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Novartis Files New Drug Application for Zelmac(TM)(tegaserod) Tablets for the Treatment of Irritable Bowel Syndrome

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By Press Release: Novartis Pharmaceuticals Corporation • • February 25, 2000

EAST HANOVER, N.J., Feb. 16 /PRNewswire/ -- Novartis Pharmaceuticals Corporation today announced that it has submitted a new drug application (NDA) to the US Food and Drug Administration for Zelmac(TM) (tegaserod) tablets, an innovative treatment for the multiple symptoms of irritable bowel syndrome (IBS). A regulatory submission was also filed with the European Medicines Evaluation Agency (EMEA).
Phase III studies have demonstrated that within the first week after starting treatment, Zelmac therapy provided statistically significant relief of IBS symptoms in patients who suffered primarily from abdominal pain and constipation.

"Zelmac offers an entirely new approach to treat the multiple symptoms of irritable bowel syndrome, a debilitating disorder of GI function that involves altered motility and an increase in pain perception," said Marvin M. Schuster, M.D., Professor of Medicine, Johns Hopkins University of Medicine, Baltimore, MD. "Lack of satisfactory therapies for IBS has been frustrating for both physicians and patients. Zelmac could provide a valuable new option since it improves motility and may reduce pain perception."

IBS is one of the most common disorders of function of the gastrointestinal (GI) tract, affecting up to 20 percent of the Western population. It is a chronic condition characterized by abdominal pain, bloating, and symptoms associated with irregular bowel function, such as constipation, diarrhea or an alternating pattern between the two. IBS is the second most common cause of work-related absenteeism in the US. It accounts for one in four GI visits and costs the US healthcare system $8 billion annually. To date, no medication has proven to be safe and effective in treating IBS patients who suffer from abdominal pain, constipation and bloating as their primary symptoms.

"While all IBS sufferers experience pain, it is important to understand that the majority of patients also have constipation as a primary symptom," said Dr. Schuster. "The prevalence of constipation makes the potential availability of Zelmac attractive for treating the multiple symptoms of IBS patients."

Study Results:
The filing submitted to the regulatory authorities includes data from three phase III clinical studies of Zelmac, involving more than 2,500 patients in 15 countries.

Two multicenter, double-blind, placebo-controlled studies of similar design involving 1,680 patients found those treated with Zelmac showed clinically relevant and statistically significant relief of symptoms as measured by the Subject's Global Assessment (SGA) of relief. SGA of relief is a global assessment that incorporates symptoms of abdominal pain, overall well being and altered bowel function. Significant improvement of symptoms was demonstrated within the first week and was sustained over the course of the 12-week treatment period.

Specific effects of Zelmac on IBS symptoms were also assessed through analysis of a daily diary kept by the patients. Zelmac was found to significantly reduce abdominal pain in both studies and bloating in one study. Additionally, Zelmac increased the number of bowel movements per day and reduced the number of days with no bowel movements. Zelmac also improved bowel function as early as day one.

Safety and Tolerability :
Zelmac was found to be well tolerated with side effects comparable to placebo. Diarrhea was the predominant adverse event reported more often in Zelmac treatment groups (12% on Zelmac vs. 5% on placebo). In most cases, the diarrhea occurred early, was transient, and resolved with continued therapy. Only 1.6% of patients discontinued Zelmac therapy due to diarrhea. A long- term study of IBS patients treated up to 12 months, reported a similar safety and tolerability profile.

About Zelmac:
Zelmac belongs to a new chemical class of compounds which selectively target and act on 5-HT4 receptors present throughout the GI tract. These serotonin receptors are believed to play a key role in pain perception and GI motility. By acting on the 5-HT4 receptor pathway, Zelmac reduces abdominal pain and may normalize altered GI function in IBS patients who suffer from abdominal pain, constipation and bloating as their predominant symptoms.

Other Potential Indications:
Novartis is currently conducting clinical trials studying Zelmac as a potential treatment for gastroesophageal reflux disease (GERD).

"Zelmac is designed to tackle one of the most common digestive tract disorders," said A. N. Karabelas, CEO Novartis Pharma AG. "It may offer significant benefits to IBS patients and could help address one of the leading causes of lost days from work. The filing also represents an important milestone for Novartis as it enters the gastrointestinal therapeutic market."

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