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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

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