Forest and Cypress Announce Submission of New Drug Application for Milnacipran for the Treatment of Fibromyalgia Syndrome
December 31 2007 - 7:05AM
PR Newswire (US)
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
(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; 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 http://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.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Forest Laboratories, Inc.
CONTACT: Charles Triano, Vice President - Investor Relations,
Forest Laboratories, Inc., +1-212-224-6714, ; or Michael Hufford,
VP Corporate Development, or Mary Gieson, Investor Relations, ,
Cypress Bioscience, Inc, +1-858-452-2323 Web site:
http://www.frx.com/ http://www.cypressbio.com/
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