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Novartis Phase III Study Shows RLX030 Improved Symptoms and Reduced Deaths by One-Third in Patients with Acute Heart Failure

Novartis Phase III Study Shows RLX030 Improved Symptoms and Reduced Deaths by
                One-Third in Patients with Acute Heart Failure

-- RELAX-AHF study met one of its two primary endpoints in reducing dyspnea or
shortness of breath, and was therefore positive under pre-specified criteria

-- Newly presented data show that at six months, RLX030 reduced all-cause and
cardiovascular mortality by 37% in patients with acute heart failure (AHF)

-- RLX030 is the first in a new class of medicines and the only agent to show
a reduction in mortality in AHF

-- Within one year after hospitalization for AHF, approximately 20-30% of
patients die from various causes

PR Newswire

EAST HANOVER, N.J., Nov. 6, 2012

EAST HANOVER, N.J., Nov. 6, 2012 /PRNewswire/ --The Phase III RELAX-AHF study
has shown that investigational RLX030 (serelaxin) improved symptoms and
reduced deaths by one-third at the end of six months in patients with acute
heart failure (AHF). Most of these deaths were due to cardiovascular causes.
RLX030 is the first in a new class of medicines and is believed to act through
multiple mechanisms on the heart, kidneys and blood vessels.

To view the multimedia assets associated with this release, please click:
http://www.multivu.com/mnr/59014-novartis-phase-iii-relax-ahf-study-rlx030-serelaxin

RELAX-AHF demonstrated that RLX030 significantly reduced dyspnea (i.e.
shortness of breath), the most common symptom of AHF and the primary endpoint
of the study. As one of two co-primary endpoints was met, the study achieved
its primary objective based on pre-specified protocol criteria.

Results of the study were presented today at the American Heart Association
(AHA) Scientific Sessions in Los Angeles and published simultaneously in The
Lancet.

"This study with serelaxin is important because it may offer the prospect of a
much-needed new medicine for acute heart failure, where the death rate remains
high and there have been few new therapies for several decades," said
Professor John R. Teerlink, MD of the Section of Cardiology, San Francisco
Veterans Affairs Medical Center, University of California, San Francisco, the
co-lead investigator of the RELAX-AHF study.

Professor Marco Metra, Director of the Institute of Cardiology at the
University and Civil Hospital of Brescia, Italy, the other co-lead
investigator of the study, said: "The reduction in mortality seen with
serelaxin is supported by the decreases in episodes of worsening of heart
failure, as well as by the biomarker data collected during the study,
suggesting that the clinical effects of serelaxin may be linked to a
beneficial effect on organs such as the heart and kidneys."

Novartis has begun discussing the results of this single Phase III study with
health authorities worldwide.

"The survival results with RLX030 are encouraging for patients, their families
and society at large," said Tim Wright, Global Head of Development, Novartis
Pharmaceuticals. "Novartis is committed to significantly improving treatment
outcomes for patients with heart failure, and these results support our
research into this therapeutic area which may lead to better management of the
disease."

Study details
RELAX-AHF was an international randomized, double-blind study involving 1,161
patients and was designed to compare the efficacy and safety profile of RLX030
to placebo in addition to standard therapy for the treatment of AHF. RLX030
was given upon hospitalization in the form of an intravenous infusion (30 mcg
per kg per day) for 48 hours in addition to conventional therapy for AHF, i.e.
loop diuretics and other medicines.

The study had two primary endpoints using different scales to measure
reduction in dyspnea. The visual analog scale (VAS) showed a significant
benefit up to day five (p=0.0075), whereas the Likert scale (a
baseline-related short-term assessment of dyspnea relief) did not reach
significance at 6, 12 and 24 hours (p=0.702). As one of the primary endpoints
was met the study was positive according to protocol criteria.

The study did not meet its secondary efficacy endpoints, namely days alive and
out of hospital up to day 60 (p=0.37), and cardiovascular death or
re-hospitalization due to heart or kidney failure up to day 60 (p=0.89).

Results showed that 7.3% of patients died from all causes in the RLX030 group
compared to 11.3% in the placebo group (p=0.02) ^ at 180 ^ days of follow-up.
All-cause mortality up to day 180 was a safety endpoint of the study. The
number of deaths due to cardiovascular causes to day 180 (an additional
pre-specified efficacy endpoint) was also significantly lower with RLX030 than
placebo (6.1% vs. 9.6%, p=0.028). RLX030 was therefore associated with a 37%
reduction in all-cause and cardiovascular mortality at the end of six months.

