# Novartis launches irritable bowel syndrome treatment Zelmacï¿½ in first market, Mexico



## Jeffrey Roberts (Apr 15, 1987)

http://dominoext.novartis.com/NC/NCPRRE01....c3?OpenDocument Novartis launches irritable bowel syndrome treatment Zelmacï¿½ in firstmarket, MexicoBasel / Mexico City, 24 July 2001 - Novartis Pharma Mexico announced todaythat it has launched Zelmacï¿½ (tegaserod) the Group's new treatment forirritable bowel syndrome. This is the first market introduction for Zelmac.IBS is estimated to affect between 16 and 21% of the population in Mexico1and up to 20% of the population worldwide2."We are excited to make Zelmac available to the millions of patientssuffering from IBS in Mexico to offer them a new hope", said Victor Rubira,Country and Pharma Head of Novartis Mexico.About IBSIBS is a chronic disorder that can have a dramatically negative impact onpatients' daily functioning and well-being. It represents a significanthealth cost to the economy and remains, globally, the second leading causeof workplace absenteeism after the common cold.IBS is characterised by the key symptoms of abdominal pain/discomfort,bloating and altered bowel habits that vary in pattern and severity. It isa chronic fluctuating disorder that has a significant impact on dailyfunctioning and overall well-being. People who suffer from IBS often becomedissatisfied with current treatments, which include fiber,gastroprokinetics and antispasmodic drugs, because of their generalineffectiveness. In many cases, the frustration causes them to discontinuetherapy and contributes to the social and economic impact of the condition.About Zelmac (tegaserod)Zelmac is one of a new class of drugs and is the first selective 5HT4receptor partial agonist to be introduced for the treatment of abdominalpain/discomfort, bloating, and altered bowel habits in patients with IBS.In the most recent published placebo-controlled, double-blind study3, morethan 1 500 female IBS patients were randomly assigned to either 6 mg biddaily of Zelmac or placebo for 12 weeks, followed by a four-week withdrawalperiod. Within the first week, patients treated with Zelmac experiencedsignificant improvements (p<0.05) as measured by the Subject's GlobalAssessment (SGA) of Relief, which is a self-administered questionnaire ofrelief of overall IBS symptoms. These improvements persisted throughout the12-week treatment trial period.Significant improvements (p<0.05) in the three bowel-related assessments(stool frequency, stool consistency and straining) also occurred within thefirst week and were sustained throughout the treatment period. Upondiscontinuation of drug treatment symptoms returned. In this study,discontinuations due to adverse events occurred in 6.4% (tegaserod) and4.7% (placebo) patients. The most common adverse events were mild,transient diarrhoea and headache.Novartis continues to work with the US Food and Drug Administration andother regulatory authorities regarding tegaserod and is committed tohelping bring this important new therapy to patients in need.The forgoing press release contains certain forward-looking statements,related to the business of Novartis, which can be identified by the use offorward-looking terminology such as "to make available", "offer new hope,""committed to helping bring this important new therapy to patients inneed", or similar expressions. Such forward looking statements involveknown and unknown risks, uncertainties and other factors that may causeactual results to be materially different from any future results,performance or achievements expressed or implied by such statements.Management's expectation regarding the commercial of tegaserod in anymarket could be affected by, amongst other things, uncertainties relatingto product development, regulatory actions or delays or governmentregulation generally, the ability to obtain or maintain patent or otherproprietary intellectual property protection and competition in general, aswell as factors discussed in the Company's Form 20F filed with theSecurities and Exchange Commission. Should one or more of these risks or uncertainties materialise, orshould underlying assumptions prove incorrect, actual results may varymaterially from those described herein anticipated, believed, estimated orexpected.Novartis (NYSE: NVS) is a world leader in healthcare with core businessesin pharmaceuticals, consumer health, generics, eye-care, and animal health.In 2000, the Group's ongoing businesses achieved sales of CHF 29.1 billion(USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion).The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D.Headquartered in Basel, Switzerland, Novartis employs about 69 000 peopleand operates in over 140 countries around the world. For furtherinformation please consult http://www.novartis.com.[/URL] # # #References1 Schmulson M., Colon Irritable. En Villalobos JJ., Valdovinos MA, OliveraMA. Ed. Principios de Gastroenterologï¿½a. 1a.Ediciï¿½n. Mï¿½ndez Editores, Mï¿½xico, D.F., 2000 Cap. 44 pg. 501-5102 Thompson, WG et al "Functional bowel disorders and functional abdominalpain", Gut, 1999, 45, (Suppl 11)1143-11473 Lefkowitz M., Liugozio G., et al. "Tegaserod provides relief of symptomsin female patients with IrritableBowel Syndrome (IBS) suffering from abdominal pain and discomfort, bloatingand constipation." Oralpresentation at Digestive Disease Week, 20-25 May 2001, Atlanta, Ga.[This message has been edited by Jeffrey Roberts (edited 07-24-2001).]


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## badfoot (Oct 5, 1999)

Thanks for this update. I live in San Diego and may be tempted to make a border crossing for Zelmac.


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