Less Ads, More Data, More Tools Register for FREE

Pin to quick picksImmupharma Regulatory News (IMM)

Share Price Information for Immupharma (IMM)

London Stock Exchange
Share Price is delayed by 15 minutes
Get Live Data
Share Price: 2.10
Bid: 2.02
Ask: 2.20
Change: -0.03 (-1.41%)
Spread: 0.18 (8.911%)
Open: 2.10
High: 2.10
Low: 2.10
Prev. Close: 2.13
IMM Live PriceLast checked at -

Watchlists are a member only feature

Login to your account

Alerts are a premium feature

Login to your account

LupuzorT granted approval to start phase III

3 Nov 2011 07:00

RNS Number : 4007R
Immupharma PLC
03 November 2011
 



FOR IMMEDIATE RELEASE 3 NOVEMBER 2011

 

Immupharma plc

ImmuPharma's Lupuzorâ„¢ 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 Lupuzorâ„¢.

 

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 Lupuzorâ„¢ 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 Lupuzorâ„¢, 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'sâ„¢ 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 Lupuzorâ„¢.

 

Commenting on the positive update and the prospects for Lupuzorâ„¢, ImmuPharma's Chief Executive Officer, Dimitri Dimitriou, said:

 

"We are excited about the prospects of Lupuzorâ„¢, 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 496Mark 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
 
 
MSCUGGQUGUPGGBP
Date   Source Headline
7th Feb 20077:01 amRNSBoard Changes
19th Jan 20078:57 amRNSTotal Voting Rights
5th Jan 20072:27 pmRNSIssue of Equity
27th Dec 20062:53 pmRNSTotal Voting Rights
21st Dec 20067:01 amRNSIssue of Equity
30th Oct 20067:01 amRNSFurther Phase II Data
17th Oct 20067:00 amRNSPhase II Data
2nd Oct 20067:01 amRNSFDA Meeting on Lupus
26th Sep 20067:01 amRNSInterim Results
1st Aug 20067:01 amRNSPreliminary Results
5th Jul 20067:00 amRNSStart of phase II trial
12th Jun 20065:04 pmRNSAccounting reference dates
10th May 20067:00 amRNSPhase 1 Lupus results
11th Apr 20067:00 amRNSResearch Grants
15th Feb 20061:56 pmRNSResult of EGM and Placing
24th Jan 20064:30 pmRNSSch 1 Update - ImmuPharma plc
23rd Jan 20064:27 pmRNSCirc re. ImmuPharma posted
30th Nov 20051:38 pmRNSInterim Results
27th May 20051:29 pmRNSFinal Results

Due to London Stock Exchange licensing terms, we stipulate that you must be a private investor. We apologise for the inconvenience.

To access our Live RNS you must confirm you are a private investor by using the button below.

Login to your account

Don't have an account? Click here to register.

Quickpicks are a member only feature

Login to your account

Don't have an account? Click here to register.