Study shows Rasilez®, the first and only approved direct renin
inhibitor, reduces a marker of heart failure severity and is
* Rasilez significantly reduces brain natriuretic peptide (BNP), a
widely accepted indicator of heart failure severity
* Rasilez generally well-tolerated when added to standard heart
failure treatment, unlike some other blood pressure medicines
that can worsen heart failure,
* ALOFT study is the first to highlight potential benefits of
Rasilez beyond blood pressure lowering
* Heart failure a growing cause of hospitalization and death,
Basel, September 2, 2007 - Rasilez® (aliskiren), the first new type
of high blood pressure medicine in more than a decade, is generally
well-tolerated and can potentially reduce the severity of heart
failure based on new data showing significant reductions in BNP, a
substance secreted by the heart and whose levels are viewed as an
indicator of disease severity.
The ALOFT (ALiskiren Observation of Heart Failure Treatment) study
results, presented today at the European Society of Cardiology
Congress in Vienna, were the first to highlight the potential
benefits of Rasilez beyond blood pressure lowering. Rasilez, which is
the first in a new class of high blood pressure medicines called
direct renin inhibitors, was launched in the US in March 2007 and
received European Union approval in August.
Heart failure, also often referred to as congestive heart failure,
may develop slowly over years and occurs when the heart's ability to
pump blood is weaker than normal. This condition is particularly seen
in patients with high blood pressure and is a growing cause of
hospitalization and death. Most cases of heart failure lead to death
within five years.
Unlike some other blood pressure medicines, such as calcium channel
blockers and some beta blockers that can worsen heart failure,,
Rasilez demonstrated good safety and a tolerability profile similar
to placebo (or sugar pill) when used in this hard-to-treat patient
In the 12-week trial, Rasilez was added to existing standard-of-care
therapies including ACE inhibitors and angiotensin receptor blockers
(ARBs), which are other types of high blood pressure medicines. As
expected, a slightly higher but non-significant number of patients
receiving Rasilez experienced hyperkalemia (elevated potassium
levels) compared to those receiving a placebo. This was usually mild
and did not lead to an adverse outcome.
The results showed that the addition of Rasilez to standard heart
failure treatments resulted in reductions in BNP (brain natriuretic
peptide) nearly five times greater than the standard therapy alone
(-61 pg/ml versus -12 pg/ml). This difference in BNP reductions was
highly significant (p= 0.016).
BNP is a substance released from the heart's lower ventricles in
response to increased wall tension. The level of BNP in the
bloodstream increases when heart failure symptoms worsen, and
decreases when the heart failure condition is stable.
"Blocking the renin angiotensin aldosterone system (RAAS) with an
angiotensin converting enzyme (ACE) inhibitor is of unequivocal
benefit in heart failure," said Professor John McMurray, British
Heart Foundation Cardiovascular Research Centre, University of
"The question we asked is whether adding aliskiren to an ACE
inhibitor, to further block the RAAS, would be safe and have
potentially greater benefit in heart failure. In our study,
aliskiren, when added to standard therapy, was well-tolerated and
reduced the plasma concentration of BNP, a blood test used as a
marker of cardiac strain. Further research is needed to tell us
whether this reduction in BNP might be associated with improvements
in clinical outcomes," Dr. McMurray said.
The ALOFT study is the first of a series of trials in ASPIRE HIGHER,
an extensive ongoing clinical program studying the benefits of
Rasilez beyond reducing blood pressure due to its direct inhibition
of renin, an enzyme that triggers a process that can lead to high
blood pressure. Additional data involving the use of Rasilez in
patients with heart failure and new data in patients with kidney
failure are expected to be presented later this year.
Rasilez is the first in a new class of high blood pressure medicines
called direct renin inhibitors and has demonstrated significant blood
pressure lowering when used alone, or in combination with other
blood pressure medicines,,,. It is not currently
indicated for use in treating patients with heart failure, and
additional long-term studies are needed to assess its potential
effects on heart failure.
"Rasilez has consistently shown good tolerability and strong blood
pressure lowering across trials," said James Shannon, MD, Global Head
of Development at Novartis Pharma AG. "The ALOFT study highlights the
potential benefits of Rasilez beyond blood pressure lowering in a
vulnerable, hard-to-treat patient population."
Rasilez was approved in the European Union in August 2007 and in the
US in March 2007 under the trade name Tekturna®. In July 2007,
Novartis announced Swiss approval of Rasilez. It was developed in
collaboration with Speedel.
The foregoing release contains forward-looking statements which can
be identified by the use of terminology such as "potential,", "may,"
"can" and "expected" or similar expressions, or by express or
implied discussions regarding the potential regulatory approval of
Rasilez/Tekturna, or potential future revenue from Rasilez/Tekturna.
Such forward-looking statements reflect the current views of Novartis
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results to be
materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Rasilez/Tekturna reach any particular sales levels. In
particular, management's expectations regarding Rasilez/Tekturna
could be affected by, among other things, unexpected clinical trial
results, including additional analysis of clinical data, or
unexpected new clinical data; unexpected regulatory actions or delays
or government regulation generally; competition in general; increased
government, industry, and general public pricing pressures; our
ability to obtain or maintain patent or other proprietary
intellectual property protection; 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, cure 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. We
are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
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self-medication OTC brands. Novartis is the only company with
leadership positions in these areas. In 2006, the Group's businesses
achieved net sales of USD 37.0 billion and net income of USD 7.2
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Headquartered in Basel, Switzerland, Novartis Group companies employ
more than 100,000 associates and operate in over 140 countries around
the world. For more information, please visit
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Fang H, Satlin A. Aliskiren, a novel renin inhibitor, has greater BP
lowering than ramipril and additional BP lowering when combined with
ramipril in patients with diabetes and hypertension. Poster presented
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amlodipine provides significant additional blood pressure lowering
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