Biotech Values

[DewDiligence]

Forest Laboratories, Inc. and Cypress Bioscience, Inc. to Commence Third Milnacipran Phase III Trial

[FRX and CYPB are not giving up on fibromyalgia, but the timeline for a potential market launch has been pushed back substantially on account of the failure of the first phase-3 trial (#msg-7921554).

In our iHub calendar (#msg-9057037), I had previously inserted the word “maybe” as a qualifier to the old guidance from these companies that the second phase-3 fibromyalgia trial would report results in 3Q06. Indeed, this guidance has now been pushed back to mid 2007 because the second trial has been up-sized by 50% in order to increase the statistical power. An ultimate NDA would be based on the outcome of the *third* phase-3 trial, which is not yet underway. Hence, a potential NDA for Milnacipran in fibromyalgia appears to be a 2008-09 event at the earliest.

I’m actually surprised that FRX is committing more money to this program. If the decision were up to me, I wouldn’t do it.]

http://biz.yahoo.com/prnews/060105/nyth025.html?.v=39

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Thursday January 5, 8:12 am ET

NEW YORK and SAN DIEGO, Jan. 5 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc. (NYSE: FRX ) and Cypress Bioscience, Inc. (Nasdaq: CYPB ) 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.

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.
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