Exforge Approved in Europe as Powerful New Blood Pressure Therapy Combining Two Leading Medications in a Single Pill
Exforge combines the actions of valsartan and amlodipine, two of
the world's most prescribed branded antihypertensive
medications1,2 Clinical data show Exforge delivers
powerful blood pressure reductions, getting up to nine out of 10
patients to blood pressure goal3 EU approval based on
clinical trials in more than 5,000 patients, showing better
efficacy and less edema than with amlodipine
alone3,4
BASEL, Switzerland, Jan. 18, 2007- - Novartis announced today that
the European Commission has granted approval for Exforge® as a
new and highly effective single-pill treatment for patients with
high blood pressure.
Exforge combines in one tablet the power of the two most commonly
prescribed branded hypertension medicines - Diovan® (valsartan)
and Norvasc® (amlodipine besylate). Exforge is indicated for
the treatment of hypertension in patients whose blood pressure is
not adequately controlled by amlodipine or valsartan
alone[1,2].
Exforge will be launched shortly in Germany followed by launches in
most other European Union countries throughout the year, pending
expiration of the patent protection for Norvasc. The EU decision,
which applies in all 27 EU member states plus Iceland and Norway,
follows recent tentative approval in the US and approval in
Switzerland.
"High blood pressure is a major health concern. If left
uncontrolled, it can lead to heart attacks, strokes, heart and
kidney failure and premature death," said Professor Rainer
Düsing, internist at the Medizinische
Universitäts-Poliklinik at the University of Bonn in Germany.
"The combination of these two well-known and powerful
antihypertensive medications in one tablet will help patients reach
and maintain their blood pressure goal with favorable
tolerability."
Clinical trials involving over 5,000 patients demonstrated that
Exforge helped up to nine out of 10 patients to reach their blood
pressure goal (i.e. diastolic blood pressure under 90 mmHg or a
more than 10 mmHg reduction from baseline)[3]. Exforge has been
shown in trials to deliver reductions in blood pressure of 36mmHg
and up to 43mmHg in some patient populations[5].
Overall, clinical trials have demonstrated that Exforge is highly
efficacious and well tolerated with an improved side effect profile
over amlodipine alone[3]. In particular, Exforge has demonstrated a
lower incidence of peripheral edema (or swelling) compared to
amlodipine monotherapy[3].
"Exforge promises to be an attractive therapy option for patients
because it brings together two of the most powerful mechanisms of
action in one pill," said James Shannon, MD, Global Head of
Development at Novartis Pharma AG. "Delivering two agents in a
single pill is associated with better compliance[6]. Research has
shown that improving compliance in patients being treated for high
blood pressure leads to a reduction in medical costs, a reduced
risk of hospitalisation[7] and reduced use of outpatient
resources[8]."
About high blood pressure
High blood pressure and its consequences is the world's number one
cause of death[9], It causes damage to the arteries, burdening the
heart, kidneys, brain and other vital organs[10]. If left
uncontrolled, high blood pressure can lead to heart attacks,
strokes, heart and kidney failure and premature death. At present,
high blood pressure affects at least 25% of all adults and
approximately one billion people suffer from the condition
globally. It is predicted that this figure will rise to 1.56
billion by 2025[11].
The treatment of high blood pressure continues to be a major
problem. It is estimated that seven out of 10 people with high
blood pressure do not have their condition controlled to
recommended levels, and adequate control is achieved even less
frequently in patients at particularly high risk, such as those
with diabetes[12,13,14]. The majority of patients require two or
more therapies in order to gain adequate control of their blood
pressure[15].
Disclaimer
The foregoing release contains forward-looking statements which can
be identified by the use of terminology such as, "pending
expiration", "will help", "promises to be", or similar expressions,
or by express or implied discussions regarding the potential
regulatory approval of Exforge, or potential future revenue from
Exforge. Such forward-looking statements 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 Exforge will be approved
for any other indications in the European Union, the United States
or any other market or in any indications in currently non-approved
markets, that Exforge will be brought to market in the EU, the US
or in any other country, nor that Exforge will reach any particular
sales levels. In particular, management's expectations regarding
the approval and commercialization of Exforge could be affected by,
among other things, additional analysis of clinical data; new
clinical data; unexpected clinical trial results; unexpected
regulatory actions or delays or government regulation generally;
our ability to obtain or maintain patent or other proprietary
intellectual property protection; competition in general; increased
government, industry, and general public pricing pressures; 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 AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to
discover, develop and successfully market innovative products to
treat patients, ease suffering and enhance the quality of life. We
are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. Novartis is the only company with
leadership positions in these four areas. In 2006, the Group's
businesses achieved net sales of USD 37.0 billion and net income of
USD 7.2 billion. Approximately USD 5.4 billion was invested in
R&D. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 101,000 associates and operate in
over 140 countries around the world. For more information, please
visit http://www.novartis.com.
References
[1] Diovan web site. http://www.diovan.com/info/about/about_diovan.jsp.
Accessed November 28, 2006.
[2] Norvasc web site.
http://www.norvasc.com/high-blood-pressure-medicine/aboutnorvasc.asp?print=true.
Accessed November 28, 2006.
[3] Data on file (Study VAA489A2201 and Study VAA489A2307).
Novartis Pharmaceuticals Corporation. East Hanover, New Jersey.
07936.
[4] Data on file (Exforge Summary Clinical Efficacy). Novartis
Pharmaceuticals Corporation. East Hanover, New Jersey. 07936.
[5] Comparative safety and blood pressure (BP)-lowering efficacy of
a combination of amlodipine + valsartan and lisinopril +
hydrochlorothiazide in patients with stage 2 hypertension; ASH 2006
21st Annual Scientific Meeting, New York, USA. 16-20 May
2006.
[6] Ofili. Dispelling the myth of "aggressive" antihypertensive
therapy. Journal of Clinical Hypertension. 2006; 8:4-11.
[7] Sokol et al. Impact of medication adherence on hospitalization
risk and healthcare costs. Medical Care. 2005;43:521-30
[8] Halpern et al. Impact of compliance (adherence) and persistence
of treatment with valsartan on hypertension clinical outcomes.
Poster presented at ISPOR 8th Annual European Congress, Florence,
Italy. 6-8 November 2005.
[9] Ezzati et al. Selected major risk factors and global regional
burden of disease. Lancet. 2002; 360: 1347-1359
[10] Statistical fact sheet: International Cardiovascular Disease
Statistics. American Heart Association. 2004
[11] Kearney et al. Global burden of hypertension: analysis of
worldwide data. Lancet 2005; 365: 217-223
[12] Banegas et al. Blood Pressure Control and Physician Management
of Hypertension in Hospital Hypertension Units in Spain.
Hypertension. 2004; 43:1338-1344.
[13] Hajjar and Kotchen. Trends in Prevalence, Awareness, Treatment
and Control in Hypertension in the United States, 1988-2000.
Journal of the American Medical Association. 2003; 290:
199-206.
[14] Chobanian et al. Seventh report of the Joint National
Committee on prevention, detection evaluation and treatment of high
blood pressure. Hypertension. 2003; 42:1206-1251.
[15] Brown et al. Better blood pressure control: how to combine
drugs. Journal of Human Hypertension. 2003; 17:81-86.
# # #
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Posted: January 2007
