Results From Novartis Phase III Study Show That RLX030 Reduced Deaths in Patients With Acute Heart Failure
• RELAX-AHF study met one of its two primary endpoints in
reducing dyspnea or shortness of breath, and showed RLX030
(serelaxin) was well tolerated[1]
• Six-month study shows that investigational RLX030 reduced
all-cause mortality in patients with acute heart failure
(AHF)[1]
• Results of single Phase III clinical trial to be discussed
with health authorities worldwide
• RELAX-AHF data will be presented at American Heart
Association congress in November
Basel, September 24, 2012 - Phase III study results show that
investigational RLX030 (serelaxin) reduced all-cause mortality in
patients with acute heart failure (AHF)[1]. The six-month RELAX-AHF
study shows that RLX030 reduces the number of deaths in patients
with this disease, which has a higher mortality rate than most
other cardiovascular diseases[2].
The study had two primary endpoints using different scales to
measure reduction in dyspnea, only one of which reached statistical
significance[1]. Dyspnea, or shortness of breath, is the most
common symptom of AHF[3]. RLX030 was well tolerated in the
study[1].
RELAX-AHF was a Phase III clinical trial to investigate the
efficacy and safety of RLX030 for the treatment of AHF. It was a
randomized, double-blind, placebo-controlled study involving 1,161
patients in 11 countries[1]. In the study, RLX030 was given on
admission to the hospital in the form of an intravenous infusion
for up to 48 hours in addition to loop diuretics and other
medicines and was compared to placebo on top of standard of care
treatment for AHF[4],[5].
The study will be presented at the American Heart Association (AHA)
congress in Los Angeles in November, 2012. Novartis will initiate
discussions of the results of this single Phase III study with
health authorities worldwide shortly.
Heart failure is a disease in which the heart is unable to supply
enough blood to meet the body's needs[6],[7]. Around half of all
patients die within five years of diagnosis[8], particularly as a
result of acute episodes in which their symptoms suddenly become
worse and urgent hospital treatment is needed[6]. Acute heart
failure (AHF) places an enormous burden on healthcare systems and
accounts for around two million hospitalizations each year in the
EU and US[9].
RLX030 is the first in a new class of medicines and is a
recombinant form of the human hormone relaxin-2 which occurs
naturally in both men and women[10]. In women, levels of relaxin-2
rise to support important physiological changes during
pregnancy[10]. Serelaxin acts by relaxing the blood vessels,
leading to reduced stress on the heart and kidneys in both men and
women[11].
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as "to be discussed," "will," or
similar expressions, or by express or implied discussions regarding
potential marketing submissions or approvals for RLX030 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. 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; the
company's ability to obtain or maintain patent or other proprietary
intellectual property protection; unexpected manufacturing
difficulties; 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 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 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 126,000
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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References
1. Novartis Pharma AG. Data on file.
2. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart Disease and Stroke
Statistics - 2011 Update. A Report From the American Heart
Association. Circulation. 2011;123:e18-e209.
3. Goldberg RJ, Spencer FA, Szklo-Coxe M, et al. Symptom
presentation in patients hospitalized with acute heart failure.
Clin Cardiol. 2010;33:e73-80.
4. Clinicaltrials.gov: Efficacy and Safety of Relaxin for the
Treatment of Acute Heart Failure (RELAX-AHF).
http://clinicaltrials.gov/ct2/show/NCT00520806; Accessed September
2012.
5. Ponikowski P, Metra M, Teerlink JR, et al. Design of the RELAXin
in Acute Heart Failure Study. Am Heart J. 2012;163:149-55.
6. McMurray JJV, Adamopoulos S, Anker SD, et al. ESC Guidelines for
the diagnosis and treatment of acute and chronic heart failure
2012: The Task Force for the Diagnosis and Treatment of Acute and
Chronic Heart Failure 2012 of the European Society of Cardiology.
Developed in collaboration with the Heart Failure Association (HFA)
of the ESC. Eur Heart J. 2012;33:1787-1847.
7. Hunt SA, Abraham WT, Chin MH, et al. 2009 Focused Update
Incorporated Into the ACC/AHA 2005 Guidelines for the Diagnosis and
Management of Heart Failure in Adults: A Report of the American
College of Cardiology Foundation/American Heart Association Task
Force on Practice Guidelines. J Am Coll Cardiol.
2009;53:e1-90.
8. Roger VL, Lloyd-Jones DM, Benjamin EJ, et al. Heart disease and
stroke statistics - 2012 update: a report from the American Heart
Association. Circulation. 2012;125:e2-e220.
9. Opportunity Assessment for Relaxin in Acute Heart Failure,
Decision Resources. Oct 2010.
10 Dschietzig T, Bartsch C, Baumann G, et al. Relaxin - a
pleiotropic hormone and its emerging role for experimental and
clinical therapeutics. Pharmacol Therap. 2006;112:38-56.
11. Conrad KP. Unveiling the vasodilatory actions and mechanisms of
relaxin. Hypertension. 2010;56:2-9.
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Posted: September 2012
