Research Update
Hutchison China Meditech Limited
02 July 2007
Hutchison China MediTech Limited ('Chi-Med')
(AIM: HCM)
Chi-Med Announces Positive Phase II Proof-of-Concept Data
for HMPL-004 in Ulcerative Colitis
London, Monday, 2 July 2007: Chi-Med, the Hutchison Whampoa backed
pharmaceutical and healthcare Group, today announces positive results for its
Phase II proof-of-concept study for HMPL-004 in mild-to-moderate Ulcerative
Colitis, a form of inflammatory bowel disease. The trial met its objective in
that HMPL-004 was well tolerated and showed an equivalent drop in clinical
symptom score to the comparator drug, Mesalazine, the current first-line
standard of care in mild-to-moderate Ulcerative Colitis.
The Phase II proof-of-concept study, conducted by Chi-Med's wholly-owned drug R&
D subsidiary, Hutchison MediPharma Limited ('Hutchison MediPharma'), was a
multi-center, randomized, double-blind, comparator study of 120 patients with
mild-to-moderate Ulcerative Colitis conducted in China. The study evaluated
HMPL-004 at 400mg taken three times a day, orally, compared to Mesalazine, the
current first-line standard of care. The four trial endpoints were patients:
clinical symptom score; overall clinical evaluation; colonoscopic score; and
safety evaluation. After treatment for eight weeks, the percentage of patient's
clinical symptom score reduction for HMPL-004 was 56% versus 59% for Mesalazine
in the Intent-To-Treat population. The overall remission rate (combination of
complete and partial remissions) for HMPL-004 was 57% by clinical score compared
to 53% for Mesalazine in the Intent-To-Treat population and 47% for HMPL-004
versus 42% for Mesalazine by colonoscopy in the Intent-To-Treat population.
HMPL-004 was well tolerated in the study and the adverse event rate was half
that of the Mesalazine group.
Chi-Med's extensive preclinical work with HMPL-004 has shown that HMPL-004 acts
on multiple cellular targets in the inflammatory signal transduction pathways
resulting in suppressed inflammation cytokine expression including TNF-alpha,
IL-1beta and IL-6. HMPL-004 was demonstrated to inhibit TNF-alpha and IL-1beta
production in cell-based assays and is also able to inhibit NF-kB activation.
The novel mechanism of action of HMPL-004, compared to current conventional
therapies, including Mesalazine, allows it to access a unique patient
population. Moreover, Mesalazine is well known to be effective in about 60% of
the patients it is used in and patients' resistance over long-term use is
common. The Directors believe that today's result is highly important because it
shows that HMPL-004 has a similar margin of effect yet offers a different
mechanism of action and therefore provides a direct alternative to the current
best standard of care. If ultimately approved, HMPL-004 will provide significant
commercial value to Chi-Med.
HMPL-004 is an orally active, proprietary botanical product that acts on
multiple targets in the pathogenesis of inflammation. It is a compound extracted
from a Chinese herb that has extensive history of use in China and South East
Asia against respiratory infections and inflammation. This documentation enabled
Chi-Med to accelerate the clinical process for HMPL-004 by by-passing Phase I
trials, based on the FDA's 2004 guidance on botanical drug products. HMPL-004 is
currently also in Phase II trial in the US for the treatment of Crohn's Disease.
Chi-Med has a further botanical candidate, HMPL-002, a radio-sensitizer for head
and neck and non-small cell lung cancer, which is in Phase I/II in the US and in
proof-of-concept study in China. Chi-Med's further pre-clinical drug development
pipeline is focused on oncology and auto-immune indications. These compounds
include synthetic and semi-synthetic single chemical entities in addition to
botanical and natural product candidates.
At the meeting of Hutchison MediPharma's Scientific Advisory Board held in
Shanghai, China in late-June 2007, the Board, which includes key opinion leaders
in the inflammatory bowel disease area, such as Dr. William J. Sandborn,
Professor of Medicine at the Mayo Clinic College of Medicine, Vice Chair of the
Division of Gastroenterology and Hepatology, and Director of the Inflammatory
Bowel Disease Interest Group of the Mayo Clinic and Dr. Stephan Targan, Director
of both the Inflammatory Bowel Disease Center and Division of Gastroenterology
at Cedars-Sinai Medical Center, Los Angeles expressed high enthusiasm over
HMPL-004.
Dr. Stephan Targan commented:
'HMPL-004 has a different mechanism of action. Based on the promising results
from this study, HMPL-004 is warranted for further clinical studies to fully
evaluate its efficacy and safety profile for the treatment of Ulcerative
Colitis.'
Dr. Samantha Du, Chief Scientific Officer of Chi-Med and Managing Director of
Hutchison MediPharma said:
'This is a significant milestone for us. We are encouraged by the positive
results from this study, which suggest HMPL-004 can be a novel class of
anti-inflammatory drug for the treatment of Ulcerative Colitis. We believe that
HMPL-004 has significant potential to bring patients another option for the
treatment of this chronic, painful and frequently recurring disease, which may
lead to abdominal surgery. We are looking forward to further clinical studies to
fully evaluate the clinical benefits of HMPL-004. Today's announcement further
validates our new drug discovery and development capability and will also
further accelerate recruitment in the on-going Phase II Crohn's Disease trial in
the US.'
