Novo Nordisk to market Prandin (repaglinide)

Novo Nordisk Inc. has announced that it has signed an exclusive agreement with Sciele Pharma, Inc. to market Prandin (repaglinide).

Under the terms of the agreement, Sciele will exclusively market Prandin and, upon approval by the US Food and Drug Administration, PrandiMet (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 and PrandiMet.

"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."

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 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."

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. Full prescribing information is available at novonordisk-us.com.

http://www.novonordisk-us.com/