my personal edition > gastro other > news


  E-Mail this DGNews to a colleague

DGNews

New Research Validates Use Of Once-Daily High Dose "Good" Bacteria In Patients With Recurrent Or Refractory Pouchitis: Presented at DDW

Probiotic VSL#3™ is Found To Maintain Remission and Improved Quality of Life for Patients Suffering From Inflammation of the Intestinal Reservoir

SAN FRANCISCO, CA -- May 24, 2002 - Questcor Pharmaceuticals, Inc. announced that new research presented here during the annual Digestive Disease Week (DDW) conference demonstrated that the company's therapeutic probiotic product, VSL#3™, provides clinical benefit to patients suffering from pouchitis, which can be described as inflammation of a surgically created intestinal reservoir.

The reservoir, or pouch, is considered an alternative to external ostomy appliances for about 15 percent of the estimated 500,000 patients suffering from ulcerative colitis in the U.S. Ulcerative colitis is a form of inflammatory bowel disease (IBD), which according to the Crohn's and Colitis Foundation of America (CCFA), affects as many as one million Americans.

VSL#3™ is a nonprescription preparation of live freeze-dried lactic acid bacteria developed specifically to provide the optimal concentration and types of healthy bacteria for the gastrointestinal tract.

The findings presented today by Toshiki Mimura, MD, University of Tokyo, Japan, were based on a placebo-controlled study of 36 patients with active refractory or recurrent pouchitis who had successfully been brought into remission by antibiotics. Patients were randomized to receive either VSL#3™ (20 patients) or placebo (16 patients) once daily over a one-year period. The study revealed that 90 percent of the group on VSL#3™ effectively remained in remission while 94 percent of the group on placebo relapsed. Moreover, quality of life as measured by the Inflammatory Bowel Disease Questionnaire (IBDQ) was maintained among the 17 patients who remained on VSL#3™ therapy, while those on placebo experienced quality of life deterioration within the 12-month study period.

"We are excited about the results of this study because a specific amount and type of probiotic has demonstrated that it can dramatically improve patient outcome for pouchitis," said lead investigator, Dr. Mimura. "Furthermore, because pouchitis may be considered a model for other inflammatory bowel diseases (IBD), these findings indicate we may have found an effective, inexpensive, and widely available therapeutic treatment for various forms of IBD, such as ulcerative colitis."

Results from the study presented today confirm earlier findings reported in Gastroenterology [2000 August; (2): 305-9], in which administration of VSL#3™ was found to be effective in preventing flare-ups of chronic pouchitis. In this earlier study, 40 patients in remission from pouchitis were randomized to receive either VSL#3™ (20 patients), or placebo (20 patients), for a period of nine months. Only three patients (15 percent) experienced relapse in the VSL#3™ group, while all 20 patients in the placebo group relapsed.

Severe cases of IBD may result in permanent damage of the gastrointestinal tract and the need for surgery to restore proper function. One approach employed by surgeons is to create an internal pouch using part of the patient's small intestine for the storage of stool. Inflammation of the pouch lining, called pouchitis, occurs in 15 percent of patients within one year of surgery and in nearly half of all patients within ten years.

Considered an important topic of the annual DDW meeting, probiotics -- commonly referred to as "good" bacteria -- are the subject of more than 20 abstracts, posters and presentations this week. Among them are two additional VSL#3™ abstracts, titled, "DNA from Probiotic Bacteria Exerting Anti-inflammatory Actions on Intestinal Epithelial Cells," presented by Karen Madsen, MD on Tuesday, May 21st, and "Probiotics and Antibodies to TNF Inhibit Inflammatory Activity and Improve Non Alcoholic Fatty Liver Disease," presented by Zhiping Li, MD on Sunday, May 19th.

A patented probiotic therapy, VSL#3™, is different from other probiotic therapies in that it contains high concentrations of bacteria (450 billion bacteria), additionally, the number and type of strains that make up VSL#3™ specifically target the gastrointestinal tract. Proof of efficacy for this probiotic therapy is shown in more scientific studies and clinical trials than any other probiotic product on the market. Marketed by Questcor Pharmaceuticals, Inc, VSL#3™ is only available to consumers through the Questcor website, www.questcor.com <http://www.questcor.com>, or by calling toll free (866) GET-VSL3.

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Participating societies in the DDW include 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 the Surgery of the Alimentary Tract (SSAT).


About Questcor
Questcor Pharmaceuticals, Inc. is a specialty pharmaceutical company that serves the needs of the acute care and critical care hospital markets with its proprietary products including: VSL#3™ for helping to maintain health of the gastrointestinal tract, HP Acthar® Gel for a seizure complex, referred to as West Syndrome or infantile spasm, and patients with multiple sclerosis, Ethamolin® for sclerotherapy, Glofil™-125 and Inulin for measuring renal glomerular filtration rate, and Pramidin® which is marketed in Italy for various gastrointestinal disorders including nausea and vomiting. Questcor's clinical stage pipeline products are being developed to treat delayed onset emesis (vomiting), congenital lactic acidosis (CLA), and various central nervous system disorders. As part of a strategy to develop its products globally, Questcor has entered into over 20 contractual relationships with public and private companies including: Ahn-Gook Pharmaceuticals of Korea; Aventis Pharmaceuticals Inc. of Bridgewater, NJ;
CSC Pharmaceuticals Handels GmbH of Vienna, Austria; Crinos Group of Como, Italy; Dainippon Pharmaceutical Co. Ltd., of Osaka, Japan; Rigel, Inc. of South San Francisco, CA; Sigma-Tau Finanziaria S.p.A of Rome, Italy; Tularik, Inc. of South San Francisco, CA and VSL Pharmaceuticals of Ft. Lauderdale, FL.

About VSL Pharmaceuticals
VSL Pharmaceuticals, Inc. is a company that has been established in North America to oversee the development, production, distribution and use of VSL#3™, a proprietary innovative probiotic preparation. VSL Pharmaceuticals has a proprietary platform technology in the area of probiotics. In particular, new products addressing prevention of oxalate kidney stones, dermatitis, enteral nutrition and non-alcoholic steatohepatitis are in advanced stages of development.

Note: Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties. Such statements are subject to certain factors, which may cause Questcor's results to differ from those reported herein. Factors that may cause such differences include, but are not limited to, Questcor's ability to accurately forecast the demand for each of their products, the gross margins achieved from the sale of those products and the expenses and other cash needs for the upcoming periods, Questcor's ability to obtain finished goods from its sole source contract manufacturers on a timely basis if at all, Questcor's need for additional funding, uncertainties regarding Questcor's intellectual property and other research, development, marketing and regulatory risks, and, to the ability of Questcor to implement its strategy and acquire products and, if acquired, to market them successfully as well as the risks discussed in Questcor's report on Form 10-K for the calendar year ended December 31, 2001 and other documents filed with the Securities and Exchange Commission. The risk factors and other information contained in these documents should be considered in evaluating Questcor's prospects and future financial performance.

Questcor undertakes no obligation to publicly release the result of any revisions to these forward-looking statements, which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

SOURCE: Questcor Pharmaceuticals

E-Mail this DGNews to a colleague

To print, use this version