Novartis seeks European approval for Rasilez® to become the first in a new class of medicines to help patients with high blood pressure
* Direct renin inhibitors expected to be the first new class of high blood pressure medicines available in more than 10 years
* Rasilez shows significant double-digit blood pressure reductions when used alone and significant additive reductions when added to other blood pressure medicines
* New clinical data show Rasilez also provides rapid onset of action, 24-hour blood pressure control maintained over time and placebo-like safety and tolerability
Basel, September 28, 2006 - Rasilez® (aliskiren), a new medicine that would represent the first new treatment approval for people with high blood pressure in more than a decade, has been submitted for European Union approval.
The submission, which was accepted by the European Medicines Agency (EMEA), includes data from more than 7,800 patients with high blood pressure taking Rasilez in 44 clinical trials. These results show Rasilez produces sustained double-digit reductions in blood pressure, reaches its maximal lowering effect within four weeks, and has placebo-like safety and tolerability within the expected therapeutic dose range.
In addition to being effective by itself as a monotherapy, Rasilez further reduces blood pressure when co-administered with many common anti-hypertension therapies, including angiotensin converting enzyme inhibitors (ACE inhibitors), calcium channel blockers (CCBs) or the diuretic hydrochlorothiazide (HCTZ).
High blood pressure - and its consequences - is the world’s No. 1 killer and is estimated by the American Heart Association to affect one in four adults - around one billion people globally,,. Despite extensive use of current therapies, about 70% of all people with high blood pressure do not reach their target blood pressure levels. Many patients require three or more medicines to control their blood pressure. Meanwhile, many existing treatments fail to provide sustained 24-hour blood pressure control, particularly during the early morning hours.
Rasilez, which was developed in collaboration with Speedel AG, is a first-of-its-kind treatment resulting from the long search for effective renin inhibition through an oral medicine. It acts within the renin system, which is central to blood pressure regulation. By suppressing the renin system’s point of activation - renin - Rasilez decreases the activity of this system, as measured by plasma renin activity (PRA).
“Physicians and patients need new therapeutic approaches for controlling blood pressure and its associated complications. We’ve been hoping for a direct renin inhibitor for long time,” said Professor Roland Schmieder, Department of Nephrology and Hypertension at the University of Erlangen-Nürnberg in Germany. “Data on aliskiren show that directly inhibiting renin can provide the control our patients need and might provide other long-term benefits.”
The most recent clinical data, which was presented in September, highlighted the power of Rasilez to maintain its 24-hour blood pressure lowering over one year of therapy and to continue its lowering effects for up to four weeks after the medicine was stopped.
Throughout the clinical program, Rasilez has consistently shown tolerability comparable to placebo at doses up to 300 mg daily. Rasilez has also been well-tolerated when used alone or with other common cardiovascular and anti-diabetic medicines.
“For more than 40 years, medical researchers have focused on controlling over-activation of the renin system,” said James Shannon, MD, Global Head of Development at Novartis. “As a direct renin inhibitor, Rasilez has the potential to redefine how high blood pressure is treated. We intend to conduct a large clinical program involving more than 40,000 patients to evaluate the potential long-term benefits of Rasilez beyond blood pressure control.”
In April 2006 the US Food and Drug Administration (FDA) accepted aliskiren for regulatory review. Submissions in other markets are planned.
The foregoing release contains forward-looking statements which can be identified by the use of terminology such as “intend,” “seeks,” “expected to be,” “would represent,” “might provide,” “potential,” “estimated,” or similar expressions, or by express or implied discussions regarding potential future regulatory filings, approvals or future sales of 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 Rasilez will be approved for sale in any market, or 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, unexpected clinical trial results, including additional analysis of existing clinical data and new clinical data; 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.
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 97,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.
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6. Rasilez data on file at Novartis
7. Sica, et al. Aliskiren, a novel renin inhibitor, is well tolerated and has sustained BP-lowering effects alone or in combination with HCTZ during long-term (52 weeks) treatment of hypertension. Poster presented at the 15th World Congress of Cardiology 2006.
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