Novartis launches Prevacid®24HR over-the-counter for full 24-hour
frequent heartburn treatment
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Prevacid®24HR prevents acid production that causes frequent heartburn pain for a full 24 hours with one pill a day * Prevacid®24HR provides America's 50 million frequent heartburn sufferers[1] with convenient and easy accessibility to this effective heartburn treatment * First new over-the-counter treatment for frequent heartburn sufferers in six yearsClick here for multimedia contentBasel, November 12, 2009 - Novartis announced the availability ofPrevacid®24HR (lansoprazole delayed-release capsules 15 mg/acidreducer) over-the-counter in pharmacies and retail stores across theUS to treat frequent heartburn. Prevacid®24HR received US Food andDrug Administration (FDA) approval in May 2009. It is the first andonly over-the-counter (OTC) Proton Pump Inhibitor (PPI) for thetreatment of frequent heartburn in its original formulation."It is well known that Americans are taking more ownership of theirhealth-care decisions. The launch of Prevacid®24HR for the treatmentof frequent heartburn is a milestone in the over-the-counter medicinecategory, expanding the treatment choices for the millions of adultswho suffer from frequent heartburn," said Dirk Van de Put, GlobalHead, Over the Counter Business Unit, Novartis Consumer Health."We're looking forward to providing frequent heartburn sufferers withbroad access to this very effective treatment and expect the launchto drive strong incremental growth for the OTC Digestive Healthcategory."Prevacid® (lansoprazole)[2] was one of the most prescribed acidreducer brands in the US over the last decade[3] based on IMS Data.The same medicine in Prevacid is now available over-the-counter inPrevacid®24HR for the treatment of frequent heartburn. Frequentheartburn is defined as heartburn that occurs two or more days perweek.Prevacid®24HR is clinically proven to work for a full 24 hours, bothday and night. It is the only PPI approved for OTC treatment offrequent heartburn that contains the active ingredient lansoprazole.Starting today, Prevacid®24HR is expected to be available in morethan 100,000 pharmacies, drug stores, supermarkets, massmerchandisers and other retail locations throughout the US.Prevacid®24HR is clinically proven to treat frequent heartburnPrevacid®24HR prevents acid production that causes frequent heartburnpain for a full 24 hours, with one pill a day. Clinical study datashows that Prevacid®24HR provides frequent heartburn sufferers moreheartburn-free days and nights than placebo[4],[5]. Prevacid®24HRstarts working early to treat frequent heartburn and maintains itseffectiveness for the full 14-day course of treatment. In twoclinical trials, 88% of people who used Prevacid®24HR for frequentheartburn were satisfied[6].In addition to Prevacid®24HR, Novartis Consumer Health, Inc. hasdemonstrated success with switching other prescription products overthe counter, enabling more consumers to get access to the medicinesthey need, while continuing to build the brands. Three of thecompany's biggest and most successful global switches come from thePharmaceuticals Division of Novartis AG - Voltaren®, Lamisil® andNicotinell® and account for 30 percent of Novartis Consumer Healthglobal sales.Frequent heartburn significantly affects sufferers' quality of lifeWhile frequent heartburn is a common condition, its impact onsufferers may be under-estimated. According to the Experience ofFrequent Heartburn in America, 2009[7], a national study of 1,075frequent heartburn sufferers conducted by the Center for HealthOutcomes Research & Evidence Based Medicine, LLC and United BioSourceCorporation, frequent heartburn is not only painful, but can alsosignificantly impact sufferers' quality of life. The study, conductedin consultation with leading physicians and gastroenterologists, wasdesigned to measure and validate the quality of life impact thatfrequent heartburn currently can have on sufferers. It found thatfrequent heartburn can affect sufferers' ability to get a goodnight's sleep, be productive at work, have positive personalrelationships and enjoy social activities. The study also showed thatthose with more severe frequent heartburn pain can experience agreater impact on their quality of life."Until now, frequent heartburn has been largely misunderstood inAmerica. The data from this study confirms how frequent heartburnaffects my patients' daily lives - it can interrupt sufferers' work,social activities and a full night's sleep," said Dr. Brian Fennerty,practicing gastroenterologist and professor of Medicine in theDivision of Gastroenterology at Oregon Health & Science University inPortland, Oregon. "The over-the-counter availability of a provenmolecule like lansoprazole provides choice and options to themillions of frequent heartburn sufferers and empowers them to treattheir symptoms."The study, which was funded by Novartis Consumer Health, Inc.revealed that[7]: * About 75% of frequent heartburn sufferers experienced some sleep problems as a result of their heartburn - either problems falling asleep or staying asleep. * Living with frequent heartburn pain can affect personal relationships, including social activities with family and friends, quality time with children and spouses, and even sexual relationships. * For 52% of sufferers, discomfort from frequent heartburn has some impact on their work, including their ability to focus in meetings and their overall ability to be productive.The study also found that reducing the frequency and severity offrequent heartburn pain could result in significant improvements in asufferer's mood, relationships with family, productivity at work,diet and enjoyment of social activities[7]. Additional results of thestudy are available at www.Prevacid24HR.com.As part of the launch of Prevacid®24HR, Novartis Consumer Health ispartnering with Dr. Fennerty and MSN.com Lifestyle Expert KelleyMoore to educate the public about frequent heartburn and motivatethem to take action. Through the Heartburn Action Plan, Dr. Fennertyand Ms. Moore will share treatment