecific antibodies through hexamerization. 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. Genmab is headquartered in Copenhagen, Denmark with
sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and
Tokyo, Japan.
Contact:
Marisol Peron, Corporate Vice President, Communications &
Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, 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®. Arzerra® and Kesimpta® are
trademarks of Novartis AG or its affiliates. DARZALEX® and DARZALEX
FASPRO™ are trademarks of Janssen Pharmaceutica NV. TEPEZZA® is a
trademark of Horizon Therapeutics plc.
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, May
2020. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf
Last accessed May 20204 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. 44CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 131020_CA44_DARZALEX Q3 20
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