NEW YORK and SAN DIEGO, Oct. 20 /PRNewswire-FirstCall/ -- Forest
Laboratories, Inc. (NYSE: FRX) and Cypress Bioscience, Inc. (Nasdaq: CYPB)
(the "Companies") today announced that the U.S. Food and Drug
Administration (FDA) has advised the Companies that it was not able to take
final action by the scheduled Prescription Drug User Fee Act action date of
October 18, 2008, on their New Drug Application for milnacipran, a
selective serotonin and norepinephrine reuptake inhibitor for the
management of fibromyalgia. The FDA has not requested any additional
information from the Companies but did indicate that a clinical data
question related to the NDA submission required confirmation. The FDA
indicated that their assessment could be completed in a matter of weeks,
but could not confirm specific timing. The FDA could not provide further
information as to the reason for the delay. The Companies continue to plan
for a first quarter 2009 product launch meeting.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
About Forest Laboratories
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company
with a long track record of building partnerships and developing and
marketing products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a wide
range of therapeutic areas. The company is headquartered in New York, NY.
To learn more about Forest Laboratories, visit http://www.FRX.com.
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
Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
About Cypress Bioscience
Cypress Bioscience, Inc. is developing therapeutics and personalized
medicine services, to facilitate improved and individualized patient care.
Cypress' goal is to address the evolving needs of specialist physicians and
their patients by identifying unmet medical needs in the areas of pain,
rheumatology, and physical medicine and rehabilitation, including
challenging disorders such as fibromyalgia and rheumatoid arthritis. We
intend to use this approach to improve patient care and create a unique
partnership with physicians.
For more information about Cypress, please visit the Company's 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, that the FDA review may be completed in a matter of weeks and
that Cypress continues to plan for a first quarter 2009 product launch
meeting 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,
milnacipran may not ever receive marketing approval from the FDA and even
if it does, that the FDA review may take longer than weeks to complete,
that the FDA may request additional information from Cypress and that the
milnacipran launch may be delayed such that it may not occur in the first
quarter of 2009.
SOURCE Forest Laboratories, Inc.; Cypress Bioscience, Inc.
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Related links:
http://www.cypressbio.com
http://www.FRX.com
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://www.prnewswire.com/comp/329163.html
CONTACT:
Forest Laboratories, Inc., Frank Murdolo,
Vice President - Investor Relations, +1-212-224-6714,
Frank.Murdolo@frx.com; or Cypress Bioscience, Inc., Michael
Hufford, Ph.D., Vice President - Corporate Development or Mary
Gieson, Investor Relations, +1-858-452-2323,
mgieson@cypressbio.com
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