Healthcare Industry News:  amlodipine 

Biopharmaceuticals FDA

 News Release - June 9, 2006

FDA Approves New Lotrel(R) 5/40 mg and 10/40 mg Dosage Strengths

Lotrel Now Provides More Flexible Dosing for Managing High Blood Pressure

EAST HANOVER, NJ--(Healthcare Sales & Marketing Network)--Jun 9, 2006 -- Novartis Pharmaceuticals Corporation announced it has received marketing approval from the U.S. Food and Drug Administration (FDA) for two new dosing strengths of Lotrel (amlodipine besylate/benazepril HCl), 5/40 mg and 10/40 mg. The new dosing strengths combine the calcium channel blocker (CCB) amlodipine with the highest available dose of the ACE inhibitor benazepril.

Lotrel has the broadest marketed dosing range of any CCB and ACE inhibitor combination. Lotrel has proven efficacy and tolerability and is one of the fastest growing branded antihypertensives on the market with sales exceeding a billion dollars in 2005.

The addition of the new higher strengths provides physicians with expanded dosing flexibility and offers two additional treatment options for previously uncontrolled patients who need powerful blood pressure lowering with the benefits of the higher dose ACE inhibitor.

"Lotrel 5/40 mg and 10/40 mg offer physicians powerful new options to manage high blood pressure effectively, conveniently and efficiently with the highest available dose of an ACE inhibitor," said Marjorie Gatlin, M.D., Vice President CVM, Novartis Pharmaceuticals Corporation. "Bringing to market additional doses of Lotrel demonstrates Novartis' continuing commitment to improving the care of patients with hypertension."

Both new Lotrel strengths contain a higher dose of the ACE inhibitor benazepril, compared with other Lotrel doses. Lotrel 5/40 mg contains 5 mg of amlodipine besylate and 40 mg of benazepril HCl, and the 10/40 mg contains 10 mg of amlodipine besylate and 40 mg of benazepril. The additional 5/40 mg and 10/40 mg doses of Lotrel will be available in June 2006, after which Lotrel will be marketed in six dosage strengths -- 2.5/10 mg, 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, 10/40 mg.

Novartis continues to explore Lotrel's clinical potential in the landmark large-scale clinical trial ACCOMPLISH, which is designed to determine if Lotrel is more effective at preventing cardiovascular disease and death than an ACE/diuretic combination. Results are expected in 2009.

About High Blood Pressure

More than 65 million Americans have high blood pressure. However, nearly 70 percent of these do not have their blood pressure controlled to the recommended level of less than 140/90 mm Hg. National guidelines recommend most patients will require a combination of medications to lower their blood pressure to goal.

Important Considerations

Lotrel should be discontinued as soon as pregnancy is detected because it may cause harm or even death to the unborn child. If you get pregnant or plan to get pregnant, call your doctor right away.

Do not take Lotrel if you are allergic to any of the ingredients in this product, or to any ACE inhibitor.

In rare cases with Lotrel, a potentially dangerous swelling of the mouth and throat can occur. Rarely, worsening chest pain (angina) or heart attack has been reported, particularly in patients who already have severe heart disease. Serious side effects such as low blood pressure (hypotension) and kidney problems could occur. The most common side effects include cough, headache, edema (swelling of the feet, ankles, legs, or hands) and dizziness.

Lotrel is not indicated for the initial treatment of high blood pressure. Lotrel may be the right medication for you if certain other blood pressure medicines have not worked or have caused too much swelling.

Lotrel is a prescription medication. Please see Important Product Information at www.lotrel.com or contact Christine Cascio at 862-778-8026.

The foregoing release contains forward-looking statements that can be identified by terminology such as "commitment," "designed to determine," "expected," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Lotrel, or regarding potential future revenues from Lotrel. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Lotrel to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Lotrel will be approved for any additional indications or labeling in any market. Neither can there be any guarantee that Lotrel will achieve any particular levels of revenue. In particular, management's expectations regarding Lotrel could be affected by, among other things, unexpected clinical trial results, including new clinical data or additional analyses of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's 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 the Company'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, treat 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. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. 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. In 2005, the Group's businesses achieved net sales of USD 32.2 billion and net income of USD 6.1 billion. Approximately USD 4.8 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 96,000 people and operate in over 140 countries around the world. For more information, please visit http://www.novartis.com.


Source: Novartis

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