AZM Alizyme

    RNS Number : 4894D
  Alizyme PLC
  16 September 2008
   

 For Immediate Release  16 September 2008


    ALIZYME plc

    ALIZYME TO RECEIVE US$3 MILLION MILESTONE FROM TAKEDA ON DECISION TO COMMENCE CETILISTAT PHASE III PROGRAMME IN JAPAN

    Cambridge UK, 16 September 2008: Alizyme plc (LSE:AZM) is pleased to announce that it is to receive a US$3 million milestone payment
from Takeda Pharmaceutical Company Limited ("Takeda") as a result of Takeda's decision to commence a Phase III clinical trial in Japan of
cetilistat for the treatment of obesity.

    Highlights

    *     Takeda Phase II data support efficacy of cetilistat in treatment of obesity
    *     Significant weight loss and significant improvement in glycaemic control over 6 months' treatment
    *     Improvement in other metabolic syndrome parameters
    *     Takeda has decided to commence Phase III programme in Japan
    *     Alizyme to receive US$3 million milestone payment

    Takeda has completed a randomised, double blind, placebo controlled, dose ranging, Phase II study in approximately 450 diabetic obese
patients with other obesity related diseases, performed in Japan. Patients received one of four doses of cetilistat or placebo for 6 months.
Following positive results from this Phase II study, Takeda has decided to commence Phase III development of cetilistat in Japan. This
triggers a milestone payment of US$3 million to Alizyme under the licence and development agreement between Takeda and Alizyme.

    In August 2003, Alizyme granted exclusive rights to Takeda to develop, manufacture and market cetilistat in Japan for the treatment of
obesity and its associated conditions, such as type 2 diabetes. Following receipt of the current milestone of US$3 million, Alizyme will
have received four payments under this agreement, totalling US$10 million. In addition, Alizyme may receive further payments of up to US$32
million dependent on future milestones and other events, including continuing successful development and commercialisation of cetilistat by
Takeda in Japan. Takeda is responsible for all development and commercialisation costs in Japan and payment of royalties to Alizyme on
future sales in Japan.


    Tim McCarthy, Chief Executive Officer, Alizyme plc, commented:

    "Takeda's decision to commence Phase III development of cetilistat in Japan is a key milestone in the progress of this product. The
Phase II results not only support Alizyme's conclusions from its own studies in Europe, but also demonstrate that the weight reducing
efficacy of cetilistat and its impact on other parameters of diabetes and metabolic syndrome continue to at least 6 months. Our working
relationship with Takeda over the past five years has been excellent and we look forward to continuing to work together as cetilistat is
progressed through Phase III development in Japan and on to commercialisation of this exciting product."





    For further information, please contact:

 Alizyme plc                       Tel: + 44 (0) 1223 896000
 Tim McCarthy, Chief Executive
 Officer

 Buchanan Communications          Tel: + 44 (0) 20 7466 5000
 Lisa Baderoon                      Mobile: +44 (0) 7721 413
 Rebecca Skye Dietrich                                   496


    Further information on Alizyme can be found on the Company's website: www.alizyme.com




    Editor's Note

    Alizyme plc

    Alizyme is a speciality biopharmaceutical development company, focused on the therapeutic areas of metabolic disorders, gastrointestinal
disorders and cancer supportive care. It is developing cetilistat for the treatment and management of obesity and associated co*morbidities,
including type 2 diabetes, COLAL*PRED� for ulcerative colitis, and ATL*104 for mucositis, a side effect of cancer therapy.


    Takeda Pharmaceutical Company Limited

    Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one
of the industry's leaders worldwide, Takeda is committed to strive toward better health for individuals and progress in medicine by
developing superior pharmaceutical products.

    Additional information about Takeda is available through its corporate website: www.takeda.com


    Cetilistat

    Cetilistat is a gastrointestinal lipase inhibitor that blocks fat digestion and absorption, leading to reduced energy intake, and thus
weight loss. It is distinct from most other anti-obesity agents as it does not act on the brain to reduce appetite, but acts peripherally.
The compound remains in the gastrointestinal tract with no significant absorption into the body. It can, therefore, be expected to have a
superior risk*benefit profile to centrally acting drugs. Accordingly, as a peripherally acting drug with a good safety profile demonstrated
over a wide range of doses, cetilistat is not subject to the safety concerns relating to the consequences of deliberate or accidental
overdose. As well as the inherent safer nature of peripherally acting drugs, there is less chance of interaction with concomitant
medications being used to treat associated co*morbidities.

    Xenical� is an approved obesity product and, as such, has been shown to be suitable for long*term use. Both cetilistat and Xenical� are
peripherally acting lipase inhibitors. However, in clinical trials, although both have been demonstrated to be safe and exhibit similar
efficacy, cetilistat has been demonstrated to be significantly better tolerated than Xenical�, which has tolerability side effects that
include anal leakage and oily spotting, and which detrimentally affect patient compliance. This superior tolerability side effect profile
exhibited by cetilistat is attributable to the differences between the molecular structures of orlistat (Xenical�) and cetilistat.

    Other main competitors on the market and in development are centrally acting drugs that have a range of potential side effects such as
depression, cardiovascular disorders, nausea and dizziness, as well as other compound specific side effects.

    Commercial opportunity

    Obesity has reached global epidemic proportions. According to the World Health Organisation there are up to 1.6 billion overweight
adults worldwide, with at least 400 million of them clinically obese. However, it is estimated that only 6% of patients are treated
pharmacologically, there being few effective treatments available.

    Patient compliance in taking medication is critical to a successful product in this patient population. An effective drug with no safety
or patient compliance issues could have potential sales in excess of US$1 billion per annum.


    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
 
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