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lilotomab satetraxetan) has received a positive opinion from the European
Medicines Agency (EMA) on the application for orphan drug designation for the
treatment of marginal zone lymphoma (MZL). The positive opinion is expected to
be adopted by the European Commission shortly.
In the LYMRIT 37-01 Phase 1/2a trial, Betalutin® showed a highly encouraging 78%
overall response rate (ORR) and 44% complete response (CR) in the MZL patient
group (n=9) - the highest response rates of any patient sub-population in this
study. This followed a once-only administration of Betalutin® in this heavily
pre-treated group of patients with advanced disease.
MZL is a form of indolent (slow-growing) B-cell non-Hodgkin’s lymphoma (NHL)
that accounts for approximately eight percent of all NHL cases. EMA orphan
designation is designed to encourage the development of new treatments for life
-threatening or chronically debilitating conditions that are rare (affecting not
more than five in 10,000 people in the European Union). Medicines that meet the
EMA’s orphan designation criteria qualify for several incentives to help support
advancement.
Betalutin® received Orphan Drug Designation for the treatment of follicular
lymphoma in the US and Europe in 2014.
Lars Nieba, Interim Chief Executive Officer, commented “We are very pleased to
receive a positive opinion on Orphan Drug Designation in the European Union for
Betalutin® in MZL. There is a clear need for new therapeutic options for MZL
patients who no longer respond to anti-CD20 immunotherapy (rituximab), the
current backbone of treatment in first and second-line patients. We look forward
to receiving the final decision by the European Commission in the coming
weeks.”
For further information, please contact:
IR enquiries
Malene Brondberg, CFO
Cell: +44 7561 431 762
Email: ir@nordicnanovector.com
Media Enquiries
Mark Swallow/Frazer Hall/David Dible (Citigate Dewe Rogerson)
Tel: +44 203 926 8535
Email: nordicnanovector@citigatedewerogerson.com
About Nordic Nanovector:
Nordic Nanovector is committed to develop and deliver innovative therapies to
patients to address major unmet medical needs and advance cancer care. The
Company aspires to become a leader in the development of targeted therapies for
haematological cancers.Nordic Nanovector’s lead clinical-stage candidate is
Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to
advance the treatment of non-Hodgkin’s lymphoma (NHL). NHL is an indication with
substantial unmet medical need, representing a growing market forecast to be
worth nearly USD 29 billion by 2026. Nordic Nanovector retains global marketing
rights to Betalutin® and intends to actively participate in the
commercialisation of Betalutin® in the US and other major markets.Further
information can be found at www.nordicnanovector.com.
Forward-looking statements
This press release contains certain forward-looking statements. These
statements are based on management’s current expectations and are subject to
uncertainty and changes in circumstances, since they relate to events and depend
on circumstances that will occur in the future and which, by their nature, will
have an impact on Nordic Nanovector’s business, financial condition and results
of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”,
“estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”,
“should”, “projects”, “targets”, “will”, “would” or, in each case, their
negative, or other variations or comparable terminology are used to identify
forward-looking statements. These forward-looking statements are not historic
facts. There are a number of factors that could cause actual results and
developments to differ materially from those expressed or implied in the forward
-looking statements. Factors that could cause these differences include, but are
not limited to, risks associated with implementation of Nordic Nanovector’s
strategy, risks and uncertainties associated with the development and/or
approval of Nordic Nanovector’s product candidates, ongoing and future clinical
trials and expected trial results, the ability to commercialise Betalutin®,
technology changes and new products in Nordic Nanovector’s potential market and
industry, Nordic Nanovector’s freedom to operate (competitors patents) in
respect of the products it develops, the ability to develop new products and
enhance existing products, the impact of competition, changes in general economy
and industry conditions, and legislative, regulatory and political factors. No
assurance can be given that such expectations will prove to have been correct.
Nordic Nanovector disclaims any obligation to update or revise any forward
-looking statements, whether as a result of new information, future events or
otherwise.
This information is subject to a duty of disclosure pursuant to Sections 4-2 and
5-12 of the Securities Trading Act.
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