Cypress Bioscience, Inc., Forest Laboratories, Inc. and Pierre Fabre Medicament Announce Development and Marketing Agreement for
January 09 2004 - 11:03AM
PR Newswire (US)
Cypress Bioscience, Inc., Forest Laboratories, Inc. and Pierre
Fabre Medicament Announce Development and Marketing Agreement for
Milnacipran SAN DIEGO and NEW YORK, Jan. 9 /PRNewswire-FirstCall/
-- Cypress Bioscience, Inc. , Forest Laboratories, Inc. , and
Pierre Fabre Medicament announced today that the companies have
entered into an agreement for the development and marketing for
Cypress' product, milnacipran, licensed from the product's
originator, Pierre Fabre Medicament, for indications in the United
States market. Milnacipran is currently being evaluated in a Phase
III program sponsored by Cypress for the treatment of Fibromyalgia
Syndrome (FMS). Fibromyalgia is a frequent cause of chronic,
widespread pain and is estimated to affect six to twelve million
people in the United States. There are currently no products
approved for the treatment of FMS. (Logo:
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO ) (Logo:
http://www.newscom.com/cgi-bin/prnh/20040108/LAPHOTO1LOGO )
Specific terms of the transaction were not disclosed but the total
upfront and milestone payments to Cypress under the agreement could
be between $200 and $250 million. In addition Forest will pay
Cypress a royalty based on sales and will fund all continuing
development activities, which will be managed jointly by both
companies. Forest will be responsible for sales and marketing
activities, with Cypress having the option to co-promote up to 25
percent of the total physician details. Cypress holds two patents
covering the use of milnacipran for FMS, both expiring in 2021. As
a new compound in the United States, milnacipran also qualifies for
five years of marketing exclusivity upon marketing approval under
the Hatch-Waxman legislation. The current Phase III program, which
is designed to support registration of milnacipran for the
treatment of FMS in the U.S., is based on the results of a
controlled, randomized Phase II study with 125 FMS patients. Data
from the study demonstrated that milnacipran provided statistically
significant improvements in multiple measures of clinical pain and
many secondary symptoms, including fatigue, mood and patient global
status reports. The Phase III program consists of multiple
randomized, placebo controlled clinical trials. Enrollment in the
first study is underway and progressing on schedule at
approximately 30 clinical sites in the U.S. The study includes male
and female outpatients with a primary diagnosis of FMS who meet
other entry criteria. The Phase III program could possibly be
completed in 2006 and, if successful, a New Drug Application for
FMS could possibly be submitted later in that year. Howard Solomon,
Chairman and Chief Executive Officer of Forest, said: "We are
intrigued by the impressive results for the Phase II study of
milnacipran in FMS conducted by Cypress and its potential for other
pain syndromes. We are also impressed by the safe and successful
use of milnacipran in Europe where it has been developed and
marketed by Pierre Fabre Medicament as a dual-acting agent for
depression for several years." Mr. Solomon added: "We look forward
to working with Cypress on the further development of milnacipran
in the future." "Forest has distinguished itself as an outstanding
developer and marketer of novel drugs in its primary therapeutic
markets, which include central nervous system disorders and pain
management," commented Jay D. Kranzler, M.D., Ph.D., Chairman of
the Board and Chief Executive Officer of Cypress. "They are an
ideal partner for milnacipran." "Our activities with milnacipran
are an example of Cypress' corporate strategy to identify unmet
market opportunities and potentially valuable therapeutic compounds
acting on the central nervous system that could address these
needs," Dr. Kranzler noted. "We have used our medical, scientific,
and drug development expertise to plan and initiate the late-stage
clinical development of milnacipran and to establish a patent
position for the agent. We are optimistic about milnacipran's
future with Forest as a partner. The business deal allows Cypress
to share significantly in the continued research and development
activities, promotion of the product, and profits from product
sales. The agreement with Forest enhances our cash balance and
financial resources which we expect will help expedite our efforts
identifying, licensing and developing our next product candidate."
