Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure

Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------

* Valturna combines in a single pill valsartan, an angiotensin
receptor blocker, with aliskiren, the only approved direct renin
inhibitor

* Valturna is the first therapy to target two points within the
renin angiotensin aldosterone system (RAAS), which plays a key
role in regulating blood pressure

* Valturna offers significantly greater blood pressure reduction
than either valsartan or aliskiren alone[1]

Basel, September 17, 2009 - The US Food and Drug Administration (FDA)
has approved Valturna® (aliskiren and valsartan) tablets, the first
and only medicine to target two key points within the renin system,
also known as the renin angiotensin aldosterone system (RAAS), an
important regulator of blood pressure[2]. This is the first approval
for Valturna, which is indicated for the treatment of high blood
pressure in patients not adequately controlled on aliskiren or
angiotensin receptor blocker (ARB) monotherapy and as initial therapy
in patients likely to need multiple drugs to achieve their blood
pressure goals[1].

"This unique combination brings together the powerful blood pressure
lowering effects of valsartan and aliskiren," said Joe Jimenez, CEO
of the Novartis Pharmaceuticals Division. "It offers an important
additional treatment option for physicians and hypertension patients,
many of whom are not at their blood pressure goal. Valturna builds
upon our strong cardiovascular franchise and is consistent with our
long-term commitment to developing effective and innovative
therapies. It further strengthens our growing portfolio of
single-pill combinations to treat high blood pressure."

Valturna combines in a single pill valsartan, the active ingredient
in Diovan®, the number one selling blood pressure medication
worldwide[3], and aliskiren, the active ingredient in Tekturna®, the
only approved direct renin inhibitor (DRI). Valturna offers
significantly greater blood pressure reduction than either valsartan
or aliskiren alone[1].

"When it comes to diagnosing and treating high blood pressure, there
is a real need for innovative therapies that help patients get to a
healthier blood pressure range," said John Flack, M.D., Valturna
investigator, and Chairman of the Department of Internal Medicine,
Wayne State University, Detroit. "Now for the first time, we have a
treatment option in one pill that targets two key points of the RAAS,
which may be overactive in many hypertensive patients."

This approval was primarily based on a pivotal eight-week randomized,
double-blind, placebo-controlled clinical trial in approximately
1,800 patients, which studied aliskiren 150 mg and 300 mg and
valsartan 160 mg and 320 mg alone and in combination. The initial
doses of aliskiren and valsartan were 150 mg and 160 mg,
respectively, and were increased at four weeks to 300 mg and 320 mg,
respectively. Blood pressure reductions with the aliskiren/valsartan
combination were significantly greater than with the monotherapies or
placebo at the 8-week primary endpoint. Mean systolic and diastolic
blood pressure reductions from baseline were 17.2/12.2 mmHg for
aliskiren 300 mg/valsartan 320 mg, compared with 12.8/9.7 mmHg for
valsartan 320 mg, 13.0/9.0 mmHg for aliskiren 300 mg, and 4.6/4.1
mmHg for placebo (p<0.05 for aliskiren/valsartan vs monotherapies or
placebo).

The single-pill combination Valturna targets the RAAS in two ways.
Valsartan blocks, at the receptor level, the action of angiotensin
II, a component of the RAAS that causes blood vessels to tighten and
narrow. Aliskiren directly inhibits renin, an enzyme produced by the
kidneys that starts a process that leads to formation of angiotensin
II. An overactive RAAS may contribute to high blood pressure. By
targeting two key points within the RAAS, Valturna helps blood
vessels relax and widen so blood pressure is lowered.

Research suggests that up to 85% of patients with high blood pressure
may need multiple medications to help control their blood
pressure[4],[5] underscoring the need for effective combination
treatments.

High blood pressure affects over one billion individuals
globally[6],[7] and is a major risk factor for cardiovascular
disease, the number one leading cause of death worldwide[8]. If left
untreated, patients with high blood pressure are at risk of
cardiovascular events such as stroke, heart attack and heart failure,
and of organ damage including kidney failure and vision problems[6].
Up to 65% of patients with high blood pressure do not have the
condition under control[9].

About Diovan
The number one selling blood pressure medication worldwide[3] and one
of the fastest-growing high blood pressure drugs on the market today,
Diovan is available as a powerful first-line treatment for high blood
pressure in more than 90 countries and in more than 65 countries for
the treatment of heart failure in patients who also take usual
therapy including diuretics, digitalis and either beta blockers or
ACE inhibitors, but not both. In the US and Switzerland, among other
countries, Diovan is indicated for the treatment of heart failure in
patients who cannot tolerate ACE inhibitors. Diovan is also indicated
in more than 50 countries to treat patients who have survived a heart
attack.

About Tekturna
Tekturna, a direct renin-inhibitor, is the only drug that works by
directly targeting renin to decrease the activity of the RAAS[10].
Renin is an enzyme produced by the kidneys that starts a process that
narrows blood vessels and, when inappropriately activated, may lead
to high blood pressure. Tekturna reduces plasma renin activity and
helps blood vessels relax and widen so blood pressure is lowered.

