- Studies show investigational medicine Rasilez provides significant and sustained blood pressure reduction over 24-hour period
- Potential for use both as monotherapy and in combination with other high blood pressure medicines
- Direct renin inhibitors will be the first new class of high blood pressure medicines available in more than 10 years
- US submission completed in April, EU submission expected by end-2006
Basel, May 17, 2006 - New data for Rasilez® (aliskiren), the first orally effective direct renin inhibitor, reaffirmed that it provides a significant and sustained blood pressure response over a 24-hour period, both when used alone or in combination with the diuretic hydrochlorothiazide (HCTZ), one of the most commonly-used high blood pressure medicines.
The Rasilez data, which was presented today at the American Society of Hypertension, Inc., Annual Scientific Meeting and Exposition (ASH 2006) in New York, showed durable and persistent blood pressure lowering over the entire 24-hour dosing period. This is important because blood pressure often surges during early morning hours.
Throughout the clinical program, Rasilez has also shown significant blood pressure response when used in combination with ACE inhibitors and calcium channel blockers, with a superior response seen in trials against the ACE inhibitor ramipril. Rasilez has shown placebo-like tolerability as a monotherapy and has been well tolerated when used with other common cardiovascular as well as anti-diabetic medicines.
"High blood pressure - and its consequences - is the world's No.1 killer, estimated to affect nearly one billion people. The overwhelming number of patients who remain uncontrolled despite current treatments speaks to the urgent need for new options," said Dr. James Shannon, MD, Head of Development at Novartis Pharma AG. "These new data for Rasilez underscore our commitment to developing novel medicines to help physicians get their patients' blood pressure under control."
If approved, Rasilez, developed with Speedel, will represent the first new treatment approach for people with high blood pressure in more than a decade. 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 system's activity, as measured by plasma renin activity (PRA).[1]
Submission in the US was completed in April 2006, while European submission remains on track for the end of 2006. The trade name Rasilez is pending FDA and other regulatory approvals.
Rasilez offers consistent 24-hour control[1]
Rasilez provides sustained blood pressure control throughout a 24-hour dosing period. This was shown in a randomized, double-blind, multicenter, placebo-controlled study with 672 people with mild-to-moderate high blood pressure given Rasilez 150 mg, 300 mg, or 600 mg once a day, or placebo.
"Sustained 24-hour control is particularly important because blood pressure fluctuates during the day and often surges in the early morning hours," said lead investigator Dr. Jerry Mitchell, MD, of the Texas Center for Drug Development in Houston. "Patients need to control their blood pressure around the clock, and our study shows that aliskiren can provide that control."
Ambulatory systolic and diastolic blood pressure measurements over 24 hours were lowered and statistically significant (p<0.0001). Also with Rasilez 300 mg, the trough-to-peak ratio for lowering diastolic blood pressure was 0.98, indicating that reductions were consistent and nearly identical over the entire 24-hour period. The trough-to-peak ratio for Rasilez 150 mg was 0.64 and for 600 mg was 0.86.
Rasilez significantly reduces blood pressure alone and in combination[2]
Rasilez provides effective blood pressure control when used alone or in combination with the diuretic (HCTZ). A randomized double-blind 8-week study of 2,776 people with high blood pressure who received Rasilez at 75 mg, 150 mg or 300 mg in various combinations with HCTZ or placebo showed that Rasilez significantly reduced mean sitting systolic (p<0.0001) and diastolic blood pressure (p<0.0002).
"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," said study author Dr. Alberto Villamil, MD, of 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 alone."
Similarly, the combination of Rasilez 300 mg and HCTZ 25mg resulted in the highest percentage of responders, defined as patients who reached the goal for diastolic blood pressure of less than 90 mmHg and/or decreased blood pressure by at least 10 mmHg.
In the overall clinical program, Rasilez - at doses up to 300 mg (within the expected therapeutic dose range) - has consistently shown tolerability similar to placebo.
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as "potentially innovative", "potential", "will", "expected", "promising", "if approved . will", "submission remains on track" or similar expressions, or by express or implied discussions regarding the potential regulatory approval of Rasilez, or potential future revenue from Rasilez. Such statements reflect the current views of the Novartis group of companies with respect to future events and are subject to certain risks, uncertainties and assumptions. There can be no guarantee that any current or future regulatory filings will satisfy the FDA's or other health authorities' requirements, that Rasilez will be approved for any indications in any market, that Rasilez will be brought to market in the US or in any other country, nor that it will reach any particular sales levels. In particular, management's expectations regarding the approval and commercialization of Rasilez could be affected by, among other things, additional analysis of 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; increased government, industry, and general public pricing pressures; and other risks and factors referred to in Novartis AG's current Form 20-F on file 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 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.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, treat disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics, human vaccines and leading self-medication OTC brands. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,000 people and operate in over 140 countries around the world. For more information, please visit
http://www.novartis.com.
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References
1. Mitchell J, Oh B, Herron J, Chung J, Khan M, Satlin A. Once-daily aliskiren provides effective, smooth 24-hour blood pressure control in patients with hypertension. Abstract to be presented at American Society of Hypertension (ASH) 21st Annual Meeting and Exposition.
2. Villamil A, Chrysant S, Calhoun D. Schober B, Hsu H, Zhang J. The novel oral renin inhibitor aliskiren provides effective blood pressure control in patients with hypertension when used alone or in combination with hydrochlorothiazide. Abstract to be presented at American Society of Hypertension (ASH) 21st Annual Meeting and Exposition.
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