NEW YORK, May 22 /PRNewswire-FirstCall/ -- Forest Laboratories, Inc.
(NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB) today announced
that preliminary top-line results from a 1,196 patient randomized, three
month, double-blind, placebo-controlled pivotal Phase III study demonstrate
statistically significant therapeutic effects of milnacipran as a treatment
of fibromyalgia syndrome. At this time the companies have only been able to
review initial top-line results and further analyses will be completed in
the coming weeks to examine the results in greater detail.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Preliminary Study Results
In the study, patients were randomized to receive either 200mg per day
of milnacipran (n=396), 100mg per day of milnacipran (n=399) or placebo
(n=401). The primary pre-defined endpoints of this trial were composite
responder assessments to evaluate either the treatment of the pain
associated with fibromyalgia syndrome or the overall treatment of
fibromyalgia syndrome. This composite responder analysis approach, which
requires a clinically meaningful improvement in multiple domains, captures
in one endpoint improvement in numerous symptoms which comprise this
syndrome.
The treatment of pain associated with fibromyalgia is assessed by
evaluating pain as measured by the Patient Experience Diary (PED), and the
overall impression of patient well being as measured by the Patient Global
Impression of Change (PGIC) for patients receiving either dose of
milnacipran compared to placebo. The difference between active doses and
placebo was assessed by a responder analysis with a responder defined as a
subject experiencing both a 30% or greater reduction in pain compared to
baseline as measured by a visual analog scale (VAS) and a self assessment
of his or her condition by the patient of either "much" or "very much"
improved compared to baseline.
The broader evaluation of treatment of fibromyalgia syndrome is
assessed by evaluating pain as measured by the Patient Experience Diary
(PED), the overall impression of patient well being as measured by the
Patient Global Impression of Change (PGIC) and an analysis of physical
function as measured by the SF-36 Physical Component Summary for patients
receiving either dose of milnacipran compared to placebo. The difference
between active doses and placebo was assessed by a responder analysis with
a responder defined as a subject meeting the criteria for the treatment of
pain associated with fibromyalgia and in addition showing improvement in
physical function as assessed by the SF-36 Physical Component Summary.
Treatment of Pain Associated with Fibromyalgia
This endpoint showed statistically significant improvement for
milnacipran compared to placebo for patients receiving 200 mg per day of
milnacipran (p=0.004) and for patients receiving 100 mg per day of
milnacipran (p=0.025).
These results were analyzed using the Baseline Observation Carried
Forward (BOCF) analysis, as agreed to with the U.S. Food and Drug
Administration (FDA).
Treatment of Fibromyalgia Syndrome
This endpoint also showed statistically significant improvement for
milnacipran compared to placebo for both the 200mg per day dose (p=0.015)
and 100mg per day dose (p=0.011) using the Baseline Observation Carried
Forward (BOCF) analysis. Results for both endpoints listed above were also
statistically significant when analyzed using a Last Observation Carried
Forward (LOCF) method.
Component Assessments
In addition, when analyzed according to the pre-specified analysis plan
both the pain and the PGIC components of the composite endpoint
individually achieved statistical significance in favor of milnacipran at
both doses and the SF-36 Physical Component Summary met statistical
significance at one dose.
Tolerability
Milnacipran was generally well tolerated, with the majority of patient
withdrawals occurring early in the trial. 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 American College 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 of this syndrome, there are no treatments
specifically approved for FMS in the United States or elsewhere and the
addressable patient population is not yet well established. For more
information about fibromyalgia, visit http://www.fmsresource.com.
About Cypress
Cypress is committed to be the innovator and leader in providing
products that improve the treatment of Functional Somatic Syndromes and
other central nervous system conditions, including fibromyalgia syndrome.
Cypress' strategy involves acquiring/in-licensing undervalued central
nervous system active compounds and developing them for new indications.
For more information about Cypress, please visit Cypress' web site at
http://www.cypressbio.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 Fibromyalgia
Syndrome and our planned NDA filing for 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 more detailed analysis of the trial
results may not be favorable or may lead to different conclusions; the FDA
may not accept our first Phase III clinical trial as one of the two pivotal
trials required for NDA approval, that upon further reflection that we may
determine not to submit an NDA in 2007, that we may not be able to protect
our milnacipran patent portfolio and that milnacipran may never be approved
as a drug by the FDA.
About Forest Laboratories and Its Products
Forest Laboratories (http://www.frx.com) is a US-based pharmaceutical company
dedicated to identifying, developing and delivering products that make a
positive difference in peoples' lives. Forest Laboratories' growing product
line includes Lexapro(R) (escitalopram oxalate), an SSRI indicated for
adults for the initial and maintenance treatment of major depressive
disorder and generalized anxiety disorder; 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, and Benicar*
HCT(R) (olmesartan medoxomil- hydrochlorothiazide), an angiotensin receptor
blocker and diuretic combination product, each indicated for the treatment
of hypertension; and Campral(R)* (acamprosate calcium), indicated in
combination with psychosocial support for the maintenance of abstinence
from alcohol in patients with alcohol dependence who are abstinent at
treatment initiation.
* Benicar is a registered trademark of Daiichi Sankyo, Inc., and Campral
is a registered trademark of Merck Sante s.a.s., subsidiary of Merck
KGaA, Darmstadt, Germany.
Except for the historical information contained herein, this release
contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the 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 Forest Laboratories' SEC reports, including the Company's Annual Report
on Form 10-K for the fiscal year ended March 31, 2006 and on Form 10-Q for
the periods ended June 30, 2006, September 30, 2006 and December 31, 2006.
SOURCE Forest Laboratories, Inc. and Cypress Bioscience, Inc.
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Related links:
http://www.frx.com
http://www.fmsresource.com http://www.cypressbio.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Sabrina Martucci-Johnson, Chief Financial
Officer or Mary Geison, Investor Relations, both of Cypress
Bioscience, Inc., +1-858-452-2323; or Charles E. Triano, Vice
President - Investor Relations, Forest Laboratories, Inc.,
+1-212-224-6714, or Charles.Triano@frx.com
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