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

    PARSIPPANY, N.J., June 22 /PRNewswire-FirstCall/ -- 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(R) in the U.S. and Nicotinell(R) 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, Inc.