Alizyme antiobesity to Japan

Alizyme has granted rights to a licence and devel-opment agreement with Takeda Chemical Industries, the largest pharmaceutical company in Japan, for Japanese rights to ATL-962 for the treatment of obesity and all related diseases.

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$2m, followed by additional payments of up to US$40m 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 five European countries including the UK.

Preliminary results of this trial, which should 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 (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 diges-tion 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 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, Actos and Basen.

Commenting on today's announcement, Dr. Richard Palmer, Alizyme's ceo 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.'