Aventis Pharmaceuticals' Lantus® (Insulin Glargine [rDNA Origin] Injection) Approved by FDA for Treatment of Diabetes

- LANTUS Is the First Long-Acting Recombinant Human Insulin Analog with Once-Daily Administration and 24-hour Glucose-Lowering Effect to Be Approved by the FDA -

PARSIPPANY, N.J., April 24 /PRNewswire/ -- Aventis Pharmaceuticals (NYSE: AVE), the U.S. pharmaceutical business of Aventis Pharma AG, announced today that the U.S. Food and Drug Administration (FDA) has approved LANTUS® (insulin glargine [rDNA origin] injection) for the treatment of type 2 and type 1 diabetes. Aventis Pharmaceuticals plans to have product available for patients later this year.

LANTUS is indicated for once-daily subcutaneous administration at bedtime in the treatment of adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia and for adult and pediatric patients with type 1 diabetes mellitus. Studies have shown that LANTUS provides a relatively constant concentration/time profile over 24 hours with just one shot a day.

Long-acting human insulin analog

LANTUS is a recombinant human insulin analog -- a biosynthetic insulin that closely mimics human insulin. LANTUS is long acting (basal) and can be administered once daily at bedtime for people with type 2 or type 1 diabetes.

The chemical structure of LANTUS regulates its release from the subcutaneous tissue into circulation, providing a relatively constant profile with no pronounced peak with a glucose-lowering effect over 24 hours.

Clinical Studies

Controlled clinical trials showed that LANTUS demonstrated similar levels of efficacy, in regards to metabolic control, as NPH human insulin. In clinical studies, LANTUS showed a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH human insulin.

Safety Information

Human insulin therapy may be associated with hypoglycemia, worsening of diabetic retinopathy, lipodystrophy, skin reactions (such as injection-site reaction, pruritus, and rash), allergic reactions, sodium retention, and edema. Hypoglycemia is the most common adverse effect of insulins, including LANTUS® (insulin glargine [rDNA origin] injection). As with all insulins, the timing of hypoglycemia may differ among various insulin formulations.

Glucose monitoring is recommended for all patients with diabetes. Any change in insulin should be made cautiously and only under medical supervision. In clinical studies of adult patients, there was a higher incidence of treatment-emergent injection-site pain (2.7 percent LANTUS versus 0.7 percent NPH). The reports of pain at the injection site were usually mild and did not result in discontinuation of therapy.

LANTUS must not be diluted or mixed with any other insulin or solution, as it may result in a delayed onset of action.

Aventis Pharmaceuticals Growing Diabetes Portfolio

"Aventis Pharmaceuticals and its predecessor companies have a long and distinguished history of innovation in the development of insulins, as well as other therapies in the diabetes arena. The development of LANTUS underscores our ongoing commitment to offer novel products that will help people with diabetes achieve control of the disease," said Gerald P. Belle, president, Aventis Pharmaceuticals North America. "Because there is a significant medical need for treatment options for the management of diabetes, we are pleased that the FDA reviewed and approved this drug in a timely manner. The approval of LANTUS adds to Aventis Pharmaceuticals' established and growing diabetes portfolio, which is focused on benefiting patients throughout the progression of the disease."

The New Drug Application (NDA) for LANTUS was submitted simultaneously in the U.S. and Europe on April 22, 1999.

Diabetes: A widespread and serious disease

Diabetes affects an estimated 16 million Americans and more than 140 million people worldwide. According to the World Health Organization, the global incidence of diabetes is expected to more than double by the year 2025.

Diabetes is a chronic condition that results when the body produces either no insulin or amounts of insulin that are inadequate to utilize sugars normally. Diabetes can result in serious medical complications that include kidney failure, blindness, cardiovascular, and neurological conditions. The American Diabetes Association estimates the combined direct and indirect annual cost of the disease at $98 billion in the U.S. alone.

Aventis Pharmaceuticals is the U.S. business of Aventis Pharma AG, the pharmaceutical company of Aventis S.A. (NYSE: AVE). Aventis Pharmaceuticals, with headquarters in Parsippany, N.J., focuses its activities on important therapeutic areas such as cardiology, oncology, anti-infectives, arthritis, allergy and respiratory, diabetes, and the central nervous system.

Aventis Pharma is dedicated to treating and preventing human disease through the discovery, development, manufacture, and sale of innovative pharmaceutical products aimed at fulfilling unmet medical needs. The corporate headquarters of Aventis Pharma is in Frankfurt, Germany. Aventis Pharma comprises Aventis Pasteur, a world leader in vaccines, with corporate headquarters in Lyon, France, and Aventis Behring, a world leader in therapeutic proteins, with corporate headquarters in King of Prussia, Pa.

Aventis S.A., one of the world's leading life sciences companies, is focused on two core business areas: pharmaceuticals and agriculture. With global corporate headquarters in Strasbourg, France, Aventis employs nearly 90,000 people in 120 countries. Aventis S.A. was launched in December 1999 through the merger of Hoechst AG and Rhone-Poulenc S.A.