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Novartis International AG: FDA issues Complete Response Letter for RLX030 for acute heart failure

Novartis International AG / FDA issues Complete Response Letter for RLX030 for
acute heart failure. Processed and transmitted by NASDAQ OMX Corporate
Solutions. The issuer is solely responsible for the content of this
* Agency states further evidence of the efficacy of RLX030 is required for US
* Second phase III study RELAX-AHF-2 progressing well - Novartis intends to
resubmit NDA with additional data when available

Basel, May 16, 2014
Novartis announced today that the US Food and Drug Administration (FDA) has
issued a Complete Response Letter (CRL) regarding the Biologics License
Application (BLA) for RLX030 (serelaxin) for the treatment of acute heart
failure (AHF), stating that further evidence on the efficacy of RLX030 is
required for a US license to be granted.

"We continue to believe RLX030 has the potential to be an important treatment
for AHF and have been encouraged by feedback from FDA advisory committee
members noting the data are intriguing," said Tim Wright, Global Head of
Development, Novartis Pharmaceuticals. "In accordance with the FDA's advice
we will continue to expedite our clinical trial program to build the
supporting body of evidence."

The RLX030 submission to the FDA included phase II and III efficacy and safety
data from the clinical development program, including the pivotal phase III
RELAX-AHF study. Novartis is continuing to expand the data supporting the
efficacy of RLX030 in acute heart failure with an extensive global clinical
program, including the RELAX-AHF-2 trial which will enroll over 6,300

About RLX030

RLX030, a relaxin receptor agonist[1], is a recombinant form of a naturally
occurring hormone (human relaxin 2) present in both men and women which rises
in women during pregnancy to help the body cope with the additional
cardiovascular demands[2],[3]. RLX030 has multiple effects including relaxing
the blood vessels and reducing fluid buildup. Some evidence also suggests it
can reduce damage to heart and vital organs, which may be of particular
importance when considering the cascade of damage that occurs during an AHF

Novartis' commitment in heart failure

Heart failure is a debilitating and potentially life-threatening condition
where the heart cannot pump enough blood around the body. This, in most
cases, happens because the heart muscle responsible for the pumping action
weakens over time or becomes too stiff. Heart failure is a significant and
growing public health concern affecting over 20 million people
worldwide[6],[7]and costing the world economy $45

Novartis is committed to research in heart failure with a portfolio including
RLX030 for acute heart failure and LCZ696 for chronic heart failure.


The foregoing release contains forward-looking statements that can be
identified by words such as "progressing," "intends," "when available,"
"continue," "potential," "will," "expedite," "continuing," "suggests," "can,"
"may," "commitment," "growing," "committed," or similar terms, or by express
or implied discussions regarding potential marketing approvals for RLX030 or
LCZ696, or regarding potential future revenues from RLX030 and LCZ696. You
should not place undue reliance on these statements. Such forward-looking
statements are based on the current beliefs and expectations of management
regarding future events, and are subject to significant known and unknown
risks and uncertainties. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those set forth in the forward-looking statements.
There can be no guarantee that RLX030 or LCZ696 will be submitted or approved
for sale in any market, or at any particular time. Nor can there be any
guarantee that RLX030 or LCZ696 will be commercially successful in the
future. In particular, management's expectations regarding RLX030 and LCZ696
could be affected by, among other things, the uncertainties inherent in
research and development, including unexpected clinical trial results and
additional analysis of existing clinical data; unexpected regulatory actions
or delays or government regulation generally; the company's ability to obtain
or maintain proprietary intellectual property protection; general economic
and industry conditions; global trends toward health care cost containment,
including ongoing pricing pressures; unexpected manufacturing issues, and
other risks and factors referred to in Novartis AG's current Form 20-F on
file with the US Securities and Exchange Commission. 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, over-the-counter and animal health products. Novartis is the only
global company with leading positions in these areas. In 2013, the Group
achieved net sales of USD 57.9 billion, while R&D throughout the Group
amounted to approximately USD 9.9 billion (USD 9.6 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 135,000 full-time-equivalent associates and sell products in
more than 150 countries around the world. For more information, please

Novartis is on Twitter. Sign up to follow @Novartis


[1] Du X-J, Bathgate RAD, Samuel CS, Dart AM, Summers RJ. Cardiovascular
effects of relaxin: from basic service to clinical therapy.Nat. Rev. Cardiol.

[2] Teichman SL, Unemori E, Dschietzig, T, et al. Relaxin, a pleiotropic
vasodilator for the treatment of heart failure.Heart Fail Rev.

[3] Teichman SL, Unemori E, Teerlink JR, Cotter G, Metra M. Relaxin: Review of
biology and potential role in treating heart failure.Curr Heart Fail Rep.

[4] Teerlink JR, Cotter G, Felker GM, et al. Serelaxin, recombinant human
relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised,
placebo-controlled trial.Lancet.

[5] Metra M, Cotter G, Davison BA, et al. Effect of Serelaxin on Cardiac,
Renal, and Hepatic Biomarkers in the Relaxin in Acute Heart Failure
(RELAX-AHF) Development Program.J Am Coll Cardiol.

[6] Gheorghiade M, Pang PS. Acute Heart Failure Syndromes.J Am Coll Cardiol.

[7] Go et al, Heart Diseaseand Stroke Statistics--2014 Update: A Report From
the American Heart Association, Circulation 2014, 4;129:e28-e292
[8] Lloyd-Joneset al.
Heart disease and stroke statistics--2010 update: a report from the American
Heart Association.Circulation.

[9] Neumannet al.
Heart failure: the commonest reason for hospitalization in Germany-medical and
economic perspectives.Dtsch Arztebl Int
. 2009;106:269-75

[10] Berryet al.
Economics of chronic heart failure.Eur J Heart Fail
. 2001;3:283291

[11] Stewartet al.
The current cost of heart failure to the National Health Service in the UK.Eur
J Heart Fail.

# # #

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Media release (PDF)


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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Novartis International AG via Globenewswire


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