Immupharma PLC FDA GRANTS IMMUPHARMA AMENDED SPA (5274K)
July 31 2013 - 2:00AM
UK Regulatory
TIDMIMM
RNS Number : 5274K
Immupharma PLC
31 July 2013
FOR IMMEDIATE RELEASE 31 JULY 2013
ImmuPharma PLC
FDA GRANTS IMMUPHARMA AMENDED SPA FOR LUPUZOR PHASE III;
COMPANY PROGRESSES DEVELOPMENT ACTIVITIES
ImmuPharma plc (LSE:IMM) ("ImmuPharma" or the "Company" or the
"Group"), the specialist drug discovery and development company, is
delighted to announce that following its discussions with the FDA
(the US Food & Drug Administraton), it has been granted an
updated SPA (Special Protocol Assessment) for Lupuzor.
Under the new SPA, the necessary number of patients for the
phase III programme has been reduced to 2 studies with 200 patients
each. This number is lower compared to other drugs in clinical
trials for lupus and underpins the significant efficacy shown by
Lupuzor. Furthermore, the design of the phase III study is similar
to that of the ImmuPharma phase IIb study.
ImmuPharma is now completing the manufacturing of the phase III
drug supplies as well as the CMC (chemistry manufacturing and
controls) section proving appropriate stability of the drug
product.
Commenting on the announcement, Dr Robert Zimmer, President
& Chief Scientific Officer of ImmuPharma, said: "The amended
SPA is a tremendous success and validation of our development
efforts and the reduced number of patients, due to the unrivalled
efficacy that Lupuzor has shown in phase IIb means that the cost of
the phase III trial will also be substantially lower. The phase III
programme has a similar design to our phase IIb study which
demonstrated substantial efficacy compared to other drugs in Lupus
clinical trials."
For further information please see the Group's web site,
www.immupharma.org, or contact:
ImmuPharma PLC
Dimitri Dimitriou, Chief Executive +44 20 7152
Officer 4080
Robert Zimmer, President & Chief +33 389 66 13
Scientific Officer 22
+44 20 7152
Richard Warr, Chairman 4080
Lisa Baderoon, Head of Investor +44 7721 413
Relations 496
+44 20 7886
Panmure Gordon & Co 2955
Hugh Morgan, Fred Walsh, Grishma
Patel (Corporate Finance)
Hannah Woodley (Corporate Broking)
Notes to Editors
ImmuPharma
ImmuPharma
ImmuPharma is focusing on developing novel medicines with high
sales potential in specialist markets with serious unmet need.
ImmuPharma has five drug candidates in development, two platform
technologies and approximately 70 patents. The Company's most
advanced drug candidate, Lupuzor(TM) a potential blockbuster drug
for Lupus, a chronic autoimmune disease has received the approval
from the US FDA to enter phase III with a Special Protocol
Assessment and "Fast Track" designation. Most recent news confirmed
a five year GBP50m funding facility from Darwin Strategic and the
establishment of a Scientific Advisory Board to provide scientific
advice and support for Lupuzor's pivotal phase III programme.
ImmuPharma was founded and is led by a commercially focused Board
and management team with extensive experience.
www.immupharma.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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