TIDMGEN
Company Announcement
-- Net sales of DARZALEX(R) 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 --
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Genmab A/S (Nasdaq: GMAB) announced today that worldwide net trade
sales of DARZALEX(R) (daratumumab), including sales of the
subcutaneous (SC) formulation (daratumumab and hyaluronidase-fihj,
sold under the tradename DARZALEX FASPRO(R) 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(R) (daratumumab)
DARZALEX(R) (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
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and follow us on Twitter.com/Genmab
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.
Contact:
Marisol Peron, Senior Vice President, Global Investor Relations
& Communications
T: +1 609 524 0065; E: mmp@genmab.com
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For Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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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
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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
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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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination
with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody
in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in
combination with the HexaBody logo(R) ; DuoHexaBody(R) ;
HexElect(R) ; and UniBody(R) . DARZALEX(R) and DARZALEX FASPRO(R)
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 2022
(2) DARZALEX Summary of Product Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed April 2022
(3) DARZALEX FASPRO Prescribing information, available at:
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761145
Last accessed April 2022
(4) 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.
(5) 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.
(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. 16
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 190422_CA16_DARZALEX Q1 2022 Sales
https://ml-eu.globenewswire.com/Resource/Download/81af9e30-1f18-44ba-aeef-f03ad6ca3dad
(END) Dow Jones Newswires
April 19, 2022 06:29 ET (10:29 GMT)
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