Forest and Cypress Announce FDA Acceptance for Review of New Drug Application for Milnacipran for the Treatment of Fibromyalgia
February 21 2008 - 8:00AM
Marketwired
NEW YORK, NY and SAN DIEGO, CA and Cypress Bioscience, Inc.
(NASDAQ: CYPB) announced today that the U.S. Food and Drug
Administration (FDA) has accepted for review the New Drug
Application (NDA) for milnacipran for the treatment of
fibromyalgia. With a standard 10-month review timeline, the FDA
Prescription Drug User Fee Act (PDUFA) target action date is
expected to occur by the end of October 2008.
The Companies submitted their NDA for milnacipran for the
treatment of fibromyalgia syndrome based on results from a
composite responder analysis requiring that each patient
experienced concurrent and clinically meaningful improvements in
three validated measures: pain, patient global impression of change
in disease status, and physical function. The FDA advised that they
are moving toward class labeling for drugs used to treat
fibromyalgia, with any distinctions among therapies reflected in
specific product labels instead of differences in the approved
indications.
About Milnacipran
Milnacipran is a unique dual-reuptake inhibitor that
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 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. Fibromyalgia is defined by
widespread chronic pain, as well as a broad spectrum of related
symptoms including fatigue, cognitive dysfunction, and reduced
physical function.
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� (escitalopram
oxalate), an SSRI indicated for adults for the initial and
maintenance treatment of major depressive disorder and generalized
anxiety disorder; Namenda� (memantine HCl), an N-methyl D-aspartate
(NMDA)-receptor antagonist indicated for the treatment of moderate
to severe Alzheimer's disease; Campral�* (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�* (olmesartan medoxomil), an angiotensin
receptor blocker, Benicar HCT�* (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 from 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.
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 timing of the PDUFA target
action date, whether the FDA will implement class labeling for
drugs used to treat fibromyalgia, the potential of milnacipran to
treat fibromyalgia, the NDA filing for milnacipran and Cypress'
evaluation of potential strategic alternatives. 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 milnacipran trial results may not be
favorable or may lead to different conclusions; that the
milnacipran NDA may not be approved by the FDA or that the FDA's
review of the NDA could be delayed, 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.
Contacts: Charles Triano Vice President - Investor Relations
Forest Laboratories, Inc. Tel: (212) 224-6714 Email Contact Michael
Hufford, PhD Vice President, Corporate Development Cypress
Bioscience, Inc. Tel: (858) 452-2323 Email Contact
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