Mr. Christian Hogg, CEO of Chi-Med, said:
'We are extremely pleased with the trial results, which fully meet our
expectations. Ulcerative Colitis and Crohn's Disease are core focus areas of our
R&D programme, and we also look forward to the delivery of the Phase II results
for HMPL-004 in Crohn's Disease after which we would seek to out-license this
product, in line with our stated strategy. Today's results once more also
highlight the potential of Traditional Chinese Medicine to provide a reservoir
for innovative new drugs for the global pharmaceutical market.'
Ends
Enquiries
Chi-Med Telephone: +852 2121 8200
Christian Hogg, CEO
Citigate Dewe Rogerson Telephone: +44 (0) 20 7638 9571
Anthony Carlisle +44 (0) 7973 611 888
Yvonne Alexander +44 (0) 7866 610 682
Notes to Editor
About Intestinal Bowel Disease
Ulcerative Colitis and Crohn's Disease are forms of inflammatory bowel disease,
which is considered an auto-immune disorder. They are chronic diseases which,
once they start, recur regularly and cannot currently be cured. Ulcerative
Colitis generally affects the large intestine and Crohn's Disease generally
affects the small intestine. Ulcerative Colitis is the inflammation of the gut,
which results in extensive ulceration of its inner surface with consequential
pain, loss of function and blood loss. The disease can require surgical removal
of sections of the gut and, in extreme cases, it may cause death. Crohn's
Disease displays similar but more severe laceration of the lining of the small
intestine.
Current first line treatments have effect on around 60% of patients. They can
cause adverse events such as nausea, heartburn, diarrhea and headaches. Second
line treatments can cause more severe adverse events and can be significantly
more expensive.
In 2005 in the US, Ulcerative Colitis affected approximately 347,000 patients,
an increase from around 300,000 patients in 2001. Potentially a further two to
three times as many individuals may suffer from Ulcerative Colitis but are
currently undiagnosed. Crohn's Disease is more prevalent with an estimated
558,000 cases in the US in 2005. The US market for Ulcerative Colitis drugs was
estimated to be US$420 million in 2002 and is expected to reach US$500 million
by 2012, a CAGR of four percent. The US market for Crohn's Disease drugs was
estimated to be US$590 million, growing to around US$980 million by 2012. In
both cases, the global market is estimated to be twice the size of the US.
Global sales of Ulcerative Colitis drugs are estimated to reach US$1 billion by
2012 and, for Crohn's Disease, the estimate is around US$2 billion. Current
treatments include Aminosalicylates (5-ASAs) to reduce and control inflammation.
In addition, Corticosteroids and Immunomodulators are prescribed for patients
who do not respond to first line treatments.
About HMPL-004
HMPL-004 acts on multiple cellular targets in the inflammatory signal
transduction pathways resulting in suppressed inflammation cytokine expression
including TNF-alpha, IL-1beta and IL-6. HMPL-004 was demonstrated to inhibit
TNF-alpha and IL-1beta production in cell-based assays. HMPL-004 is also able to
inhibit NF-kB activation. NF-kB is a family of transcriptional factors that
regulate a wide spectrum of genes critically involved in host defence and
inflammation. The mechanism of action of HMPL-004 was further supported in
inflammatory bowel disease pre-clinical models. Treatment of inflammatory bowel
disease rats with HMPL-004 caused a significant drop in plasma cytokine
concentrations, including TNF-alpha and IL-1beta. Pre-clinical trails for
HMPL-004 have shown the almost total restoration of the inner lining of the gut.
About Chi-Med
Chi-Med is the holding company of a pharmaceutical and healthcare group based
primarily in China and was admitted to trading on the Alternative Investment
Market of the London Stock Exchange in May 2006. Chi-Med is focused on
researching, developing, manufacturing, and selling pharmaceuticals, health
supplements and other consumer health and personal care products derived from
Traditional Chinese Medicine and botanical ingredients.
Hutchison MediPharma is Chi-Med's wholly-owned drug R&D subsidiary and has a
team of around 120 scientists and staff focusing on botanical drugs,
semi-synthetic natural product drugs, and synthetic single chemical entity
drugs. It currently has two candidates in clinical development in both the US
and China. HMPL-002, a radiosensitiser for head and neck and non-small cell lung
cancer, is in Phase I/II in the US and in proof-of-concept in China. HMPL-004,
an inhibitor to a group of inflammatory cytokines, has completed a Phase II
proof-of-concept study in Ulcerative Colitis and is in Phase II studies in
Crohn's Disease in the US. Hutchison MediPharma also has a pipeline of single
molecular entity discovery projects in auto-immune/inflammatory diseases and
oncology therapeutic areas, which have shown activity against clinically
validated targets.
Chi-Med is majority owned by Hutchison Whampoa Limited, an international
corporation listed on the Main Board of The Stock Exchange of Hong Kong Limited.
This announcement does not constitute or form part of any offer of securities,
or constitute a solicitation of any offer to purchase or subscribe for
securities.
This information is provided by RNS
The company news service from the London Stock Exchange