Cypress Bioscience Launches Phase II Program for Milnacipran in the Treatment of Fibromyalgia Syndrome


SAN DIEGO--(BW HealthWire)--Feb. 25, 2002--Cypress Bioscience, Inc. (Nasdaq:CYPB) today announced that it has launched its Phase II clinical development program for milnacipran, a drug candidate for the treatment of fibromyalgia syndrome (FMS).

Fifteen physician practices across the United States were represented at the Investigator Meeting that took place this past weekend in San Diego, California. The participating sites are a mix of large community-based rheumatology practices and academic medical centers, including The Cleveland Clinic, and The Hospital for Special Surgery in NY. Patient recruitment into the trial is expected to begin in March, with a goal of enrolling approximately 200 patients by the end of the year.

Cypress' trial is distinguished from previous trials by the novel assessment tools that have been developed by the Company to be incorporated into the study design. For example, it is known that FMS patients suffer from widespread spontaneous pain, while also having a lower threshold for "evoked" pain in response to an unpleasant stimulus. Therefore, both spontaneous and evoked pain will be measured throughout the trial, and Cypress has developed improved methodologies for testing each. To measure spontaneous pain, the Company has worked with invivodata, inc.(TM) to develop an electronic patient experience diary system to collect patient-reported real-time data to improve the quality of the information. For evoked pain assessment, Cypress has designed and validated an instrument -- the Automated Pain Threshold Tester (APT(2)) -- to automate and standardize the testing. During the recent Investigator Meeting, site representatives were trained on these new methodologies.

"By adding a level of analytic rigor to the assessment of pain in FMS patients, Cypress is positioned to both improve the outcomes of its ongoing clinical trials, while also making a significant contribution to the field as a whole. Cypress' innovative tools may become a standard for characterizing pain in a wide variety of pain syndromes," said Daniel J. Clauw, MD, Director, Georgetown Chronic Pain and Fatigue Research Center, a noted expert in the study of FMS and related disorders.

FMS is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue and headache. It affects an estimated 2%-4% of the population worldwide and is the second most common diagnosis by rheumatologists in the United States, after osteoarthritis. Despite the high prevalence and severity of this syndrome, there are no approved treatments specifically for FMS in the United States or elsewhere.

"The drugs commonly used for FMS are at best palliative or are limited in efficacy due to dose limiting side effects," stated Philip Mease, M.D., of the Swedish Medical Center, Division of Clinical Research in Seattle, Washington, and an investigator in the Phase II trial. "Milnacipran, the first of a new class of agents known as NSRI's, or Norepinephrine Serotonin Reuptake Inhibitors, acts on the two key neurotransmitters in the human body which are involved with the central modulation of chronic pain. With its unique pharmacology, the compound has the potential to provide relief of FMS symptoms by acting on more than one pain pathway. Furthermore, the fact that milnacipran has little activity at other receptor systems should result in a favorable side-effect profile."

Cypress licensed the North American rights to develop and market milnacipran for the treatment of FMS and related chronic pain syndromes from Pierre Fabre Medicament (Pierre Fabre), the pharmaceutical division of bioMerieux Pierre Fabre of Paris, France. The license also gives Cypress an option to expand the field of use to include other indications.

About Cypress Bioscience, Inc.

Cypress is committed to be the innovator and commercial leader in providing products that improve the diagnosis and treatment of patients with FMS. In January 2001, the Company began a strategic initiative focused on FMS. In August 2001, Cypress licensed its first product for clinical development, milnacipran, to treat the widespread pain associated with FMS. In January of 2002, the Company's Initial New Drug Application (IND) was opened to commence a Phase II clinical trial to treat FMS with milnacipran in the United States. Milnacipran, the first of a new class of agents known as NSRI's, or Norepinephrine Serotonin Reuptake Inhibitors, shares a pharmacological profile with the tricyclic antidepressants (TCAs), considered the most effective drugs for treatment of FMS, while lacking the side effects associated with the latter. For more information about Cypress, please visit the Company's web site at www.cypressbio.com. For more information about FMS, please visit www.FMSresource.com.
This press release, as well as Cypress' SEC filings and web site at http://www.cypressbio.com, contain forward-looking statements, including statements about future clinical trials for milnacipran and the potential of milnacipran in treating FMS, within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could vary materially from those described as a result of a number of factors, including those set forth in Cypress Annual Report on Form 10-K and any subsequent SEC filings. In addition, there is the risk that we may not begin our clinical trials for milnacipran in March 2002, that we may not be able to successfully develop or market any products for the treatment of FMS under the Pierre Fabre agreement or at all; that our clinical development plan or timeline for milnacipran may be delayed, including our plan to begin treating patients in a Phase II clinical trial in early 2002; that we may encounter regulatory or other difficulties in the development of milnacipran for FMS; that milnacipran may not significantly improve the treatment of FMS, that we will not be successful in identifying or developing products under the Georgetown agreement; that Fresenius may not be able to successfully market the PROSORBA column; and that we may not receive any future royalties under our revised agreement with Fresenius. Cypress undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

CONTACT:

Cypress Bioscience, Inc.

Sabrina Martucci Johnson, 858/452-2323 (CFO)

Manda Hall, 858/452-2323 (IR Administrator)