Rights to License and Develop
August 08 2003 - 2:00AM
UK Regulatory
RNS Number:4711O
Alizyme PLC
08 August 2003
Meetings today:
Alizyme will be holding meetings at 10.00 am and 11.30 am at the offices of
Buchanan Communications, 107 Cheapside, London EC2V. If you would like to attend
please call Charlie Forsyth or Lisa Baderoon on 020 7466 5000.
Immediate Release 8 August 2003
ALIZYME GRANTS RIGHTS TO TAKEDA TO LICENSE AND DEVELOP
OBESITY DRUG FOR JAPAN WORTH UP TO US$42 MILLION
Cambridge UK, 08 August 2003: Alizyme plc (AZM: London Stock Exchange) announces
today that its wholly owned subsidiary has granted rights to a licence and
development agreement with Takeda Chemical Industries, Ltd. ("Takeda"), the
largest pharmaceutical company in Japan, for Japanese rights to ATL-962 for the
treatment of obesity and all related diseases.
* Exclusive rights for Japan
* Total agreement worth up to US$42 million
US$2 million payable immediately
US$40 million payable on future milestones/events
* Double digit royalties on future sales by Takeda in Japan
* All development costs in Japan paid by Takeda
Under the terms of the agreement, Takeda has acquired rights to an exclusive
licence to develop, manufacture and market ATL-962 in Japan for the treatment of
obesity coupled with its associated conditions, such as type II diabetes.
Alizyme will immediately receive US$2 million, followed by additional payments
of up to US$40 million dependent on future milestones and other events,
including results satisfactory to Takeda from the current European Phase IIb
clinical trial and continuing successful development and commercialisation of
ATL-962 by Takeda in Japan. Takeda will also pay for all development and
commercialisation costs in Japan and pay royalties to Alizyme on future sales by
Takeda in Japan.
In March 2003 Alizyme announced completion of recruitment into its Phase IIb
trial for ATL-962, in which 370 clinically obese patients have been enrolled in
specialist clinics across 5 European countries including the UK.
Preliminary results of this trial, which are anticipated to be announced in
October 2003, are expected to define the product profile relating to efficacy,
safety and tolerability and will assist in the design of the Phase III programme
outside Japan. Positive results would also facilitate Alizyme's commercial
exploitation of ATL-962 through further out-licensing agreements for the rest of
the world. In a series of three Phase Ib trials, ATL-962 demonstrated similar
efficacy to that of orlistat, the active ingredient of Xenical(R)? (the
gastrointestinal lipase inhibitor marketed by Roche), as measured by a surrogate
marker, together with improved tolerability effects.
ATL-962, an inhibitor of gastro-intestinal lipases, is designed to cause weight
loss by reducing the digestion and thus the absorption of fat from the diet. The
incidence of obesity, and the closely related disease of Type II diabetes,
continues to escalate worldwide. Conservative estimates of the economic costs of
obesity range from 2% to 8% of the total costs of healthcare of the developed
world.
There is a high incidence of Type II diabetes in Japan, with obesity becoming
increasingly prevalent especially amongst young adults. A Body Mass Index
("BMI", see Editor's Note) of 25 is classified as clinically obese in Japanese
patients, compared with a measurement of 30 in Western patients, hence requiring
a separate and specific development programme in Japan. Takeda has a leading
position in diabetes in Japan with a market share of approximately 60%,
including their products, ActosTM? and BasenTM?.
Commenting on today's announcement, Dr. Richard Palmer, Alizyme's Chief
Executive Officer said:
" We are delighted to have Takeda as our partner in Japan for the development
and commercialisation of ATL-962. As the leading Japanese company in metabolic
disease they are uniquely positioned to maximise the potential of ATL-962 in
Japan. This collaboration marks an important achievement for Alizyme as it is
the first step in the commercialisation of our product portfolio. "
For further information, please contact:
Dr Richard Palmer, Chief Executive Officer
Mr Tim McCarthy, Finance Director
ALIZYME plc Tel No: + 44 (0)1223 896000
Lisa Baderoon Mobile : 07721 413 496
BUCHANAN COMMUNICATIONS Tel No: + 44 (0) 20 7466 5000
Further information on Alizyme can be found on the Company's website:
www.alizyme.com
Editor's Note
Alizyme plc
Alizyme is a biopharmaceutical company, based in Cambridge, UK, targeting the
treatment and management of gastrointestinal disorders, obesity and diabetes. It
has a portfolio of products, which, in addition to ATL-962, includes COLAL-PREDTM?
