PRINCETON, N.J., Nov. 19 /PRNewswire-FirstCall/ -- Novo Nordisk Inc. announced today that it has signed an exclusive agreement with Sciele Pharma, Inc. to market Prandin(R) (repaglinide). Under the terms of the agreement, Sciele will exclusively market Prandin(R) and, upon approval by the US Food and Drug Administration, PrandiMet(R) (the name submitted to FDA for a repaglinide/metformin fixed dose combination tablet) to physicians in the U.S., and will have a right of first refusal to obtain marketing rights in the U.S. to other Novo Nordisk products containing repaglinide, the active pharmaceutical ingredient in both Prandin(R) and PrandiMet(R).
“This partnership in the U.S. 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 of 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(R).”
Patrick Fourteau, president and CEO of Sciele Pharma, Inc., added, “We are pleased to initiate this partnership with Novo Nordisk, a company that is widely recognized as a global leader in diabetes care. Prandin(R) fits well within our Diabetes product portfolio and will be an excellent complement to Fortamet(R). Promoted by our Primary Care sales force, Prandin(R) will strengthen our presence in the diabetes treatment market.”
About Prandin(R)
Prandin(R) is an oral blood glucose-lowering drug of the meglitinide class used in the management of type 2 diabetes mellitus. PrandiMet(R) is a combination tablet of repaglinide and metformin, which has yet to be approved by the FDA.
Prandin(R) 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(R) 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(R) 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(R) is not indicated for use in combination with NPH insulin. All oral blood glucose-lowering drugs, including Prandin(R), are capable of producing hypoglycemia. Full prescribing information is available at novonordisk-us.com.
Financial terms of the agreement are not being disclosed.
About Novo Nordisk Inc.
Novo Nordisk is a healthcare company with an 84-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk’s business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs more than 25,800 employees in 79 countries, and markets its products in 179 countries. Novo Nordisk’s B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol ‘NVO’. For global information, visit novonordisk.com; for United States information, visit novonordisk-us.com.
About Sciele Pharma, Inc.
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 Pediatrics. 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 Pediatric products treat allergies, asthma, coughs and colds, and attention deficit and hyperactivity disorder (ADHD). Founded in 1992 and headquartered in Atlanta, Sciele Pharma employs more than 900 people. The Company’s success is based upon placing the needs of patients first, improving health and quality of life, and implementing its business platform -- an Entrepreneurial Spirit, Innovation, Speed of Execution, Simplicity and Teamwork.
CONTACT: Media, Sean Clements, +1-609-514-8316; Investors, Christian Qvist
Frandsen, +1-609-919-7937
Web site: http://www.novonordisk-us.com/
http://www.novonordisk.com/
