Genmab A/S Genmab Announces The Initial Resolution Of Its Arbitration With Janssen Relating To Their Daratumumab License Agreement
April 07 2022 - 7:44PM
UK Regulatory
TIDMGEN
Company Announcement
COPENHAGEN, Denmark; April 8, 2022 --
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Genmab A/S (Nasdaq: GMAB) announced today an award in the binding
arbitration of two matters arising under its license agreement with
Janssen Biotech, Inc. (Janssen) relating to daratumumab. The
arbitral tribunal issued an award on April 7, 2022, deciding both
issues in favor of Janssen. 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.
The first issue concerned the question as to whether Janssen's
obligation to pay royalties on sales of licensed product extends,
in each applicable country, until the expiration or invalidation of
the last-to-expire relevant Genmab-owned patent or the
last-to-expire relevant Janssen-owned patent covering the product,
as further defined and described in the license agreement.
As to that issue, the tribunal determined by majority opinion
that Janssen's obligation to pay royalties to Genmab on sales of
licensed product, in each applicable country, extends through the
expiration or invalidation of the last-to-expire relevant
Genmab-owned patent covering the product or use thereof, but not
the relevant Janssen-owned patent. The relevant Genmab-owned issued
U.S., European and Japanese patents will expire in the late 2020s
and early 2030s.
The second issue concerned the question as to whether Genmab is
required to share in Janssen's royalty payments to Halozyme
Therapeutics, Inc. for the Halozyme enzyme technology used in the
subcutaneous formulation of daratumumab (marketed as DARZALEX
FASPRO(R) in the U.S.). The royalties Janssen pays to Halozyme
represent a mid-single digit percentage rate of subcutaneous
daratumumab sales. Janssen reduced its royalty payments to Genmab
by what it claims to be Genmab's share of Janssen's royalty
payments to Halozyme beginning in the second quarter of 2020 and
has continued to do so through December 31, 2021.
As to that issue, the 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 Therapeutics, Inc. Genmab had already assumed that
Janssen would continue to withhold what it claims to be Genmab's
share of Janssen's royalty payments to Halozyme as a reduction to
estimated 2022 revenue in its guidance as of February 16, 2022, and
as such our 2022 financial guidance remains unchanged.
In accordance with the license agreement, the arbitration was
conducted before a tribunal of three arbitrators. The arbitration
is confidential, subject to the parties' disclosure obligations
under applicable law. Other than pursuant to these obligations,
Genmab does not intend further to comment or to provide additional
information regarding the arbitration. Genmab's collaborations with
Janssen, including relating to daratumumab, will continue.
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) and
HexElect(R) . DARZALEX FASPRO(R) is a trademark of Johnson &
Johnson.
Company Announcement no. 14
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 080422_CA14_Arbitration_Final
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April 07, 2022 19:44 ET (23:44 GMT)
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