FDA Meeting on Lupus
Immupharma PLC
02 October 2006
FOR IMMEDIATE RELEASE 2 October 2006
ImmuPharma
Announces Summary of Meeting with FDA for design of development programme for
IPP-201101 treatment for Lupus
- Feedback reinforces model for potential fast track approval -
ImmuPharma PLC (LSE:IMM), the specialist drug discovery and development company,
announced today that it held a meeting with the United States Food and Drug
Administration ('FDA') on its IPP-201101 treatment for Lupus, a chronic,
life-threatening autoimmune disease.
The meeting was held following the successful completion of the phase I trial of
IPP-201101 and the initiation of the phase II trial, results of which are due to
be announced before year-end. The purpose of the meeting was to discuss
technical and scientific information and the proposed clinical protocol design
for IPP-201101.
Highlights
• The FDA stated their interest in IPP-201101 and believe the existing data
would support the proposed clinical development programme. The FDA also
provided useful advice on the construction of the remaining development
activities.
• IPP-201101 may be launched sooner than anticipated with a Phase 2/3 trial in
150 patients if a correlation is shown between the current phase II
biomarker end-points and clinical benefit.
• If development is completed successfully, marketing approval could be
granted through the FDA 'fast track mechanisms'. This will require only a 6
month review period.
Commenting on the announcement, Dr. Robert Zimmer, President and Chief
Scientific Officer, said 'We are very pleased with the outcome of our meeting
with the FDA and are grateful for their advice and input. It gives us further
confidence that we are developing a drug candidate to help patients suffering
from Lupus around the world.'
For further information please contact:
ImmuPharma PLC
Dr Robert Zimmer, President & Chief Scientific +33 389 32 76 50
Officer
Dimitri Dimitriou, Chief Executive Officer: +44 20 7152 4080
Richard Warr, Chairman: +44 20 7152 4080
Buchanan Communications + 44 20 7466 5000
Lisa Baderoon:
Rebecca Skye-Dietrich
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:
o blockbuster potential in niche markets
o low promotional costs in few specialised physicians and centres and
o 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)
Lupus is 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. By selectively modulating the aberrant T-cells in Lupus,
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 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 have serious side effects
associated with a morphine-like mechanism of action. ImmuPharma's new approach
is based on met-enkephalin, one of the body's internal analgesics. 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 counter the effects of 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
MRSA and other bacterial strains. It is hoped this novel approach will reduce
their potential to become resistant.
Key management
Richard Warr, MA, Chairman, has 20 years experience in investment banking and
the capital markets. He was previously a director of ABN Amro; director and head
of European sales and marketing at Credit Lyonnais; executive director at
Dresdner Kleinwort Benson Securities Ltd; and head of European equity
distribution at Swiss Bank Corporation. He has extensive experience in corporate
and governmental equity capital market transactions.
Dimitri F Dimitriou, MSc, Chief Executive Officer, has over 20 years experience
in the pharmaceutical and biotech industry. He was senior director, worldwide
business development, at GlaxoSmithKline, where his responsibilities included
licensing deals, alliances and collaborations on a worldwide basis.
Dr Robert Zimmer, MD, PhD, President and head of R&D, began his career with
Roche in Basle, where he was responsible for numerous Phase I studies. In 1990
he joined Jago in Basle and, on its acquisition by SkyePharma, became director
and head of research and development at SkyePharma. His expertise includes
managerial experience in multifunctional research and development and the
assessment of technologies with multi-national pharmaceutical companies.
Paddy Walker-Taylor, FCA, MCT Chief Financial Officer, was previously finance
director of Sir Robert McAlpine Ltd. He was involved in the AIM float of ISG
Group, in which McAlpine had a minority shareholding. Previously he had held a
number of key financial positions including finance director of Woolworths plc
and treasurer of Marks & Spencer.
Douglas Paterson, MA, FCA, senior Non-Executive Director, has been a chartered
accountant for 37 years and was a senior audit partner at Coopers & Lybrand (now
PricewaterhouseCoopers) for 22 years. He currently holds a number of
non-executive directorships, including Close Brothers Group plc and Goldman
Sachs International Bank.
Anthony Johnson, B Pharm, MSc, Non-Executive Director, has over 30 years
experience in the pharmaceutical industry, focused on the scientific aspects of
deal making, support during competitive analysis, technical due diligence and
input in development strategy. He was formerly senior director of scientific
licensing at SmithKline Beecham (now GlaxoSmithKline).
Collaboration with Centre National de la Recherche Scientifique (CNRS)
ImmuPharma has important collaboration arrangements with Centre National de la
Recherche Scientifique, France's scientific research institution, including a
research collaboration agreement relating to the therapeutic use of peptides and
peptide derivatives. ImmuPharma has been granted the worldwide exclusive rights
to exploit all discoveries made under this agreement. ImmuPharma will co-own the
relevant intellectual property with CNRS which will share in the revenue
generated by ImmuPharma from exploiting CNRS' licensed and co-owned rights.
This information is provided by RNS
The company news service from the London Stock Exchange