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Novartis Says Stalevo Trial Results Positive (Parkinson's Disease News)

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www.ProHealth.com • September 2, 2003


ZURICH -(Dow Jones)- Novartis AG said Monday that results from new clinical studies with Stalevo(TM) presented at the 7th Congress of the European Federation of Neurological Societies in Helsinki, Finland confirm clear patient benefits.

Data from these first-ever studies in patients with Parkinson's disease taking Stalevo - the new levodopa combination product containing levodopa, carbidopa and entacapone - show enhanced symptomatic benefits resulting in greater control of PD symptoms, as well as convenience of administration compared to traditional levodopa therapy. While levodopa therapy remains the cornerstone of PD treatment, its long term utility is limited by the occurrence of motor complications. Stalevo was therefore developed to optimize the pharmacokinetic profile of levodopa and enhance its clinical benefits.

The individual components of Stalevo have a well-established efficacy record supported by numerous clinical trials1,2,3,4,5,6, which provided the basis for regulatory agency approval of Stalevo7. These first-ever clinical studies provide valuable data regarding dosing, tolerability and efficacy of Stalevo. Commenting on the clinical relevance of the TC-INIT study8, one of the lead investigators, Professor David Brooks, of the Medical Research Council Clinical Sciences Centre and Imperial College London, UK said: "These interim data show that levodopa treated PD patients may be switched to Stalevo and experience enhanced benefits of their levodopa therapy.

In addition, this real-life experience is significant as it demonstrates that the switch can be achieved easily and conveniently". The TC-INIT study compares the switch from traditional levodopa/ dopa decarboxylase inhibitor (DDCI) therapy to either Stalevo or levodopa/DDCI plus entacapone (Comtess/Comtan) tablets taken separately in 200 PD patients experiencing wearing-off symptoms. Interim results of 111 patients show that patients taking Stalevo experience improved symptom control comparable to levodopa/DDCI plus entacapone taken separately.

At the end of week two, a majority of patients saw their condition improve when their levodopa therapy was optimized. When switched to Stalevo, 82% (investigator assessment) and 81% ( patient assessment) of patients reported improved symptom control versus 76% ( investigator assessment) and 73% (patient assessment) when switched to levodopa/ DDCI plus entacapone taken separately. In addition, treatment with Stalevo as a single tablet was easy to initiate and provided simplicity and convenience of administration for patients.

Interim data from a second study (SELECT-TC) assessing the switch to Stalevo in 160 PD patients currently being treated with levodopa/carbidopa and experiencing wearing-off symptoms, indicate that the majority of patients can easily be transferred to Stalevo with few, or no levodopa dose adjustments.9 "These data show that dose modifications are rarely needed when switching from levodopa treatment to Stalevo and can be accomplished with ease and convenience, and most importantly with the patient's acceptance.

There are a number of complicated regimens that currently exist in PD treatment. Many patients often have to take medications for other co-existing conditions. Stalevo clearly has everyday practical benefits for patients and for physicians prescribing the treatment by combining three medicines in one", added Professor David Brooks. In a third, four-week completed study (SIMCOM) more than two- thirds of the patients preferred taking Stalevo to levodopa/DDCI and entacapone taken separately. Furthermore, the vast majority of patients reported that Stalevo was easier to dose, use, handle and swallow.10

In all studies, Stalevo was generally well tolerated. The most common side effects were dopaminergic in nature (e.g. dyskinesia or involuntary movements, nausea). These side effects are mild and moderate in nature, and when they occur, they can usually be managed with dose modifications. Side effects seldom lead to treatment discontinuation. In addition, the components of Stalevo have a well-established safety and tolerability profile supported by numerous clinical trials1,2,3,4,5,6 and over 300 000 patient years of experience with levodopa/DDCI plus entacapone.11

Novartis and Orion Pharma received US Food and Drug Administration (FDA) approval for Stalevo in June 2003 and have recently [26 June 2003] received a positive opinion from the European Committee for Proprietary Medicinal Products (CPMP). This release contains certain forward-looking statements relating to the Company's business, which can be identified by the use of forward-looking terminology such as "first-ever studies" or similar expressions, or by express or implied discussions regarding potential future sales of Stalevo.

Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Stalevo to be materially different from any future results, performance or achievements expressed or implied by such statements.

There can be no guarantee that the aforementioned clinical trials will result in the commercialization of Stalevo in any market. Any such commercialization can be affected, among other things, uncertainties relating to unexpected regulatory delays, further clinical trial results, the ability to obtain or maintain patent or other proprietary intellectual property protection, government regulation or competition in general, increased government pricing pressures, 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 these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.

Company Website: www.novartis.com

-Zurich Bureau, Dow Jones Newswires; 41-1-212-2181

Edited Press Release

VIENNA -(Dow Jones)- Swiss pharmaceutical company Novartis AG Tuesday said data from a landmark trial on its blockbuster heart failure drug Divoan showed that atrial fibrillation is cut 35% when patients are taking the Swiss pharmaceutical company's drug

Data from the landmark trial Val-HeFT showed Diovan (valsartan) reduced new cases of atrial fibrillation by 35% versus placebo in heart failure patients who also took usual heart failure treatments.

Atrial fibrillation is the irregular beating of the heart.

The new data, presented Tuesday at the European Society of Cardiology, or ESC, Congress 2003, also showed that atrial fibrillation is an independent contributor to all cause mortality in heart failure patients.

"Because of its size, Val-HeFT offered an extraordinary opportunity to study both the onset and consequences of atrial fibrillation in a large population of heart failure patients," said Professor Aldo Maggioni, the Val-HeFT investigator who presented the findings and is from the GISSI Group, coordinated by the Italian Association of Hospital Cardiologists, or ANMCO, and the Instituto di Ricerche Farmacologie, Mario Negri, Milan, Italy.

"The data clearly shows valsartan works independently to prevent atrial fibrillation in heart failure patients already receiving the best, currently recommended heart failure treatment."

The study was one of several new abstracts from Val-HeFT presented at the ESC 2003.

One of the largest studies ever conducted in the treatment of heart failure, Val-HeFT was sponsored by Novartis Pharma AG, the makers of Diovan. Diovan has proven to have combined mortality and morbidity benefits in heart failure - and is indicated in more than 30 countries for the treatment of heart failure in patients also taking usual heart failure therapy such as diuretics, digitalis and either an ACE, or angiotensin-converting-enzyme, inhibitor or a beta blocker, but not both.

In the US, Diovan is the only drug in its class approved for the treatment of heart failure in patients who cannot tolerate ACE inhibitors. The fastest growing antihypertensive drug on the market today, Diovan is also approved for first-line treatment of high blood pressure in more than 80 countries.

"Val-HeFT continues to yield a wealth of new data to advance the care of patients with heart failure," said Joerg Reinhardt, Global Head Pharma Development, Novartis Pharma AG.

"The new data also strengthen our commitment to develop the full potential of Diovan as a cardio protective agent. We look forward to the results of VALIANT, another Diovan mega trial that will report later this year. VALIANT is studying Diovan in post-myocardial infarction - MI or heart attack - a different point on the cardiovascular disease continuum. Like Val-HeFT, VALIANT is designed to serve as a reference trial for the future treatment of the disease it is studying."

Company Web Site: http://www.novartis.com



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