Basel, 21 May 2003 - New data presented this week at the 2003 Digestive Disease Week (DDW) meeting in Orlando demonstrates Zelmac®* (tegaserod) is effective, safe and well tolerated in the treatment of patients suffering from Irritable Bowel Syndrome (IBS). Data presented from China, Latin America, Pakistan, Germany and the Nordic region shows Zelmac significantly relieves the abdominal discomfort/pain, bloating and constipation experienced by patients with IBS.
Placebo Controlled Studies
- China: In a 4-week study conducted in China, Zelmac-treated patients experienced a significant reduction of IBS symptoms including abdominal pain, bloating and constipation, versus placebo-treated patients (p<0.0001).
- Nordic region: In a similar 12-week study conducted in the Nordic region, Zelmac-treated patients had significantly greater overall relief of their IBS symptoms (p<0.05, 2-sided 5% test) than placebo-treated patients at weeks two and three and for each week from weeks five to twelve. Zelmac also increased the number of days patients experienced >3 bowel movements for weeks 1-4 (p<0.0001).
"These data are key in reinforcing the efficacy and safety profile of Zelmac in both controlled clinical trials and in normal clinical practice settings for patients with IBS," said Dr. Joerg Reinhardt, Head of Development, Novartis Pharma AG. "Zelmac offers a real option for physicians and patients around the world who have struggled to manage this devastating condition."
Open-label Studies
- Germany: The aim of this study was to determine if retreatment with Zelmac is as effective and safe as an initial course of therapy. 436 patients responded to Zelmac (85%) during the initial treatment phase of 12 weeks. 88 percent of patients who entered the re-treatment phase of the trial, responded to treatment.
- Latin America: The results from an open-label study conducted in Latin America found that 82 percent of patients were responsive to Zelmac treatment over a one-month initial treatment period. Patients who were maintained on the therapy were less likely to relapse compared with patients who were in the withdrawal arm (10% vs. 67%, respectively).
"These re-treatment studies point to the potential benefit of continuous treatment to delay symptom relapse in patients with IBS," said Dr. Reinhardt.
- Pakistan: In a small 6-week study in Pakistan, treatment with Zelmac significantly decreased the number of patients experiencing abdominal pain/discomfort, bloating, sense of incomplete evacuation and straining at defecation (p=0.001 for all variables). Further, results show Zelmac was equally effective in males and females in relieving the symptoms of abdominal pain, bloating and straining.
Previous studies have demonstrated Zelmac to be safe and well tolerated in European and North American patients with IBS with constipation. The abstracts presented at DDW 2003 extend this safety profile to patients from China, Pakistan, Latin America with IBS with Constipation, and in patients from the Nordic region with IBS whose primary bowel symptom was not diarrhea. The overall frequency of adverse events was similar among studies. The most common adverse event was diarrhea in the Zelmac groups, and was generally mild, transient and typically resolved with continued treatment. The overall discontinuation rate due to side effects was small. In addition, the safety profile was shown to be the same for initial treatment and retreatment with Zelmac in patients with IBS with Constipation.
About Irritable Bowel Syndrome (IBS)
IBS is characterized by abdominal pain and discomfort, bloating, and altered bowel function (constipation and/or diarrhea). Until recently, the cause of IBS has been poorly understood and under appreciated. However, in recent years, new research has yielded a better understanding of IBS and its causes. People who have abdominal pain and discomfort, bloating and constipation associated with IBS may have altered sensitivity, motility and impaired secretory functions of their GI tract. This may be due to the way their lower GI tract reacts to changes in 5HT (serotonin), a naturally occurring substance, in their body that regulates motility and perception of pain and discomfort in the intestinal system.
About Zelmac
Zelmac is the first in a new class of medicines, known as 5HT-4 agonists (serotonin type 4 agonists) developed especially for the treatment of the multiple symptoms associated with IBS with constipation. By activating 5HT4 receptors in the gastrointestinal tract, Zelmac normalizes impaired motility and reduces sensitivity of the intestinal tract. In clinical studies, significantly more patients experienced a general relief of symptoms when treated with Zelmac, such as a decrease in abdominal pain, bloating and constipation. In most patients who responded to Zelmac, the onset of relief occurred within just one week. The medicine was well tolerated and showed a profile of side effects similar to that of placebo.
Zelmac was discovered and developed by Novartis. Zelmac, known in the United States, Canada, the Philippines and South Africa as Zelnorm®, is approved in more than 45 countries including Switzerland, Canada, the United States, Mexico and Brazil. In the Asian Pacific region, Zelmac is also approved for use in Australia, Thailand, Singapore, Vietnam and Indonesia.
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 17-22, 2003 in Orlando, Florida. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.
The foregoing press release contains certain forward-looking statements related to the business of Novartis, which can be identified by express or implied discussions regarding potential new indications or approvals for Zelmac, or potential future sales of Zelmac. 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 can be no guarantees that Zelmac will be approved for any additional indications or in any additional markets. Nor can there be any guarantee that Zelmac will achieve any particular sales levels. Management's expectation regarding the commercial potential of tegaserod in any market could 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 20-F filed with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, 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 pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 77 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
# # #
