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."

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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 coߛmorbidities, including type 2 diabetes, COLALߛPRED® for ulcerative colitis, and ATLߛ104 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 riskߛbenefit 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 coߛmorbidities.

Xenical® is an approved obesity product and, as such, has been shown to be suitable for longߛterm 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. 

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