In addition to its effects on mortality and symptoms, RLX030 met several other
efficacy endpoints including significantly reducing the worsening signs and
symptoms of heart failure up to day 14 (p=0.024), thereby decreasing the need
for intensified heart failure treatment. RLX030 also reduced the mean length
of stay in hospital by 0.9 days (p=0.039) and in the intensive/cardiac care
unit by 0.4 days (p=0.029).

RLX030 was well tolerated and adverse events (AEs), including low blood
pressure (hypotension), were generally comparable between RLX030 and placebo.
There was a lower incidence of adverse events related to renal impairment with
RLX030 than placebo (4.6% vs. 8.6%). The most common AEs in both treatment
groups were cardiac disorders, metabolism and nutrition disorders, and
gastrointestinal disorders. No clinically significant differences in the
incidence of serious adverse events were seen between treatment groups.

Heart failure is a disease in which the heart is unable to supply enough blood
to meet the body's needs. The disease leads to a spiral of physical decline
often leading to acute episodes in which patients' symptoms suddenly become
worse and urgent hospital treatment is needed. These episodes are called acute
heart failure (AHF) and are also referred to as acute decompensated heart
failure. Acute heart failure (AHF) places an enormous burden on healthcare
systems. It is the most frequent cause of hospitalization in patients over 65
years of age in the United States. Death rates remain high despite currently
available treatments. In 2009, there were more than 650,000 AHF
hospitalizations in the United States.

Novartis progress in heart failure
RLX030 (serelaxin) is a recombinant form of the human hormone relaxin-2 which
occurs naturally in both men and women. The results presented at AHA are
consistent with those of a Phase II dose-ranging study called Pre-RELAX-AHF
which investigated RLX030 in 234 patients with AHF. This study indicated that
RLX030 improved dyspnea and suggested the potential for longer-term benefits.

Novartis and its wholly owned subsidiary Corthera Inc. have the exclusive
worldwide rights to RLX030 (except in Canada).

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "may," "prospect," "suggesting,"
"encouraging," "committed," "potential," or similar expressions, or by express
or implied discussions regarding potential marketing submissions or approvals
for RLX030, or the timing of any such submissions or approvals, or regarding
potential future revenues from RLX030. You should not place undue reliance on
these statements. Such forward-looking statements reflect the current views
of management regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with RLX030 to
be materially different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee that RLX030
will be submitted or approved for sale in any market, or at any particular
time. Nor can there be any guarantee that RLX030 will achieve any particular
levels of revenue in the future. In particular, management's expectations
regarding RLX030 could be affected by, among other things, unexpected clinical
trial results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; unexpected regulatory actions
or delays or government regulation generally; competition in general;
government, industry and general public pricing pressures; unexpected
manufacturing issues; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; the impact that the
foregoing factors could have on the values attributed to the Novartis Group's
assets and liabilities as recorded in the Group's consolidated balance sheet,
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 Pharmaceuticals Corporation researches, develops, manufactures and
markets innovative prescription drugs used to treat a number of diseases and
conditions, including cardiovascular, dermatological, central nervous system,
bone disease, cancer, organ transplantation, psychiatry, infectious disease
and respiratory. The company's mission is to improve people's lives by
pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is
an affiliate of Novartis AG, which provides innovative healthcare solutions
that address the evolving needs of patients and societies. Headquartered in
Basel, Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, eye care, cost-saving generic pharmaceuticals,
preventive vaccines and diagnostic tools, over-the-counter and animal health
products. Novartis is the only global company with leading positions in these
areas. In 2011, the Group's continuing operations achieved net sales of USD
58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding
impairment and amortization charges) was invested in R&D throughout the Group.
Novartis Group companies employ approximately 127,000 full-time-equivalent
associates and operate in more than 140 countries around the world. For more
information, please visit http://www.novartis.com.

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SOURCE Novartis Pharmaceuticals Corporation

Website: http://www.novartis.com
Contact: Julie Masow of Novartis Corporation, +1-212-830-2465 (direct),
+1-862-579-8456 (mobile), julie.masow@novartis.com,
us.mediarelations@novartis.com, Christine Cascio of Novartis Pharmaceuticals
Corporation, +1-862-778-8026 (direct), +1-862-926-7992 (mobile),
christine.cascio@novartis.com
 
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