Dec. 6, 2001 – Cypress Bioscience Inc.(Nasdaq:CYPB – news) today announced that it recently filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to begin a Phase II clinical trial of milnacipran, its drug candidate for the treatment of fibromyalgia syndrome (FMS), a chronic pain disorder.
Pending normal FDA review, the company will commence clinical studies in
the first half of 2002.
“The filing of an IND for milnacipran represents a significant
achievement for Cypress in the development of therapies for the
treatment for FMS,” said Jay D. Kranzler, M.D., Ph.D., chairman and CEO
of Cypress. “Milnacipran is a dual action drug that is distinguished in
its ability to affect serotonin and norepinephrine – two neurotransmitters involved in modulating pain within the human body.
As increasing evidence suggests that modulation of more than one
transmitter is likely to be required for better efficacy in addressing
the pain associated with FMS, we believe that milnacipran could
significantly improve the treatment of this condition.”
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 percent of the population
worldwide and is the second most common diagnosis by rheumatologists in
the U.S. after osteoarthritis. Despite the high prevalence and severity
of this syndrome, today there are no approved treatments for FMS.
‘Currently, only about half of FMS patients are prescribed drugs for
pain management, since most available treatments have proven largely
ineffective,’ said Dr. Daniel Clauw, chief of the Division of Rheumatology, the Chronic Pain and Fatigue Research Center at Georgetown. “There have been few clinical trials performed for FMS – which is why Cypress’ efforts with milnacipran are so important.”
In August of this year Cypress licensed the North American rights to
develop and market milnacipran for the treatment of FMS and related
chronic pain syndromes. The license from Pierre Fabre Medicament (Pierre
Fabre), the pharmaceutical division of bioMerieux Pierre Fabre of Paris,
France also gives Cypress an option to expand the terms to include other
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
focusing on FMS. For more information about Cypress, please visit the
company’s Web site at http://www.cypressbio.com.
This press release, as well as Cypress’ SEC filings and Web site at
http://www.cypressbio.com, contain forward-looking statements 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 Cypress 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 the clinical development plan or timeline for milnacipran may not shortened; that we may not be able to obtain appropriate regulatory approvals to begin Phase II clinical trials of milnacipran in the first half of 2002; that milnacipran may not significantly improve the
treatment of FMS, that Cypress 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; that the sales
of the PROSORBA column may decrease; and that Cypress may not receive
any future royalties under its 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., Lisa Walters-Hoffert or Manda Hall at 858/452-2323