Y-mAbs and Nobelpharma Announce Exclusive License and Distribution Agreement for DANYELZA® (naxitamab-gqgk) in Japan
04 November 2024 - 11:35PM
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB), a commercial-stage biopharmaceutical company focused on the
development and commercialization of novel radioimmunotherapy and
antibody-based therapeutic products for the treatment of cancer,
and Nobelpharma Co., Ltd. today announced that they have entered
into an exclusive license and distribution agreement for the
development and commercialization in Japan of DANYELZA for the
treatment of patients with relapsed/refractory high-risk
neuroblastoma and, upon agreement by the parties, potentially
relapsed osteosarcoma.
Under the terms of the agreement, Nobelpharma
will employ its regulatory, marketing, sales and access expertise
to carry out development work and to submit DANYELZA for approval
by Japanese regulatory authorities, and to market, sell, and
distribute DANYELZA in Japan, if approved. Pursuant to the
agreement, Y-mAbs will receive an upfront payment of $2.0 million
from Nobelpharma in connection with entering into the agreement and
is entitled to receive up to $31.0 million in product and
commercial milestone payments in addition to profit sharing on
commercial sales on DANYELZA, if successfully approved and
commercialized in Japan.
“Our exclusive license and distribution
agreement with Nobelpharma in Japan is an important step in our
continued global expansion efforts of DANYELZA,” said Michael
Rossi, President and Chief Executive Officer of Y-mAbs. “If
approved in the region, we believe DANYELZA can deliver a
meaningful impact to patients in Japan fighting relapsed/refractory
high-risk neuroblastoma and improve long-term quality of life for
these children.”
“We believe that Nobelpharma is the right
partner for Y-mAbs in Japan, and we are excited to work with
Nobelpharma towards the potential approval and commercial launch of
DANYELZA in the region,” said Thomas Gad, Founder and Chief
Business Officer of Y-mAbs. “DANYELZA, if approved in Japan for
relapsed/refractory high-risk neuroblastoma, will provide a new
out-patient anti-GD2 therapeutic option for physicians in the
treatment of children facing this advanced form of pediatric
cancer. We remain steadfast in our commitment to provide access to
DANYELZA and improve the lives of children and families around the
globe facing advanced cancers.”
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed DANYELZA® (naxitamab-gqgk), which is
exclusively licensed by MSK to Y-mAbs. MSK has institutional
financial interests in the compound and Y-mAbs.
About DANYELZA®
(naxitamab-gqgk)DANYELZA® (naxitamab-gqgk) is indicated,
in combination with granulocyte-macrophage colony-stimulating
factor ("GM-CSF"), for the treatment of pediatric patients 1 year
of age and older and adult patients with relapsed or refractory
high-risk neuroblastoma in the bone or bone marrow who have
demonstrated a partial response, minor response, or stable disease
to prior therapy. This indication was approved under accelerated
approval based on overall response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefits in a confirmatory
trial. DANYELZA® includes a Boxed Warning for serious
infusion-related reactions, such as cardiac arrest and anaphylaxis,
and neurotoxicity, such as severe neuropathic pain and transverse
myelitis. See full Prescribing Information for complete Boxed
Warning and other important safety information.
DANYELZA is currently not approved for the
treatment of osteosarcoma in any jurisdiction.
About Y-mAbs Y-mAbs is a
commercial-stage biopharmaceutical company focused on the
development and commercialization of novel, radioimmunotherapy and
antibody-based therapeutic cancer products. The Company’s
technologies include its investigational Self-Assembly DisAssembly
(“SADA”) Pretargeted Radioimmunotherapy Platform (“PRIT”) and
bispecific antibodies generated using the Y-BiClone platform. The
Company’s broad and advanced product pipeline includes the anti-GD2
therapy DANYELZA® (naxitamab-gqgk), the first FDA-approved
treatment for patients with relapsed or refractory high-risk
neuroblastoma in the bone or bone marrow after a partial response,
minor response, or stable disease to prior therapy.
Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
“forward-looking statements” within the meaning of Section 27A
of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Such statements include, but are
not limited to, statements about expectations relating to the
Company’s partnership with Nobelpharma, including the development
process and regulatory submissions with respect to the potential
approval and commercialization of DANYELZA in Japan and the
potential indications thereof; the receipt by the Company of any
payments or royalties from Nobelpharma; and other statements that
are not historical facts. Words such as ‘‘anticipate,’’
‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’
‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’
‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’
“will,” ‘‘would’,’ “guidance,” “goal,” “objective,” and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these
identifying words. Our product candidates and related technologies
are novel approaches to cancer treatment that present significant
challenges. Actual results may differ materially from those
indicated by such forward-looking statements as a result of various
factors, including but not limited to: risks associated with the
Company’s reliance on a third-party for development work associated
with the regulatory process with respect to and potential
commercialization of DANYELZA in Japan; cost and success of the
Company’s and Nobelpharma’s product development activities and
clinical trials; the risks of delay in the timing of the Company’s
and Nobelpharma’s regulatory submissions or failure to receive
approval of DANYELZA in Japan; and the risks related to
commercializing any approved pharmaceutical product in a territory,
including with respect to the rate and degree of market acceptance.
All statements are subject to the risks described in the “Risk
Factors” section included in the Company’s Annual Report on
Form 10-K for the fiscal year ended December 31,
2023, and the Company’s Quarterly Reports on Form 10-Q for the
quarterly periods ended March 31, 2024 and June 30, 2024, and
future filings and reports by the Company. Any forward-looking
statements contained in this press release speak only as of the
date hereof, and the Company undertakes no obligation to update any
forward-looking statement, whether as a result of new information,
future events or otherwise.
DANYELZA® and Y-mAbs® are registered trademarks
of Y-mAbs Therapeutics, Inc.
Investor Contact:Courtney DuganVP, Head of
Investor Relationscdu@ymabs.com
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