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Forest Laboratories, Inc. and Cypress Bioscience, Inc. Announce,Positive Results of Phase III Study for Milnacipran as a Treatment,for Fibromyalgia Syndrome

Overall premature discontinuation rates (all causes including adverse event related) were 35% for patients receiving 200mg per day of milnacipran, 34% for patients receiving 100mg per day of milnacipran and 28% for patients receiving placebo. The most common adverse events that led to early withdrawal among the milnacipran treated patients were nausea, palpitations, depression and headache, each of which occurred at a rate of less than 5%.

Future Development Plans

Subject to a favorable review of the full study results for the just completed trial and based in part on communication with the FDA, the Companies would plan to submit a New Drug Application (NDA) including data from this study and the first Phase III study for milnacipran around the end of 2007.

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 depression in over 32 countries and has been used safely by more than 5 million patients during more than seven 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 of Rheumatology, FMS is estimated to affect over six 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 o
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