No definitely not. We are still not sure whether IMM are going it alone into phase III or they will strike a deal with one of the pharmas who will take it forward. If it is the former we will get an RNS appointing a CRO and notification of a drawdown on the Darwin facility. If it's the latter then we'll get an RNS announcing the deal.
At the moment all IMM have told us is that they are continuing negotiations and the appointment of Torreya Partners would suggest that their preferred route is a deal. Either way phase III is definitely not underway.
The natives are growing restless. My reply is that RNSs from IMM are few and far between. The next Preliminary Results RNS should be out around April 9th. News then? Or just, "discussions with Torreya are ongoing"?
COPYOF RNS DATED AS LO-------NG AGO AS NOVEMBER 2011... ( Two Thousand & Eleven ) Thu, 3rd Nov 2011 07:00 RNS Number : 4007R Immupharma PLC 03 November 2011
FOR IMMEDIATE RELEASE 3 NOVEMBER 2011
ImmuPharma's Lupuzor™ 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™.
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 progressi
pomander, yes, you are probably wright. I'm sure that Big Pharma has no interest in a tiny 400 patient trial costing just £30m which if successful brings in $1bn-6bn / year. They have great pipelines, wonderful lupus drugs on the market and no patent cliffs. ;-)
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