Genmab Announces the Initial Resolution of its Arbitration with Janssen Relating to their Daratumumab License Agreement
08 April 2022 - 1:44AM
Company Announcement
COPENHAGEN, Denmark;
April 8, 2022
– 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® 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 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® and HexElect®. DARZALEX FASPRO® is a trademark of
Johnson & Johnson.
Company Announcement no. 14CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 080422_CA14_Arbitration_Final
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