Check out CYPB there will be FDA advisory Panel on October'29
FDA Advisory Panel to Review Prosorba Column for Use in Rheumatoid Arthritis
Also, check out insider buying for this stock at quote.yahoo.com
or
companysleuth.com
Wednesday September 16, 8:15 am Eastern Time
Company Press Release
FDA Advisory Panel to Review Prosorba Column for Use in Rheumatoid Arthritis
Company Announces Completion of Private Placement
SAN DIEGO--(BW HealthWire)--Sept. 16, 1998--Cypress Bioscience, Inc. (NASDAQ:CYPB - news) announced today that a U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Device Advisory Panel will review the Company's application to extend labeling of its Prosorba(R) column for use in rheumatoid arthritis (RA) at its October 29, 1998 meeting. The Prosorba(R) column has been FDA approved since 1987 for the treatment of Idiopathic Thrombocytopenic Purpura (ITP), an immune-mediated bleeding disorder.
''We are delighted to be invited for Panel review much earlier than initially anticipated,'' said Debby Jo Blank, M.D., President and Chief Operating Officer of Cypress Bioscience, Inc. ''A positive panel recommendation, followed by formal approval, would make it possible for us to provide a product for patients who have not responded to other currently available therapies. We are under late-stage discussions with several potential marketing partners who can help us launch this novel product.'' The Prosorba(R) column, a non-drug therapeutic medical device, will join new pharmaceutical products in the pipeline for rheumatoid arthritis such as Immunex's (NASDAQ:IMNX - news) TNF inhibitor, ENBREL(TM) (etanercept), under Advisory Panel review today, and Hoechst Marion Roussel's (NYSE:HOE - news) recently approved Arava(TM) (leflunomide).
Phase III Trial of Most Severely Affected RA Patients Confirmed Results of Pilot Trials
In May 1996, Cypress Bioscience began a pivotal Phase III trial to confirm results of an earlier pilot study in which the Prosorba(R) column showed effectiveness in patients with rheumatoid arthritis. The Phase III double-blinded, sham-apheresis procedure controlled clinical trial was designed to enroll up to 250 patients. In January, 1998, after reviewing the interim data, an independent Data Safety and Monitoring Board (DSMB), consisting of experts in the fields of rheumatology, hematology and biostatistics, directed the Company to halt the trial -- nearly a year ahead of schedule -- because statistically significant safety and efficacy data had been achieved. The Company's efforts since then have shifted to pre-launch activities and the preparation of its PMA Supplement for submission to the FDA.
Conducted at 12 leading arthritis centers around the United States, the trial directed patients to receive treatment either with the Prosorba(R) column or with a sham apheresis procedure once a week for twelve weeks. Of the patients who participated in the trial and completed all twelve Prosorba(R) column treatments, nearly half showed significant clinical improvement by stringent American College of Rheumatology (ACR) criteria. In patients who responded, there was a statistically significant reduction in swoolen and tender joint counts, among other improvements, measured at follow-up. In the absence of any other therapy, during and after twelve weeks of Prosorba(R) column treatments, the responders maintained an ACR-defined response to week 40. Overall, there was no evidence of increased adverse effects due to Prosorba(R) column therapy vs. the control arm of sham apheresis.
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. Patients enrolled in the Cypress trial suffered from the disease an average of 15.5 years and had failed an average of over 5 different second-line treatment regimens known as Disease-Modifying Anti-Rheumatic Drugs (DMARDs), including methotrexate -- the most commonly prescribed medication for RA. Over 40% of the trial patients were classified as having functional disability status of Grade 3, defined as, ''ambulatory only with assistance.'' To the Company's knowledge, the Cypress trial is the first placebo-controlled trial to study this severe group of patients.
In May 1998, the Prosorba(R) column was granted ''Special Review'' status. This designation means that the FDA attempts to expedite its review of the product and permits the Company to submit portions of the PMA application as sections are available. The submission was completed in July of this year, and requested extended labeling for RA, an indication which would expand the use of the Prosorba(R) column into rheumatology, an overall market estimated at $2 billion. The Company's manufacturing facility had already passed a full Good Manufacturing Practices (GMP) inspection by FDA earlier this year.
Cypress Bioscience's Prosorba(R) column is a plastic cylinder that contains highly purified protein A immobilized on a silica matrix. Protein A binds to antibodies, products of the immune system which contribute to the inflammation characteristic of rheumatic joints. The Column is used in conjunction with a plasmapheresis machine in a closed loop procedure. Blood is drawn from a vein in the patient's arm and passed through the machine where the blood cells are separated from the plasma, the liquid portion of the blood. The plasma then passes through the Column where certain antibodies are removed and additional immunomodulatory effects occur. The mechanism of these effects continues to be actively investigated by the Company. After the plasma passes through the Column, it is returned, along with the cells, to the patient through a vein in the other arm. The procedure takes about 2-1/2 hours and is performed once a week for twelve weeks in a course of RA therapy.
Private Placement Completed to Support Product Launch
Independently, Cypress announced today that it had raised $3.3MM in a private placement of 2,180,000 Series A Preferred Stock, convertible on a one-to-one basis into common shares. The investors included both current, significant stockholders of the Company as well as some new institutional investors. The Company believes that this money, combined with its current resources, will be sufficient to launch the Prosorba(R) column for RA.
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.
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; 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; whether the funds raised in the private placement will be sufficient to successfully launch the Prosorba(R) column for the treatment of RA; whether Cyplex(TM) will become a substitute for traditional platelet infusions, or whether the Company will be successful in raising any additional funds in the private placement, 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.
Abi |
