New Formulation Of Lotrel(R), 10/20 mg, Now Available

Market Wire, 20050229

Novartis Pharmaceuticals Corporation announced today that it has expanded its Lotrel(R) (amlodipine/benazepril HCl) franchise to include a new 10/20 mg formulation. Lotrel is a once-a-day medication that combines amlodipine, the calcium channel blocker found in Norvasc(R), with the ACE inhibitor Lotensin(R) (benazepril HCl) in one convenient capsule. Lotrel 10/20 mg, the fourth dose formulation in the Lotrel franchise, contains 10 mg of amlodipine and 20 mg of benazepril -- representing a higher dose of amlodipine than other Lotrel formulations. This new strength will provide physicians with a powerful treatment option for patients requiring aggressive blood pressure lowering or patients whose blood pressure is not adequately controlled with single-medication therapy. Lotrel 10/20 mg extends the clinical utility of the product while providing physicians greater dosing flexibility to better tailor treatment to meet the individual needs of patients.

The U.S. Food and Drug Administration (FDA) granted marketing approval to Lotrel 10/20 mg on June 21, 2002. In recent years Lotrel has steadily emerged as a major part of Novartis' cardiovascular franchise and is now one of the fastest growing, branded antihypertensives in the United States.

"The management of hypertension has changed dramatically in the past few years. It is now abundantly clear that therapy with only one drug is inadequate to achieve blood pressure goals in many patients. Clinical studies show treatment that combines an ACE inhibitor and calcium channel blocker is a very effective way to bring blood pressure under control," said William Daley, MD, MPH, Executive Director, Cardiovascular & Metabolism, US Medical Affairs, Novartis Pharmaceuticals Corporation. "Physicians are embracing the value of combination therapy for difficult-to-treat hypertensive patients and this new formulation is a timely solution for patients who have not achieved goal blood pressure with one medication."

Helping patients to get to the recommended blood pressure goal of less than 140/90 mm Hg is critically important. However, nearly three out of four people with hypertension have uncontrolled blood pressure, which, if left untreated, can damage the heart and blood vessels and lead to heart attacks, stroke and kidney disease. Hypertension is especially serious for patients who also have coronary artery disease or diabetes. For these patients, an even lower goal of less than 130/80 mm Hg is recommended by the National Kidney Foundation and American Diabetes Association.

Lotrel is indicated for the treatment of high blood pressure when blood pressure control is inadequate with any dihydropyridine calcium channel blocker or any angiotensin converting enzyme (ACE) inhibitor, or when the patient achieves adequate blood pressure control with amlodipine but experiences unacceptable edema.

Lotrel is also available in 2.5/10 mg, 5/10 mg and 5/20 mg capsules. Lotrel should be discontinued as soon as pregnancy is detected because of concerns of its effect on the unborn child. In a trial (n=386) comparing placebo, Lotrel 5/20 mg and Lotrel 10/20 mg, edema and dizziness were most commonly reported in the Lotrel 10/20 mg group. Also, in clinical trials, the most common adverse events were cough and headache. In rare cases, angioedema, a potentially dangerous swelling of the mouth and throat, has been reported in patients receiving Lotrel. For full prescribing information consult www.pharma.us.novartis.com/product/pi/pdf/lotrel.pdf.>This release contains certain forward-looking statements, relating to the business of Novartis, which can be identified by the use of forward-looking terminology such as "will provide," "fastest growing," 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 relating to Lotrel could be affected by, among other things, uncertainties relating to further or additional clinical trials, including different or additional adverse affects data; product development; unexpected regulatory delays or government regulation generally; the ability to obtain or maintain patent or other proprietary intellectual property protection; and competition in general, as well as factors discussed in the Company's Form 20-F filed with the US Securities and Exchange Commission. Should one or more of those risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, estimated or expected.

Novartis Pharmaceuticals Corporation researches, develops, manufacturers and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company's mission is to improve people's lives by pioneering novel healthcare solutions.