Alizyme to receive $2 million milestone from Takeda for cetilistat phase 2 study

By Lisa Kerner

Erie, Pa., Jan. 20 - Alizyme plc said it will receive a $2 million milestone payment from Takeda Pharmaceutical Co. Ltd. as a result of Takeda beginning a phase 2 clinical trial in Japan of cetilistat for the treatment of obesity and related diseases.

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. Under this license agreement, Alizyme has received three payments totalling $7 million to date, including the current milestone payment of $2 million.

Alizyme may receive further payments of up to $35 million dependent on future milestones and successful development and commercialization of cetilistat by Takeda in Japan.

Takeda is responsible for all development and commercialization costs in Japan as well as royalty payment to Alizyme on future sales in Japan.

The phase 2 trial is a randomized, placebo-controlled, double-blind, parallel-group dose-ranging study enrolling up to 450 clinically obese Japanese patients with obesity related diseases.

Takeda has already completed a phase 1 clinical trial in healthy Japanese subjects.

Cetilistat, an inhibitor of lipases, is designed to cause weight loss by blocking the digestion and thus the absorption of fat from the diet.

"We are delighted with Takeda's progress with cetilistat in Japan," Richard Palmer, Alizyme chief executive officer, said in the release. "The commitment of Takeda and its development team, together with the excellent working relationship with our development team, is very encouraging for the future successful progress of cetilistat in Japan.

"With our recent announcement of successful phase 2 clinical trial results in obese diabetic patients in the West, cetilistat is now poised to enter late stage development worldwide."

The World Health Organization said obesity is the largest global, chronic health problem in adults, according to the release. In 2003, the organization estimated that worldwide, more than 300 million adults are estimated to be clinically obese, while 1 billion are overweight.

Alizyme is a speciality biopharmaceutical development company based in Cambridge, England.

Takeda Pharmaceutical is a research-based pharmaceutical company with its headquarters in Osaka, Japan.

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