NORTH CHICAGO, Illinois and
COPENHAGEN, Denmark, June 10, 2020 /PRNewswire/ -- AbbVie (NYSE:
ABBV) and Genmab A/S (Nasdaq: GMAB) announced today that AbbVie and
Genmab have signed a broad collaboration agreement to jointly
develop and commercialize three of Genmab's early-stage
investigational bispecific antibody product candidates and enter
into a discovery research collaboration for future differentiated
antibody therapeutics for cancer. The companies will partner to
develop Genmab's next-generation bispecific antibody programs,
epcoritamab (DuoBody®-CD3xCD20),
DuoHexaBody®-CD37 and DuoBody-CD3x5T4. The
collaboration combines Genmab's world-class discovery and
development engine and next-generation bispecific antibody
therapeutic candidates with AbbVie's deep clinical expertise,
innovative antibody-drug conjugate (ADC) platform and global
commercial leadership in hematological cancers.
The discovery research collaboration will combine proprietary
antibodies from both companies along with Genmab's DuoBody
technology and AbbVie's payload and ADC technology to select and
develop up to four additional differentiated next-generation
antibody-based product candidates, potentially across both solid
tumors and hematological malignancies. Genmab's DuoBody-CD3
technology engages and directs cytotoxic T cells selectively to
tumors to elicit an immune response towards malignant tumor cells.
AbbVie's ADC technology allows the delivery of a therapeutic toxin
directly to cancer cells while sparing normal, healthy cells,
providing for a more targeted, less toxic treatment approach.
"This transformative collaboration will allow us to accelerate,
broaden and maximize the development of some of our promising
early-stage bispecific antibodies, including epcoritamab, with the
ultimate goal of bringing these potential therapies much faster to
cancer patients," said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab. "Today's
announcement marks the beginning of a new journey for Genmab that
combines our world-class knowledge in antibody biology and deep
expertise in truly innovative next-generation antibody technology
platforms, with AbbVie's R&D prowess and their leadership
position in hematological cancers."
"Epcoritamab is a strong fit for our robust hematological
oncology franchise", said Michael
Severino, M.D., Vice Chairman and President, AbbVie. "By
combining the strengths of our two organizations, we can advance
the treatment landscape for patients battling cancer."
Collaboration Details
This collaboration will provide
for the joint development and commercialization of the three
bispecific antibody therapeutic candidates. For epcoritamab, the
companies will share commercial responsibilities in the U.S. and
Japan, with AbbVie responsible for
further global commercialization. Genmab will book net sales in the
U.S. and Japan and receive tiered
royalties on remaining global sales. For DuoHexaBody-CD37,
DuoBody-CD3x5T4 and any product candidates developed as a result of
the companies' discovery research collaboration, Genmab and AbbVie
will share responsibilities for global development and
commercialization in the U.S. and Japan. Genmab retains the right to
co-commercialize these products, along with AbbVie, outside of the
U.S. and Japan. For the discovery
research partnership, Genmab will conduct Phase 1 studies for these
programs. AbbVie retains the right to opt-in to program
development.
Financial Terms
Under the terms of the agreement,
AbbVie will pay Genmab USD 750
million in upfront payment with the potential for Genmab to
receive up to USD 3.15 billion in
additional development, regulatory and sales milestone payments for
all programs as well as tiered royalties between 22% and 26% on net
sales for epcoritamab outside the U.S. and Japan. Except for these royalty-bearing sales,
the parties share in pre-tax profits from the sale of products on a
50:50 basis. Included in these potential milestones are up to
USD 1.15 billion in payments related
to clinical development and commercial success across the three
existing bispecific antibody programs. In addition, if all four
next-generation antibody product candidates developed as a result
of the discovery research collaboration are successful, Genmab is
eligible to receive up to USD 2.0
billion in option exercise and success-based milestone
payments.
Conference Call
Genmab will hold a conference call in
English to discuss this news today, Wednesday, June 10, 2020, at 6:00 AM CDT / 7:00 AM
EDT / 1:00 PM CEST. The dial
in numbers are:
+1 855 857 0686 (US participants)
+44 3333000804 (international participants)
Confirmation code: 48035919
A live and archived webcast of the call and relevant slides will
be available at www.genmab.com.
About Epcoritamab (DuoBody-CD3xCD20)
Epcoritamab
(DuoBody-CD3xCD20) is a bispecific antibody created using Genmab's
proprietary DuoBody technology. Epcoritamab is designed to target
CD3, which is expressed on T cells and is part of the T cell
receptor signaling complex, and CD20, a clinically well validated
therapeutic target. CD20 is expressed on a majority of B cell
malignancies, including chronic lymphocytic leukemia (CLL), diffuse
large B cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle
cell lymphoma (MCL). In a number of laboratory models, epcoritamab
has shown highly effective killing of CD20+ tumors and induced
potent tumor cell lysis across a panel of B cell tumor lines.
Epcoritamab is currently evaluated in a Phase 1/2 study for
multiple hematological B cell malignancies.
Complete dose escalation data for epcoritamab was presented at
the American Society of Clinical Oncology 2020 (ASCO20) Virtual
Scientific Program. The data and preliminary activity from the
Phase 1/2 study of subcutaneous epcoritamab in patients with
relapsed / refractory B-cell non-Hodgkin lymphoma (B-NHL) are
highly encouraging showing substantial single-agent activity for
epcoritamab with a manageable safety profile. In the study,
epcoritamab induced rapid and deep responses in heavily pretreated
patients with B-NHL across different subtypes and no dose-limiting
toxicities were observed.
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
three 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, Arzerra® (ofatumumab, under
agreement with Novartis AG), for the treatment of certain chronic
lymphocytic leukemia indications in the U.S., Japan and certain other territories 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, DARZALEX FASPRO™ (daratumumab and
hyaluronidase-fihj), has been approved in the U.S. for the
treatment of adult patients with certain multiple myeloma
indications. Daratumumab is in clinical development by Janssen for
the treatment of additional multiple myeloma indications, other
blood cancers and amyloidosis. A subcutaneous formulation of
ofatumumab is in development by Novartis for the treatment of
relapsing multiple sclerosis. 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.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines that solve serious health issues today
and address the medical challenges of tomorrow. We strive to have a
remarkable impact on people's lives across several key therapeutic
areas: immunology, oncology, neuroscience, eye care, virology,
women's health and gastroenterology, in addition to products and
services across its Allergan Aesthetics portfolio. For more
information about AbbVie, please visit us at www.abbvie.com. Follow
@abbvie on Twitter, Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statements for Genmab
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.
Forward-Looking Statements for AbbVie
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe,""expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie's acquisition of Allergan
plc ("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2019 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as 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®
is a trademark of Novartis AG or its affiliates.
DARZALEX® and DARZALEX FASPRO™ are trademarks of Janssen
Pharmaceutica NV. TEPEZZA™ is a trademark of Horizon Therapeutics
plc.
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SOURCE AbbVie