• Brand name in US: Prandin™ (in USA); NovoNorm™ (elsewhere).
• Class: meglitinides (nonsulfonylurea oral hypoglycemic agents)
• For: Type 2 Diabetes
• Route of Administration: oral
• Dose: 0.5 - 4.0 mg before each meal; maximum of 16 mg/day
• Action: enhances insulin secretion; works differently than sulfonylurea; fast-acting, and short duration of action concentrates its effect around meal time
• Manufacturer: Novo Nordisk; developed in cooperation with Boehringer Ingelheim GmBH.
• Status: New Drug Application filed with the FDA June, 1997; Preliminary approval from the FDA Endocrine Advisory Committee November 20, 1997; approved by FDA December, 1997. In final stages of clinical trials in Europe. Available in the USA.
• Other drugs in same class: nateglinide
• Source of Information: Drug Topics, June 12, 1995; Diabetes Self-Management, July/August 1996; letter from Novo Nordisk 10/30/97; Internet press articles (below).

BW1053 DEC 23,1997 5:54 PACIFIC 08:54 EASTERN

(BW)(NOVO-NORDISK/PRANDIN)(NVO) US Food and Drug Administration Approves Prandin, New Oral Treatment for Type 2 Diabetes

BAGSVAERD, Denmark--(BUSINESS WIRE)--Dec. 23, 1997--Novo Nordisk A/S (NYSE:NVO) today announced that the United States Food and Drug Administration (FDA) has approved Prandin(TM) (repaglinide), a new anti-diabetic agent for treatment of Type 2 diabetes.

Lars Rebien Sorensen, Corporate Executive Vice President, head of Health Care at Novo Nordisk said, "We are extremely pleased to have received an approval from the FDA so quickly. We believe that Prandin™ strengthens the physicians' treatment armamentarium and offers people with Type 2 diabetes therapeutic advantages over other existing oral anti-diabetic drugs."

Bill Poole, President, Novo Nordisk Pharmaceuticals Inc., said, "Prandin™ helps people with Type 2 diabetes to manage their diabetes specifically when they need to-at mealtimes. Prandin™ is a highly potent, fast-working agent that is absorbed rapidly after dosing and cleared quickly from the bloodstream. We are very eager to introduce this exciting new product to the US marketplace so that physicians and patients with Type 2 diabetes may experience the benefits of Prandin™ for the treatment of this disease."

Prandin™ Basics

The starting dose of Prandin™ in oral hypoglycemic agent (OHA) naive patient or patients with HbA1c_<8% is 0.5 mg before each meal. In OHA treated patients with HbA1c>8% the starting dose is 1 or 2 mg before each meal. The dose can be adjusted by physicians up to 4 mg before each meal. If a meal is skipped, so is the Prandin™ tablet; if a meal is added during the day, a tablet is added for that meal.

Prandin™ stimulates insulin secretion from the beta cells of the pancreas by binding to sites on the beta cell. Prandin™ is minimally excreted by the kidney, which may be an advantage for patients (often elderly) who often suffer from decreased kidney function.

Prandin™ was developed in cooperation with the German pharmaceutical company Boehringer Ingelheim GmBH. The agent is in-licensed by Novo Nordisk for worldwide development and marketing. The product trade name outside the US will be NovoNorm™.

Novo Nordisk filed for regulatory approval of Prandin™ with the FDA and the European authorities in June 1997. The product received priority review status from the FDA in August, and in November the FDA Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of Prandin™. Prandin™ will be available in the US in Spring 1998.

Novo Nordisk A/S is the world leader in insulin and diabetes care and also manufactures and markets a variety of other pharmaceutical products. Furthermore the company is the world's largest producer of industrial enzymes. Headquartered in Denmark, Novo Nordisk employs approximately 13,900 people n 61 countries and markets its products in 130 countries. Its B shares are listed on the stock exchanges in Copenhagen, London and Zurich. Its ADSs are listed on the New York Stock Exchange under the symbol "NVO."

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