NEW YORK, June 25, 2021 (GLOBE NEWSWIRE) – Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (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 the designation of orphan drug (“OMPD”) in the European Union (“EU”) for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma. The positive opinion of the EMA 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 a global plan aimed at expanding the Company’s European development programs and ultimately obtaining the exclusivity of orphan drugs to protect 177Lu-omburtamab-DTPA for the treatment of medulloblastoma in the EU.
Under EMA Regulation (EC) No 141/2000, an orphan drug designation gives companies access to an assistance protocol and advice to prepare a case that will meet European regulatory requirements and maximize thus the chances of approval at the time of marketing authorization. Once approved, an orphan drug also benefits from a 10-year market exclusivity during which similar directly competing products cannot normally be placed on the market.
The EMA grants the orphan drug designation based on several criteria, including: the potentially fatal and debilitating nature of the disease; the medical plausibility of the proposed orphan indication; a prevalence in Europe of less than five cases per 10,000 inhabitants; there is no satisfactory method of diagnosis, prevention or treatment or, if such a method exists, the drug will be of significant benefit to those affected by this condition.
Y-mAbs Founder, Chairman and Chairman Thomas Gad said: “We are very pleased that COMP has issued a favorable opinion for an orphan drug designation at 177Lu-omburtamab-DTPA which will give us a series of development incentives.
Dr Claus Moller, Chairman and CEO, adds: “We believe the orphan designation strengthens our opportunity to bring 177Lu-omburtamab-DTPA for patients who are in desperate need of alternative methods of treatment. In addition, the designation marks an important step in the expansion of Y-mAbs in European development.
MSK researchers developed omburtamab, which is exclusively licensed by MSK at Y-mAbs. As a result of this license agreement, MSK has institutional financial interests in the product.
Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel antibody-based therapeutics for the treatment of cancer. The Company has a broad portfolio of advanced products, including an FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and a pivotal stage candidate, omburtamab, which targets tumors that express B7-H3.
Statements in this press release regarding future expectations, plans and prospects, as well as any other statements regarding matters which are not historical facts, may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act. from 1995. These statements include, but are not limited to, statements about our business model and our product development, marketing and distribution plans; current and future clinical and preclinical studies and our research and development programs; expectations related to the timing of initiation and completion of regulatory submissions; regulatory, marketing and reimbursement approvals; rate and degree of market acceptance and clinical utility as well as price and reimbursement levels; retain and hire key employees; our marketing, marketing and manufacturing capabilities and strategy; our position and strategy on intellectual property; additional product candidates and technologies; strategic collaborations or partnerships and their potential benefits; expectations regarding the use of our cash and cash equivalents, and the necessity, timing and amount of any future financing transactions; our financial performance, including our estimates of income, expenses, capital expenditure requirements; developments relating to our competitors and our industry; and other statements which are not historical facts. Words such as ” anticipate, ” ” believe, ” “contemplate”, ” continue ”, ” might, ” ” estimate, ” ” wait, ” “hope”, ” intend, ” ” may, ” ” might, ” ” plan, ” ” potential, ” ” predict, ” ” project, ” ” should, ” ‘ ‘target,’ ” will ‘,’ ” and similar phrases are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Our product candidates and associated technologies are new approaches to cancer treatment that present significant challenges. Actual results may differ materially from those indicated by these forward-looking statements due to various factors, including, but not limited to: risks associated with our financial condition and the need for additional capital; risks associated with our development work; the cost and success of our product development and clinical trial activities; risks of delays in the timing of our regulatory submissions or of not obtaining approval for our drug candidates; risks associated with the commercialization of any approved pharmaceutical product, including the rate and degree of market acceptance of our product candidates; the development of our sales and marketing capabilities and the risks associated with the inability to obtain sufficient reimbursement for our products; risks related to our dependence on third parties, including for the conduct of clinical trials and the manufacture of products; our inability to enter into partnerships; risks associated with government regulations; risks associated with market approval; risks associated with the protection of our intellectual property rights; risks associated with employee issues and growth management; risks associated with our common stocks, 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 section “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the SEC and in our other filings with the SEC. All forward-looking statements contained in this press release speak only as of the date hereof, and the Company assumes no obligation to update any forward-looking statements, whether as a result of new information, events future or otherwise.
“DANYELZA” and “Y-mAbs” are registered trademarks of Y-mAbs Therapeutics, Inc.
Y-mAbs Therapeutics, Inc.
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