Novartis Announces Efficacy Data on New Investigational High Blood Pressure Therapies at the American Society of Hypertension Annual Meeting

Market Wire, May, 2006

--  Studies show Rasilez® (aliskiren), investigational agent in a new
    class of direct renin inhibitors, provides significant blood pressure
    reductions, sustained over 24 hours

--  New Exforge® (amlodipine besylate/valsartan) data show dual
    mechanism of action lowered systolic blood pressure up to 43 mm Hg in
    patients with stage 2 high blood pressure; majority of patients reach blood
    pressure goal

--  Diovan® data evaluating potential impact on lowering an important
    marker of inflammation, high sensitivity C-reactive protein, to be
    presented on Friday
    

Data demonstrating the blood pressure efficacy of two new investigational high blood pressure medicines being developed by Novartis Pharmaceuticals Corporation were presented today at the American Society of Hypertension, Inc., Annual Scientific Meeting and Exposition (ASH 2006) in New York. In addition, on Friday, the results of Val-MARC (Valsartan-Managing blood pressure Aggressively and evaluating Reductions in hsCRP) with currently available Diovan® /Diovan HCT® will also be presented. Val-MARC evaluates the effects of Diovan on high sensitivity C-reactive protein (hsCRP), an important marker for inflammation. In total, there will be more than 30 abstracts with new data on currently marketed and investigational agents within the company's hypertension portfolio presented at the ASH 2006 meeting.

"High blood pressure -- and its consequences -- is the world's number one killer, estimated to affect nearly one billion people. The overwhelming numbers of patients who remain uncontrolled despite treatment speaks to the urgent need for more therapeutic options," said James Shannon, M.D., Head of Development, Novartis Pharma AG. "Data presented at ASH 2006 shows our commitment to expand our investigations for additional benefits of Diovan and to develop new agents to help physicians get their patients to blood pressure goal."

Investigational agents Rasilez® (aliskiren) and Exforge® (amlodipine besylate/valsartan) are under regulatory review in the United States.

If approved, Rasilez, developed with Speedel, would be the first effective oral direct renin inhibitor. It acts within the Renin System, which is central to blood pressure regulation. By directly inhibiting the system's point of activation -- renin -- Rasilez decreases the activity of the Renin System, as measured by plasma renin activity (PRA).

Exforge is a potential new treatment for high blood pressure. Exforge utilizes two complementary mechanisms of action, calcium channel blockade with amlodipine and angiotensin receptor blockade with valsartan, both agents being the number one prescribed medications in their respective classes.

The trade names Rasilez and Exforge are currently pending regulatory approval.

Newly released aliskiren data highlights:

POSTER #228 "The novel oral renin inhibitor aliskiren provides effective blood pressure control in patients with hypertension when used alone or in combination with hydrochlorothiazide"

Alberto Villamil, M.D., Fundapres, Las-Heras, Buenos Aires, Argentina

A randomized, double-blind eight-week multifactorial study of 2,776 patients who received aliskiren at 75 mg, 150 mg or 300 mg, hydrochlorothiazide (HCTZ) or placebo showed that aliskiren provides effective blood pressure control in people with high blood pressure when used alone or in combination with HCTZ. Aliskiren significantly reduced mean sitting systolic and diastolic blood pressure. The combination of aliskiren and HCTZ lowered blood pressure more effectively than either agent alone. Aliskiren 300 mg in combination with HCTZ 25 mg reduced diastolic blood pressure by 21.2 mm Hg and systolic levels by 14.3 mm Hg. Similarly, this combination resulted in a 76.9% responder rate defined as patients who reached a diastolic blood pressure of less than 90 mm Hg and/or a decrease of at least 10 mm Hg.

"This study showed that aliskiren is an effective treatment for high blood pressure when given alone, and provided additional blood pressure reductions when combined with HCTZ," commented study author Alberto Villamil, M.D., Fundapres, Las-Heras, Buenos Aires, Argentina. "The additive effect is particularly promising because when aliskiren and HCTZ were used together, blood pressure dropped significantly more than with either agent individually."

POSTER #209 "Once-daily aliskiren provides effective, smooth 24-hour blood pressure control in patients with hypertension"

Jerry Mitchell, M.D., Texas Center for Drug Development, Houston

A randomized, double-blind, multicenter, placebo-controlled study of 672 people with mild-to-moderate high blood pressure given either aliskiren 150 mg, 300 mg or 600 mg once a day or placebo showed that once-daily aliskiren provides sustained blood pressure control throughout a 24-hour dosing period.

Ambulatory systolic and diastolic blood pressure measured over 24 hours was lowered significantly. With aliskiren 300 mg, the trough-to-peak ratio for lowering diastolic blood pressure was 0.98, indicating that reductions were consistent over 24 hours without loss of effect. The trough-to-peak ratio was 0.64 with aliskiren 150 mg and 0.86 with the 600 mg dosage.