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 a license agreement with SciClone
Pharmaceuticals International Ltd (“SciClone”) to be the exclusive
co-development and commercialization partner 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 in China.
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. The Company plans to resubmit its
Biologics License Application (“BLA”) to the FDA for omburtamab by
the end of 2020 or in early 2021.
The license agreement includes Greater China,
including Mainland China, Taiwan, Hong Kong and Macau. Under the
terms of the agreement, SciClone will employ its development,
sales, marketing and regulatory expertise to commercialize DANYELZA
and omburtamab, if approved, in the territory. All other
unpartnered geographies worldwide remain with the Company. Under
the terms of the agreement, SciClone will pay Y-mAbs a $20 million
upfront payment with the potential for Y-mAbs to receive up to $100
million in additional development, regulatory and sales milestone
payments for both programs, as well as double-digit royalties on
net sales for DANYELZA and omburtamab in the territory.
“We are very pleased to enter this license
agreement with SciClone, and hope to see a DANYELZA and omburtamab,
if approved, being made available to appropriate children with
unmet medical needs in China. This partnership marks an important
milestone in our aim to make our lead product and product candidate
globally available,” said Thomas Gad, founder, Chairman and
President at Y-mAbs.
“DANYELZA and omburtamab were initially
identified and sourced from Memorial Sloan Kettering Cancer Center
in New York, and have been developed by Y-mAbs as novel therapies.
We believe these antibodies show great promise,” said Hong Zhao,
President and Chief Executive Officer of SciClone. “We are excited
to partner with Y-mAbs team to commercialize DANYELZA for the
treatment of relapsed/refractory high-risk neuroblastoma and
omburtamab for the treatment of pediatric patients with
CNS/leptomeningeal metastasis from neuroblastoma, if approved. This
strategic partnership recognizes SciClone’s capability as a leading
biotech company with integrated platform of development and
commercialization.”
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 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 SciClone Pharmaceuticals
(Holdings) Limited
SciClone Pharmaceuticals (Holdings) Limited is a
leading biopharmaceutical company with an integrated platform for
product development and commercialization, focusing on some of the
largest and fast-growing therapeutics areas with significant unmet
medical needs in China, primarily including oncology and severe
infection. Leveraging their integrated platform, SciClone has a
proven track record in developing and commercializing a balanced
portfolio of high-quality marketed products and innovative pipeline
drugs in their focused therapeutic areas. For more information
regarding to SciClone, go to: http://www.sciclone.com/
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 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 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.
Contact:
Y-mAbs
Therapeutics, Inc. |
For SciClone
Pharmaceuticals |
230 Park Avenue, Suite 3350 |
CEO Office |
New York, NY 10169 |
|
USA |
|
+1 646 885 8505 |
+852 29592922 |
E-mail: info@ymabs.com |
Email: CEOoffice@sciclone.com |
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