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


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