Business Editors & Health/Medical Writers
BIOWIRE2K
SAN DIEGO--(BUSINESS WIRE)--Dec. 17, 2002
Cypress Bioscience Inc. (Nasdaq:CYPB) announced today results demonstrating that milnacipran, Cypress' lead drug candidate, preferentially blocks the reuptake of norepinephrine (NE) over that of serotonin (5-HT).
Dr. Mike Owens and Dr. Charles Nemeroff, both in the Department of Psychiatry at the Emory University School of Medicine, conducted the research.
Previous in vitro studies in rodent tissue-based assays have suggested that milnacipran is unique among clinically available dual reuptake inhibitors in preferentially blocking the reuptake of NE over that of 5-HT by approximately 2:1. This has led to the recent suggestion that this compound represents the first of a new class of non-tricyclic agents, the Norepinephrine Serotonin Reuptake Inhibitors (NSRI).
The goals of the present study were to assess milnacipran's binding and reuptake profile when using human monoamine transporters and to compare milnacipran to a variety of other antidepressant agents in these assays. The recent studies confirm that while milnacipran, duloxetine (Cymbalta(R), Eli Lilly, NYSE:LLY) and venlafaxine (Effexor(R), Wyeth, NYSE:WYE) all block the reuptake of serotonin (5-HT) and norepinephrine (NE) when tested using human monoamine transporters, only milnacipran preferentially blocks the reuptake of NE. In contrast, duloxetine and venlafaxine both preferentially block the reuptake of 5-HT, consistent with their classification as Serotonin Norepinephrine Reuptake Inhibitors (SNRIs).
Milnacipran's unique reuptake profile may make this compound particularly well suited to the treatment of chronic pain, as it affects multiple pain mechanisms in a manner similar to that seen with some tricyclic antidepressants (TCAs), a class of compounds that are known to be effective analgesics in multiple chronic pain conditions, including fibromyalgia syndrome. Therefore, milnacipran is expected to potentially replicate the analgesic effect of the TCAs, without the many side effects associated with TCA treatment because milnacipran is devoid of the pharmacology that make TCAs particularly difficult to tolerate.
Fibromyalgia Syndrome (FMS), the initial clinical target for milnacipran, is a condition characterized by chronic somatic pain. Earlier this month the company completed its Phase II clinical trial to evaluate milnacipran as a treatment for FMS. Preliminary results announced last week demonstrated that milnacipran-treated patients randomized to the twice a day dosing group (BID) showed statistically significant improvements in pain compared to those who received placebo. Of the 95 patients that had completed the trial as of the date of the analysis, 87 percent of all milnacipran-treated patients reported overall improvement, compared to 33 percent in the placebo group (p less than 0.001). Further, 36 percent of milnacipran BID-treated patients reported at least a 50 percent reduction in pain intensity, compared to 9 percent of patients who received placebo, a difference that was statistically significant (p=0.030, intent to treat analysis). In addition, milnacipran-treated patients showed significant improvements in fatigue and depressed mood. The company expects to announce the results of the trial in early 2003.
About Cypress Bioscience Inc.
Cypress is committed to be the innovator and commercial leader in providing products for the diagnosis and treatment of patients with Functional Somatic Syndromes, such as Fibromyalgia Syndrome, or FMS, and other related chronic pain and central nervous system disorders. In August 2001, Cypress licensed from Pierre Fabre Medicament its first product for clinical development, milnacipran. Milnacipran, the first of a new class of agents known as NSRIs, or Norepinephrine Serotonin Reuptake Inhibitors, shares a pharmacological profile with the tricyclic antidepressants (TCAs), considered the most effective drugs for treatment of FMS, while appearing to lack the side effects associated with the latter. Cypress recently completed a Phase II trial in which milnacipran is being evaluated as a potential treatment for FMS. 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 within the meaning of the Private Securities Litigation Reform Act of 1995 including statements about the potential of milnacipran to treat FMS. 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 the final results from the Phase II trail of milnacipran will be significantly different than the preliminary analysis, that we may not be able to successfully develop or market milnacipran or any other products for the treatment of FMS; that our clinical development plan or timeline for milnacipran may be delayed, including the final results of our Phase II clinical trial; that our current working capital will not allow us to execute our business plans into 2003; that we may encounter regulatory or other difficulties in the development of milnacipran for FMS; and that milnacipran may not significantly improve the treatment of FMS. 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.