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| |  Canada Approves Pantoloc+ (Pantoprazole Sodium) For Treatment Of Heartburn TORONTO, ON -- March 29, 2001 -- Byk Canada Inc. and Solvay Pharma Inc. announced that Pantoloc+ (pantoprazole sodium), the newest member of a class of drugs known as proton pump inhibitors, was recently approved by Health Canada for the treatment of symptomatic gastroesophageal reflux disease (GERD), also known as heartburn. This means that physicians can now prescribe Pantoloc+ based solely on symptoms such as heartburn, the most common indicator of GERD. A Canadian trial which randomized patients to either Pantoloc+ or nizatidine (a histamine-receptor blocker) was pivotal in the approval for the symptomatic GERD indication for Pantoloc+. This trial, developed by the Canadian Pantoprazole GERD Study Group, compared symptomatic relief of heartburn with Pantoloc+ once daily to nizatidine twice daily in patients with endoscopy negative reflux disease and in patients with esophagitis. The study was a four-week, randomized, double-blind, multi-centre study of 220 patients from across Canada. Patients were randomized to either Pantoloc+ 40 mg once daily or nizatidine 150 mg twice daily. Pantoprazole treatment resulted in a significantly greater relief of heartburn symptoms in a higher proportion of patients at seven days than nizatidine at 28 days. According to Dr. David Armstrong, Assistant Professor, Department of Medicine from the Division of Gastroenterology at McMaster University in Hamilton, Ontario, and lead investigator of the study group, "This is a superb outcome that suggests that Pantoloc+ is a highly effective first-line therapy that results in daytime and nighttime relief for people who suffer from GERD. Now that physicians can prescribe based on symptoms alone, patients will receive effective treatment immediately." President John Suk of Byk Canada indicated, "The GERD study was a good example of Byk and Solvay's commitment to research and development in Canadian gastroenterology." Solvay Pharma's president and CEO, Dr. Laurence Downey, agreed, "We are excited that the GERD study was so well received by the Canadian gastroenterology community and are confident that the results will positively impact peoples' lives." GERD, commonly known as heartburn, is a condition in which gastric acid, secreted by the stomach and needed to help digest food, regurgitates into the esophagus. GERD is often caused by a weakness in a circular muscle, known as the lower esophageal sphincter (LES), which is located where the esophagus joins the stomach. The LES should remain closed at all times, except when a person is eating and drinking, or if gas builds up in the stomach; however, for some people, the LES weakens or opens at the wrong time, causing gastric acid to regurgitate into the esophagus. Over 40 percent of the Canadian population suffer from symptoms of GERD, with at least 10 percent of them experiencing symptoms weekly. Common symptoms of GERD include a burning sensation in the chest or a feeling of fullness, usually coming on 30 - 60 minutes after eating, or when patients are lying down. GERD can be particularly problematic for patients at night. In a 2000 U.S. Gallup survey involving 1000 adults who suffer from heartburn, nearly 8 out of 10 respondents experienced heartburn at night. Of respondents who experience both daytime and nighttime heartburn, 50 percent say that their nighttime symptoms affect them more than daytime symptoms. More than 63 percent of all respondents claim that heartburn affects their ability to get a good night's sleep, and 40 percent report that it has some effect on their ability to function well at work the next day. Pantoloc+, available in tablet form, works by reducing acid secretion in the stomach by inhibiting both basal and stimulated gastric secretion. A unique benefit of Pantoloc+ is the absence of known interactions with other drugs. Pantoloc+ has no discernible interaction with drugs such as diazepam, diclofenac, digoxin, phenytoin, nifedipine, theophylline and warfarin, nor with the beta blockers metoprolol and propranolol or with oral contraceptives. Pantoloc+ is now offered in over 60 countries around the world and has been available in Canada since 1997 where, within a year, it made its mark as the second fastest growing prescription drug. Pantoloc+ is jointly marketed by Byk Canada Inc. and Solvay Pharma Inc. This is just one example of the companies' dedication to research and development in the area of gastroenterology.
SOURCE: BYK CANADA INC., SOLVAY PHARMA INC.
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