New Clinically Important BP Efficacy Data with Novartis' Antihypertensives Diovan & Co-Diovan Presented at Leading Hypertension Meeting

Novartis' Co-Diovan(R) (valsartan and hydrochlorothiazide) aggressively lowers blood pressure to recommended target goals as effectively as amlodipine but with fewer side effects in African Americans, considered a difficult-to-treat patient population.  The study called AADVANCE (African American Diovan (Valsartan) Amlodipine (Norvasc(R)*) Clinical Efficacy Trial), was among several new studies examining the efficacy of Diovan(R) (valsartan) and Co-Diovan presented this week during the American Society of Hypertension 19th Annual Scientific Meeting and Exposition in New York.

High blood pressure is a public health crisis.  One billion people worldwide suffer from high blood pressure, which accounts for one in four adults or one-sixth of the world's population.  As a result of genetic and other factors, high blood pressure is often difficult to treat in African Americans, particularly in those who also have diabetes.  According to new treatment guidelines,1,2 most of these patients need more than one type of high blood pressure treatment to achieve healthy blood pressure levels.

Despite proven cardiovascular benefits, inhibitors of the renin-angiotensin-system (RAS) - angiotensin II receptor blockers (ARBs) and angiotensin-converting-enzyme (ACE) inhibitors - are underused in the African American population.  "The compelling new data in the AADVANCE study and the other studies presented add to the cumulative clinical evidence of the wide range of benefits that Diovan and Co-Diovan provide in terms of double-digit blood pressure lowering, superior tolerability, long-term patient persistency with therapy, and cardioprotection, further demonstrating that Diovan and Co-Diovan offer a new standard of care in cardiovascular disease," said Joerg Reinhardt, Head of Development, Novartis Pharma AG.

A leading fixed-dose combination of two effective anti-hypertensive medicines from Novartis, Co-Diovan combines a diuretic and Diovan in a convenient once-a-day tablet.  Diovan, the fastest growing branded antihypertensive globally, blocks the RAS, a hormonal system that regulates blood pressure and which can have harmful effects on the heart and blood vessels.  Diovan not only powerfully lowers blood pressure, but is known to have additional positive effects beyond lowering blood pressure.  In fact, Diovan is proven to have all of the life-saving and other established benefits of ACE inhibitors in patients following a heart attack.  In addition to hypertension, Diovan is also available in more than 40 countries for the treatment of heart failure in patients who also take usual therapy including diuretics, digitalis and either beta blockers or angiotensin converting enzyme (ACE) inhibitors, but not both.

About AADVANCE

AADVANCE was a prospective, double-blind, randomised, head-to-head comparison of Co-Diovan and amlodipine, a calcium channel blocker, in 482 African Americans with mild to moderate high blood pressure (between 140 and 180 mmHg/ between 90 and 110 mmHg).  After a 2-3 week placebo run-in, patients were randomised to Diovan 160 mg monotherapy or amlodipine 5 mg for 2 weeks and then force-titrated to Co-Diovan 160/12.5 mg or amlodipine 10 mg for an additional 10 weeks.  AADVANCE showed Co-Diovan reduced blood pressure as effectively as amlodipine (mean reduction in 24-hr ABPM systolic BP  -15.9 plus or minus 12.1 mmHg vs. -14.5 plus or minus 12.2 mmHg and diastolic BP -10.2 plus or minus 8.6 mmHg vs. -9.1 plus or minus 8.3 mmHg respectively; p<0.0001) but was significantly less likely to cause peripheral oedema (leg swelling) (1.7% vs. 5.8% respectively; p=0.0309) or joint swelling (0% vs. 2.9% respectively; p=0.0082).  The incidence of other adverse events was similar between groups.  Several previous studies have also shown Diovan has proven efficacy and tolerability and additional benefits in relation to amlodipine.  Val-Syst, for example, showed Diovan was as effective as amlodipine in lowering isolated systolic hypertension in the elderly, but it was much less likely to cause peripheral oedema (p<0.0001).(3)

VALUE (Valsartan Antihypertensive Long-term Use Evaluation Trial) is also exploring the differential effects of Diovan-based therapy vs. amlodipine-based therapy in 15,313 hypertensives at high-risk for cardiovascular events because of at least one other co-existing disease or risk factor (e.g., diabetes, history of stroke, high cholesterol, angina).  VALUE is designed to discover whether, in high-risk patients with the same level of blood pressure control, Diovan-based therapy has additional effects on cardiovascular outcomes such as heart attack, heart failure and stroke.  The findings of VALUE will be reported at the 14th European Meeting on Hypertension in Paris on June 14, 2004.

