FDA Grants Additional Six Months Marketing Exclusivity For The High Blood Pressure Medicine Diovan(R)

Main Category: Hypertension
Article Date: 11 Aug 2007 - 0:00 PDT

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Diovan(R) (valsartan) has been granted pediatric exclusivity by the US Food and Drug Administration (FDA) based on studies conducted in children with high blood pressure. This action extends marketing exclusivity associated with the valsartan compound patent by six months from March to September 2012.

Although high blood pressure is more prevalent in adults (30%)(1), it has been reported that nearly five percent of children and adolescents in the US may have the condition(2). A FDA decision on a possible indication to treat children and adolescents with high blood pressure is anticipated by year end.

"Novartis feels that wherever possible it is important to ensure that medications are studied in patient groups usually excluded from general clinical trials, such as younger people," said James Shannon, MD, Global Head of Development at Novartis Pharma AG.

Diovan is the only agent in its class (angiotensin receptor blocker or ARB) indicated to treat adults not only with high blood pressure, but also those with heart failure and also heart attack survivors.

The need for high blood pressure medicines is strong given that the condition affects approximately 72 million adult Americans(3). Of those that are being treated, more than 40% do not have the condition controlled(4). Uncontrolled high blood pressure has been shown in adults to increase the risk of heart attack and stroke, which are among the world's leading causes of death(5).

About Diovan

Clinical studies have shown that Diovan effectively lowers blood pressure. Diovan specifically blocks a hormone that causes arteries to constrict, or tighten and narrow, an action that can cause high blood pressure.

In adults, Diovan is indicated for the treatment of hypertension when used alone or in combination with other high blood pressure agents. Diovan is also indicated for the treatment of heart failure (NYHA class II-IV). In clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, Diovan is indicated to reduce cardiovascular mortality.

Diovan is not indicated to prevent a heart attack or stroke resulting from hypertension.

Taking Diovan during pregnancy can cause injury and even death to an unborn baby. Women who plan to become pregnant, or are pregnant should stop taking DIOVAN and call their doctor right away.

Patients should not take DIOVAN if they are allergic to any of the ingredients in the product.

The most serious side effects with Diovan are low blood pressure (hypotension) and kidney problems. Other side effects with Diovan have generally been mild. In hypertensive patients, the most common side effects with Diovan are headache and dizziness.

The most common side effects of Diovan when used to treat people after a heart attack which cause them to stop taking the drug include low blood pressure, cough, rash and high blood creatinine (decreased kidney function). When used to treat people with heart failure, the most common side effects include dizziness, low blood pressure and diarrhea.

Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as "expected," "may," "possible," "anticipated," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Diovan or regarding potential future revenue from Diovan. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results with Diovan to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Diovan will be approved for any additional indications or labelling in any market. Nor can there be any guarantee that Diovan will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Diovan 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, and other risks and factors referred to in the 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 Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including those in the cardiovascular, metabolic, cancer, organ transplantation, central nervous system, dermatological, gastrointestinal and respiratory areas. The company's mission is to improve people's lives by pioneering novel healthcare solutions.

Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE: NVS), 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 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 100,000 associates and operate in over 140 countries around the world. For more information, please visit http://www.pharma.us.novartis.com.

References

(1) Rosamond W, Flegal K, Friday G, et al. Heart Disease and Stroke Statistics - 2007 Update, A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2007;115(5):e69-171.

(2) Sorof J, Lai D, Turner J, et al. Overweight, ethnicity and the prevalence of hypertension in school-aged children. Pediatrics 2004;113:475- 482.

(3) Rosamond W, Flegal K, Friday G, et al. Heart Disease and Stroke Statistics - 2007 Update, A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Circulation 2007;115(5):e69-171.

(4) Ong KL, Cheung BMY, Man YB, et al. Prevalence, awareness, treatment and control of hypertension among United States adults 1999 - 2004. Hypertension 2007; 49:69-75.

(5) The World Health Organization. The World Health Report 2002: Reducing Risk, Promoting Healthy Life.

Novartis Pharmaceuticals Corporation
http://www.pharma.us.novartis.com