# Analysis Shows Favorable Effect Of Tegaserod In Treating IBS-C



## Jeffrey Roberts (Apr 15, 1987)

Tuesday May 21, 9:15 am Eastern TimePress ReleaseSOURCE: Novartis *Analysis Shows Favorable Effect Of Tegaserod In Treating Multiple Symptoms Of Irritable Bowel Syndrome With Constipation*SAN FRANCISCO, CA--(INTERNET WIRE)--May 21, 2002 -- Zelnormï¿½ (tegaserod maleate), an investigational gastrointestinal serotonin receptor agonist (GI-SRA) developed by Novartis, was found to be well tolerated and significantly more effective than placebo at providing patients with sustained relief of multiple symptoms of irritable bowel syndrome (IBS) with constipation, according to a meta-analysis of Phase III trials consisting of more than 4,000 IBS patients presented today at the Digestive Disease Week annual conference."There are currently no approved medications that effectively treat the multiple symptoms of IBS with constipation," said Philip Schoenfeld, MD, MSEd, MSC, assistant professor of gastroenterology at the University of Michigan School of Medicine and a lead author of the analysis. "These findings are very encouraging for the millions of people suffering from this serious disorder."About Irritable Bowel SyndromeIBS is characterized by abdominal pain or discomfort, bloating, and altered bowel function (constipation, diarrhea, or alternating). Symptoms are highly bothersome and can negatively impact patients' health-related quality of life. IBS affects up to one in five Americans and is the second leading cause of workplace absenteeism in the United States after the common cold. The disease costs the U.S. healthcare system an estimated $30 billion annually in direct and indirect costs.About TegaserodZelnorm is an investigational gastrointestinal serotonin receptor agonist (GI-SRA) developed by Novartis. In clinical trials with Zelnorm, the most commonly reported side effects associated with treatment compared with placebo were diarrhea (9% vs 4%), headache (15% vs 12%), and abdominal pain (12% vs 11%).This analysis was supported by an unrestricted grant from Novartis Pharmaceuticals Corporation.This release contains certain "forward-looking statements," relating to the Company's business, which can be identified by the use of forward-looking terminology such as "encouraging," "investigational," and "clinical trials." Such statements include descriptions of the potential benefit of Zelnorm as evidenced by the results of clinical studies. Those statements reflect the current views of the Company with respect to future events and are subject to certain risks, uncertainties and assumptions. Many factors could cause the actual results of the Company with respect to Zelnorm to be materially different from any future results that may be expressed or implied by such forward-looking statements. There are no guarantees that the aforementioned studies will result in the commercialization of Zelnorm in any market. Any such commercialization can be affected by, amongst other things, uncertainties relating to product development, regulatory actions or delays or government regulation generally, results in ongoing or future clinical studies, the ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general and other risks and factors referred to in the Company's current Form 20-F on file with the Securities and Exchange Commission of the United States. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG (NYSE:NVS - news), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 71,000 people and operate in over 140 countries around the world. For further information please consult www.novartis.com. --------------------------------------------------------------------------------Contact: Contact: Laura Hortas Company: Novartis Pharmaceuticals Corporation Voice: 973-781-7845 Mobile: 203-376-1425 Contact: Tom Jones Company: Novartis Pharmaceuticals Corporation Voice: 973-781-3772 Mobile: 973-342-3136 Contact: Chantal Beaudry Company: Ruder Finn Voice: 212-593-6400 Contact: John Mc Inenary Company: Ruder Finn Voice: 212-593-6400 Contact: Kamran Tavangar Company: Novartis Corporation Title: Investor Relations Voice: 212-830-2433


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## trbell (Nov 1, 2000)

great news, jeff. I think I saw another article, also. But there are no indications on when it will be out?tom


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## Jeffrey Roberts (Apr 15, 1987)

Tom,The drug has still not been approved by the FDA for use in the US. Novartis has appealed the FDA non-approval letter that they received and is still in discussions with the FDA.Jeff


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## trbell (Nov 1, 2000)

is there anything people can do to speed up discussions? Join the LAG group?tom


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## Jeffrey Roberts (Apr 15, 1987)

Join the ZAG group, http://groups.yahoo.com/group/zelnorm , write to the FDA, http://www.geocities.com/zelnormactiongroup/ , write to Congress, http://www.ibsassociation.org/main/appeal.html


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## GailSusan (Dec 23, 2000)

I know Zelnorm has been a lifesaver for me. I've felt discouraged that so few people have posted about their successes with Zelnorm on this forum. I know of one woman in Chicago who thought it was a miracle drug like I did, she posted here once. Any others that people can recall?


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## linesse (Sep 18, 2000)

Before I obtained Z, I swore that when I did, I would keep posting and inform and encourage every one. I wanted to cheer everyone on!Well, I have some and have not been impressed. I wish I had more to say about it.I find that it does help C. Very well at times. I have been having a hard time because it is increasing my spastic pain.Pain is my worst symptom, C I can control(with work) without Z, but pain:no,it is too much.I wish I could share a great success story!


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## trbell (Nov 1, 2000)

it's pretty apparent from the few posts I've seen about it that many people ne4ed to make adjustments using it like other drugs. doctors here are hampered tremendously in that they have no experience with itand can't get information. This bb is only only place to get info and no one seems to be sharing information?tom


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