Prosorba Column Recommended for Approval by FDA Advisory Panel for Use in Rheumatoid Arthritis.

SAN DIEGO--(BUSINESS WIRE)--Oct. 29, 1998--

Unique Treatment May Provide Non-Drug Alternative

To Currently Available Therapies

Conference Call Scheduled for Monday

Cypress Bioscience, Inc. (NASDAQ: CYPB) announced today that the Prosorba(R) column was recommended for approval for the treatment of moderate to severe rheumatoid arthritis (RA) by the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Device Advisory Panel. The Panel voted ten to one in favor of this recommendation.

The Panel recommended the approval of the Company's Pre-Market Application (PMA), which would extend labeling of the Prosorba(R) column to include RA, subject to the requirement that the Company conduct a post-marketing study. The column received FDA approval in 1987 for treatment of Idiopathic Thrombocytopenic Purpura (ITP), an immune-mediated bleeding disorder, and has been used safely for 11 years. For RA, the Prosorba(R) column would be used in moderate to severe patients who have failed second-line, or Disease Modifying Anti-Rheumatic Drugs (DMARDs), such as methotrexate.

Today's recommendation, although not binding, will be considered by the FDA in its final review of Cypress's PMA. The application, which was submitted in July, has been given priority attention by the FDA.

"This is an extremely exciting and important day for Cypress Bioscience," said Jay Kranzler, M.D., Ph.D., Chief Executive Officer, Chief Scientific Officer, Chairman of the Board, Cypress Bioscience, Inc. "We believe that the Prosorba(R) column will play an important role in meeting the needs of moderate to severe rheumatoid arthritis patients, which may not be adequately addressed with existing therapies. The Panel's confidence in our product is encouraging, and we will continue to work closely with the FDA as it completes the review process."

"We are very happy with the Panel's recommendation," said Debby Jo Blank, M.D., President and Chief Operating Officer of Cypress Bioscience, Inc. "Rheumatoid arthritis can be a devastating illness that prevents patients from doing everyday activities that most people take for granted. We believe the Prosorba(R) column has the potential to ease the suffering of these patients, and help them to regain their lives."

"The Prosorba(R) column offers a promising approach to the treatment of moderate to severe rheumatoid arthritis," said Dr. George Ehrlich, Adjunct Professor of Medicine, University of Pennsylvania and Member, Rheumatology Advisory Board, Cypress Bioscience, Inc. "The Prosorba(R) column can serve as a valuable complement and add-on to new and existing drug treatments. Pre-approval studies have focused on patients who have failed to respond adequately to a variety of our best existing treatments, and the Prosorba(R) column has helped a significant proportion of these patients to improve."

Phase III Trial Halted Early Due to Achieving Statistical

Significance

The Advisory Panel's decision was based, in part, on a review of the Company's pivotal Phase III clinical trial. The study ended in January 1998 - more than a year ahead of schedule - after an independent Data Safety and Monitoring Board recommended an early cessation due to favorable safety and statistically significant efficacy results.

In the double-blinded, sham-apheresis procedure controlled clinical trial, nearly half of the patients who completed all 12 treatments showed significant clinical improvement by stringent American College of Rheumatology (ACR) criteria. The response was often durable, lasting up to 75 weeks in some patients. The patients had a statistically significant reduction in swollen and tender joint counts, as well as other improvements, and their response was maintained in the absence of any other therapy during and after treatment.

Twelve leading arthritis centers - including Virginia Mason Medical Center in Seattle, University Hospitals of Cleveland and the University of Pennsylvania - served as sites for the Phase III clinical trial. The study enrolled 109 patients who were considered the most severely affected of the RA population, having suffered from the disease for an average of 15.5 years and having failed an average of 5 different DMARD regimens.

About Rheumatoid Arthritis and the Prosorba(R) Column

Rheumatoid arthritis is a chronic and often debilitating autoimmune disease in which the body's immune system attacks its own tissue, often leading to painful inflammation and deformity of the joints. The disease affects more than 2.5 million Americans, 70% of them women - most between the ages of 25 and 60.

Cypress's Prosorba(R) column is a polycarbonate (plastic) cylinder that contains highly purified protein A immobilized on an inert silica matrix. The protein A binds to and removes antibodies, including clusters of Circulating Immune Complexes (CICs) and antigens, that contribute to the symptoms characteristic of RA. The device has additional immunomodulatory effects, and the mechanism of these effects continues to be actively investigated by the Company.

The standard course of treatment involves 12 weekly outpatient apheresis sessions. Each session takes approximately two hours. In a process similar to kidney dialysis, a patient's blood is removed from an arm and passed through a machine that separates the blood cells from the plasma. The plasma is then passed through the Prosorba(R) column, recombined with the blood cells and finally returned to the patient through the other arm.

The Company's manufacturing facility passed the full Good Manufacturing Practices (GMP) inspection by the FDA earlier this year.

Cypress Will Hold Conference Call to Discuss FDA Panel

Recommendation

Cypress has scheduled a conference call to review the data as well as its plans for moving forward at 12:00 p.m. EST on Monday, November 2, 1998. Instructions for those interested in participating in the call are attached.

Cypress Bioscience, Inc. 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. In addition to Cypress's lead product, the Prosorba(R) column, the Company acquired Cyplex(tm) (Infusible Platelet Membranes), which is positioned to become an alternative for traditional platelet infusions.

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 receive regulatory approval for the Prosorba(R) column or Cyplex(tm) on a timely basis, if at all; even if it is ultimately approved whether the Company will be successful in marketing the Prosorba(R) column for use as a treatment for RA; whether the Company will be successful in collaborating with a marketing partner or not; and whether Cyplex(tm) will become a substitute for traditional platelet infusions, 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 December 31, 1997.

(See attached conference-call instructions)

Note: B-roll video including clinician and patient interviews is available on request

NOTICE OF CONFERENCE CALL

Please be advised that Cypress Bioscience, Inc. (NASDAQ: CYPB), will be holding a conference call on Monday, November 2, 1998 at 12:00 p.m., Eastern Standard Time, to discuss the positive FDA Panel recommendation received today. Please call 212-896-6035 if you wish to participate. Phone lines will open at 11:50 a.m.

The call will include a brief discussion of the FDA Advisory Panel hearing followed by a question-and-answer period. Participants from Cypress Bioscience will include:

-- Dr. Jay Kranzler, Chairman, CEO and Chief Scientific Officer -- Dr. Debby Jo Blank, President and Chief Operating Officer -- Dr. Michael Gendreau, Vice President and Chief Medical Officer

Playback Information

A taped replay will be available following completion of the conference call. The replay will be available for 48 hours beginning at 2:00 p.m. Eastern Standard Time on Monday, November 2nd and ending at 2:00 p.m. on Wednesday, November 4th. To access playback of the call, telephone [phone] and enter the seven-digit reservation number 1696542. International callers may dial 303-248-1201, reservation number 1696542.

For additional information, please call James Ankner at [phone].