Last checked at 31 Jul 2013 07:00
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 Officer | +44 20 7152 4080 |
Robert Zimmer, President & Chief Scientific Officer | +33 389 66 13 22 |
Richard Warr, Chairman
| +44 20 7152 4080 |
Lisa Baderoon, Head of Investor Relations | +44 7721 413 496 |
Panmure Gordon & Co | +44 20 7886 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, LupuzorTM 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 £50m 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