Genmab Commences Binding Arbitration of Two Matters Under License Agreement with Janssen
September 22 2020 - 05:04PM
Company Announcement
Copenhagen, Denmark; September 22, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today that it has
commenced binding arbitration of two matters arising under its
license agreement with Janssen Biotech, Inc. (Janssen) relating to
daratumumab. Under the license agreement, Genmab is, among
other things, entitled to royalties from Janssen on sales of
daratumumab (marketed as DARZALEX® for intravenous administration
and, in the United States, as DARZALEX FASPRO™ for subcutaneous
administration).
The arbitration first is to settle 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. The royalties Janssen pays to Halozyme
represent a mid-single digit percentage rate of subcutaneous
daratumumab sales. 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 for the second quarter of
2020.
The arbitration is also to settle 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. The relevant
Genmab-owned issued U.S., European and Japanese patents will expire
in the late 2020s and early 2030s. The relevant Janssen-owned
issued patents and patent applications (if granted) covering the
subcutaneous formulation of daratumumab would expire in the
mid-2030s.
Under the agreement, the arbitration will be conducted in New
York pursuant to the rules of the CPR Institute for Dispute
Resolution for Non-Administered Arbitration before a panel of three
arbitrators. While Genmab intends to vigorously protect its rights
under the agreement, the outcome of any arbitration proceeding, as
well as its duration, is inherently uncertain. The arbitration will
be confidential, subject to the parties’ disclosure obligations
under applicable law. Other than pursuant to these obligations,
Genmab does not intend to comment or provide additional information
regarding the arbitration until an order on the merits or other
material order is issued in the arbitration or the arbitration is
otherwise concluded. While the arbitration is pending, Genmab’s
collaborations with Janssen on daratumumab and HexaBody®-CD38 will
continue.
Based on currently available information, Genmab does not expect
these matters to materially affect its 2020 financial guidance.
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.
Company Announcement no. 39CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
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