Full Press Release Details
177Lu-omburtamab-DTPA for the Treatment of Patients with Medulloblastoma Receives Positive Opinion on Orphan Medicinal Product
New York, NY, June 25, 2021
(GLOBE NEWSWIRE) - 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, today announced that the Committee for Orphan Medicinal Products ("COMP") of the European Medicines Agency
("EMA") has recommended the granting of orphan medicinal product designation ("OMPD") in the European Union ("EU")
for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma. The positive opinion from the EMA's COMP has been sent to
the European Commission ("EC"), which is expected to grant the orphan drug designation within 30 days.
Obtaining OMPD for 177Lu-omburtamab-DTPA
is part of an overall plan to expand the Company's European development programs and ultimately obtain orphan drug exclusivity
to protect 177Lu-omburtamab-DTPA for the treatment of medulloblastoma in the EU.
Under the EMA's Regulation (EC) No. 141/2000
an orphan medicinal product designation gives companies access to protocol assistance and guidance on preparing a dossier that will meet
European regulatory requirements and thereby maximize the chance of approval at the time of marketing authorization. Once approved, an
orphan drug is also granted 10 years of market exclusivity during which directly competitive similar products cannot normally be placed
The EMA grants orphan medicinal product designation
based upon several criteria, including: the life threatening and debilitating nature of the condition; the medical plausibility of the
proposed orphan indication; a prevalence in Europe of less than five cases for each 10,000 of population; no satisfactory method of diagnosis,
prevention or treatment exists or if such method exists the medicinal product will be of significant benefit to those affected by that
Y-mAbs' founder, Chairman and President,
Thomas Gad said, "We are very pleased that the COMP has issued a positive opinion for an orphan drug designation to 177Lu-omburtamab-DTPA
which will give us a string of development incentives."
Dr. Claus Moller, Chief Executive Officer further
notes, "We believe that the orphan designation strengthens our opportunity to bring 177Lu-omburtamab-DTPA to patients
who desperately need alternative methods of treatment. Further, the designation marks a substantial milestone in Y-mAbs' expansion
into European development."
Researchers at MSK developed omburtamab, which
is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the
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.
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
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words. Our product candidates and related technologies are novel approaches to cancer treatment that present significant challenges. Actual
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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
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and "Y-mAbs" are registered trademarks of Y-mAbs Therapeutics, Inc.