2009-10-23 07:17:02 -
London, October , 23, 2009
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* Exforge HCT combines the efficacy of three widely prescribed
blood pressure treatments, valsartan, amlodipine and
hydrochlorothiazide, in a single pill
* Up to 85% of patients may need multiple medications to help
control their blood pressure[1],[2], underscoring the need for
more effective combination treatments
* Single-pill combinations reduce daily pill burden and simplify
treatment schedules[3]
Basel, October 23, 2009 - The European Commission has granted
Novartis marketing authorization for Exforge HCT®, a new 3-in-1
treatment for people with high blood pressure.
Exforge HCT combines in a once-daily single pill the efficacy of
three widely prescribed blood pressure medications: the angiotensin
receptor blocker valsartan (Diovan®), the calcium channel blocker
amlodipine, and the diuretic hydrochlorothiazide (HCT). All three
have been used extensively for many years in patients with
hypertension.
"Novartis is committed to helping patients improve their treatment
compliance. Simplified treatment regimens and reduced pill burdens
have been shown to help achieve this," said Joe Jimenez, CEO of the
Novartis Pharmaceuticals Division. "We are pleased that with the
approval of Exforge HCT, a new 3-in-1 treatment for high blood
pressure is now available to patients in the EU. With Diovan as the
foundation of this new therapy, we are confident that it will become
an important new treatment option."
In the EU, Exforge HCT is indicated for substitution therapy in adult
patients whose blood pressure is adequately controlled on the
combination of valsartan, amlodipine and HCT, taken either as three
single-component formulations or as a dual-component and a
single-component formulation[4].
High blood pressure, or hypertension, is one of the most important
but treatable risk factors for cardiovascular disease - the number
one cause of death worldwide[5]. Nearly half of Europeans suffer from
high blood pressure[6] and up to 85% of these patients may need
multiple medications to help reach treatment goals[1],[2]. The
primary patient-related factor for hypertension treatment failure is
non-compliance with the prescribed antihypertensive medication[7].
Patients therefore may find treatment more convenient with one single
pill rather than multiple separate pills. One recent, large-scale
study showed that approximately 75% of patients achieved their blood
pressure treatment goal after switching to a single-pill combination
therapy[8].
"It is not uncommon for patients with severe hypertension, or those
requiring stricter blood pressure control, to need three or more
medications," said Professor Rainer Düsing, MD, of the Faculty of
Medicine, University of Bonn, Germany. "Now that this new single-pill
triple-combination option is available, appropriate patients may find
it easier to comply with their prescribed treatment regimens
involving a once-daily single pill versus multiple medications,
especially if it has also been proven to be highly effective at
helping patients reach their blood pressure goals."
Exforge HCT was approved in the United States by the Food and Drug
Administration (FDA) in April 2009 for the second-line treatment of
high blood pressure[9]. It was approved in Switzerland in September
2009 for the treatment of patients whose blood pressure is not
adequately controlled by dual therapy[10].
The EU approval was supported by the results of Study 230211, a
multinational, randomized, double-blind, parallel-group, Phase III
study designed to compare the efficacy and safety of triple therapy
(valsartan, amlodipine and HCT) with the various dual combinations of
its components - valsartan/HCT, amlodipine/valsartan or
amlodipine/HCT - in patients with moderate-to-severe hypertension.
The trial was conducted in 15 countries, with 2,271 patients
randomized to double-blind treatment.
Study 2302 showed that triple therapy was more effective in reducing
systolic and diastolic blood pressure than dual combinations of its
components in patients with moderate-to-severe hypertension[11].
Reductions in mean sitting systolic blood pressure of 40 to 50 mmHg
were achieved, with up to 58% more patients receiving triple therapy
achieving overall blood pressure control versus dual therapy (i.e.
blood pressure <140/90 mmHg). The maximum dose of triple therapy
(valsartan/amlodipine/HCT 10/320/25 mg) demonstrated additional
reductions of 18-29% in systolic blood pressure and 19-32% in
diastolic blood pressure when compared to all dual combinations of
its components at the same doses. Ambulatory blood pressure
monitoring showed that the blood pressure- lowering effect of triple
therapy was maintained throughout the 24-hour period[12]. In
addition, the study showed that triple therapy was highly effective
regardless of patients' age, gender, race, ethnicity or baseline
blood pressure, and was generally well tolerated versus dual
therapy[11].
