# Novartis Press Release on Zelnorm's Long-Term Safety



## GailSusan (Dec 23, 2000)

10/10/2001New data shows underdiagnosis of Irritable Bowel Syndrome (IBS) burdens patients and healthcare systems worldwideSeparate study presented at international medical meeting reinforces long-term safety of Novartis' Zelmacï¿½ for treatment of IBSBasel, Switzerland, 10 October 2001 ï¿½ Novartis announced today results of an international study, "Truth In IBS", that found IBS affects up to 12% of the population, and that under-diagnosis and lack of effective treatment create a considerable burden on patients and healthcare systems. Additional data from a multicentre study reinforced that Zelmacï¿½ (tegaserod) is safe and well-tolerated in relieving the multiple symptoms of IBS (abdominal pain/discomfort, bloating, and constipation). Both studies were presented today at the 9th annual United European Gastroenterology Week (UEGW) meeting in Amsterdam."Truth In IBS" studyTo assess the global prevalence and impact of IBS, the "Truth In IBS" study was conducted in nine countries: the UK, Germany, Belgium, the Netherlands, Switzerland, Spain, Italy, France and the US. "This large, international study provides compelling new evidence that IBS is a debilitating condition for which there is no single effective treatment," said Professor Jan Tack, study author and staff member at the Department of Gastroenterology and Principal Researcher, Centre for Gastroenterological Research at the University Leuven, Belgium. The study found that the prevalence of IBS in Europe ranges from 6% in the Netherlands to 12% in Italy, including patients who have been formally diagnosed for the condition and those who have not. Women were predominantly affected, averaging between 63% and 74% of identified IBS sufferers in the nine countries. Diagnosed and undiagnosed sufferers were all ages, with an average of 43 years. Significantly, researchers also found that more than 90% of IBS cases in Europe have not been diagnosed.1 The study was conducted in two phases, the first consisting of 5 000 screening calls in each country to identify diagnosed and undiagnosed IBS sufferers. Undiagnosed patients were identified using Manning, Rome I and Rome II diagnostic criteria captured through questionnaires concerning each patient's experience with abdominal pain, bowel function and bloating.2-4 In the second phase of the study, follow-up phone interviews with identified sufferers collected further information about the impact of IBS on their lives. Interviews determined that 89% of IBS sufferers experienced bloating, 85% constipation, and 76% abdominal pain. A majority said that IBS affected their diet (69%), concentration (60%) and physical appearance (54%), and said the symptoms have reduced their productivity at work (60%). A majority of IBS sufferers had been to healthcare professionals (90% to a primary care physician) regarding their symptoms with 17% going to a hospital at least once relating to their condition. The study also revealed IBS patients find currently available treatments to be largely ineffective against bloating (89%), constipation (85%) and abdominal pain (76%). Multicentre dose-titration studyAlso at the UEGW meeting, data was presented from a long-term safety and tolerability study5 which found 62% of IBS patients reported considerable relief of symptoms at 12 months when treated with Zelmac. The multicentre, dose-titration study evaluated 579 patients to reinforce past studies that established the safety of Zelmac. As in previous studies, Zelmac was found to be safe and well-tolerated with mild side effects, the most common being transient diarrhoea (10%) and headache (8%). Patients treated with Zelmac showed no haematological or biochemical abnormalities. Blood pressure and pulse rate remained normal, as did the results of urinalysis. Previous clinical trials5-8 involving more than 4 500 patients found that two thirds of patients treated with Zelmac experienced overall symptom relief, including improvements in abdominal pain/discomfort and constipation. The majority had relief within one week.4,5 Zelmac has been shown to reduce abdominal pain/discomfort, bloating and constipation (p<0.05) in patients with IBS.7,8 The drug was well-tolerated with an adverse event profile similar to that of placebo, with the exception of headache and diarrhoea, which in most cases was mild and transient.5,6 Discontinuations based on adverse events were 6.8% for the Zelmac treated group compared with 4.8% for the placebo group in the final trial.8 Zelmac is approved for the treatment of abdominal pain, bloating and constipation in IBS patients in Mexico, Venezuela, Columbia and the Czech Republic. The Swiss Health Authority, Intercantonal Office for the Control of Medicines (IKS), is expected to rule on marketing approval for the treatment in the near future. Novartis remains committed to working with the US Food and Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA) and other regulatory authorities to help bring the benefits of this new therapy to patients in need. The foregoing 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 "new", "create a considerable burden", "well-tolerated", "compelling new evidence", "considerable relief", "are expected to follow suit", "remains committed" 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. Management's expectation regarding the commercial potential of tegaserod in any market could be affected by, among 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 as anticipated, believed, estimated or expected. Novartis AG (NYSE: NVS) is a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Novartis Group's ongoing businesses achieved collective 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. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 70 000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.[/URL] # # #References1.Hungin APS, et al. Prevalence and impact of Irritable Bowel Syndrome on Patients' Lives ï¿½ An International Study. Presented at the 9th annual United European Gastroenterology Week (UEGW) meeting, Oct. 10th, 2001, Amsterdam, Holland.2.Thompson WG, et al. Functional bowel disease and functional abdominal pain. Gastoenterol Int 1992;5:7591.3.Thompson WG, et al. Functional bowel disease and functional abdominal pain. Gut 1999;45(suppl.11):11431147.4.Manning AP, et al. Towards positive diagnosis of the irritable bowel. B Med J 1978;2:6534.5.Mï¿½ller-Lissner S, et al. Long-term safety and tolerability of tegaserod in patients with irritable bowel syndrome. Presented at the 9th annual United European Gastroenterolgy Week (UEGW) meeting, Oct. 10th, 2001, Amsterdam, Holland.6.Integrated safety summary, December 2000. Novartis, data on file.7.Mï¿½ller-Lissner S, et al. Tegaserod, a 5-HT4 partial agonist, relieves symptoms in irritable bowel syndrome patients with abdominal pain, bloating and constipation. Aliment Pharmacol Ther 2001;16:16551666.8.Lefkowitz M, et al. Tegaserod provides relief of symptoms in female patients with irritable bowel syndrome (IBS) suffering from abdominal pain and discomfort, bloating and constipation. (Abstr). Gastroenterology 2001;12:A104.


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