The heart and kidney protection potential of Rasilez/Tekturna, in
addition to its blood pressure lowering ability, is currently being
investigated further in the landmark ASPIRE HIGHER program, the
largest ongoing cardio-renal outcomes program worldwide involving
more than 35,000 patients in 14 trials.

Rasilez/Tekturna is approved in over 70 countries. Tekturna was
approved in the US in March 2007 and in the European Union in August
2007 under the trade name Rasilez. In July 2009, Rasilez also
received approval in Japan. Tekturna HCT, the first single-pill
combination involving Tekturna, was approved in the US in January
2008 for second-line treatment of high blood pressure, and more
recently for first-line use. The single-pill combination Rasilez HCT
was approved in the European Union in January 2009. Other single-pill
combinations with Rasilez are currently in development including a
single pill combination with amlodipine.

Novartis is focused on improving the lives of the hundreds of
thousands of people with cardiovascular and metabolic diseases. As a
global leader in cardiovascular and metabolic health for nearly 50
years, Novartis provides innovative therapies and support programs to
treat high blood pressure and diabetes - both major public health
issues. The portfolio includes the number one selling blood pressure
medication worldwide, the first and only approved direct renin
inhibitor, a single pill combining two leading high blood pressure
medicines, and a DPP-4 inhibitor.

Valturna is available in two strengths as tablets containing
aliskiren and valsartan: 150 mg/160 mg and 300 mg/320 mg.

Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "commitment," "may," "risk,"
"potential," or similar expressions, or by express or implied
discussions regarding potential additional marketing approvals for
Valturna, potential new indications or labeling for Tekturna, or
regarding potential future revenues from Valturna, Tekturna or
Diovan. 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
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Valturna will be approved for sale in any additional
markets. Nor can there be any guarantee that Tekturna will be
approved for any additional indications or labeling in any market.
Neither can there be any guarantee that Valturna, Tekturna or Diovan
will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding these products could
be affected by, among other things, unexpected regulatory actions or
delays or government regulation generally; unexpected clinical trial
results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; 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; 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 healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in each of these areas. In
2008, the Group's continuing operations achieved net sales of USD
41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2
billion was invested in R&D activities throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 99,000 full-time-equivalent associates and operate in
more than 140 countries around the world. For more information,
please visit http://www.novartis.com.

# # #

References
[1.] Valturna [prescribing information]. East Hanover, NJ: Novartis
Pharmaceuticals Corporation; 2009.
[2.] CVF-300094/"RAAS"ing Your IQ. Novartis Pharmaceuticals
Corporation. July 2009.
[3.] IMS Midas Sales Worldwide. May 2009.
[4.] Pepine CJ, Handberg EM, Cooper-DeHoff RM, et al, for the INVEST
Investigators. A calcium antagonist vs. a non- calcium antagonist
hypertension treatment strategy for patients with coronary artery
disease. The International Verapamil-Trandolapril Study (INVEST): a
randomized controlled trial. JAMA 2003; 290:2805-2816.
[5.] Dahlöf B et al. Cardiovascular morbidity and mortality in the
Losartan Intervention For Endpoint reduction in hypertension study
(LIFE): a randomised trial against atenolol. Lancet 2002; 359:
995-998.
[6.] Chobanian AV, Bakris GL, Black HR, et al. and the National High
Blood Pressure Education Program Coordinating Committee. The seventh
report of the Joint National Committee on prevention, detection,
evaluation, and treatment of high blood pressure. NIH Publication No.
04-5230. August 2004.
[7.] Kearney P, et al. Global Burden of Hypertension: Analysis of
Worldwide Data. Lancet 2005;365:217-23.
[8.] World Health Organization. Cardiovascular disease factsheet.
Available at:
http://www.who.int/mediacentre/factsheets/fs317/en/index.html. Last
accessed September 2009.
[9.] Rosamond W et al. Heart disease and stroke statistics 2008
update: a report from the American Heart Association Statistics
Committee and Stroke Statistics Subcommittee. Circulation
2008;117:e25-e146.
[10.] Tekturna® (aliskiren) Prescribing Information. Available at:
www.tekturna.com.

# # #

Novartis Media Relations

Central media line : +41 61 324 2200
Eric Althoff Yanyan Chang
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 61 324 2339 (direct)
+41 79 593 4202 (mobile) +41 79 292 0959 (mobile)
eric.althoff@novartis.com yanyan.chang@novartis.com

e-mail: media.relations@novartis.com

Novartis Investor Relations

Central phone: +41 61 324 7944
Ruth +41 61 324 9980 North America:
Metzler-Arnold
Pierre-Michel +41 61 324 1065 Richard Jarvis +1 212 830
Bringer 2433
John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830
2445
Thomas +41 61 324 8425 Edwin Valeriano +1 212 830
Hungerbuehler 2456
Isabella Zinck +41 61 324
7188

e-mail: e-mail:
investor.relations@novartis.com investor.relations@novartis.com

--- End of Message ---

Novartis International AG
Posfach Basel

WKN: 904278; ISIN:
CH0012005267; Index: SLCI, SMI, SPI, SLIFE;
Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Copyright © Hugin AS 2009. All rights reserved.