NEW YORK and SAN DIEGO, Jan. 5 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. and Cypress Bioscience, Inc. today announced that they will initiate a third randomized, double-blind, placebo-controlled pivotal Phase III study evaluating milnacipran as a treatment for fibromyalgia (FMS) in the first quarter of 2006. In addition, the Companies announced that based on an analysis of the results from the first Phase III study, which was supportive of milnacipran’s effect in fibromyalgia patients, certain modifications have been made to the ongoing second Phase III study. These modifications include increasing the size of the second study from approximately 800 patients to 1,200 patients. Based on the anticipated time necessary to recruit the additional patients the Companies expect to announce initial results from the second Phase III study no earlier than mid-calendar 2007.
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About Milnacipran
Milnacipran is the first of a new class of agents known as norepinephrine serotonin reuptake inhibitors, or NSRIs, which exerts its effect by preferentially inhibiting the reuptake of norepinephrine over serotonin, two neurotransmitters known to play an essential role in regulating pain and mood. It has been approved for the treatment of non-pain indications in 32 countries and has been used safely by more than 3 million patients during more than six years of commercial availability outside the U.S. Milnacipran is being developed for fibromyalgia in the United States market jointly by Forest and its licensor, Cypress Biosciences, Inc.
About Fibromyalgia (FMS)
FMS is a chronic and debilitating condition characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. According to the American College of Rheumatology, FMS is estimated to affect six to twelve million people in the United States. FMS is most often diagnosed in the primary care setting and in addition is the second most commonly diagnosed condition in rheumatology clinics in the United States after osteoarthritis. Despite the high prevalence and severity of this syndrome, there are no treatments specifically approved for FMS in the United States or elsewhere. For more information about fibromyalgia, visit http://www.fmsresource.com.
About Cypress Biosciences, Inc.
Cypress is committed to be the innovator and leader in providing products that improve the treatment of Functional Somatic Syndromes, including Fibromyalgia Syndrome (FMS), and other Central Nervous System conditions, such as Obstructive Sleep Apnea (OSA). Cypress’ strategy involves acquiring/ in-licensing central nervous system active compounds and developing them for new indications.
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 and our continued development of milnacipran. 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, the most recent Quarterly Report on Form 10-Q and any subsequent SEC filings and including, but not limited to, that the FDA may not accept these trials as one of the two pivotal trials required for NDA approval, that we and Forest may elect not to continue development of milnacipran.
About Forest Laboratories, Inc.
Forest Laboratories’ growing line of products includes: Lexapro(R) (escitalopram oxalate), an SSRI antidepressant indicated for the initial and maintenance treatment of major depressive disorder and for generalized anxiety disorder in adults; Namenda(R)(memantine HCl), an N-methyl-D-aspartate (NMDA)- receptor antagonist indicated for the treatment of moderate to severe Alzheimer’s disease; Benicar(R)*(olmesartan medoxomil), an angiotensin receptor blocker indicated for the treatment of hypertension; Benicar HCT(R)(olmesartan medoxomil hydrochlorothiazide), an angiotensin receptor blocker and diuretic combination product indicated for the second-line treatment of hypertension; Campral(R)*(acamprosate calcium), a glutamate receptor modulator, indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation in combination with psychosocial support; and Combunox(TM)(Oxycodone HCl and Ibuprofen), an opioid and NSAID combination indicated for the short-term management of acute, moderate to severe pain. Further information is available at http://www.frx.com.
Except for the historical information contained herein, this release contains forward looking statements that involve a number of risks and uncertainties, including the difficulty of predicting FDA approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, the timely development and launch of new products and the risk factors listed from time to time in the Company’s SEC reports, including the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2005 and Quarterly filing on Form 10-Q for the period ended June 30, 2005 and quarterly reports on Form 10-Q for the periods ended June 30, 2005 and September 30, 2005. Actual results may differ materially from those projected.
* Benicar(R) is a registered trademark of Sankyo Pharma, Inc.;
and Campral(R) is a registered trademark under license from
Merck Sante s.a.s., subsidiary of Merck KGaA, Darmstadt, Germany.
Photo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGOForest Laboratories, Inc.; Cypress Bioscience, Inc.
CONTACT: Charles Triano, Vice President, Investor Relations of ForestLaboratories, Inc., +1-212-224-6714, charles.triano@frx.com; or SabrinaMartucci Johnson, Chief Financial Officer of Cypress Bioscience, Inc.,+1-858-452-2323 x131, sjohnson@CypressBio.com
