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2014-05-23

Novartis International AG: Novartis provides update on EU marketing authorization application for RLX030 in acute heart failure

Novartis International AG / Novartis provides update on EU marketing
authorization application for RLX030 inacute heart failure . Processed and
transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* CHMP confirms negative opinion following re-examination of RLX030 - further
evidence is required

* Novartis aims to resubmit for approval with data from ongoing second Phase
3 study (RELAX-AHF-2)

Basel, May 23, 2014
-
Novartis announced today that the Committee for Medicinal Products for Human
Use (CHMP) has adopted a negative opinion for the use of RLX030 (serelaxin)
in the treatment of acute heart failure (AHF) indicating that further
evidence is required for a license to be granted in the EU. This follows the
company's request for re-examination after a previous negative opinion was
issued in January. Novartis aims to resubmit for approval as soon as
additional data is available from the ongoing global trial program, including
the 6,300 patient RELAX-AHF-2 study, one of the largest and most robust
programs undertaken by a company for an AHF drug.

"We are disappointed that patients in Europe will not have access to RLX030 in
2014 but we believe in the value that RLX030 can bring to patients and are
committed to extending the current evidence base to confirm this," said Tim
Wright, Global Head of Development, Novartis Pharmaceuticals. "20 million
people across the world face poor quality of life and high risk of death from
heart failure and it remains our mission to change the course of this disease
with our research and development efforts."

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[1]. Heart failure is a significant and
growing public health concern affecting over 20 million people
worldwide[2],[3] and costing the world economy $45 billion annually.[3]-[6]

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

About RLX030 and Acute Heart Failure
Patients experiencing an AHF episode have rapidly worsening, life-threatening
symptoms requiring urgent hospital treatment, including difficulty breathing
and swelling around the body as fluid accumulates in the lungs and tissues.
Despite significant progress in other heart conditions, there have been no
treatment breakthroughs for AHF in 20 years[7]. Commonly used medicines only
treat the immediate symptoms and have not been proven to have an impact on
longer-term outcomes[8]-[10].

RLX030 is a 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.[11],[12]It 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 episode.[2],[13],[14]

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by words such as "aims," "negative opinion," "as soon as," "will,"
"believe," "can," "committed," "mission," "growing," "suggests," "may," 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
visithttp://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis
athttp://twitter.com/novartis.

References
[1] Harrison's 'Principles of Internal Medicine', Seventeenth Edition pages
1442 - 1455
[2] Gheorghiade M, Pang P, Acute heart failure syndromes, Journal of the
American College of Cardiology 2009; 53 (7):557-73
[3] Go AS, Mozaffarian D, Roger VL, et al. American Heart Association
Statistics Committee and Stroke Statistics Subcommittee. Executive summary:
heart disease and stroke statistics-2014 update: a report from the American
Heart Association. Circulation. 2014;128:00-00
[4] Lloyd-Jones et al. Heart disease and stroke statistics--2010 update: a
report from the American Heart Association. Circulation. 2010;121:e46-215
[5] Berry et al. Economics of chronic heart failure. Eur J Heart Fail.
2001;3:283291
[6] Stewart et al. The current cost of heart failure to the NationalHealth
Service in the UK. Eur J Heart Fail. 2002;4:361371
[7] Cowie et al, Acute heart failure - a call to action, The British Journal
of Cardiology, 2013, 20(2):S1-S11
[8] Hunt S et al. 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 Developed in Collaboration With the
International Society for Heart and Lung Transplantation. Circulation.
2009;119:e391-e479
[9] McMurray 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
[10] Gheorghiade et al. The challenge of acute heart failure syndromes. Am J
Cardiol. 2005;96:86G89.
[11] Teichman S et al. Relaxin, a pleiotropic vasodilator for the treatment of
heart failure. Heart Fail Rev. 2009;14:321-329
[12] Teichman SL et al. Relaxin: Review of biology and potential role in
treating heart failure. Curr Heart Fail Rep. 2010;7:75-82
[13] 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. 2013;381:29-39.
[14] 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. 2013;61:196-206.

# # #

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