REG - Immupharma PLC - Update on submission to the FDA

ImmuPharmaAnnouncement

11/09/2020 08:00

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™ 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™'s Phase III trial in Lupus patients.
  
In ImmuPharma's discussions with Avion Pharmaceuticals ("Avion"), ImmuPharma's licensing partner for Lupuzor™, 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) 
Patrick Claridge
John Howes
Bob Pountney 
 
SI Capital (Joint Broker)
Nick Emerson
 


+44 (0) 203 368 3550
 
 
+44 (0) 203 815 8880
 
 
+44 (0) 1483 413500
 
 




4Reliance (Euronext Growth Listing Sponsor)
Jean-Charles Snoy
 
Degroof Petercam (Liquidity Provider)
Erik De Clippel
 
Backstage Communication
Olivier Duquaine
Gunther De Backer


+32 (0) 2 747 02 60
 
 
+32 (0) 2 287 95 34
 
 
 
+32 (0) 477 504 784
+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™, 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™ to fund a new international Phase III trial for Lupuzor™ 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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