SUMMARY: The Prosorba column, a therapeutic device used to remove harmful substances from the blood, has been approved in Europe for treating rheumatoid arthritis. This promising new treatment yields impressive results in clinical trials; in one study, 75 percent of patients who had completed seven or more treatments of the total 12-week treatment course responded to treatment.
LISBON, PORTUGAL — April 10, 2000 — Cypress Bioscience Inc. and Fresenius HemoCare GmbH, Bad Homburg, Germany, jointly announced the European launch of the Prosorba® column treatment for rheumatoid arthritis (RA).
Speaking at a special Symposium on the Prosorba column at the International Society for Rheumatic Therapies (ISRT), Cypress and Fresenius reported that registration of the Prosorba treatment system has been completed, thereby permitting the sale of the product in Europe. In addition to the Prosorba column, the treatment system includes the Fresenius Cell Separator and Leukocyte Filter, and the disposables necessary to use these products with the Prosorba column.
Fresenius HemoCare is the sole European marketer and distributor of the Prosorba column.
Rainer Baule, chief operating officer of Fresenius HemoCare, said, “Fresenius HemoCare Adsorber Technology GmbH, in partnership with Cypress Bioscience, is preparing extensively for the European launch, and will introduce the Prosorba column system in multiple European countries over the next few months.” Initially, the product will be launched in France, Italy and Germany. ” As in the United States, we expect that availability of this exciting new therapy to be a boon for European patients with difficult to treat RA,” Mr. Baule added.
In a symposium at the ISRT, leading rheumatologists involved in clinical trials with the Prosorba column discussed Immunoadsorption, the process by which harmful substances can be removed from the blood, and its applications in rheumatology. R. Michael Gendreau, M.D., Ph.D., executive vice president, research and development, chief scientific officer and chief medical officer for Cypress Bioscience Inc., also provided a clinical update on data gathered on patients since the product became commercially available one year ago in the United States.
Overall, 75 percent of patients who had completed seven or more treatments of the total 12-week treatment course responded to treatment. There was no difference in response rate noted between those patients who had a history of having failed one of the new “TNF blocker” drugs such as Enbrel® (manufactured by Immunex and distributed by Wyeth-Ayerst, a division of American Home Products) and those with no previous experience with “TNF blockers.”
Source: Cypress Bioscience, Inc.