Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) (the “Company” or
“Y-mAbs”) 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/NYSE:TAK) (“Takeda”) announced today that they have
entered into an exclusive license and distribution agreement for
the registration and commercialization in Israel of DANYELZA for
the treatment of patients with relapsed/refractory high-risk
neuroblastoma and omburtamab for the treatment of pediatric
patients with CNS/leptomeningeal metastasis from neuroblastoma.
DANYELZA (naxitamab-gqgk) was approved by the U.S. FDA on November
25, 2020. Additionally, Y-mAbs plans to resubmit the amended BLA
for omburtamab for the treatment of pediatric patients with
CNS/leptomeningeal metastasis from neuroblastoma to the FDA by the
end of 2020 or in early 2021.
Under the terms of the agreement, Takeda will
employ its proven platform of sales, access, marketing and
regulatory expertise to distribute DANYELZA and omburtamab, if
approved, in the territory. The license and distribution agreement
includes the State of Israel, West Bank and Gaza Strip. All other
geographies worldwide remain with the Company. Financial details
were not disclosed.
“We are very pleased to enter into this license
and distribution agreement with Takeda, and now expect to see a
treatment cluster established in the Middle East, thereby making
DANYELZA and omburtamab, if approved, available to children with
unmet medical needs in the region,” said Thomas Gad, founder,
Chairman and President at Y-mAbs.
Arie Kramer, General Manager at Takeda further
notes, “Relapsed/refractory high-risk neuroblastoma and
CNS/leptomeningeal metastasis from neuroblastoma are cancers for
which there are currently no approved therapies in Israel, and we
are excited to partner with Y-mAbs, making these compounds
available and bringing new hopes to pediatric patients suffering
from these devastating conditions in Israel.”
Researchers at MSK developed DANYELZA and
omburtamab, which are exclusively licensed by MSK to Y-mAbs. As a
result of this licensing arrangement, MSK has institutional
financial interests in the compounds and in 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 is 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 Neuroblastoma
Neuroblastoma is a solid tumor of childhood that
arises in the nervous system, outside of the brain. The clinical
behavior of neuroblastoma is highly variable, with some tumors
being easily treatable, but the majority being very aggressive. All
patients are staged based on the International Neuroblastoma
Staging System Committee (“INSS”) system, ranging from stage 1
through stage 4S. All patients with stage 4 disease diagnosed after
one year of age are classified in the high-risk category, where the
neuroblastoma tumor cells have already metastasized to other sites
in the body, such as the bone or bone marrow. Essentially all
patients who have tumors with many copies, or amplification, of the
MYCN oncogene also have high-risk disease, even if they do not have
evidence of the tumor having spread.
About
Y-mAbs
Y-mAbs (Nasdaq: YMAB) is a commercial-stage
biopharmaceutical company focused on the development and
commercialization of novel, antibody-based therapeutic products for
the treatment of cancer. The Company has a broad and advanced
product pipeline, including one FDA approved product, DANYELZA ®
(naxitamab-gqgk), which targets tumors that express GD2, and one
pivotal-stage product candidate, omburtamab, which targets tumors
that express B7-H3.
Y-mAbs 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, may 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 about our business model and our
development, commercialization and 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,’’ ‘‘intend,’’ ‘‘may,’’
‘‘might,’’ ‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’
‘‘should,’’ ‘‘target,’’ “will”, ‘‘would’’ 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 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 related
to the impact of the pandemic caused by the novel coronavirus known
as COVID-19, 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 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.
“DANYELZA” and “Y-mAbs” are registered
trademarks of Y-mAbs Therapeutics, Inc.
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.
Important Notice
For the purposes of this notice, “press release”
means this document, any oral presentation, any question and answer
session and any written or oral material discussed or distributed
by Takeda Pharmaceutical Company Limited (“Takeda”) regarding this
release. This press release (including any oral briefing and any
question-and-answer in connection with it) is not intended to, and
does not constitute, represent or form part of any offer,
invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any
securities or the solicitation of any vote or approval in any
jurisdiction. No shares or other securities are being offered to
the public by means of this press release. No offering of
securities shall be made in the United States except pursuant to
registration under the U.S. Securities Act of 1933, as amended, or
an exemption therefrom. This press release is being given (together
with any further information which may be provided to the
recipient) on the condition that it is for use by the recipient for
information purposes only (and not for the evaluation of any
investment, acquisition, disposal or any other transaction). Any
failure to comply with these restrictions may constitute a
violation of applicable securities laws.
The companies in which Takeda directly and
indirectly owns investments are separate entities. In this press
release, “Takeda” is sometimes used for convenience where
references are made to Takeda and its subsidiaries in general.
Likewise, the words “we”, “us” and “our” are also used to refer to
subsidiaries in general or to those who work for them. These
expressions are also used where no useful purpose is served by
identifying the particular company or companies.
Takeda Forward-Looking
Statements
This press release and any materials distributed
in connection with this press release may contain forward-looking
statements, beliefs or opinions regarding Takeda’s future business,
future position and results of operations, including estimates,
forecasts, targets and plans for Takeda. Without limitation,
forward-looking statements often include words such as “targets”,
“plans”, “believes”, “hopes”, “continues”, “expects”, “aims”,
“intends”, “ensures”, “will”, “may”, “should”, “would”, “could”
“anticipates”, “estimates”, “projects” or similar expressions or
the negative thereof. These forward-looking statements are based on
assumptions about many important factors, including the following,
which could cause actual results to differ materially from those
expressed or implied by the forward-looking statements: the
economic circumstances surrounding Takeda’s global business,
including general economic conditions in Japan and the United
States; competitive pressures and developments; changes to
applicable laws and regulations; the success of or failure of
product development programs; decisions of regulatory authorities
and the timing thereof; fluctuations in interest and currency
exchange rates; claims or concerns regarding the safety or efficacy
of marketed products or product candidates; the impact of health
crises, like the novel coronavirus pandemic, on Takeda and its
customers and suppliers, including foreign governments in countries
in which Takeda operates, or on other facets of its business; the
timing and impact of post-merger integration efforts with acquired
companies; the ability to divest assets that are not core to
Takeda’s operations and the timing of any such divestment(s); and
other factors identified in Takeda’s most recent Annual Report on
Form 20-F and Takeda’s other reports filed with the U.S. Securities
and Exchange Commission, available on Takeda’s website
at:https://www.takeda.com/investors/reports/sec-filings/ or at
https://www.sec.gov. Takeda does not undertake to update any of the
forward-looking statements contained in this press release or any
other forward-looking statements it may make, except as required by
law or stock exchange rule. Past performance is not an indicator of
future results and the results or statements of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast, guarantee or projection of Takeda’s future results.
For more information, visit
https://www.takeda.com.
Contact:
Y-mAbs Therapeutics, Inc.230 Park Avenue, Suite 3350New York, NY
10169USA+1 646 885 8505E-mail: info@ymabs.com |
Takeda Israel Ltd,25 Efal St., Kiriat Arie Petach TikvaIsraelMedia
contacts:Michal Zagon Rogel+972-3-3733140E-mail:
michal.zagon-rogel@takeda.com |
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