28 January 2025
Nuformix
plc
("Nuformix" or the "Company")
NXP002 Orphan Drug
Designation Application Submitted
Nuformix plc (LSE:NFX), a
pharmaceutical development company targeting unmet medical needs in
fibrosis and oncology via drug repurposing, is pleased to announce,
further to the Company's announcement on 13 January 2025, that it
has submitted an application to the European Medicines Agency
("EMA") regarding Orphan Drug Designation ("ODD") for the Company's
lead asset NXP002, a potential novel inhaled treatment for
Idiopathic Pulmonary Fibrosis ("IPF"). The application
follows an earlier pre-submission meeting to discuss the Company's
draft application document, following which the Company was advised
to proceed.
Following submission, the
application is assigned two coordinators:
· one
member of the Committee for Orphan Medicinal Products ("COMP");
and
· one
scientific administrator from the EMA secretariat.
A summary report on the application
will be prepared by the coordinators and circulated to all COMP
members and discussed at the COMP's next plenary meeting. The
COMP will then either adopt a positive opinion or raise a list of
questions and invite a Nuformix representative to an oral
explanation at the next COMP plenary meeting.
The COMP is expected to adopt an
opinion by day 90 of the procedure. It then forwards this to
the European Commission for adoption of a decision. The
European Commission issues a decision on a COMP opinion within 30
days of receipt.
Further information regarding
applications to the EMA for ODD can be found at
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development/applying-orphan-designation
The Company is also pleased to
confirm that constructive discussions continue with a number of
potential partners with a view to the Company securing an
out-licence or option agreement for NXP002.
Enquiries:
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Nuformix plc
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Dr Dan Gooding, Executive
Director
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Via IFC Advisory
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CMC
Markets
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Douglas Crippen
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+44 (0) 20 3003 8632
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IFC
Advisory Limited
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Tim Metcalfe
Zach Cohen
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+44 (0) 20 3934 6630
nuformix@investor-focus.co.uk
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About Nuformix
Nuformix is a pharmaceutical
development company targeting unmet medical needs in fibrosis and
oncology via drug repurposing. The Company aims to use its
expertise in discovering, developing and patenting novel drug
forms, with improved physical properties, to develop new products
in new indications that are, importantly, differentiated from the
original (by way of dosage, delivery route or presentation), thus
creating new and attractive commercial opportunities.
Nuformix has a pipeline of preclinical assets with potential for
significant value and early licensing opportunities.