Jean Pierre Couzinier, MD, Chief Operating Officer of Pierre Fabre
Medicament said: "I am pleased with the finalization of this
agreement which is the perfect illustration of the Pierre Fabre
Medicament partnership strategy, as already implemented by the
success of milnacipran in Japan with our licensee Asahi-Kasei. I am
very confident that the combined capabilities of Forest and Cypress
will ensure the success of milnacipran in the United States." About
Milnacipran Milnacipran is a novel compound which exerts its effect
by inhibiting the reuptake of both norepinephrine and 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 22 countries and has been used safely by more than 2
million patients during more than six years of commercial
availability outside the U.S. About Fibromyalgia Fibromyalgia is
considered one of a group of related chronic pain syndromes
characterized by both physical and psychiatric symptoms that
include conditions such as irritable bowel syndrome (IBS), chronic
tension headache, non-cardiac chest pain, and certain types of
lower back pain. The use of milnacipran in these other chronic pain
syndromes may also be explored under the agreement with Forest. 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. For
more information about FMS, please visit
http://www.fmsresource.com/. About Cypress Bioscience, Inc. Cypress
is committed to be the innovator and commercial leader in providing
products for the treatment of patients with Functional Somatic
Syndromes, such as FMS, and other related chronic pain and central
nervous system disorders. In August 2001, Cypress licensed from
Pierre Fabre Medicament its first product for clinical development,
milnacipran. The license agreement provides Cypress with an
exclusive license to develop and sell any products with the
compound milnacipran as an active ingredient for any indication in
the United States and Canada. In October 2003, Cypress began
initiating its Phase III clinical trials for the use of milnacipran
as a potential treatment for FMS. For more information about
Cypress, please visit the Company's 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 FMS and other related
Functional Somatic Syndromes. 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. In addition, there is the risk that we may not be able to
successfully develop or market milnacipran or any other products
for the treatment of FMS and other related Functional Somatic
Syndromes, and, as a result, would not receive any milestone or
royalty payments from Forest Laboratories; that we may encounter
regulatory or other difficulties in the development of milnacipran
for FMS, including delays in completing Phase III trials or
submitting a New Drug Application by the end of 2006; that we may
not be able to protect our patents or proprietary technology; that
milnacipran may not significantly improve the treatment of FMS or
any other related Functional Somatic Syndrome; and that we may not
be successful in identifying, licensing and developing any
additional product candidates. Cypress undertakes no obligation to
revise or update these forward-looking statements to reflect events
or circumstances after the date of this press release, except as
required by law. About Forest Laboratories and Its Products Forest
Laboratories' growing line of products includes: Lexapro(R), an
SSRI antidepressant indicated for the initial and maintenance
treatment of major depressive disorder and Generalized Anxiety
Disorder; Celexa(R), an antidepressant; Namenda(TM), an N-methyl
D-aspartate (NMDA) receptor antagonist indicated for the treatment
of moderate to severe Alzheimer's disease; Tiazac(R), a once-daily
diltiazem, indicated for the treatment of angina and hypertension;
Benicar(R)*, an angiotensin receptor blocker indicated for the
treatment of hypertension; Benicar HCT, an angiotensin receptor
blocker and diuretic combination product indicated for the second-
line treatment of hypertension; and Aerobid(R), an inhaled steroid
indicated for the treatment of asthma. *Benicar(R) is a registered
trademark of Sankyo Pharma, Inc. Except for historical information
contained herein, this release contains "forward-looking
statements" within the meaning of the Private Securities Litigation
Reform Act of 1995. These statements are subject to risks and
uncertainties that affect our business, including 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, 2003, and Quarterly Reports on Form 10-Q for the periods
ending June 30, 2003, and September 30, 2003. Actual results may
differ materially from those projected. About Pierre Fabre
Medicament Pierre Fabre Medicament is dedicated to treating and
preventing disease by discovering and developing innovative
prescription drugs. In 2002, Pierre Fabre Group generated a
turnover of $1.4 billion and employed approximately 9,000 people
worldwide. Pierre Fabre Medicament dedicates 21% of its annual
turnover to R&D activities, in 5 therapeutic areas, decisive in
terms of public health: Central Nervous System, Oncology,
Cardiology, Internal Medicine/Urology and Dermatology.
http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://www.newscom.com/cgi-bin/prnh/20040108/LAPHOTO1LOGODATASOURCE:
Cypress Bioscience, Inc.; Forest Laboratories, Inc. CONTACT:
Sabrina Martucci Johnson, Chief Financial Officer, Mary Gieson,
Investor Relations, both of Cypress, +1-858-452-2323; Charles
Triano, Vice President - Investor Relations of Forest Laboratories,
+1-212-224-6714 Web site: http://www.frx.com/
http://www.fmsresource.com/ http://www.cypressbio.com/
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