Aventis and Peptor Limited Sign Agreement for the License, Development and Commercialisation of New Diabetes Therapy

30-Jul-2002

Strasbourg, France -Aventis and Peptor Limited, a biopharmaceutical company based in Rehovat, Israel, and in Erkrath, Germany, have signed an exclusive worldwide license, development and commercialisation agreement for a new diabetes therapy. The new drug, called DiaPep277TM, is being developed for the prevention and treatment of latent autoimmune diabetes in adults (LADA) and type 1 diabetes. DiaPep277 TM has shown in Phase II human clinical trials to arrest the progression of type 1 diabetes, prevent destruction of insulin-producing pancreatic cells, and reduce the need for injected insulin in newly diagnosed patients. These clinical effects were mediated by disease-specific immunological regulation.

"The new drug represents an important development in the battle to help the millions of people suffering from diabetes," said Frank L. Douglas, Member of the Board of Management and Head of Drug Innovation and Approval at Aventis. "The agreement with Peptor is another step in the efforts of Aventis to offer diabetes patients the most innovative and comprehensive line of diabetes therapies worldwide."

LADA is a slowly progressing form of type 1 diabetes, characterized by the similar immune destruction of the insulin-producing cells in the pancreas, which eventually leaves the patient insulin dependent for life. Most LADA patients are initially misdiagnosed after age 40 as having type 2 diabetes, the more common, progressive form of the disease in which the body produces insulin but is unable to utilize it. Type 2 diabetes patients have more treatment options available to them to encourage more efficient use or supply of their natural insulin. As the disease progresses, type 2 diabetes patients will often require a insulin injections as needed by all type 1 and the majority of LADA patients to manage their disease. LADA is diagnosed by a blood test for antibodies to a protein known as GAD.

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Type 1 diabetes (formerly known as juvenile diabetes or insulin dependent diabetes mellitus) is a condition in which the immune system attacks and destroys insulin-producing beta cells in the pancreas. This attack renders the pancreas unable to produce insulin, a hormone that controls blood sugar levels. People with type 1 diabetes must take insulin shots several times a day in order to survive. Late stage complications frequently include heart disease, stroke, high blood pressure, blindness, kidney disease, nervous system damage, and amputations.

There are an estimated 10-12 million people in the United States, Europe, and Japan with autoimmune diabetes (including type 1 diabetes and LADA). There is currently no way to treat the underlying cause of autoimmune diabetes or to halt the progression of the disease.

Peptor has successfully conducted multicenter clinical Phase II studies for type 1 diabetes in Europe, Israel, and more recently has initiated multicenter clinical phase II studies for LADA in the United States and in Europe. Under terms of the agreement between Aventis Pharma Germany and Peptor, Aventis will be responsible for further clinical development and commercialisation. The costs of the development of the manufacturing process and the capital expenditures for the required scaling up of manufacturing plants will be the responsibility of Peptor. A series of milestone payments to be made by Aventis to Peptor marking steps to the successful approval and commercialisation of the new drug were agreed upon. Upon approval of DiaPep277 by the relevant registration authorities Peptor will exclusively manufacture DiaPep277 for Aventis, which will have worldwide exclusive rights to sell and distribute the product. Financial details were not disclosed.

Aventis is committed to expanding its global position in the global insulin market, in which it ranked third based on sales, according to IMS Health. It presently offers a wide range of oral and injectable insulin products for the treatment of type 1 and type 2 diabetes, including Lantus, the first true once-daily basal insulin. Exubera , an innovative inhaled insulin being developed in partnership with Pfizer.

Diabetes is increasing at an alarming rate. The World Health Organization estimates it affects 140 million people worldwide. The incidence of diabetes is expected to double by 2025. Experts blame the rise on an increasingly sedentary lifestyle and a poor diet.

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