BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

ImmuPharma plc (IMM.L)'s Lupuzor™ Granted Approval to Start Phase III and Fast Track Designation by the FDA


11/3/2011 8:43:34 AM

November 03, 2011 -- ImmuPharma plc (LSE:IMM) (“Immupharma” or the “Company” or the “Group”), the specialist discovery and development pharmaceutical company is pleased to provide an update on the development status of its Lupus drug candidate Lupuzor™.

Following ImmuPharma’s IND (Investigational New Drug) filing with the FDA and the successful completion of the phase IIb study run by ImmuPharma, the Company licensed the global rights of Lupuzor™ to Cephalon in return of $45m upfront as part of a deal worth $500m plus royalties on product sales. As part of the deal, Cephalon became responsible for the continuation of development and as part of the overall development programme, they commenced an additional phase IIb study with a different formulation, which is still ongoing.

ImmuPharma recently regained rights to Lupuzor™, due to the acquisition of Cephalon by Teva Pharmaceutical Industries Ltd. Following the review of information from Cephalon the Company is pleased to report the highlights of Lupuzor’s™ development status:

- An “End of Phase 2” meeting package with ImmuPharma’s phase IIb data was submitted to the FDA and the FDA responded to all the questions.

- The IMPD (Investigational Medicinal Product Dossier) submitted via the Voluntary Harmonized Procedure (VHP) in the EU was approved.

- The Scientific Advice meeting with the European Medicines Agency (EMA) was held; the recommendations were very similar to those in the FDA’s “End of Phase 2” responses. Recommendations were incorporated into the phase III pivotal programme.

- The Japanese equivalent authorities (PMDA) have agreed to the initiation of clinical trials in Japan.

- The FDA has granted Lupuzor™ the approval to start phase III with a Special Protocol Assessment (“SPA”).

- The FDA has granted Lupuzor™ “Fast Track” designation.

- The commercial validation batches of the active ingredient of Lupuzor™ necessary for phase III have already been manufactured.

ImmuPharma is now in discussions with pharmaceutical companies for a corporate deal regarding Lupuzor™.

Commenting on the positive update and the prospects for Lupuzor™, ImmuPharma’s Chief Executive Officer, Dimitri Dimitriou, said:

“We are excited about the prospects of Lupuzor™, its progress in development and the approvals of the authorities in the US, Europe and Japan regarding its progression to the final stage of testing. The interest we are seeing already from pharma companies as potential partners gives us great confidence.”

For further information, please contact:

ImmuPharma PLC:

Dimitri Dimitriou, Chief Executive Officer

+44 (0) 20 7152 4080

Buchanan Communications

Lisa Baderoon

+ 44 (0) 7721 413 496

Mark Court

+44 (0) 20 7466 5000

Panmure, Gordon & Co., NOMAD & Broker

Andrew Burnett, Hannah Woodley

+44 (0) 20 7459 3600

Espirito Santo Investment Bank, Joint Broker

James Bromhead, Richard Crawley

+44 (0) 20 7456 9191



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES