SAN DIEGO, June 12 /PRNewswire-FirstCall/ -- Neurocrine Biosciences, Inc.
(Nasdaq: NBIX) announced today that they have resubmitted its New Drug
Application (NDA) for indiplon 5 mg and 10 mg capsules for the treatment of
insomnia in both adult and elderly patients to the U.S. Food and Drug
Administration (FDA). The resubmission is a complete response to the FDA's
May 15, 2006 approvable letter. The indiplon NDA resubmission is based on
analyses discussed with statistical, clinical and regulatory consultants. In
addition the Company has had interactions with the FDA regarding additional
analyses of data previously submitted on indiplon capsules.
"We are pleased to announce the resubmission of the NDA for indiplon
capsules and we look forward to working with the FDA in the review process of
our resubmission," said Gary A. Lyons, President and CEO of Neurocrine
Biosciences. "We believe that indiplon's unique profile can offer an effective
solution for those patients who need help getting to sleep or returning to
sleep after a nighttime awakening."
About Indiplon
Indiplon is a non-narcotic non-benzodiazapine agent that acts on a
specific site of the GABA-A receptor and potentiates the action of GABA. While
other drugs also act on this receptor, indiplon's mechanism is unique in that
it has been shown to bind more selectively to the specific subtype of GABA-A
receptors within the brain believed to be responsible for promoting sleep.
Indiplon was licensed from DOV Pharmaceutical in 1998.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company
focused on neurological and endocrine diseases and disorders. The product
candidates address some of the largest pharmaceutical markets in the world
including insomnia, anxiety, depression, endometriosis, irritable bowel
syndrome, pain, and diabetes. 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 as well as, risk
and uncertainties associated with the Company's indiplon program and planned
commercialization activities, including but not limited to; risk that
regulatory authorities may refuse to accept the filing of our resubmission of
the indiplon capsule NDA; risk that regulatory authorities may find our
resubmission of the indiplon capsule NDA incomplete or insufficient or
otherwise unapprovable or that approval may be delayed; risk that following
approval of indiplon capsules, commercialization may be delayed for any of a
number of reasons including market conditions and product supply; risk that we
will not be able to independently commercialize indiplon capsules or find a
marketing partner on reasonable terms or at all; risk that the indiplon
capsule labeling granted by regulatory authorities may limit the commercial
success of indiplon capsules; and risk relating to market acceptance of
indiplon capsules following marketing approval; in addition to the other risks
described in the Company's report on Form 10-K for the year ended December 31,
2006 and Form 10-Q for the quarter ended March 31, 2007. Neurocrine undertakes
no obligation to update the statements contained in this press release after
the date hereof.
SOURCE Neurocrine Biosciences, Inc.
06/12/2007
CONTACT: Investor Contacts, Elizabeth Foster or Timothy Coughlin, both
of Neurocrine Biosciences, +1-858-617-7600
Web site: http://www.neurocrine.com
(NBIX)