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 Powerful New Blood Pressure Therapy Combining Two Leading Me

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Registration date : 2007-09-19

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PostSubject: Powerful New Blood Pressure Therapy Combining Two Leading Me   Powerful New Blood Pressure Therapy Combining Two Leading Me Icon_minipostedThu Sep 20, 2007 11:51 pm

Exforge(R) 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

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 -- January 25, 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

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].



1. Diovan web site. High Blood Pressure Medication — DIOVAN. Accessed November 28, 2006.

2. Norvasc web site. 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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