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
- 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
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:
Dimitri Dimitriou, Chief Executive Officer
+44 (0) 20 7152 4080
+ 44 (0) 7721 413 496
+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