New 160/25 mg Dose Of Diovan HCT(R) Significantly Reduces Systolic And Diastolic Blood Pressure

Novartis Pharmaceuticals Corporation announced today it has expanded its Diovan(R) (valsartan) franchise by adding a new Diovan HCT(R) dosing strength that provides impressive reductions in both systolic and diastolic blood pressure. The new addition of Diovan HCT (valsartan/hydrochlorothiazide) 160/25mg tablets creates the broadest dosing range of any angiotensin receptor blocker (ARB)/diuretic therapy marketed. The availability of Diovan HCT 160/25 mg provides physicians with more treatment options for patients that require additional blood pressure control beyond that provided with Diovan or hydrochlorothiazide (HCTZ) monotherapy. Diovan is one of the fastest growing agents among the top 10 branded prescription antihypertensives on the market today, and leading angiotensin receptor blocker (ARB) franchise in the U.S.

The efficacy of Diovan HCT has been studied in controlled clinical trials involving more than 1,500 patients. Studies demonstrated the combination of Diovan 160 mg and HCTZ 25 mg significantly decreased both systolic and diastolic blood pressure when compared to the individual medications, Diovan and HCTZ. The combination of Diovan 160 mg and HCTZ 25 mg resulted in a 21 mmHg and 11 mmHg reduction in systolic and diastolic blood pressure compared to a 10 mmHg and a 6 mmHg reduction for Diovan 160 mg alone; and a 10 mmHg and 5 mmHg reduction for HCTZ 25 mg alone. In long-term follow-up studies, the overall response to the combination of Diovan and HCTZ was similar for black and non-black patients. The safety of Diovan HCT has been evaluated in more than 1,300 patients and Diovan HCT demonstrated excellent tolerability.

Diovan HCT 160/25 mg tablet is a once-daily, fixed dose combination tablet which contains a higher dose of the diuretic HCTZ than existing formulations of Diovan HCT and was approved by the U.S. Food and Drug Administration on January 17, 2002. The co-administration of Diovan and HCTZ provides greater blood pressure lowering than either single antihypertensive agent. The new tablets complements the existing broad Diovan product line of once-daily dosing options that includes Diovan tablets 80 mg, 160 mg and 320 mg and Diovan HCT tablets 80/12.5 mg and 160/12.5 mg. Diovan 80 mg is well tolerated and offers the strength of leading antihypertensives (Norvasc(R) 5 mg, Zestril(R) 10 mg and Vasotec(R) 20 mg). Diovan HCT offers patients added efficacy without compromising tolerability.

Diovan is indicated for first-line treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. Diovan HCT is available for patients who need additional blood pressure control beyond that provided with Diovan or hydrochlorothiazide (HCTZ) alone. All products containing ARBs carry a warning that the drugs should not be used in pregnant women due to the risk of injury and even death to the fetus. The most common adverse events seen in controlled clinical trials with Diovan and Diovan HCT were headache and dizziness. Because of the HCTZ component, Diovan HCT should not be taken by patients who have a history of reduced urine output or have had allergic reactions to drugs of the sulfonamide class. Volume- and/or salt-depletion should be corrected in patients prior to administering Diovan or Diovan HCT or symptomatic hypotension may occur. A dose-related increase in the incidence of dizziness was observed in Diovan HCT-treated patients from 80/12.5 mg (6%) to 160/25 mg (16%). Diovan HCT is not indicated for initial therapy. For full prescribing information, visit the Novartis website at www.diovan.com.

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 "expanded," "impressive reductions," "broadest dosing range," "more treatment options," "leading...franchise," "fastest growing," "significantly decreased," "overall response," "demonstrated excellent tolerability," "provides greater blood pressure lowering," "complements," "well tolerated," 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 Diovan 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 form those described herein as anticipated, estimate or expected.