Forest Laboratories, Inc. and Cypress Bioscience, Inc. to Commence Third Milnacipran Phase III Trial
Forest Laboratories Inc. logo. (PRNewsFoto)
NEW YORK, NY USA 09/01/2004
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.
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.
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.
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
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
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
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
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.
SOURCE: Forest Laboratories, Inc.; Cypress Bioscience, Inc.
Web Site: http://www.frx.com http://www.cypressbio.com