Healthcare Industry News:  nicotine replacement therapy 

Biopharmaceuticals FDA

 News Release - June 22, 2007

FDA Approves Novartis Consumer Health, Inc.'s Over-the-Counter THRIVE(TM) Gum for Cessation of Smoking

Doubles smokers' chances of kicking the habit and helps smokers be smoke free in just 12 weeks

Smoking-related diseases claim the lives of an estimated 438,000 Americans each year, costing the U.S. more than $167 billion in health care and lost productivity expenses annually

70 percent of smokers report they are interested in completely quitting but are not yet smoke-free


PARSIPPANY, N.J., June 22 (HSMN NewsFeed) -- Novartis Consumer Health, Inc., announced today that the U.S. Food and Drug Administration (FDA) has given approval of Thrive(TM) (Nicotine Polacrilex Gum USP) 2mg and Thrive(TM) (Nicotine Polacrilex Gum USP) 4mg to help smokers quit smoking in 12 weeks. The unexpectedly bold, mint-flavored nicotine replacement gum will be available as an over-the-counter (OTC) product nationwide beginning in late 2007 to help smokers double their chances of kicking the habit.

"The health benefits of living smoke-free are substantial and nearly immediate," said Ray Niaura, Ph.D., professor of psychiatry, Brown Medical School. "However, quitting smoking is not easy. People who combine the correct combination of counseling, pharmacotherapy such as Thrive gum, and support from friends and family are more likely to succeed."

According to the Centers for Disease Control (CDC), more than 44 million Americans over the age of 18, or one in five adults, are smokers. Additionally, 33 million, or 70 percent, of them report they are interested in completely quitting but are not yet smoke-free. The American Legacy Foundation, a non-profit organization committed to smoking cessation and prevention, encourages those trying to quit to use a combination of nicotine replacement therapy (NRT), such as Thrive gum, counseling (professional, online or telephonic) and social support from friends and family as part of a comprehensive quit plan.

When used as directed, Thrive gum delivers low, controlled levels of nicotine to the bloodstream to help reduce cravings and other withdrawal symptoms associated with the cessation of smoking. Thrive gum 2mg is designed for those who smoke fewer than 25 cigarettes each day, and Thrive gum 4mg is designed for those who smoke 25 or more cigarettes each day.

"Thrive will help smokers to conquer smoking in just 12 weeks, while continuing to lead the fulfilling lifestyle they've always enjoyed," said Brian McNamara, Senior Vice President and General Manager, Novartis Consumer Health OTC. "As a global health care leader with a tradition of delivering innovative, self-medication treatments, Novartis applauds the efforts of those who are taking steps toward leading a smoke-free life."

According to the CDC, smoking-related diseases claim the lives of an estimated 438,000 Americans each year, costing the U.S. more than $167 billion in health care and lost productivity expenses annually. The approval of Thrive gum comes on the heels of the U.S. Surgeon General's report on the effects of second-hand smoke stating that smoke-free environments are the only approach that protect non-smokers from the dangers of secondhand smoke.

Through a 12-week program with the Thrive user's guide and available audio CD, those interested in quitting smoking can gradually reduce nicotine levels in their body to help conquer their smoking habit in 12 weeks. Additionally, Thrive has established a toll-free counseling line to aid smokers in their attempt to quit smoking. For more information, please call 866-384-3011.

Thrive gum is a medicine and must be used as directed to achieve the best results. Chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again until the tingle returns. Repeat this process until most of the tingle is gone (about 30 minutes). For best results do not eat or drink anything for 15 minutes before or while chewing the gum.

Important Safety Information

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking, however, the risks to your child from this medicine are not fully known.

Do not use Thrive gum if you continue to smoke, chew tobacco, use snuff, or use a nicotine patch or other nicotine containing products.

Ask your doctor before use if you have a sodium restricted diet, heart disease, a recent heart attack or irregular heartbeat, high blood pressure not controlled with medication, stomach ulcer or diabetes.

Ask a doctor or pharmacist before use if you are using a non-nicotine, stop-smoking drug or taking prescription medicine for depression or asthma.

Stop use and ask a doctor if mouth, teeth or jaw problems occur, or if irregular heartbeat or palpitation occur or if you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, weakness and rapid heartbeat.

Keep Thrive out of reach of children and pets. Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Novartis currently markets Habitrol® in the U.S. and Nicotinell® in Europe and adds Thrive to its nicotine replacement therapy portfolio.

Disclaimer

This release contains certain "forward-looking statements", relating to the Novartis Group's business, which can be identified by the use of forward-looking terminology such as "will," "more likely to," "believed to be," or similar expressions, or by express or implied discussions regarding potential future revenue from Thrive. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Thrive to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Thrive will reach any particular levels of revenue. Management's expectations regarding Thrive could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry, and general public pricing pressures; uncertainties relating to clinical trials, including new clinical data and additional analysis of existing clinical data; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; as well as 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 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.novartis.com.


Source: Novartis Consumer Health

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