Novartis receives FDA approval for Starlix, a new treatment for type 2 diabetes

December 21, 2000

Novel new treatment approved for treating type 2 diabetes

Studies show Starlix reduces mealtime glucose spikes

EAST HANOVER, N.J., December 22, 2000 - Novartis Pharmaceuticals Corporation today received marketing approval from the U.S. Food and Drug Administration (FDA) for Starlix® (nateglinide) for the treatment of type 2 diabetes, a disease with serious consequences that is increasing at an alarming rate among Americans. Starlix, a D-phenylalanine (amino-acid) derivative, is the first in a new class of drugs for type 2 diabetes. It is indicated for use as both monotherapy and in combination with metformin, another oral antidiabetic medication, in patients whose blood glucose (sugar) is not controlled by diet and exercise.

Type 2 diabetes is a disease in which the body does not produce or properly use a hormone called insulin that is responsible for controlling the level of glucose in the blood. Early insulin secretion by the pancreas is compromised in patients with type 2 diabetes. Starlix works by stimulating rapid, short-acting insulin secretion. By this action, Starlix effectively lowers overall blood sugar levels as measured by HbA1c (average level of glucose in the blood) and blunts increases in blood glucose levels or "mealtime glucose spikes" that most people with type 2 diabetes experience following meals.

"The uncontrolled rise in blood glucose after meals may contribute to serious long-term damage to vital organs," said Lawrence S. Phillips, MD, nateglinide clinical investigator and Professor of Medicine in the Division of Endocrinology and Metabolism at Emory University School of Medicine. "Nateglinide has been demonstrated to blunt mealtime rise in glucose while improving overall glucose control. Thus, the development of nateglinide addresses an evolving and often unmet treatment challenge for patients with type 2 diabetes and their physicians."

Postprandial Glucose (PPG) and Overall Glycemic Control
Postprandial hyperglycemia, or elevated mealtime glucose, is common in people with type 2 diabetes, yet often goes undetected. Data show that patients spend a significant part of their day in the postprandial state. These mealtime/postprandial elevations contribute to overall blood glucose levels as measured by HbA1c. However, because diabetes management has traditionally focused on fasting plasma glucose levels (measurement of glucose in the absence of food), the surges in glucose that typically occur in type 2 diabetes patients after eating are often not evaluated.

According to Ginger Kanzer-Lewis, RNC, EdM, CDE, president of the American Association of Diabetes Educators, "It is important for people with type 2 diabetes and their healthcare providers to understand the significance of high blood sugar and the need to control it. Aggressive treatment is needed earlier in the progression of the disease to achieve glucose control. Numerous studies have shown that this glucose control can help prevent serious complications of the disease like kidney failure, amputations and blindness, and this control may also be associated with lowering the risk of cardiovascular morbidity and mortality."

Starlix Clinical Trials
Starlix, a D-phenylalanine (amino-acid) derivative, has a chemical structure distinct from other oral antidiabetics. Its approval as monotherapy or in combination with metformin was based on data from clinical trials involving more than 3,100 patients with type 2 diabetes. Studies show that Starlix has a "fast on, fast off" mode of action on the beta-cell (the cell in the pancreas that produces insulin) that stimulates rapid, short-acting insulin secretion, addressing a basic defect in type 2 diabetes. In addition, Starlix does not cause late hyperinsulinemia which reduces the risk of hypoglycemia (low blood sugar).

One 24-week, randomized, double-blind, placebo-controlled study of 701 patients with type 2 diabetes evaluated the effects of Starlix, metformin, and the combination of Starlix with metformin on glycemic control, including postprandial glucose control, and assessed the tolerability and safety of these treatment regimens. The study reported that Starlix effectively controlled mealtime glucose spikes and reduced overall glucose levels as measured by HbA1c. Researchers concluded that the combination of Starlix and metformin was complementary and resulted in even greater reductions in HbA1c than either agent alone. Notably, within this study, Starlix demonstrated reductions in HbA1c comparable to metformin in a subgroup of 197 treatment-naïve patients.

In all studies, Starlix was well-tolerated with an overall safety profile comparable to placebo. Low blood sugar, or hypoglycemia, in 2.4 percent of patients was the only treatment-emergent adverse reaction observed. In clinical trials, only 0.3 percent of Starlix patients discontinued due to hypoglycemia.

Product Information
Starlix is marketed by Novartis Pharmaceuticals Corporation and is the company's first drug for the treatment of type 2 diabetes. For most patients, the recommended starting and maintenance dose of Starlix alone or in combination with metformin is 120 mg, three times daily before meals. Starlix was approved at doses of 60 mg and 120 mg.

On December 17, 1999 Novartis Pharma AG filed a regulatory submission for Starlix with the European Medicines Evaluation Agency (EMEA). Starlix is currently approved for marketing in several countries including Japan, Switzerland, Brazil, Mexico and Venezuela. Yamanouchi and Hoechst Marion Roussel market the product in Japan under brand names Starsis or Fastic. Novartis licenses Starlix from Ajinomoto Co. Inc., Japan, and has a co-marketing and co-promotion agreement with Merck KgaA within Europe, and in certain African, Southeast Asian and Latin American countries.
About Diabetes
"Starlix provides physicians with a significant new tool to fight diabetes, an extremely serious disease affecting millions in this country alone," said Dr. Horton. "I would anticipate that the treatment paradigm will change radically as a result." The seventh-leading cause of death in the United States, diabetes is today considered a public health crisis due to a dramatic increase in the number of people affected. Of the approximately 16 million Americans who have diabetes, 90-95 percent have type 2 diabetes. Of particular concern is the fact that roughly one-third of people with type 2 diabetes are unaware they have the disease. While type 2 diabetes in the past was thought to be a disease of the elderly, it is now also affecting a growing number of younger adults as well as children. It is primarily seen in overweight people with a sedentary lifestyle. African-Americans, Native Americans and Hispanics are at greater risk for developing type 2 diabetes.

About Novartis
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of the Novartis Group (NYSE:NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 1999, the Group achieved sales of CHF 25.4 billion (USD 16.9 billion) (excluding subsequently divested businesses) and invested approximately CHF 3.6 billion (USD 2.4 billion) in R&D. Headquartered in Basel, Switzerland, Novartis employs about 66,000 people and operates in over 140 countries around the world. For further information please consult For Starlix prescribing information, patients and healthcare providers may call 1-877-STARLIX.

The foregoing press release contains forward-looking statements that can be identified by terminology such as "will," "establish" and "potential" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance, or achievements expressed or implied by such statements. In particular, management's expectations could be affected by, among other things, government regulations or actions; patient and physician demand for Starlix and other methods of treatment; the company's ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general.

GCI Group

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