FOR IMMEDIATE RELEASE: EXHIBIT 99.1
Claudia Jones or Elizabeth Foster
(858) 617-7600
NEUROCRINE BIOSCIENCES ANNOUNCES RESUBMISSION STATUS OF INDIPLON
THE COMPANY ALSO ANNOUNCES CONFERENCE CALL AND WEBCAST TO PRESENT FOURTH QUARTER
AND YEAR-END 2004 FINANCIAL RESULTS
San Diego, CA February 7, 2005 - Neurocrine Biosciences (NASDAQ: NBIX) announced
today that it completed its meeting with the FDA regarding the resubmission of
its indiplon immediate release and modified release New Drug Applications
(NDAs). The company announced that based on the January 26, 2005 meeting with
the FDA, it is now expecting to resubmit the immediate release (IR) capsules NDA
at end of 1st Quarter / beginning of the 2nd Quarter 2005, followed by the
Modified Release (MR) tablets NDA also in the 2nd Quarter 2005.
"Our recent meeting with the FDA regarding the issues related to our NDA
submissions was very productive and contained no surprises. The FDA reviewed our
reformatting plans and agreed that such plans were sufficient to allow proper
FDA navigation of the document. Based on this meeting, we are moving ahead to
resubmit our electronic New Drug Applications (NDAs) as quickly as possible,
said Gary Lyons, President & CEO of Neurocrine Biosciences. "We will take
advantage of the timing of the resubmission of the MR NDA to also incorporate
data from the recently completed MR clinical study (404) into the submission
rather than amending the application during review. Results of the 404 modified
release clinical study in adults with chronic insomnia will be released in mid
February. During our fourth quarter conference call we will provide guidance to
2005 earnings and also answer questions relating to our recent regulatory
discussions and activities to ensure continued progress toward launch."
Neurocrine Biosciences, Inc. also announced today that the Company will report
fourth quarter and year-end 2004 financial results after the NASDAQ market
closes on Thursday, February 10, 2005. Neurocrine will also host a live
conference call and Webcast to discuss its year-end results and provide a
Company update Thursday afternoon, February 10, 2005 at 4:30 PM Eastern Standard
Time (EST) / 1:30 PM Pacific Standard Time (PST). The live Conference Call can
be accessed by dialing 1-800-905-0392 (U.S.) or 785-832-0201 (International) and
using the Conference ID# NBIX. The call can also be accessed via the Webcast
through the Company's website at http://www.neurocrine.com or alternatively
through a link provided by PRNewswire at
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c=68817&event
ID=1011381
If you are unable to attend the Webcast and would like further information on
this announcement please contact Claudia Jones or Elizabeth Foster in the
Investor Relations Department at Neurocrine Biosciences at 858-617-7600. A
replay of the Conference Call will be available by dialing 1-800-839-3607 (US)
or 402-220-2970 (International) and will be archived until Thursday, February
24, 2005.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company
focused on neurological and endocrine diseases and disorders. Our product
candidates address some of the largest pharmaceutical markets in the world
including insomnia, anxiety, depression, diabetes, multiple sclerosis, irritable
bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine
Biosciences, Inc. news releases are available through the Company's website via
the Internet at http://www.neurocrine.com
In addition to historical facts, this press release may contain forward-looking
statements that involve a number of risks and uncertainties. Among the factors
that could cause actual results to differ materially from those indicated in the
forward looking statements are risks and uncertainties associated with
Neurocrine's business and finances in general including, but not limited to,
risk and uncertainties associated with the Company's indiplon program and
planned regulatory activities. Specifically, the risks and uncertainties the
Company faces with respect to its indiplon program include, but are not limited
to; risk that the Company will not be able to reformat the indiplon IR and/or MR
NDA within the Company's projected timelines; risk that the Company will be
unable to reformat the indiplon IR and/or MR NDA in a manner acceptable to the
FDA; the risk that regulatory authorities may reject our regulatory submissions
or find them incomplete or insufficient; risk that additional clinical studies
may be required to support submissions for regulatory approval; risk that the
indiplon labeling granted by regulatory authorities may limit the commercial
success of indiplon; risk relating to the Company's dependence on contract
manufacturers for clinical drug supply and compliance with regulatory
requirements for marketing approval; risks associated with the Company's
dependence on corporate collaborators for commercial manufacturing and marketing
and sales activities; uncertainties relating to patent protection and
intellectual property rights of third parties; risks and uncertainties relating
to competitive products and technological changes that may limit demand for the
Company's products; risk that the Company will be unable to raise additional
funding required to complete development of all of its product candidates; and
the other risks described in the Company's report on Form 10-K for the year
ended December 31, 2003 and most recent report on Form 10-Q filed for the
quarter ended, September 30, 2004. Neurocrine undertakes no obligation to update
the statements contained in this press release after the date hereof.
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