options and lifestyle tips thatwill help empower frequent heartburn sufferers to treat theirsymptoms. Log on to www.HeartburnActionPlan.com for more information.About Frequent HeartburnMore than 50 million American adults suffer from frequentheartburn,[1] which is defined as heartburn occurring two or moredays per week. Frequent heartburn is a result of the backing up ofstomach acid into the esophagus. Typically the lower esophagealsphincter muscle opens to allow food to pass, but then quicklycloses. However, in frequent heartburn sufferers, the muscle relaxesand allows food and acid from the stomach to travel back up into theesophagus. As a result, sufferers often have a burning sensation inthe chest and/or throat, a sour or bitter taste in the mouth,difficulty swallowing, chronic coughing and wheezing or otherasthma-like symptoms. These symptoms of frequent heartburn can becomeworse when one is lying down or bending over.About Prevacid®24HRPrevacid®24HR is now available over-the-counter to treat frequentheartburn for a full 24 hours with one pill a day. It received USFood and Drug Administration (FDA) approval in May 2009. It is thefirst and only over-the-counter PPI for the treatment of frequentheartburn in its original formulation.Prevacid®24HR is clinically proven to work for a full 24 hours, bothday and night. Although some people get complete relief of symptomswithin 24 hours, it may take one to four days for full effect.Consumers should use Prevacid®24HR as directed for 14 days to treattheir frequent heartburn and may take one 14-day course of treatmentevery four months, or as directed by their doctor. If their heartburncontinues or worsens, they should stop use and ask a doctor.Prevacid®24HR is expected to be available in more than 100,000 retailstore locations nationwide, starting at an average retail price of$11.99.For more information about Prevacid®24HR, including instructions foruse, visit www.Prevacid24HR.com.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "look forward to," "expect,""expected," "can," "could," "will," "may," or similar expressions, orby express or implied discussions regarding the potential date onwhich Prevacid®24HR will be available for sale over-the-counter, theextent of the distribution of Prevacid®24HR, or regarding potentialfuture revenues from Prevacid®24HR. You should not place unduereliance on these statements. Such forward-looking statementsreflect the current views of management regarding future events, andinvolve known and unknown risks, uncertainties and other factors thatmay cause actual results with Prevacid®24HR to be materiallydifferent from any future results, performance or achievementsexpressed or implied by such statements. There can be no guaranteethat Prevacid®24HR will be available for sale over-the-counter on anyparticular date. Nor can there be any guarantee regarding the extentof the distribution of Prevacid®24HR, or that Prevacid®24HR willachieve any particular levels of revenue in the future. Inparticular, management's expectations regarding Prevacid®24HR couldbe affected by, among other things, unexpected difficulties inmanufacturing or distribution; competition in general; government,industry and general public pricing pressures; unexpected regulatoryactions or government regulation generally; the impact that theforegoing factors could have on the values attributed to the NovartisGroup's assets and liabilities as recorded in the Group'sconsolidated balance sheet, and other risks and factors referred toin Novartis AG's current Form 20-F on file with the US Securities andExchange Commission. Should one or more of these risks oruncertainties materialize, or should underlying assumptions proveincorrect, actual results may vary materially from those anticipated,believed, estimated or expected. Novartis is providing theinformation in this press release as of this date and does notundertake any obligation to update any forward-looking statementscontained in this press release as a result of new information,future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in each of these areas. In2008, the Group's continuing operations achieved net sales of USD41.5 billion and net income of USD 8.2 billion. Approximately USD 7.2billion was invested in R&D activities throughout the Group.Headquartered in Basel, Switzerland, Novartis Group companies employapproximately 99,000 full-time-equivalent associates and operate inmore than 140 countries around the world. For more information,please visit http://www.novartis.com. # # #References[1] National Heartburn Alliance:http://www.heartburnalliance.org/%20heartburn_assessment.php[2] Prevacid® is a registered trademark of Takeda PharmaceuticalsNorth America, Inc., and is used under license by TakedaPharmaceuticals North America, Inc.[3] Based on IMS Data of the total number of Prevacid® prescriptionsfrom 1998 - 2008[4] Peura, DA et al. Aliment Pharamcol Ther. 2009; 30:459-468[5] Kushner PR, et al. Postgrad Med.2009; 121(4):67-75[6] Novartis Consumer Health, Inc. Data on file.[7] "The Experience of Frequent Heartburn in America, 2009" Researchconducted by the Center for Health Outcomes Research & Evidence BasedMedicine, LLC and United BioSource CorporationNovartis Media RelationsCentral media line : +41 61 324 2200Eric Althoff Julie MasowNovartis Global Media Relations Novartis Consumer Health, Inc.+41 61 324 7999 (direct) +1 973 503 7663 (direct)+41 79 593 4202 (mobile) +1 862 579 8456 (mobile)eric.althoff(at)novartis.com julie.masow(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth Metzler-Arnold +41 61 324 North America: 9980Pierre-Michel +41 61 324 Richard Jarvis +1 212 830Bringer 1065 2433John Gilardi +41 61 324 Jill Pozarek +1 212 830 3018 2445Thomas Hungerbuehler +41 61 324 Edwin Valeriano +1 212 830 8425 2456Isabella Zinck +41 61 324 7188e-mail: e-mail:investor.relations(at)novartis.com investor.relations(at)novartis.comhttp://hugin.info/134323/R/1354451/328433.pdf --- End of Message ---Novartis International AGPosfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Datum: 12.11.2009 - 07:15 Uhr
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