(Phase III for the maintenance of remission of ulcerative colitis), renzapride
(completed Phase IIb for irritable bowel syndrome) and ATL-104 (completed Phase
I for mucositis). At the appropriate time Alizyme intends to license products to
established pharmaceutical companies, which will complete development, gain
marketing approval and commercialise the products.
Takeda Chemical Industries, Ltd.
Takeda is a global research-based pharmaceutical company, largest in Japan and
one of the leaders in the world. Takeda is committed to strive toward better
health for individuals and progress in medicine by developing superior
pharmaceutical products.
Background to ATL-962
ATL-962 arose from an Alizyme initiated collaborative drug discovery programme.
This involved Cambridge Discovery Chemistry Ltd, which was subsequently acquired
by Millennium Inc, the US-based biopharmaceutical company. The compound is a
member of one of four new chemical families of lipase inhibitors for which
patent filings have been made by Alizyme.
Obesity Incidence
The incidence of obesity has shown a substantial increase over the past twenty
years. The World Health Organisation (WHO) has identified obesity as an epidemic
and as the largest global, chronic health problem in adults. Worldwide, over 120
million people are estimated to be clinically obese (Body Mass Index over 30 -
see below for definition), while 210 million are overweight. Figures for the UK
show the problem is increasing with 13.2% and 17.0 % of men and 16.4% and 19.7 %
of women, in 1993 and 1997 respectively, being classified as clinically obese.
Although the disease is becoming high profile, the market is currently largely
unsatisfied and has a substantial unmet medical need.
Health Implications
Obesity is a poorly understood disease. It is considered to be a complex
syndrome involving many different physiological processes. What is clear is that
health risks increase as the degree of obesity increases. In particular, there
is an increased risk of Type II diabetes, cardiovascular and joint diseases.
These health risks are substantially reduced with loss of weight. Obesity and
these associated conditions are chronic, and therefore, have major consequences
for healthcare spending. Conservative estimates of the economic costs of obesity
range from 2% to 8% of the total costs of healthcare of the developed world. The
National Institutes of Health (NIH) indicate that healthcare costs attributable
to obesity in the US are approximately $100 billion annually.
Drug Treatment of Obesity
Drug treatment is being recommended for individuals with a Body Mass Index of
over 30 (see definition below). In the past, treatments have included appetite
suppressants or bulking agents. Meridia(R)?/Reductil(R)?, an appetite suppressant that
acts on the central nervous system (centrally acting), was launched by Abbot
(previously Knoll/BASF) in the USA in 1998, is now approved in Europe and was
launched in the UK during 2001.
Roche's Xenical(R)? inhibits lipase (a fat splitting enzyme in the digestive tract)
to reduce fat absorption. This leads to fewer calories being absorbed, thus
resulting in weight loss. Xenical(R)? was first approved in 1997 and is now
marketed in more than 100 countries with current sales of approximately $500
million per annum.
Weight loss with Xenical(R)? significantly improves various risk factors for
cardiovascular and metabolic disease, including elevated cholesterol and insulin
levels. Roche has received approval to extend the use of Xenical(R)? to the
treatment of Type II diabetes in obese patients in some countries. This has the
potential to greatly enhance the market opportunity for lipase inhibitors and
thus the potential for ATL-962.
Body Mass Index: Definition
The classification of overweight and obesity is based on the Body Mass Index
(BMI) measurement, calculated as:
BMI = Weight (kg)
----------
Height (m)2
Body Mass Index (BMI) and classification of obesity
BMI BMI in Medical Classification
outside Japan
Japan
30+ 25+ Clinical obesity leading to a dramatic rise in
likelihood of suffering Type II diabetes, high blood
pressure, heart disease, osteoarthritis etc. Mortality
increases significantly.
25-30 22-25 Overweight. There is a significant increase in obesity
related diseases.
20-25 18-22 Most appropriate for long term health.
The identification of compounds for successful research, their progress through
development and the obtaining of regulatory approvals or authorisations before
marketing, manufacture and/or distribution of products is not certain or a
formality.
This information is provided by RNS
The company news service from the London Stock Exchange
END
MSCPRMLTMMTMBJJ