Another news release morning of 3/9/00
(BSNS WIRE) CE Mark Granted for the PROSORBA Column in Rheumatoid Arthri
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. 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."
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 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 in 1987 for use
in Idiopathic Thrombocytopenic Purpura (ITP), an immune bleeding
disorder. In addition, Cypress is developing Cyplex(TM) (Infusible
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 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
for the year ended Dec. 31, 1998 and its most recent Quarterly
Report on Form 10-Q. |