The core of the Novartis portfolio is its cardiovascular and
metabolic medications for the treatment of high blood pressure and
diabetes. These include Diovan® (valsartan), the number one selling
blood pressure medication worldwide[13]; Exforge® (valsartan/
amlodipine), a single pill combining two leading medicines for high
blood pressure; Exforge HCT® (valsartan/amlodipine/HCT); and Rasilez®
(aliskiren), the first and only approved direct renin inhibitor, and
two single pill combinations of Rasilez, Rasilez HCT (aliskiren/HCT)
and Valturna (aliskiren/valsartan). For the treatment of type 2
diabetes, these include Galvus® (vildagliptin, a novel DPP-4
inhibitor) and Eucreas® (vildagliptin and metformin).
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "may," "committed," "confident,"
"will," or similar expressions, or by express or implied discussions
regarding potential future revenues from Exforge HCT. 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 Exforge HCT to be
materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Exforge HCT will achieve any particular levels of
revenue in the future. In particular, management's expectations
regarding Exforge HCT 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; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in
general; government, industry and general public pricing pressures;
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 www.novartis.com.
References
[1.] Dahlöf B, et al. Prevention of cardiovascular events with an
antihypertensive regimen of amlodipine adding perindopril as required
versus atenolol adding bendroflumethiazide as required, in the
Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm
(ASCOT-BPLA): a multicenter randomized controlled trial. Lancet
2005;366:895-906.
[2.] Pepine CJ, et al. 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;290:2805-16.
[3.] Mancia G, et al. 2007 Guidelines for the management of arterial
hypertension: The Task Force for the Management of Arterial
Hypertension of the European Society of Hypertension (ESH) and of the
European Society of Cardiology (ESC). Eur Heart J 2007;28:1462-536.
[4.] Exforge HCT® EU Summary of Product Characteristics. Novartis
Pharma AG.
[5.] World Health Organization. Cardiovascular diseases factsheet.
Available at:
www.who.int/mediacentre/factsheets/fs317/en/index.html.
[6.] Wolf-Maier K, et al. Hypertension prevalence and blood pressure
levels in 6 European countries, Canada, and the United States. JAMA
2003;289:2363-9.
[7.] Elliott WJ. What factors contribute to the inadequate control of
elevated blood pressure? J Clin Hypertens (Greenwich) 2008;10(1
Suppl. 1):20-6.
[8.] Jamerson K, et al. Benazepril plus amlodipine or
hydrochlorothiazide for hypertension in high-risk patients. N Engl J
Med 2008;359:2417-28.
[9.] Exforge HCT® US Prescribing Information. April 2009. Available
at: www.pharma.us.novartis.com/product/pi/pdf/exforge_hct.pdf
[10.] Exforge HCT® Swiss Prescribing Information. September 2009.
[11.] Calhoun DA, et al. Triple antihypertensive therapy with
amlodipine, valsartan, and hydrochlorothiazide. A randomized clinical
trial. Hypertension 2009;54(1):32-9.
[12.] Lacourciere Y, et al. Twenty-four hour ambulatory BP Control of
therapy with amlodipine/valsartan/HCTZ triple combination compared to
dual therapy in patients with moderate to severe hypertension.
Presented at the 19th Scientific Meeting of the European Society of
Hypertension, June 14, 2009; Abstract No: 1412. Updated information
presented at meeting.
[13.] IMS Midas Worldwide Sales Data. May 2009.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Katharine Harris
Novartis Global Media Relations Novartis Pharma Communications
+41 61 324 7999 (direct) +41 (0) 61 324 07 99 (direct)
+41 79 593 4202 (mobile) +41 (0) 79 515 2816 (mobile)
eric.althoff@novartis.com katharine.harris@novartis.com
e-mail: media.relations@novartis.com
Novartis Investor Relations
Central phone: +41 61 324
7944
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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;
