Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB) a commercial-stage biopharmaceutical company focused on the
development and commercialization of novel, antibody-based
therapeutic products for the treatment of cancer and Takeda Israel,
a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
(TSE:4502/NSY:TAK) ("Takeda"), announced today that the Israeli
Ministry of Health has approved DANYELZA in Israel for the
treatment, in combination with granulocyte-macrophage
colony-stimulating factor (“GM-CSF”), 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.
In Israel, DANYELZA is expected to be
commercialized by Takeda Israel, under the exclusive license and
distribution agreement entered in 2020 between Takeda Israel and
the Company.
“The regulatory approval of DANYELZA in Israel
represents our first marketing authorization outside of the U.S.
and is a milestone for our collaboration with Takeda and more
importantly for the pediatric patients we are dedicated to
serving,” said Thomas Gad, President, and Interim Chief Executive
Officer. “The approval in Israel further demonstrates our
commitment to expanding the reach of our commercial stage products
internationally to patients with unmet medical needs.”
“We are extremely excited by the approval of
DANYELZA in Israel,” said Arie Kramer, General Manager of Takeda
Israel. “This registration, following the expedited reimbursement
of the product last December by the Israeli Ministry of Health,
allowing Takeda and Y-mAbs to offer a new innovative treatment for
pediatric neuroblastoma patients in Israel, is in alignment with
Takeda’s vision of Better Health and Brighter Future to every
patient in the world.”
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed DANYELZA, which is exclusively licensed by
MSK to Y-mAbs. As a result of this licensing arrangement, MSK has
institutional financial interests in the compound.
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.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel,
antibody-based therapeutic cancer products. In addition to
conventional antibodies, the Company’s technologies include
bispecific antibodies generated using the Y-BiClone platform and
the SADA platform. The Company’s broad and advanced product
pipeline includes one FDA-approved product, DANYELZA®
(naxitamab-gqgk), which targets tumors that express GD2, and one
product candidate at the registration-stage, omburtamab, which
targets tumors that express B7-3.
Forward-Looking Statements
Statements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts,constitute
“forward-looking statements” within the meaning of The Private
Securities Litigation Reform Act of 1995. Such statements include,
but are not limited to, statements regarding expected
commercializtion of DANYELZA in Israel by Takeda, our commitment to
expanding the reach of our commercial stage products
internationally to patients with unmet medical needs, statements
about our business model and development, commercialization and
product distribution plans; current and future clinical and
pre-clinical studies and our research and development programs;
expectations related to the timing of the initiation and completion
of regulatory submissions; regulatory, marketing and reimbursement
approvals; rate and degree of market acceptance and clinical
utility as well as pricing and reimbursement levels; retaining and
hiring key employees; our commercialization, marketing and
manufacturing capabilities and strategy; our intellectual property
position and strategy; additional product candidates and
technologies; collaborations or strategic partnerships and the
potential benefits thereof; expectations related to the use of our
cash and cash equivalents, and the need for, timing and amount of
any future financing transaction; our financial performance,
including our estimates regarding revenues, expenses, capital
expenditure requirements; developments relating to our competitors
and our industry; 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’’, “goal,” “aim,” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Our
products, 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 our financial
condition and need for additional capital; risks associated with
our development work; cost and success of our product development
activities and clinical trials; the risks of delay in the timing of
our regulatory submissions or failure to receive approval of our
drug candidates; the risks related to commercializing any approved
pharmaceutical product including the rate and degree of market
acceptance of our product candidates; development of our sales and
marketing capabilities and risks associated with failure to obtain
sufficient reimbursement for our products; the risks related to our
dependence on third parties including for conduct of clinical
testing and product manufacture; our inability to enter into
partnerships; the risks related to government regulation; risks
related to market approval, risks associated with protection of our
intellectual property rights; risks related to employee matters and
managing growth; risks related to our common stock, risks
associated with the COVID-19 pandemic, risks associated with the
conflict between Russia and Ukraine and sanctions related thereto,
macroeconomic conditions, including inflation and uncertain global
credit and capital markets; and other risks and uncertainties
affecting the Company including those described in the "Risk
Factors" section included in our Annual Report on Form 10-K for the
year ended December 31, 2021, our Quarterly Reports on Form 10-Q
for the quarters ended March 31, 2022 and June 30, 2022, and in our
other SEC filings. 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
except as required by law.
About Takeda Israel
Takeda Israel Ltd, is a wholly owned subsidiary
of Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK), which
is a global, values-based, R&D-driven biopharmaceutical leader
headquartered in Japan, committed to bringing Better Health and a
Brighter Future to patients by translating science into
highly-innovative medicines. Takeda focuses its R&D efforts on
four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and
Gastroenterology (“GI”). We also make targeted R&D investments
in Plasma-Derived Therapies and Vaccines. Takeda is focusing on
developing highly innovative medicines that contribute to making a
difference in people's lives by advancing the frontier of new
treatment options and leveraging our enhanced collaborative R&D
engine and capabilities to create a robust, modality-diverse
pipeline. Our employees are committed to improving quality of life
for patients and to working with our partners in health care in
approximately 80 countries.
About Takeda Pharmaceutical Company Limited
Takeda Pharmaceutical Company Limited
(TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven
biopharmaceutical leader headquartered in Japan, committed to
bringing Better Health and a Brighter Future to patients by
translating science into highly-innovative medicines. Takeda
focuses its R&D efforts on four therapeutic areas: Oncology,
Rare Diseases, Neuroscience, and Gastroenterology (“GI”). We also
make targeted R&D investments in Plasma-Derived Therapies and
Vaccines. We are focusing on developing highly innovative medicines
that contribute to making a difference in people's lives by
advancing the frontier of new treatment options and leveraging our
enhanced collaborative R&D engine and capabilities to create a
robust, modality-diverse pipeline. Our employees are committed to
improving quality of life for patients and to working with our
partners in health care in approximately 80 countries.
For more information, visit https://www.takeda.com.
DANYELZA®, OMBLASTYS® and Y-mAbs® are registered
trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Y-mAbs Therapeutics, Inc. |
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Takeda Israel |
230 Park Avenue, Suite 3350 |
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25 Efal st. Kiriat Arie-Petach Tikva |
New York, NY 10169 |
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Israel |
USA |
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Media contact: |
+ 1 646 885 8505 |
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Michal Zagon-Rogel |
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+ 972-506215303 |
E-mail: info@ymabs.com |
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E- mail: michal.zagon-rogel@takeda.com |
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