Immupharma PLC
10 July 2007
For Immediate Release 10 July 2007
ImmuPharma PLC
ImmuPharma submits file to the FDA for
pivotal phase II/III trial in Lupus patients
ImmuPharma PLC (LSE:IMM), ('ImmuPharma' or the 'Company'), the specialist drug
discovery and development company, announced today that it has just submitted an
IND (Investigational New Drug) file to the US Food and Drug Administration (FDA)
for the initiation of a pivotal phase II/III trial for its drug IPP-201101 in
patients suffering from Systemic Lupus Erythematosus.
Following a previous meeting with the FDA and subsequent feedback announced in
October 2006 and the positive outcome of the phase II study showing
statistically significant clinical efficacy in patients with Lupus, ImmuPharma
has now filed with the FDA an IND for the pivotal phase II/III trial. This
proposed phase II/III double blind, randomized, placebo controlled, multicentre
study will include 240 patients treated during 12 months all in line with the
FDA guidelines. It will take place in the US, Europe and Latin America and is
expected to complete in early 2009.
If the phase II/III trial is positive, based on the feedback previously received
from the FDA, the drug could be granted fast track approval (6 month review
time) and receive US marketing authorisation at the end of 2009 / early 2010.
Similar filings will also be made in key European and Latin American countries
in the next few weeks.
For further information please contact:
ImmuPharma PLC:
Dimitri Dimitriou, Chief Executive +44 20 7152 4080
Officer
Dr Robert Zimmer, President & Chief + 33 389 32 76 50
Scientific Officer
Richard Warr, Chairman +44 20 7152 4080
Buchanan Communications + 44 20 7466 5000
Lisa Baderoon
Rebecca Skye Dietrich
Teather & Greenwood Limited +44 20 7426 7710
Thilo Hoffmann
Notes to Editors:
About ImmuPharma
ImmuPharma PLC is a drug discovery and development company headquartered in
London, UK and quoted on AIM of the London Stock Exchange (LSE:IMM). It has
research operations in France (ImmuPharma (France) SA) and Switzerland
(ImmuPharma AG). ImmuPharma is dedicated to the development of novel drugs,
largely based on peptide therapeutics, to treat serious medical conditions such
as autoimmune diseases characterised by:
* blockbuster potential in niche markets
* low promotional costs in few specialised physicians and centres and
* lower risk of drug development and lower development costs
ImmuPharma is a currently developing drug candidates for three different medical
conditions, each of which would represent a significant breakthrough in its
field. The furthest advanced drug candidate targets Lupus, a disease for which
there is currently no cure or specific treatment. The other two address moderate
to severe pain (such as that experienced by cancer sufferers and post-operative
patients), and MRSA and similar severe hospital-acquired resistant infections.
All three have significant sales potential as well as low marketing costs and a
relatively low risk of development failure. One or more have the potential to be
fast-tracked by the US Food and Drug Administration according to 'Guidance for
Industry: Fast Track Drug Development Programs - Designation, Development and
Application Review' issued July 2004 and could therefore obtain their market
authorization by 2010.
Key to the potential success of ImmuPharma is its unique collaborative agreement
with Centre National de la Recherche Scientifique, France's scientific research
institution. This agreement grants ImmuPharma worldwide exclusive rights to
exploit certain key discoveries.
In addition to its three leading drug candidates, ImmuPharma has a drug
development pipeline using its rights to a virtual chemical library of hundreds
of thousands of molecules as well as an innovative technology for converting
peptides to drug candidates.
ImmuPharma has the option to commercialise its assets itself or to license them
to other pharmaceutical companies at an earlier stage.
The products
Treatment of Lupus (IPP-201101)
This is a long-term treatment for Lupus, a chronic, life-threatening autoimmune
disease where the immune system attacks healthy cells. There is currently no
cure and existing medications only treat the symptoms whereas ImmuPharma's drug
candidate has the potential to produce remission of the disease in a substantial
proportion of patients.
Based on independent forecasts, the value of ImmuPharma's Lupus drug is
estimated to be 'substantial' with peak annual sales forecast to generate in
excess of $4 billion.
Severe pain relief (IPP-102199)
ImmuPharma is developing a potential non-addictive compound for relieving
moderate to severe pain, such as experienced by cancer sufferers and
post-surgical patients. Most existing treatments are derived from the opiate
morphine and tend to have serious side effects. ImmuPharma's new treatment is
based on met-enkephalin, the body's internal analgesic. IPP-102199 is being
developed to have major advantages over morphine such as longer pain relief
duration and reduced side effects. The market for chronic opioids in the US
currently exceeds $3.5 billion and is growing by more than 10 to 20 per cent a
year.
Antibiotic for MRSA and similar highly resistant infections (IPP-203101)
This is a novel antibiotic to combat MRSA and other severe hospital-acquired,
resistant infections which affect some two million people in the US, according
to the US Centers for Disease Control and Prevention. ImmuPharma's drug
candidate is targeted at disrupting the membrane potential of the bacterial
pathogens. It is hoped this novel approach will reduce their potential to become
resistant.
This information is provided by RNS
The company news service from the London Stock Exchange
NRARLMLTMMBMBFR
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.