Sanofi-aventis and Metabolex announced a global licensing agreement on MBX-2982, an oral agent, GPR119 receptor agonist, for the treatment of type II diabetes. GPR119 receptor agonists (or G-protein coupled receptor 119) are found to exert the effects on glucose metabolism by a dual mode of action affecting both insulin and GLP-1 (glucagon-like peptide-1) release. This innovative mechanism could offer improved glucose control over the existing oral diabetes therapies, with an additional potentially beneficial effect on weight.

Under this agreement, sanofi-aventis will receive an exclusive worldwide license to develop, manufacture and commercialize MBX-2982, currently in phase II a, and related compounds.

“The new mechanism of action of MBX-2982 is very promising and we are excited to have identified Metabolex as our partner in this very competitive field”, declared Pierre Chancel, senior vice-president, global diabetes, sanofi-aventis. “With the growing epidemic of type II diabetes, more effective and well tolerated oral treatment options continue to be a cornerstone of innovative treatment schemes. In this sense, this agreement is another important step for sanofi-aventis towards our ambition to provide integrated solutions for diabetic patients".

Under the terms of the agreement, Metabolex will receive an upfront payment and will be eligible to receive development, regulatory, and specified commercial milestone payments. The total of all those payments could reach US$ 375 million. Metabolex will also receive royalties on the worldwide product sales.

The license agreement is subject to antitrust clearance in the United States under the Hart-Scott-Rodino Act.

MBX-2982 has completed three phase 1 clinical studies and has consistently shown clinically meaningful glucose reductions in healthy volunteers and subjects with impaired glucose tolerance. In all of these studies, MBX-2982 was found to be safe and well tolerated. MBX-2982 is currently in a multi-national 28-day phase 2 clinical study in patients with type II diabetes. G-protein coupled receptor 119 (GPR119) is a receptor in the gut and pancreas that interacts with bioactive lipids to stimulate glucose-dependent incretin and insulin secretion. Agonists of GPR119 represent a potentially novel oral treatment for type II diabetes that function through a unique dual mechanism of action. First, they act directly on the pancreatic beta cell to increase insulin secretion. In addition, they stimulate release of the incretin GLP-1 from the intestines. This unique dual action may offer improved glucose homoeostasis over existing diabetes therapies, with a potential effect on weight and improved islet health.

Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy. More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed. At the same time, about 40 percent of those diagnosed are not achieving the blood sugar control target of HbA1c <7 percent recommended by the ADA. The HbA1c test measures average blood glucose levels over the past two- to three-month period.

Metabolex is a privately-held biopharmaceutical company focused on the discovery and development of proprietary new medicines for the treatment of metabolic diseases, with an emphasis on type II diabetes.