Last week saw the first shipments of VSL#3, a probiotic food ingredient marketed by Questcor Pharmaceuticals. VSL#3 is a preparation of eight highly concentrated species of live freeze-dried lactic acid bacteria which are said to have a beneficial effect on the gastrointestinal (GI) tract.
Questcor announced last December that it had obtained the rights to VSL#3 from VSL Pharmaceuticals, a private company owned in part by affiliates of Sigma-Tau Finanziaria, to promote, sell and distribute the ingredient in the United States. VSL Pharmaceuticals will continue to be responsible for the development of VSL#3, which is the subject of ongoing clinical studies.
Questcor said that VSL#3 is available for purchase through the company's website, even though the formal launch of the ingredient by Questcor will not be until 19 May in San Francisco. This will coincide with the Digestive Disease Week meeting, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
The results from several new trials will be presented to the medical community at the upcoming meeting, Questcor said. In particular, three of these trials have been accepted for oral presentation. On 19 May, Dr Zhiping Li will present the results from a study looking at the role for VSL#3 in non-alcoholic fatty liver disease, while on 21 May, Dr. Karen Madsen will present her study examining the role of VSL#3 in reducing the inflammatory response of intestinal epithelial cells. Finally, on 22 May, Dr Toshiki Mimura will present the results of a multi-centre clinical trial with VSL#3 in the prevention of recurrent chronic pouchitis, a serious condition experienced by a group of patients that have undergone surgery for their ulcerative colitis.
"This milestone represents another step forward for Questcor. We began shipments of VSL#3 ahead of the formal launch to ensure that we are properly prepared for the expected demand of VSL#3. As this product will be promoted to gastroenterologists for recommendation to their patients, it was important to wait until the presentation of this new data, which adds to the body of already published data, before the formal launch," commented Charles J. Casamento, chairman, president & CEO of Questcor.
"Although we do expect revenues, they will not be significant prior to the national launch which will initiate formal promotion of the product by our sales representatives. Our goal is to see more meaningful revenues from the sale of VSL#3 in the second half of 2002."
Probiotics are living organisms used in food or dietary supplements, which upon ingestion in certain numbers, improve the health of the host (humans) beyond their inherent basic nutrition."VSL#3 contains significantly greater concentrations of the live bacteria, 450 billion organisms per dosage unit, which is substantially greater than other probiotic preparations. VSL#3 also contains eight bacterial species as compared to traditional probiotic preparations, which usually contain no more than two or three species. VSL#3 contains four strains of lactobacilli, three strains of bifidobacteria and one strain of streptococcus salivarius.
"These species of lactic acid bacteria or 'friendly' bacteria are present in the gastrointestinal tract of people with a normal digestive system. VSL#3 helps maintain digestive health and balance by delivering these 'friendly' bacteria to the digestive system," the company said.