LupuzorT granted approval to start phase III (4007R)
November 03 2011 - 3:00AM
UK Regulatory
TIDMIMM
RNS Number : 4007R
Immupharma PLC
03 November 2011
FOR IMMEDIATE RELEASE 3 NOVEMBER 2011
Immupharma plc
ImmuPharma's Lupuzor(TM) granted approval to start phase III and
Fast Track designation by the FDA
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(TM).
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(TM) 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(TM), 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(TM) 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(TM) the approval to start phase
III with a Special Protocol Assessment ("SPA").
-- The FDA has granted Lupuzor(TM) "Fast Track" designation.
-- The commercial validation batches of the active ingredient of
Lupuzor(TM) necessary for phase III have already been
manufactured.
ImmuPharma is now in discussions with pharmaceutical companies
for a corporate deal regarding Lupuzor(TM).
Commenting on the positive update and the prospects for
Lupuzor(TM), ImmuPharma's Chief Executive Officer, Dimitri
Dimitriou, said:
"We are excited about the prospects of Lupuzor(TM), 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
This information is provided by RNS
The company news service from the London Stock Exchange
END
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