Immupharma PLC Update on submission to the FDA (7346Y)
11 September 2020 - 4:59PM
UK Regulatory
TIDMIMM
RNS Number : 7346Y
Immupharma PLC
11 September 2020
11 September 2020
ImmuPharma plc
("ImmuPharma" or the "Company")
Update on submission to the FDA for a Special Protocol
Assessment (SPA)
for the forthcoming international Phase III 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 27 July 2020, in respect to
the submission to the US Food & Drug Administration ("FDA") of
a SPA for Lupuzor(TM)'s Phase III trial in Lupus patients.
In ImmuPharma's discussions with Avion Pharmaceuticals
("Avion"), ImmuPharma's licensing partner for Lupuzor(TM), Avion
has confirmed that, whilst the review period by the FDA for an SPA
request is normally up to 45 days (which has now passed), Avion has
as yet not received a response from the FDA and as such the file is
still in the review queue, due to the current workload at the
FDA.
ImmuPharma will provide an update to the market as soon as Avion
has received a response from the FDA and notified ImmuPharma.
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, anti-infectives,
metabolic diseases and cancer. The lead program, Lupuzor(TM), is a
first-in class autophagy immunomodulator which is in Phase III for
the treatment of systemic lupus erythematosus (lupus / SLE). Lupus
is an autoimmune disease which if left untreated can be fatal.
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 III
trial for Lupuzor(TM) and commercialise in the US. For additional
information about ImmuPharma please visit www.immupharma.com.
ImmuPharma's LEI (Legal Entity Identifier) code:
213800VZKGHXC7VUS895.
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END
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