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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 8-K
Current Report
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 16, 2001
Neurocrine Biosciences, Inc.
(Exact name of registrant as specified in its charter)
Delaware 0-28150 33-0525145
(State or Other (Commission File Number) (I.R.S. Employer
Jurisdiction of Incorporation) Identification No.)
10555 Science Center Drive, San Diego, California 92121
(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (858) 658-7600
This Current Report on Form 8-K is filed by Neurocrine Biosciences, Inc., a
Delaware corporation (the "Company"), in connection with the matters described
herein.
Item 5. Other Events.
On November 16, 2001, the Company announced that it has initiated the first
pivotal Phase III clinical trial of NBI-34060 in approximately 500 patients with
chronic (primary) insomnia. A copy of the Company's press release announcing the
initiation of the clinical trial, dated November 16, 2001, is attached hereto as
Exhibit 99.1 and incorporated herein by reference.
Item 7. Exhibits.
(c) Exhibits.
Exhibit
Number Description of Exhibit
------ ----------------------
99.1 Press Release, dated November 16, 2001.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: November 16, 2001 NEUROCRINE BIOSCIENCES, Inc.
By: /s/ PAUL W. HAWRAN
--------------------------
Paul W. Hawran
Senior Vice President and
Chief Financial Officer
FOR IMMEDIATE RELEASE
Contact at Neurocrine Biosciences
Elizabeth Foster or Paul Hawran
(858) 658-7600
Neurocrine Biosciences Initiates Phase III Clinical Trial for
NBI-34060 In Chronic (Primary) Insomnia
San Diego, CA, November 16, 2001-Neurocrine Biosciences, Inc. (NASDAQ:NBIX)
today announced that it has initiated the first pivotal Phase III clinical trial
of NBI-34060 in approximately 500 patients with chronic (primary) insomnia. The
Phase III clinical trial is a randomized, double blind, parallel-group,
multi-center study to evaluate the safety of two doses of NBI-34060 Immediate
Release (IR) for the long-term treatment of chronic (primary) insomnia in
adults. The trial will be conducted in approximately 40 medical sites in the
United States and Europe.
"This trial is a major turning point for Neurocrine as we begin our first Phase
III program in the history of the Company," said Gary A. Lyons, President and
CEO of Neurocrine Biosciences.
"Two additional pivotal Phase III trials with NBI-34060-IR are planned to
initiate shortly. We are implementing an aggressive Phase III clinical
evaluation of NBI-34060 to support registration of this new sedative hypnotic
for short-term and long-term treatment of insomnia," said Henry Pan, M.D. Ph.D,
Executive Vice President of Clinical Development and Chief Medical Officer for
Neurocrine Biosciences.
Background on NBI-34060 for Insomnia
- ------------------------------------
NBI-34060 is a non-benzodiazepine that acts on a specific site of the GABA-A
receptor. It is through this same mechanism that the non-benzodiazepine
therapeutics currently on the market produce their sleep-promoting effects.
Insomnia is a prevalent neurological disorder in the United States, with about
one-half of the adult population reporting trouble sleeping a few nights per
week or more, according to the National Sleep Foundation (NSF). Approximately
29% of the adult population reports that they experience insomnia every night or
almost every night. Despite this widespread prevalence, insomnia remains a
disorder with high unmet medical needs, including the ability to maintain sleep
throughout the night without next-day residual effects.
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, malignant brain tumors and peripheral
cancers, diabetes, multiple sclerosis, irritable bowel syndrome, eating
disorders, pain, stroke, and certain female health disorders. 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 contains 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 development programs and business and finances including, but not
limited to, risk that Neurocrine's development programs will not successfully
proceed through all phases of clinical trials or that in later stage clinical
trials will not show that Neurocrine's product candidates are effective in
treating humans; determinations by regulatory and governmental authorities;
uncertainties relating to patent protection and intellectual property rights of
third parties; impact of competitive products and technological changes;
availability of capital and cost of capital; and other material risks. A more
complete description of these risks can be found in the Company's Annual Form
10K for the year ended December 31, 2000, as amended, the quarterly report on
form 10Q for the quarter ended September 30, each of which should be read before
making any investment in Neurocrine common stock. Neurocrine undertakes no
obligation to update the statements contained in this press release after the
date hereof.
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