Immupharma PLC Update : FDA confirms 4 Dec for Type 'A' meeting (9464F)
20 Novembre 2020 - 08:00AM
UK Regulatory
TIDMIMM
RNS Number : 9464F
Immupharma PLC
20 November 2020
20 November 2020
ImmuPharma PLC
("ImmuPharma" or the "Company")
FDA confirms 4 December 2020 for Type 'A' meeting to discuss
guidance on forthcoming international Phase 3 trial of Lupuzor(TM)
in Lupus patients
ImmuPharma PLC (LSE:IMM) (Euronext Growth Brussels: ALIMM), the
specialist drug discovery and development company, announces an
update on the announcement issued on 10 November 2020, in respect
to the new optimised international Phase 3 trial of Lupuzor(TM) in
systemic lupus erythematosus ("SLE"), a potentially
life-threatening auto-immune disease.
The US Food & Drug Administration ("FDA") has now confirmed
the date of 4 December 2020 for a Type 'A' Meeting Request, with
Avion Pharmaceuticals ("Avion"), ImmuPharma's licensing partner for
Lupuzor(TM).
As part of the Type 'A' Meeting, Avion has asked the FDA for
guidance on the following:
-- Key aspects of the study design, clinical end points and
approval process for Lupuzor(TM); and
-- Consideration by the FDA for a conditional approval of
Lupuzor(TM), whilst the Phase 3 trial is underway.
ImmuPharma will provide an update as soon as Avion has met with
the FDA and notified ImmuPharma of the outcome.
Commenting on the announcement, Dimitri Dimitriou, CEO of
ImmuPharma said :
"ImmuPharma and Avion are delighted that the FDA are expediting
the Type 'A' Meeting for early December 2020. We look forward to
providing a further update to the market following confirmation
from Avion of the FDA's guidance post this meeting."
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014. ("MAR")
For further information please contact:
ImmuPharma PLC ( www.immupharma.com )
Tim McCarthy, Chairman + 44 (0) 207 152 4080
Dimitri Dimitriou, Chief Executive Officer
Lisa Baderoon, Head of Investor Relations + 44 (0) 7721 413496
SPARK Advisory Partners Limited (NOMAD)
Neil Baldwin
Stanford Capital Partners (Joint Broker) +44 (0) 203 36 8 3550
Patrick Claridge
John Howes
Bob Pountney +44 (0) 203 815 8880
SI Capital (Joint Broker)
Nick Emerson +44 (0) 1483 413500
4Reliance (Euronext Growth Listing Sponsor) +32 (0) 2 747 02 60
Jean-Charles Snoy
Degroof Petercam (Liquidity Provider) +32 (0) 2 287 95 34
Erik De Clippel
Backstage Communication
Olivier Duquaine +32 (0) 477 504 784
Gunther De Backer +32 (0) 475 903 909
Notes to Editors
About ImmuPharma PLC
ImmuPharma PLC (LSE AIM: IMM - Euronext Growth: ALIMM) is a
specialty biopharmaceutical company that discovers and develops
peptide-based therapeutics. The Company's portfolio includes novel
peptide therapeutics for autoimmune diseases, metabolic diseases,
anti-infectives and cancer. The lead program, Lupuzor(TM), is a
first-in class autophagy immunomodulator which is in Phase 3 for
the treatment of lupus and preclinical analysis suggest therapeutic
activity for many other autoimmune diseases that share the same
autophagy mechanism of action. ImmuPharma and Avion Pharmaceuticals
signed on 28 November 2019, an exclusive licence and development
agreement and trademark agreement for Lupuzor(TM) to fund a new
international Phase 3 trial for Lupuzor(TM) and commercialise in
the US.
For additional information about ImmuPharma please visit
www.immupharma.co.uk
ImmuPharma's LEI (Legal Entity Identifier) code:
213800VZKGHXC7VUS895.
About Avion Pharmaceuticals LLC
Avion Pharmaceuticals, LLC, is a specialty pharmaceutical
company formed to develop, acquire and market a portfolio of
innovative pharmaceutical products in the Women's Health and other
therapeutic categories aligned with its mission to improve the
quality of patient lives. Avion Pharmaceuticals focuses on
identifying opportunities to develop, acquire and enhance the
market potential of innovative, commercially available therapeutics
and late-stage development drugs to fulfil unmet medical needs. For
more information, visit www.avionrx.com .
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