# New data demonstrates Zelmacï¿½ (tegaserod) is effective and well tolerated



## Jeffrey Roberts (Apr 15, 1987)

http://www.novartis.com/home/fs.asp?n1=htt...94?OpenDocument MEDIA RELEASE - COMMUNIQUE AUX MEDIAS - MEDIENMITTEILUNG05/21/2001New data demonstrates Zelmacï¿½ (tegaserod) is effective and well tolerated in treating the multiple symptoms of Irritable Bowel Syndrome (IBS)Basel, 21 May 2001 ï¿½ Novartis and Bristol-Myers Squibb reported today that new data shows Zelmacï¿½* (tegaserod) provides rapid and sustained relief of multiple symptoms of irritable bowel syndrome (IBS) throughout treatment duration, including abdominal pain/discomfort, bloating and constipation in female patients. The second most common cause of workplace absenteeism after the common cold1, IBS is a chronic disorder affecting 10 - 20% of the population2. The data was presented at the 32nd annual Digestive Disease Week (DDW) meeting, held in Atlanta, Georgia, US."These findings are very encouraging, demonstrating that, for the majority of patients, Zelmac works within the first week and provides patients with continued relief from the multiple symptoms of IBS," said Professor Jan Tack, staff member at the Department of Gastroenterology and Principal Researcher, Centre for Gastroenterological Research at the University Leuven, Belgium. "This represents a major scientific advancement and will be welcome news for physicians and patients. Zelmac will alleviate the unmet clinical need for a safe and effective IBS treatment and help the millions of people worldwide who suffer from this debilitating condition."Clinical data from more than 4,500 patients have demonstrated that Zelmac is well tolerated and effective in treating the multiple symptoms of IBS, including abdominal pain/discomfort, bloating and constipation. There were significant improvements in each of the key symptoms studied and the most commonly reported side effects associated with Zelmac are headache and mild diarrhoea."IBS is a common and debilitating disorder that can have an impact in patients' daily lives. IBS is one of the leading causes of work absenteeism and, untreated, represents a significant cost to society and to individuals," said Rhonda Smith, Communications Manager, Digestive Disorders Foundation in the UK. "We welcome the introduction of a safe and effective new treatment for the many patients living with IBS."In the latest placebo-controlled, double-blind study3, more than 1,500 female IBS patients were randomly assigned to either 6 mg bid daily of Zelmac or placebo for 12 weeks, followed by a four-week withdrawal period. Within the first week, patients treated with Zelmac experienced significant improvements (p<0.05) as measured by the Subject's Global Assessment (SGA) of Relief, which is a self-administered questionnaire of relief of overall IBS symptoms. These improvements persisted throughout the 12-week treatment trial period.Significant improvements (p<0.05) in the three bowel-related assessments (stool frequency, stool consistency and straining) also occurred within the first week and were sustained throughout the treatment period. Upon discontinuation of drug treatment symptoms returned. In this study, discontinuations due to adverse events occurred in 6.4% (tegaserod) and 4.7% (placebo) patients. The most common adverse events were mild, transient diarrhoea and headache.This data reinforces previously reported findings4 which demonstrate that Zelmac 6 mg bid daily decreased the number of days IBS patients experienced abdominal pain/discomfort and bloating based on a 12-week, placebo-controlled, double-blind study.In addition, a review of three placebo-controlled, double-blind trials5 of 12-weeks duration with 3,199 IBS patients (92% female) found that Zelmac provides significant, consistent and reproducible relief as measured by SGA. The review was designed to assess the predictive value of early response for continued efficacy over time. Overall, 74 - 78% of those patients who responded to Zelmac at the end of the first month continued to respond to treatment at the end of the study.In three clinical studies of 2,400 patients the cardiac safety profile of Zelmac was investigated. 11,535 ECGs were performed and analysed by a cardiologist unaware of the nature of the study and the results confirm the favourable safety profile of Zelmac similar to placebo.About Zelmac (tegaserod)Zelmac is a novel selective 5HT4 receptor partial agonist that provides rapid and sustained relief of multiple symptoms of IBS, abdominal pain/discomfort, bloating and constipation. Clinical research has established the importance of 5-HT (serotonin) receptors in the pathophysiology of IBS. Ninety five percent of the body's serotonin is found in the gastrointestinal (GI) tract, where it affects motility and sensitivity.Zelmac is currently under review by the European Medicines Evaluation Agency (EMEA) for the treatment of IBS in women. In the US, marketing approval is pending after the Food and Drug Administration (FDA) issued an approvable letter for the treatment of abdominal pain and constipation in women with IBS.The forgoing press release contains certain forward-looking statements, related to the business of Novartis, which can be identified by the use of forward-looking terminology such as "demonstrate", "will alleviate," need", "improvement", "reinforce", "novel", or similar expressions. Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There are no guarantees that the aforementioned clinical trials will result in the commercialisation of any product in any market. Any such commercialisation can be affected by, amongst other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, the ability to obtain or maintain patent or other proprietary intellectual property protection and competition in general, as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein anticipated, believed, estimated or expected.Novartis (NYSE: NVS) is a world leader in healthcare with core businesses in 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 people and operates in over 140 countries around the world. For further information please consult http://www.novartis.com Bristol-Myers Squibb Company (NYSE:BMY) is an USD 18 billion diversified global health and personal care company whose mission is to extend and enhance human life. Visit Bristol-Myers Squibb on the world wide web at http://www.bms.com.[/URL] * In the U.S.:Zelnormï¿½ (tegaserod); outside the U.S.: Zelmacï¿½(tegaserod)# # #More information can be found at http://www.IBSandhealth.com.[/URL] References1 Thompson, WG et al "Functional bowel disorders and functional abdominal pain", Gut, 1999, 45, (Suppl 11) 1143-1147.2 Schuster, M. Diagnostic Evaluation of the Irritable Bowel Syndrome. Gastroenterol Clin North Am. Vol. 20 No. 2 June 1991.3 Lefkowitz M., Liugozio G., et al. "Tegaserod provides relief of symptoms in female patients with Irritable Bowel Syndrome (IBS) suffering from abdominal pain and discomfort, bloating and constipation." Oral presentation at Digestive Disease Week, 20-25 May 2001, Atlanta, Ga.4 Lefkowitz, M. et al. "The 5HT4 receptor partial agonist tegaserod improves abdominal discomfort/pain and normalizes altered bowel function in Irritable Bowel Syndrome (IBS)." Poster presented at the annual meeting of the American College of Gastroenterology, Phoenix, USA, 15-19 October 1999.5 Mueller-Lissner S., Lefkowitz, M., et al. "Early effect of tegaserod predicts continued efficacy in treatment of constipation predominant Irritable Bowel Syndrome." Poster presented at the Annual Digestive Disease Week Meeting, Atlanta, Ga, 20-25 May 2001.


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