# Novartis Pharmaceuticals Corporation Receives FDA Approvable Letter for Zelmac



## Jeffrey Roberts (Apr 15, 1987)

Novartis Pharmaceuticals Corporation Receives FDA Approvable Letter for Zelmac(tm) - Additional Data Requested by Agency; U.S. Launch of Zelmac Still on Track for First Half of 2001 - EAST HANOVER, N.J., Aug. 11 /PRNewswire/ -- (NYSE: NVS) -- NovartisPharmaceuticals Corporation today announced that it has received an approvableletter from the U.S. Food and Drug Administration (FDA) for Zelmac(tm)(tegaserod hydrogen maleate), a potential new therapy to treat abdominalpain/discomfort and constipation in female patients withconstipation-predominant irritable bowel syndrome (IBS). The letter requestsadditional data. "Because of our intensive ongoing clinical development program for Zelmac,we are well underway with a separate 1,500 all-female patient study of thedrug that should provide ample additional data to address the agency's requestbefore year end," said Paulo Costa, president and CEO, NovartisPharmaceuticals Corporation. "Submission of this additional data should notchange our original timeline of launching Zelmac in the US in the first halfof 2001." A new drug application for Zelmac was submitted to the FDA onFebruary 11, 2000 and was granted priority review. Priority review status isgranted by the FDA to products that are considered to be a potentialtherapeutic advance over existing therapies or where none exists. On June 26,the Gastrointestinal Drug Advisory Committee of the FDA recommended approvalfor Zelmac for the treatment of abdominal pain/discomfort and constipation inwomen with IBS. An estimated 30 million American women suffer from IBS, with asignificant percent of these patients manifesting symptoms of abdominal pain,discomfort, and constipation. "Allowing additional data from our new study to be part of the labelingreview represents an excellent opportunity to better profile the efficacy andsafety of Zelmac, since the new trial design builds on the knowledge gained inour Phase III study of this complex clinical population," said Costa. "Wewill work closely with the FDA to bring this much needed therapy to market forthe millions of women suffering from the IBS symptoms of abdominal pain,discomfort, and constipation." About Zelmac Zelmac belongs to a new chemical class of compounds which selectivelytarget and act on 5-HT4 receptors present throughout the gastrointestinal (GI)tract. These serotonin receptors appear to play a key role in pain perceptionand GI motility. By acting on the 5-HT4 receptor pathway, Zelmac may improveGI function by relieving abdominal pain and constipation in women with IBS. Inaddition to the FDA submission, a regulatory submission was filed with theEuropean Medicine Evaluation Agency (EMEA) on February 16. About IBS IBS is a chronic condition and one of the most common gastrointestinal(GI) disorders of function, affecting up to 40 million American adults.(1) Itis estimated that three times more women than men suffer from IBS,(2) makingit more common than other chronic conditions that largely affect women likeosteoporosis, arthritis, diabetes and urinary incontinence.(3) The hallmarksymptoms of IBS are abdominal pain/discomfort, bloating and symptomsassociated with altered bowel function, such as constipation, diarrhea or analternating pattern of the two. IBS is second only to the common cold as acause of absenteeism from work in the US.(4,5) It accounts for one in fourvisits to gastroenterologists, and costs the healthcare system $8 billion eachyear.(6,7) Novartis Novartis Pharmaceuticals Corporation researches, develops, manufacturesand markets leading innovative prescription drugs used to treat a number ofdiseases and conditions in a variety of therapeutic areas includinggastroenterology, central nervous system, organ transplantation, cardiology,dermatology, oncology, respiratory and arthritis. The company's mission is toimprove people's lives by pioneering novel healthcare solutions. Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporationis an affiliate of Novartis AG (NYSE: NVS), a world leader in healthcare withcore businesses in pharmaceuticals, consumer health, generics, eye-care, andanimal health. In 1999, the Novartis Group (including Agribusiness) achievedsales of $21.9 billion and invested more than $2.8 billion in R&D.Headquartered in Basel, Switzerland, Novartis employs about 82,400 people andoperates in over 140 countries around the world. The Group has announcedplans to spin off its Crop Protection and Seeds sectors and to merge them withthe agrochemicals business of AstraZeneca in the second half of 2000. The foregoing press release contains forward-looking statements that canbe identified by terminology such as "expects," "potential," "suggests,""may," "will," or similar expressions. Such forward-looking statementsinvolve known and unknown risks, uncertainties and other factors that maycause the actual results to be materially different from any future results,performance, or achievements expressed or implied by such statements. Inparticular, management's expectations regarding future research developmentresults could be affected by, by among other things, uncertainties relating toclinical trials and product development; unexpected regulatory delays orgovernment regulation generally; the company's ability to obtain or maintainpatent and other proprietary intellectual property protection; and competitionin general. (1) Lynn RB, Friedman LS. Irritable bowel syndrome. N Engl J Med. 1993: 329:1940-1945. (2) Schuster, M. Diagnostic evaluation of the irritable bowel syndrome. Gastroenterology Clinics of North America. Vol. 20, No. 2, June 1991. (3) Women's Health Statistical Information, The National Women's Health Information Center: The Office on Women's Health - US Department of Health and Human Services. http://www.4women.gov.[/URL] Accessed July 26, 2000. (4) Weber, FH and McAllum, RW. Clinical approaches to irritable bowel syndrome. Lancet. Vol 340: December 12, 1992, p. 1447-1451. (5) Schuster, M. Diagnostic evaluation of the irritable bowel syndrome. Gastroenterology Clinics of North America. Vol. 20, No. 2, June 1991. (6) American Gastroenterological Association Medical Position Statement: Irritable Bowel Syndrome, November 1996. (7) Talley, J. Medical costs in community subjects with irritable bowel syndrome. Gastroenterology. 1995; 109: 1736-1741. For more information, contact: (Media) (Investor) Geoffrey Cook Joe Schepers Novartis Pharmaceuticals Novartis Pharmaceuticals Corporation Corporation 973-781-5486 212-830-2444 Susan Thiele Ruder-Finn 212-583-2740SOURCE Novartis Pharmaceuticals Corporation


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## eric (Jul 8, 1999)

Jeff, that is GREAT NEWS for the many C suffers. Thanks for posting it







------------------ http://www.ibshealth.com/


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## JeanG (Oct 20, 1999)

This is really great news, Jeff!







JeanG


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## Guest (Aug 12, 2000)

Good news! Now all I need to do is live in the US!!Roz


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## Pete (Jan 20, 2000)

Anyone know why they are not testing on males? Also I thought this was due out this year not next?


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## JudyW (Jul 14, 2000)

YES!!!!! THANK YOU, THANK YOU, THANK YOU!! I wonder when it'll be available to get a prescription from your doc?I feel so bad for those of you living outside of the U.S. There has got to be a way for you to have access to this drug! ------------------Judy (IBS-C)


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## Guest (Aug 12, 2000)

Thank you for your posting re: Zelmac. I wonder why my gastro doc said it would be a year before it would come out? Also, I really would rather wait for this drug than try the prozac or whatever. I think I'll wait. At last, a ray of hope.


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## Guest (Aug 13, 2000)

This is _great_ news Jeff ... thanks for posting it!







Julie


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## Guest (Aug 16, 2000)

Im waiting everday for this medication.. Been sick for 8 years and cant stand it much longer.


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