SUMMARY: The Prosorba column, a therapeutic device currently in use in the USA, will be launched in Europe (and Canada) as a new option for treating rheumatoid arthritis. The Prosoba column is a plastic cylinder about the size of a coffee mug that contains a sand-like substance coated with a special material called Protein A. Protein A is unique in that it binds certain elements from your blood called antibodies. Normally, antibodies protect you from disease. However, sometimes your body produces unwanted antibodies that attack your own body tissues. These unwanted antibodies can result in disease. The Prosorba column works to counter the effect of these harmful antibodies.
SAN DIEGO (BW HealthWire) – Cypress Bioscience Inc. today announced that Fresenius HemoCare GmbH, Bad Homburg, Germany, has been granted the CE Mark, which represents regulatory approval for marketing the Prosorba® column in the European Economic Community. Fresenius HemoCare is the sole European marketer and distributor of the product.
“Drugs are no longer the only option for rheumatoid arthritis patients with active disease. Now physicians and patients can consider the Prosorba column, a therapeutic device, as a new option for treating rheumatoid arthritis,” said Jay D. Kranzler, M.D., Ph.D., chief executive officer and chairman of the board of Cypress Bioscience Inc. “The European approval of this device is a significant milestone for patients suffering with painful and swollen joints even after drug treatments.”
Fresenius anticipates launch of the Prosorba column into the European Market during the second quarter of 2000. Profits from sales of the Prosorba column in Europe will be shared between Fresenius and Cypress under the terms of the previously announced partnership agreement. In commenting on the upcoming launch of the Prosorba column first in Germany and then subsequently throughout Western Europe, Rainier Baule, chief operating officer of Fresenius HemoCare stated, “Since the initiation of our partnership with Cypress, we have looked forward to the day when we could introduce this exciting new treatment to patients with severe rheumatoid arthritis in Europe. Fresenius HemoCare Adsorber Technology GmbH is actively preparing for the European launch, and will apply many of the lessons that have been learned from the product introduction last year in the United States.”
Source: Cypress Bioscience Inc