Novo Nordisk Inc. announced that it has inked an exclusive agreement with Sciele Pharma, Inc. to market Prandin (repaglinide), an oral blood glucose lowering drug in the US. Financial terms of the agreement are not being disclosed.
Under the terms of the agreement, Sciele will exclusively market Prandin and, upon approval by the US Food and Drug Administration, will also market the diabetes drug PrandiMet to physicians in the US.
The speciality pharmaceutical company will also have a right of first refusal to obtain marketing rights in the US to other Novo Nordisk products containing repaglinide, the active pharmaceutical ingredient in both Prandin and PrandiMet.
"This partnership in the US will enable us to increase the oral treatment options for people with type 2 diabetes to help them gain good glycemic control," said Martin Soeters, president, Novo Nordisk Inc. "It will also allow Novo Nordisk to concentrate on bringing our complete portfolio of three insulin analogs to health care providers, which provides the most viable opportunity to both help improve patient outcomes and realize our business aspirations, in the name of Changing Diabetes."
"We are pleased to initiate this partnership with Novo Nordisk, a company that is widely recognized as a global leader in diabetes care. Prandin fits well within our Diabetes product portfolio and will be an excellent complement to Fortamet. Promoted by our Primary Care sales force, Prandin will strengthen our presence in the diabetes treatment market," said Patrick Fourteau, president and CEO, Sciele Pharma, Inc.
Prandin is an oral blood glucose-lowering drug of the meglitinide class used in the management of type 2 diabetes mellitus. PrandiMet is a combination tablet of repaglinide and metformin, which has yet to be approved by the FDA.
Prandin is indicated as an adjunct to diet and exercise for patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone. Prandin is also indicated for combination therapy use (with metformin or thiazolidinediones) for patients whose hyperglycemia cannot be controlled by diet and exercise plus monotherapy with any of the following agents: metformin, sulfonylureas, repaglinide, or thiazolidinediones.
Prandin is contraindicated in patients with diabetic ketoacidosis (with or without coma), type 1 diabetes, or known hypersensitivity to the drug or its inactive ingredients. Prandin is not indicated for use in combination with NPH insulin. All oral blood glucose-lowering drugs, including Prandin, are capable of producing hypoglycemia.
Novo Nordisk is a healthcare company with an 84-year history of innovation and achievement in diabetes care. In addition to diabetes care, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy, and hormone therapy for women.
Sciele Pharma, Inc. is a pharmaceutical company specializing in sales, marketing and development of branded prescription products focused on Cardiovascular/Diabetes, Women's Heath and Paediatrics. The company's Cardiovascular/Diabetes products treat patients with high cholesterol, hypertension, high triglycerides, unstable angina and type 2 diabetes; its Women's Health products are designed to improve the health and well-being of women and mothers and their babies; and its paediatric products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD).