Full Press Release Details
SME Status by the European Medicines Agency
Comes with Financial and Scientific Incentives
FLORHAM PARK, N.J., June 1, 2020
-- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a clinical-stage biopharmaceutical company focused on the discovery, development
and commercialization of drugs for the treatment of cancer, today announced that it has been granted Small and Medium-Sized Enterprise
(SME) status by the European Medicines Agency's (EMA) Micro, Small and Medium-sized Enterprise (SME) office.
The newly granted SME status allows Cellectar
to participate in significant financial incentives that include a 90% to 100% EMA fee reduction for scientific advice, clinical
study protocol design, endpoints and statistical considerations, quality inspections of facilities and fee waivers for selective
EMA pre and post-authorization regulatory filings, including orphan drug and PRIME designations. Cellectar is also eligible to
obtain EMA certification of quality and manufacturing data prior to review of clinical data. Other financial incentives include
EMA-provided translational services of all regulatory documents required for market authorization, further reducing the financial
burden of the market authorization process.
"The receipt of our SME status is
timely as we prepare to engage the EMA for discussions to harmonize CLR 131's pivotal study," stated James Caruso,
president and chief executive officer. "SME status from the EMA, will allow Cellectar to pursue EU marketing authorization
in a more efficient and cost-effective manner and will greatly benefit our company as we advance CLR 131 to commercialization."
The EMA plays a central role in facilitating
the development and authorization of medicines across Europe. The SME initiative promotes innovation from smaller companies
like Cellectar to ensure Europe continues to be a favorable environment for preclinical and clinical development of promising
new therapeutic options like CLR 131. Detailed information on SME status can be found here.
Cellectar Biosciences is focused on the
discovery, development and commercialization of drugs for the treatment of cancer. The company is developing proprietary drugs
independently and through research and development collaborations. The company's core objective is to leverage its proprietary
Phospholipid Drug Conjugate (PDC) delivery platform to develop PDCs that specifically target cancer cells, delivering improved
efficacy and better safety as a result of fewer off-target effects. The company's PDC platform possesses the potential for
the discovery and development of the next-generation of cancer-targeting treatments, and it plans to develop PDCs independently
and through research and development collaborations.
The company's lead PDC therapeutic,
CLR 131, is currently in two clinical studies. The CLOVER-1 Phase 2 study completed the Part A dose-exploration portion, conducted
in relapsed/refractory (r/r) B-cell malignancies, and is now enrolling in the Part B expansion cohorts evaluating an approximate
100mCi total body dose of CLR 131 in relapsed/refractory (r/r) multiple myeloma (MM) and lymphoplasmacytic lymphoma/Waldenstrom's
macroglobulinemia (LPL/WM). The data from the Part A portion was announced on February 19, 2020. The company is also conducting
a Phase 1 dose-escalation study in pediatric solid tumors and lymphomas.
The company's product pipeline includes
one preclinical PDC chemotherapeutic program
(CLR 1900) and several partnered PDC assets.
For more information, please visit www.cellectar.com
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Forward-Looking Statement Disclaimer
This news release contains forward-looking
statements. You can identify these statements by our use of words such as "may," "expect," "believe,"
"anticipate," "intend," "could," "estimate," "continue," "plans," or
their negatives or cognates. These statements are only estimates and predictions and are subject to known and unknown risks and
uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements
are based on our current beliefs and expectations as to such future outcomes including our expectations of the impact of the recent
COVID-19 pandemic. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference
include, among others, uncertainties related to the ability to raise additional capital, uncertainties related to the disruptions
at our sole source supplier of CLR 131, the ability to attract and retain partners for our technologies, the identification of
lead compounds, the successful preclinical development thereof, patient enrollment and the completion of clinical studies, the
FDA review process and other government regulation, our ability to maintain orphan drug designation in the United States for CLR
131, the volatile market for priority review vouchers, our pharmaceutical collaborators' ability to successfully develop and commercialize
drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement. A complete description
of risks and uncertainties related to our business is contained in our periodic reports filed with the Securities and Exchange
Commission including our Form 10-K for the year ended December 31, 2019 and our Form 10-Q for the quarter ended March 31, 2020.
These forward-looking statements are made only as of the date hereof, and we disclaim any obligation to update any such forward-looking
statements. These forward looking statements are made only as of the date hereof, and we disclaim any obligation to update any
such forward-looking statements.