Aventis, a leading providers of treatments for diabetes, and Zealand Pharma A/S, a biopharmaceutical company based in Glostrup, Denmark, announced the signing of a licensing agreement for the development and worldwide commercialization of ZP10, a GLP-1 (glucagon-like peptide-1) receptor agonist of the exendin class that offers the potential to become a novel way of treating type 2 diabetes.
ZP10, Zealand's lead compound, which uses its proprietary SIP (Structure Inducing Probe) peptide modification technology, is currently in phase I/II clinical trials.
Aventis will receive the global rights to ZP10 and will be fully responsible for all further development, regulatory approval, manufacturing, marketing and sales of this compound. Zealand will receive an upfront payment of $10 million, and total milestone payments could total up to $100 million. Zealand would receive royalties on future product sales.
"Type 2 diabetes remains a challenging and complex disease, and one for which Aventis is determined to bring new treatment innovations to patients like we did through our long-acting insulin Lantus. As one of the most promising anti-diabetic compounds currently in development, ZP10 has the potential to offer a novel treatment approach to helping people with this debilitating disease," said Frank L. Douglas, executive vice president of Drug Innovation & Approval and a member of the Management Board of Aventis.
Eva Steiness, chief executive officer of Zealand Pharma, said: "We are extremely pleased to have signed this licensing deal for ZP10 with such a significant player in diabetes as Aventis. We believe that Aventis is uniquely positioned to maximize the potential of this compound. It is a major achievement for our relatively young company and follows our recent deal with Wyeth covering our new anti-arrhythmic ZP-123. These important deals highlight the exciting compounds that our unique approach to drug discovery and development delivers. This approach, which combines a creative R&D culture and a strong focus on commercialization, has enabled us to successfully progress ZP10 from discovery through to clinical trials in just four years, creating significant value for our shareholders. The benefits of this deal will allow us to accelerate the development of other novel products in our pipeline."
ZP10 is part of a new class of drugs that aim to mimic the glucose-dependent stimulation of insulin release by GLP-1, a naturally occurring hormone found in reduced concentration in people with type 2 diabetes. Drugs in this class act by stimulating insulin secretion in people with type 2 diabetes whose pancreatic beta cells can still produce insulin. In addition, they suppress the production of glucagon (a hormone produced in the pancreas that signals the liver to release stored sugar into the bloodstream) as well as reduce appetite and delay food absorption in the stomach. These actions promote the stimulation of insulin secretion when blood glucose levels are too high but not during periods of normal or low blood-glucose concentrations, which reduces the risk of hypoglycemia (low blood sugar levels).
ZP10 is currently being developed for twice-daily subcutaneous administration. A once-daily dosing and a long-acting (depot) formulation also are in early development.
Diabetes is a disease in which the body does not use sugar properly and is classified as either type 1, an auto-immune disease that usually occurs in children, or type 2, which often affects adults over age 40 when the pancreas cannot produce enough insulin or the body becomes resistant to the effects of insulin.
About 150 million people worldwide are estimated by the International Diabetes Foundation to have diabetes (90 per cent of which are type 2), and the number is expected to double to 300 million by 2025. In the U.S. alone, about 16 million people - or 6 per cent of the population - are estimated to have diabetes, while about 7 million of these people have not yet been diagnosed and treated.
Leading diabetes associations and experts worldwide have endorsed the A1C test, which measures the percentage of glucose attached to red blood cells in the bloodstream, as the best way to measure whether a person with diabetes has gained control over the disease. A person without diabetes usually has an A1C of less than 6 per cent, while people with diabetes are encouraged to maintain an A1C level of below 7 per cent. Major clinical trials have shown that the lower the A1C number, the greater the chances that people with diabetes will slow or prevent the development of serious and often deadly complications. The studies also showed that if people with diabetes can lower their A1C number by any amount, they will improve their chances of staying healthy.