Immupharma PLC Preparation of Lupuzor'sT Regulatory Submissions (7616R)
September 26 2017 - 2:00AM
UK Regulatory
TIDMIMM
RNS Number : 7616R
Immupharma PLC
26 September 2017
RNS : FOR IMMEDIATE RELEASE 26 September 2017
ImmuPharma PLC
("ImmuPharma" or the "Company")
ImmuPharma initiates preparation of Lupuzor's(TM) regulatory
submissions
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and
development company, is pleased to confirm a further update on
Lupuzor(TM) its lead programme for the potential breakthrough
compound for Lupus, the life threatening auto-immune disease.
On 21 September 2017 ImmuPharma announced that that all patients
in the Company's pivotal Phase III Lupuzor(TM) study had passed the
six month stage, with 52 patients (26%) having now completed the
full 12 months of the study. Importantly this announcement also
confirmed the continuation of a robust safety record and that the
trial remains on track to report the top line results by the end of
Q1 2018.
With the trial progressing as planned, ImmuPharma is planning
ahead in anticipation of the trial's successful outcome. In
consultation with its regulatory advisors, the Company is now
progressing the completion of the regulatory dossiers in
preparation for submission to the Food and Drug Administration
(FDA) and European Medicines Agency (EMA). This includes the
finalisation of the Drug Master File ('DMF') and in particular the
manufacture of commercial batches of the Lupuzor(TM) drug. These
will be manufactured according to the described procedures in the
DMF, to be ready for inclusion in these regulatory submissions.
Commenting on the announcement, Robert Zimmer MD, PhD President
and Chief Scientific Officer said: "We are delighted with the
progress of the Lupuzor(TM) Phase III trial and are looking forward
with confidence and planning for a successful outcome for the
study. In consultation with our regulatory advisors, we are now
completing the required regulatory dossiers to be submitted to the
FDA and EMA as part of their approval process. We are keen to
ensure that there are no delays in submission to enable us to fully
exploit our 'fast track' status, previously granted by the FDA, so
that the Company's package will be reviewed within 6 months of
submission."
For more information on the trial please visit:
www.ClinicalTrials.gov (Search term 'Lupuzor').
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014.
-Ends-
For further information please
contact:
+ 44 (0) 20
ImmuPharma plc (www.immupharma.org) 7152 4080
Tim McCarthy, Chairman
Lisa Baderoon, Head of Investor
Relations + 44 (0) 77
Twitter: @immupharma 2141 3496
Northland Capital Partners Limited
(Joint Broker)
Patrick Claridge, David Hignell,
Jamie Spotswood Corporate Finance + 44 (0) 20
Rob Rees, Corporate Broking 3861 6625
Notes to Editors
ImmuPharma PLC
ImmuPharma is a pharmaceutical development company listed since
2006 on AIM of the London Stock Exchange (LSE:IMM), focusing on
developing novel medicines with high sales potential in specialist
markets with serious unmet need. ImmuPharma is led by a
commercially focused Board and management team with extensive
experience.
Lupuzor(TM)
Lupuzor(TM) (also referred to as Forigerimod, or P140) is
ImmuPharma's lead compound and a potential treatment for lupus (or
Systemic Lupus Erythematosus), a chronic, potentially
life-threatening auto-immune disease. Lupuzor(TM) has a novel
mechanism of action aimed at modulating the body's immune system so
that it does not attack healthy cells, and avoids causing adverse
side effects. It has the potential to halt the progression of the
disease in a substantial proportion of patients.
Lupuzor(TM) has been granted Fast Track status by the US FDA and
approval to start Phase III under Special Protocol Assessment
(SPA). This SPA was subsequently amended due to its strong safety
and efficacy profile to allow for a reduced number of patients in
the pivotal Phase III trial thereby reducing the projected cost and
time of development considerably.
The pivotal Phase III clinical study is entitled "A 52-Week,
Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study
to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101
Plus Standard of Care in Patients With Systemic Lupus
Erythematosus". It is a pivotal study designed to demonstrate the
safety and efficacy of IPP-201101 and as a last step prior to the
filing of the drug for approval with the US Food & Drug
Administration ("FDA") and the European Medicines Agency ("EMA").
For more information please visit:
www.ClinicalTrials.gov/lupuzor
Commercial Opportunity
There are an estimated five million people globally suffering
from Lupus, with approximately 1.5 million patients in the US,
Europe and Japan (Source: Lupus Foundation of America). Current
'standard of care' treatments, including steroids and
immunosuppressants, can potentially have either serious side
effects for patients or limited effectiveness, with over 60% of
patients not adequately treated. GSK's Benlysta is the first Lupus
drug approved in over 50 years and paves the path to market for
Lupuzor(TM). Based on conservative estimates, and taking into
account that Benlysta is priced currently at approximately $30,000
per patient per year, Lupuzor(TM) would be entering a market with
the potential for multi-billion dollar sales. For more information
on Lupuzor(TM) please visit: www.lupuzor.com
This information is provided by RNS
The company news service from the London Stock Exchange
END
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