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
"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."
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
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
SOURCE Novo Nordisk Inc.