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CE Mark Granted for the PROSORBA Column in Rheumatoid Arthritis; First Available Non-Drug Alternative in Europe Launch Set For Second Quarter 2000.


Business Editors/Health & Medical Writers

SAN DIEGO--(BW HealthWire)--March 9, 2000

Cypress Bioscience Inc. (Nasdaq:CYPB) today announced that Fresenius HemoCare GmbH, Bad Homburg, Germany, has been granted the CE Mark, which represents regulatory approval for marketing the PROSORBA(R) column in the European Economic Community European Economic Community (EEC), organization established (1958) by a treaty signed in 1957 by Belgium, France, Italy, Luxembourg, the Netherlands, and West Germany (now Germany); it was known informally as the Common Market. . Fresenius HemoCare is the sole European marketer and distributor of the product.

"Drugs are no longer the only option for rheumatoid arthritis rheumatoid arthritis

Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course.
 patients with active disease. Now physicians and patients can consider the PROSORBA column Prosorba® column Therapeutics A blood-filtration device used during apheresis–eg, for treating ITP; it may improve severe rheumatoid arthritis in Pts who failed or are intolerant to disease-modifying antirheumatic drugs–DMARDs. See Apheresis. , 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 Chief Operating Officer (COO)

The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president.
 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."

About Cypress Bioscience Inc.

Cypress Bioscience Inc. develops and markets medical devices and therapeutics for the treatment of certain types of immune disorders and is engaged in the development of novel therapeutic agents for the treatment of blood platelet blood platelet
n.
See platelet.
 disorders. In March 1999, the company entered into an agreement that granted Fresenius AG and Fresenius Hemotechnology Inc. an exclusive license to manufacture and distribute the PROSORBA column in the U.S., Europe and certain other territories.

In April 1999, Cypress and Fresenius launched sale of the PROSORBA column for the treatment of moderate to severe rheumatoid arthritis. The PROSORBA column was previously cleared by the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 in 1987 for use in Idiopathic Thrombocytopenic Purpura Idiopathic Thrombocytopenic Purpura Definition

Idiopathic thrombocytopenic purpura, or ITP, is a bleeding disorder caused by an abnormally low level of platelets in the patient's blood.
 (ITP ITP - Intent to Package ), an immune bleeding disorder Bleeding disorder
Problems in the clotting mechanism of the blood.

Mentioned in: Lithotripsy

bleeding disorder Coagulopathy, see there
. In addition, Cypress is developing Cyplex(TM) (Infusible in·fus·i·ble  
adj.
Suitable for infusion; capable of being infused.



in·fusi·bil
 Platelet Membranes), which is positioned to become an alternative for traditional platelet infusions. For more information about the PROSORBA column and Cypress, please visit the company's Web site at www.cypressbio.com.

About Fresenius HemoCare

Fresenius HemoCare -- a company of the Fresenius Group -- is one of Europe's leading companies in blood treatment and infusion technology.

Fresenius HemoCare's products and services are used in blood donation and separation of blood components, as well as for intravenous infusion of pharmaceuticals with highly sophisticated infusion pumps. Its core competencies emphasize innovative products in immune therapy and in therapies for extracorporeal extracorporeal /ex·tra·cor·po·re·al/ (-kor-por´e-al) situated or occurring outside the body.

ex·tra·cor·po·re·al
adj.
Situated or occurring outside the body.
 blood treatment.

Fresenius HemoCare has more than 2,000 employees worldwide who are actively engaged in extending its global reach from its leading European market platform.

For additional information about Fresenius HemoCare, please visit their Web site at www.fresenius-hemocare.com.

Except for historical information contained herein, this news release contains forward-looking statements regarding Cypress Bioscience Inc. that involve risks and uncertainties, including, but not limited to the company's and Fresenius' ability to market successfully the PROSORBA column for use as a treatment for rheumatoid arthritis; whether the company will be successful in collaborating with Fresenius; whether the final survey data related to the clinical use of the PROSORBA Column as a treatment for rheumatoid arthritis will confirm the preliminary data; and the company's ability to develop and receive regulatory clearance for Cyplex(TM) on a timely basis, if at all, as well as other risks detailed from time to time in the company's SEC reports, including its Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended Dec. 31, 1998 and its most recent Quarterly Report on Form 10-Q.
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Publication:Business Wire
Geographic Code:1USA
Date:Mar 9, 2000
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