Good news announcement this morning. Joel
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Wednesday May 27, 8:01 am Eastern Time
Company Press Release
Cypress Bioscience's Prosorba Column for Rheumatoid Arthritis Receives
FDA "Special Review" Designation
SAN DIEGO--(BW HealthWire)--May 27, 1998--Cypress Bioscience Inc.
(NASDAQ:CYPB - news) announced today that it has been notified by the
U.S. Food and Drug Administration (FDA) that its Premarket Approval
Supplement (PMA) for the Prosorba(R) column has been selected for
''Special Review'' status.
The PMA Supplement seeks to extend labeling to include severe rheumatoid
arthritis (RA) on the basis of a pivotal Phase III clinical trial in RA
that completed in January 1998. The Prosorba(R) column is already
approved by the FDA for the treatment of Idiopathic Thrombocytopenic
Purpura (ITP), an immune-mediated bleeding disorder.
The FDA Modernization Act of 1997 provides for a more flexible review
process if the FDA believes a new product warrants special treatment. As
such, Cypress Bioscience has been granted permission to submit its PMA
to the FDA for review as each segment is completed rather than requiring
the entire submission before beginning the review process.
''We are very pleased that the FDA review staff is working closely with
us on our PMA supplement and believe Cypress was granted 'Special
Review' status for several reasons,'' said R. Michael Gendreau, M.D.,
Ph.D., vice president and chief medical officer of Cypress Bioscience
Inc. ''Firstly, we're dealing with a product which is already
FDA-approved and has over 10 years of safety data. Plus, in gaining
broader labeling for severe rheumatoid arthritis, we will be addressing
a major unmet medical need.''
This week Cypress completed the second of two planned PMA
pre-submissions to the FDA. These submissions support the extension of
marketing claims for the Prosorba(R) column's usage in severe rheumatoid
arthritis and include statistical approaches and preliminary safety and
efficacy analysis resulting from the company's recently completed trial.
Full submission of the PMA is estimated for mid-1998. The two
pre-submissions made to date are consistent with the previously
announced timeline, and the company anticipates submitting the final
package on schedule.
Phase III Trial Halted Early Due to Achieving Statistically Significant
Efficacy Results
In January of this year, an independent Data Safety and Monitoring Board
recommended an early cessation of the pivotal Phase III clinical trial
due to achieving favorable safety and statistically significant efficacy
results on an intent-to-treat basis.
The study, which began in the summer of 1996, had enrolled over 100
patients who suffered from advanced rheumatoid arthritis. These patients
had been suffering from the disease for an average of 15.5 years and had
failed an average of over 5 different second-line treatments known as
DMARD's, including methotrexate in almost all cases. Over 40% of the
subjects were classified as having functional disability status of grade
3, referring to patients whose disability interferes with their ability
to walk and exercise.
The trial involved twelve weekly treatments, and patients randomized to
receive treatment with either the Prosorba(R) column or a sham apheresis
procedure. Of patients who completed all 12 Prosorba(R) column
treatments, 45% were clinically improved by stringent American College
of Rheumatology (ACR) criteria. In this group, overall mean decreases of
57% in swollen joint and 64% decrease in tender joint counts were noted
among responders. The average duration of ACR defined response in this
group is approximately 36 weeks, or 20 weeks after the last treatment,
with some patients able to remain off all RA specific medication for as
long as 75 weeks.
Cypress develops, manufactures 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. The company's leading product,
the Prosorba(R) column, is approved by the FDA for sale in the treatment
of patients with Idiopathic Thrombocytopenic Purpura (ITP), an
immune-mediated bleeding disorder. The company acquired Cyplex(TM),
infusible platelet membranes, which is positioned to become an
alternative for traditional platelet infusions, an estimated $1.5
billion market worldwide.
Except for historical information contained herein, this news release
contains forward-looking statements that involve risks and
uncertainties, including, but not limited to, the company's ability to
complete final submission of its PMA on a timely basis, if at all; to
receive regulatory approval 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 report on Form 10-K for the year ended Dec. 31, 1997.
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Contact:
Cypress Bioscience Inc.
Jay D. Kranzler, Debby Jo Blank, 619/452-2323
or
StartUp Solutions (Investor Contact)
Steve Rouhandeh, Jeff Davis, 212/554-4158
or
Robinson Lerer & Montgomery (Media Contact)
Mary Jane Walker, 212/484-6788 |
