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 announced today
that it has entered into an exclusive distribution agreement with
Adium Pharma S.A. (“Adium”) to be the exclusive distributor in
Latin America of the Company’s antibodies, DANYELZA®
(naxitamab-gqgk) for the treatment of patients with
relapsed/refractory high-risk neuroblastoma and omburtamab, if
approved, for the treatment of pediatric patients with
CNS/leptomeningeal metastasis from neuroblastoma.
DANYELZA (naxitamab-gqgk) 40mg/10mL was approved
by the U.S. Food and Drug Administration (“FDA”) on November 25,
2020 and 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.
Omburtamab is an investigational, monoclonal
antibody that targets B7-H3 and is radiolabeled before
intraventricular administration. B7-H3 is an immune checkpoint
molecule that is widely expressed in tumor cells of several cancer
types. In April 2021, the Company submitted a Marketing
Authorization Application (“MAA”) to the European Medicines Agency
for omburtamab for the treatment of pediatric patients with
CNS/leptomeningeal metastasis from neuroblastoma. The Company aims
to resubmit its Biologics License Application (“BLA”) to the FDA
for omburtamab by the end of the second quarter or in the third
quarter 2021.
The distribution agreement includes the
territories of Argentina, Belize, Bolivia, Brazil, Chile, Colombia,
Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala,
Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Uruguay, and
certain Caribbean islands. Under the terms of the agreement, Adium
will employ its sales and marketing expertise to distribute
DANYELZA and omburtamab, if approved, in the territory. In
addition, Adium will submit registration files on behalf of the
Company in certain parts of the territory. All other unpartnered
geographies worldwide remain with the Company. Financial details
were not disclosed.
“We are very pleased to enter this distribution
agreement with Adium, a company with a commercial presence in 18
countries and a sustained oncology and rare disease business. We
hope to leverage Adium’s footprint in Latin America to make
DANYELZA and omburtamab, if approved, available to children with
unmet medical needs,” said Thomas Gad, founder, Chairman and
President at Y-mAbs.
Researchers at Memorial Sloan Kettering Cancer
Center (“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 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 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.
About Adium
Adium is a private pharmaceutical company based
in Montevideo, Uruguay. Adium distributes its products in 18 Latin
American & Caribbean countries including Brazil, Mexico and
Colombia. Adium has been distributing products from leading
international companies in the field of Oncology, Urology,
Hematology and Rare Diseases, for more than 20 years. Adium
provides its partners a full set of local capabilities including
commercial, market access, regulatory and pharmacovigilance.
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
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’’ 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
associated with the pandemic caused by the 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 for the year ended December 31, 2020
filed with the SEC 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.
Contact: Y-mAbs Therapeutics, Inc. 230 Park
Avenue, Suite 3350New York, NY 10169USA
+1 646 885 8505
E-mail: info@ymabs.com
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