Japanese Ministry of Health approves RasilezÂ®, a first-in-class
direct renin inhibitor (DRI), for the treatment of high blood
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The issuer is solely responsible for the content of this
* Rasilez provides significant blood pressure reductions that last
for 24 hours ,, when taken alone or in combination with
* An estimated 40 million people in Japan, nearly a third of the
population, have high blood pressure, 70% of whom are not
achieving treatment goals
* Rasilez's potential long-term benefits are being further
investigated as part of ASPIRE HIGHER - the largest ongoing
cardio-renal outcomes program
Basel, July 8, 2009 - RasilezÂ® (aliskiren), the first new type of
high blood pressure medicine in more than a decade, has been approved
for use in Japan. Rasilez directly inhibits renin, an enzyme that
triggers a process leading to high blood pressure and organ damage.
The Ministry of Health, Labour and Welfare (MHLW) in Japan approved
Rasilez for the treatment of high blood pressure alone or in
combination with other high blood pressure medicines.
High blood pressure is the leading risk factor for cardiovascular
disease, the number one cause of death worldwide. In Japan an
estimated 40 million people, nearly a third of the population, are
affected by high blood pressure with the majority of patients not
reaching their blood pressure treatment goal.
"In Japan, nearly 70% of patients are not reaching their blood
pressure goal, demonstrating a strong need for therapies with a new
mechanism of action," said Professor Toshiro Fujita, Chief of the
Department of Nephrology and Endocrinology, University of Tokyo. "It
is expected that Rasilez's unique mechanism of action will provide
significant blood pressure reductions that last for 24 hours."
It is estimated that nearly one billion people globally have high
blood pressure and many of these remain either untreated or
treated but not reaching their target. Patients are therefore at
risk of complications including heart attack, stroke, kidney failure,
blindness and death, creating an unmet need for new high blood
Rasilez, known as TekturnaÂ® in the US[*], works by directly
inhibiting renin to reduce the effects caused by an over-active renin
system. By inhibiting renin at the point of activation, Rasilez
provides significant blood pressure reductions alone or in
combination with other antihypertensives[3-6].
The potential long-term benefits of Rasilez are 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.
"We are very excited about the approval in Japan, which provides
Japanese patients access to this innovative high blood pressure
treatment that directly targets renin," said Trevor Mundel, MD,
Global Head of Development at Novartis Pharma AG. "Novartis is
committed to supporting the research and development of effective and
innovative treatments for patients suffering high blood pressure."
Rasilez 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. Tekturna HCT, the first single-pill
combination involving Tekturna, was approved in the US in January
2008. The single-pill combination Rasilez HCT was approved by the
European Commission in January 2009.
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 world's most-prescribed
angiotensin receptor blocker, the first and only approved direct
renin inhibitor, a single pill combining two leading high blood
pressure medicines, and a DPP-4 inhibitor.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "estimated," "potential,"
"expected," "will," "committed," or similar expressions, or by
express or implied discussions regarding potential new indications or
labeling for Rasilez/Tekturna or regarding potential future revenues
from Rasilez/Tekturna. 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 Rasilez/Tekturna to be materially different from any
future results, performance or achievements expressed or implied by
such statements. There can be no guarantee that Rasilez/Tekturna will
be approved for any additional indications or labeling in any market.
Nor can there be any guarantee that Rasilez/Tekturna will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding Rasilez/Tekturna 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; 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.
Novartis AG 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 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
98,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
[*] RasilezÂ® is the trade name for aliskiren throughout the world,
except in the US where it is known as TekturnaÂ®.
 Oh BH, et al. Aliskiren, an Oral Renin Inhibitor, Provides
Dose-Dependent Efficacy and Sustained 24-hour Blood Pressure Control
in Patients with Hypertension. J Am Coll Cardiol 2007; 49:1157-63.
 Palatini P, et al. Blood Pressure Reduction Following A Simulated
Missed Dose Of Aliskiren, Irbesartan, or Ramipril: A Comparative
Ambulatory Blood Pressure Monitoring Study. Presentation at American
Society of Hypertension 2008.
 Uresin Y, et al. Aliskiren Monotherapy Lowers Blood Pressure More
Effectively than Ramipril Monotherapy in Patients with Diabetes and
Grade 2 Hypertension: Subgroup Analysis of an 8-week, Double-Blind
Trial. J Hypertens 2008: 26 (Suppl 1): S479 PS33/THU/62.
 Oparil S, Yarows SA, Patel S, Fang H, Zhang J, Satlin A. Efficacy
and Safety of Combined use of Aliskiren and Valsartan in Patients
with Hypertension: A Randomised, Double-Blind Trial. Lancet 2007;
 Drummond W, et al. Antihypertensive Efficacy of the Oral Direct
Renin Inhibitor Aliskiren as Add-on Therapy in Patients not
Responding to Amlodipine Monotherapy. J Clin Hypertens 2007;9:742-50.
 Gradman A, et al. Aliskiren in Combination with
Hydrochlorothiazide is Effective and well Tolerated during Long-Term
Treatment of Hypertension. Presentation at the American Society of
 National Health and Nutrition Survey Report Japan, 2006.
 Fujita T et al. Current situation and issue on medication for
hypertension and hyperlipidemia: Progress Medicine 26:
 TekturnaÂ® (aliskiren) Prescribing Information. Available at:
 World Health Organization. Cardiovascular disease factsheet.
accessed April 2009.
 Chobanian AV et al. Seventh Report of the Joint National
Committee on prevention, detection, evaluation, and treatment of high
blood pressure. Hypertension 2003;42:1206-51.
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