NEW YORK and SAN DIEGO, Dec. 31 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB)
announced that they have recently submitted a New Drug Application (NDA) to
the U.S. Food and Drug Administration (FDA) for milnacipran, a unique
dual-reuptake inhibitor being developed for the treatment of fibromyalgia
syndrome (FMS).
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
FMS is defined by widespread chronic pain, as well as a broad spectrum of
related symptoms including fatigue, cognitive dysfunction, and reduced
physical function. The NDA for milnacipran is based on a composite responder
analysis that requires each patient to experience concurrent and clinically
meaningful improvements in three validated measures: pain, patient global
impression of change in disease status, and physical function. This approach
is considered a more stringent assessment of therapeutic effect than the
evaluation of individual symptoms.
The submission includes efficacy data from two pivotal Phase III trials
involving 2,084 patients (1,460 milnacipran, 624 placebo), which showed that
milnacipran demonstrated improvement compared to placebo in treating FMS.
Moreover, safety data collected from 2,209 patients (1,557 milnacipran, 652
placebo) during the development program demonstrated that milnacipran was
generally well tolerated with the majority of adverse events reported as mild
to moderate in nature.
About Milnacipran
Milnacipran is a unique dual-reuptake inhibitor, which preferentially
blocks the reuptake of norepinephrine with higher potency than serotonin, two
neurotransmitters known to play an essential role in regulating pain and mood.
It has been approved for a non-pain condition in over 50 countries, with
real-world commercial experience outside the U.S. for 10 years. Milnacipran
is jointly being developed for fibromyalgia syndrome in the United States
market by Forest and its licensor, Cypress Bioscience, Inc. Milnacipran was
originally developed by and is sold outside of the U.S. by Pierre Fabre
Medicament.
About Fibromyalgia
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 limited treatment options specifically approved for FMS in
the United States or elsewhere, and the addressable patient population is not
yet well established.
About Forest Laboratories and Its Products
Forest Laboratories (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; 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, and Bystolic(TM) (nebivolol), a beta-adrenergic receptor blocking
agent indicated for the treatment of hypertension. In addition to our growing
product line, Forest also co-promotes the Daiichi Sankyo, Inc. products
Benicar(R)* (olmesartan medoxomil), an angiotensin receptor blocker, Benicar
HCT(R)* (olmesartan medoxomil-hydrochlorothiazide), an angiotensin receptor
blocker and diuretic combination product, and Azor(TM)* (amlodipine and
olmesartan medoxomil) a calcium channel blocker and angiotensin receptor
blocker combination product, all indicated for the treatment of hypertension.
*Azor is a trademark of Daiichi Sankyo, Inc.; Benicar and Benicar HCT are
registered trademarks 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 form time to time in the Forest
Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and
any subsequent SEC filings.
About Cypress
Cypress is committed to being an innovator and leader in providing
products for the treatment of patients with Fibromyalgia Syndrome. As part of
its business development strategy, the company evaluates a number of Proof of
Concept stage opportunities that leverage its repurposing experience and
innovative approach to clinical trial design and regulatory strategy, and
intend to continue to do this on an ongoing basis. The company continues to
evaluate various other potential strategic transactions, including the
potential acquisition of products, product candidates, technologies and
companies.
For more information about Cypress, please visit Cypress' website at
www.cypressbio.com.
This press release, as well as Cypress' SEC filings and website 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 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; that the NDA may not be accepted and even if
accepted by the FDA, that the NDA may not ultimately be approved by the FDA.
SOURCE Forest Laboratories, Inc.
CONTACT: Charles Triano, Vice President - Investor Relations, Forest
Laboratories, Inc., 1-212-224-6714, charles.triano@frx.com; or Michael
Hufford, VP Corporate Development, or Mary Gieson, Investor Relations,
mgieson@cypressbio.com, Cypress Bioscience, Inc, 1-858-452-2323
Web site: http://www.frx.com
http://www.cypressbio.com
(FRX CYPB)