Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2022
19 Aprile 2022 - 12:29PM
Company Announcement
- Net sales of DARZALEX®
in the first quarter of 2022
totaled USD 1,856
million
- Genmab receives royalties on worldwide net sales from
Janssen Biotech, Inc.
COPENHAGEN, Denmark;
April 19,
2022 –
Genmab A/S
(Nasdaq: GMAB) announced
today that worldwide net trade sales of
DARZALEX® (daratumumab),
including sales of the subcutaneous
(SC) formulation
(daratumumab and
hyaluronidase-fihj,
sold under the tradename DARZALEX
FASPRO® in the
U.S.), as
reported by Johnson & Johnson were USD
1,856 million in the
first quarter of 2022. Net trade sales
were USD 953 million in the U.S. and USD 903 million in the rest of
the world. Genmab receives royalties on the worldwide net sales of
DARZALEX, both the intravenous and SC formulations, under the
exclusive worldwide license to Janssen Biotech, Inc. (Janssen) 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 Therapeutics, Inc.
(Halozyme), cf. company announcement No. 39 of September 22, 2020.
Subsequently, Genmab announced that an arbitral tribunal ruled by
majority opinion that Janssen is permitted to continue reducing its
royalty payments to Genmab as an offset against a share of
Janssen’s royalty payments made to Halozyme, cf. company
announcement No. 14 of April 8, 2022. Genmab has the right to seek
review of the award, which it must do within a limited period of
time. Such review should conclude with the issuance of a final
award prior to the end of 2022. Genmab is currently considering its
options.
Genmab has reflected the withholding by Janssen of royalty
payments related to the Halozyme matter as a reduction to estimated
2022 revenue in our guidance as of February 16, 2022, and as such
our 2022 financial guidance remains unchanged.
About DARZALEX®
(daratumumab)DARZALEX® (daratumumab) is the first
monoclonal antibody (mAb) to receive U.S. Food and Drug
Administration approval to treat multiple myeloma and has become a
backbone therapy in the treatment of this disease. Daratumumab is
being developed by Janssen Biotech, Inc. under an exclusive
worldwide license to develop, manufacture and commercialize
daratumumab from Genmab. The subcutaneous formulation of
daratumumab (daratumumab and hyaluronidase-fihj) is the first
subcutaneous CD38 antibody approved for the treatment of multiple
myeloma and the first and only approved treatment for patients with
light-chain (AL) amyloidosis. 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). 1,2,3,4,5,6,7
Please see local country prescribing information for all labeled
indication and safety information.
About Genmab Genmab is an international
biotechnology company with a core purpose to improve the lives of
people with cancer. For more than 20 years, Genmab’s vision to
transform cancer treatment has driven its passionate, innovative
and collaborative teams to invent next-generation antibody
technology platforms and leverage translational research and data
sciences, fueling multiple differentiated cancer treatments that
make an impact on people’s lives. To develop and deliver novel
therapies to patients, Genmab has formed 20+ strategic partnerships
with biotechnology and pharmaceutical companies. Genmab’s
proprietary pipeline includes bispecific T-cell engagers,
next-generation immune checkpoint modulators, effector function
enhanced antibodies and antibody-drug conjugates.
Genmab 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 and
follow us on
Twitter.com/Genmab.Contact: Marisol
Peron, Senior Vice President, Global Investor Relations &
CommunicationsT: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Vice
President, 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 Johnson & Johnson.
1 DARZALEX Prescribing information, available at
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761036
Last accessed April 20222 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed April 20223 DARZALEX FASPRO Prescribing information,
available at:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145
Last accessed April 20224 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. 16CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 190422_CA16_DARZALEX Q1 2022 Sales
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