Eli Lilly and Company has signed a license agreement with Taisho Pharmaceutical Co., Ltd. for TS-021, Taisho's oral DPP-IV inhibitor in Phase I clinical development for the treatment of type 2 diabetes.

Under the terms of the agreement, Taisho granted Lilly exclusive rights for the development and commercialization of TS-021 worldwide, except Japan and China. Taisho will manufacture the bulk active ingredient of TS-021 for Lilly. Under certain circumstances, Taisho may co-promote TS-021 with Lilly in the US and other designated countries.

According to a Lilly release, TS-021's mechanism of action differs from currently available diabetes treatments as it inhibits di-peptidyl peptidase-IV (DPP-IV), which is an enzyme that breaks down the human hormone known as glucagon-like peptide-1 (GLP-1). Preventing GLP-1 degradation is important because it plays a crucial role in maintaining glucose homeostasis.

GLP-1 stimulates the body to produce insulin in response to elevated levels of blood glucose, suppresses glucagon secretion leading to a reduction in the release of glucose from the liver, slows the rate of food absorption and promotes satiety and reduces appetite. These actions promote stimulation of insulin secretion in the presence of elevated blood-glucose concentrations but not during periods of normal or low blood-glucose concentrations, thereby reducing or eliminating the risk of hypoglycemia.

"As a DPP-IV inhibitor, TS-021 will further diversify our robust diabetes pipeline and may represent a new treatment option for patients with type 2 diabetes," Jose F. Caro, vice president of endocrine research and clinical investigation for Lilly said adding, "New treatment options along the entire continuum of care are vital to combat the growing epidemic of this progressive disease, which is expected to double in the next 20 years."