About VALOR

Another study presented at ASH also reinforces why Diovan and Co-Diovan are leading choices in the treatment of hypertension and specifically, the benefits of combination therapy for those patients who require more than one type of high blood pressure treatment to reach target systolic blood pressure goals.  VALOR was an eight-week, multicentre, randomised, double-blind, active controlled study at 30 sites in Canada with 767 patients.  VALOR evaluated patients with moderate to severe high blood pressure (systolic blood pressure between 160 mmHg and 200mmHg) first on Diovan 160 mg monotherapy and then titrated up to Co-Diovan 160/12.5 mg or 160/25 mg.  Mean systolic blood pressure at baseline was 167.9 mmHg.  Diovan 160 mg demonstrated excellent tolerability and blood pressure reductions from baseline (mean change: -20.7).  Titration to Co-Diovan 160/12.5 mg and 160/25 mg provided significant additional reductions in systolic blood pressure (mean change: -27.9 and -28.3, respectively) with no increase in adverse events with titration to Co-Diovan.

About ABCD-2V

In addition to AADVANCE and VALOR, data from the ABCD-2V trial was presented at this meeting.  This study was a single-centre, prospective, randomised trial investigating the long-term effects of moderate versus intensive blood pressure control on the progression or development of complications in type 2 diabetic patients.  Patients were randomised to receive either "intensive" blood pressure control with Diovan plus additional antihypertensives to achieve a target diastolic blood pressure of <75 mmHg or "moderate" blood pressure control with placebo (target diastolic blood pressure goal: <80-90 mmHg).  The average length of patient follow-up was 1.9 years.  Mean blood pressure of 119 7.8/78 3.1 mm Hg was achieved in the intensive group and 124 6.8/81 4.1 mm Hg in the moderate group.  A higher percentage of patients (77.8%) returned to normoalbuminuria with intensive than with moderate therapy (33.3%; p = 0.046).  There was no difference in change in creatinine clearance between treatment groups.

AADVANCE, VALOR, VALUE and ABCD-2V are part of the Diovan clinical trial programme, one of the world's largest cardiovascular research programmes.  The programme involves more than 50,000 patients, including 9,500 patients with diabetes, in major trials investigating potential new applications for Diovan across the cardiovascular disease continuum.  Already completed Diovan trials include VALIANT in post-heart attack patients and Val-HeFT in heart failure patients.  Ongoing or soon to be reported trials include VALUE, also NAVIGATOR in pre-diabetes patients at risk for cardiovascular disease and Val-MARC, a study of the effects of Diovan on C-reactive protein, an inflammatory marker for heart disease.

The foregoing release contains forward-looking statements that can be identified by terminology such as "soon to be reported" or similar expressions, or by express or implied discussions regarding potential new indications or labelling for Diovan or Co-Diovan, or regarding potential future revenues from Diovan or Co-Diovan.  Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Diovan and Co-Diovan to be materially different from any future results, performance or achievements expressed or implied by such statements.  There can be no guarantee that Diovan or Co-Diovan will be approved for any additional indications or labelling in any market, or that they will reach any particular levels of revenue.  In particular, management's expectations regarding Diovan and Co-Diovan could be affected by, among other things, additional analysis of Diovan or Co-Diovan clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; governmental and other pricing pressures and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission.  Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health.  In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion.  The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 500 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com .

(*) Norvasc(r) is a registered trademark of Pfizer Inc.

(1) The Seventh Report of the Joint National Committee of Prevention,

(2) Hypertension in African Americans Working Group.  Management of high

(3) Malacco E. The efficacy and safety of valsartan-based versus amlodipine-

SOURCE:  Novartis AG

CONTACT: Karen Sutherland, Novartis Pharma Communications