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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of the earliest event reported): November 27, 2001
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 0-28150 33-0525145
(State or other (Commission File Number) (IRS Employer
jurisdiction of Identification Number)
incorporation)
10555 SCIENCE CENTER DRIVE, SAN DIEGO, CA 92121
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (858) 658-7600
N/A
(Former name or former address, if changed since last report.)
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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 27, 2001, the Company announced the dosing of seven subjects in
the initiation of a Phase I clinical trial with the Company's proprietary,
orally active, gonadotropin-releasing hormone antagonist. A copy of the
Company's press release announcing the initiation of the clinical trial, dated
November 27, 2001, is attached hereto as Exhibit 99.1 and incorporated herein by
reference.
ITEM 7. EXHIBITS
(c) Exhibits. The following exhibits are filed herewith:
Exhibit
Number Description of Exhibit
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99.1 Press Release, dated November 27, 2001.
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Dated: November 27, 2001 /s/ Paul W. Hawran
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Paul W. Hawran
Executive Vice President
and Chief Financial Officer
EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
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99.1 Press Release, dated November 27, 2001.
Exhibit 99.1
FOR IMMEDIATE RELEASE
Contact at Neurocrine Biosciences
Claudia Jones or Paul Hawran
(858) 658-7600
NEUROCRINE BIOSCIENCES ANNOUNCES INITIATION OF PHASE I
CLINICAL TRIAL WITH ORALLY ACTIVE GNRH
ANTAGONIST FOR WOMEN'S HEALTH DISORDERS AND
PROSTATE CANCER
San Diego, CA, November 27, 2001 - Neurocrine Biosciences, Inc. (NASDAQ:NBIX)
announced today the completion of dosing of the first cohort of seven subjects
in the Phase I clinical trial with the company's proprietary, orally active,
gonadotropin-releasing hormone (GnRH) antagonist. GnRH is a hormone that
regulates male and female reproductive hormones. Injectable peptide drugs that
block the action of GnRH have found broad clinical utility in women's health
disorders and prostate cancer in males. This trial is an oral single dose,
double-blind, placebo controlled, dose escalating Phase I study being conducted
in up to 56 normal, healthy volunteers and is designed to study the safety,
pharmacokinetics and pharmacodynamics of a number of doses of this compound. In
addition, secondary endpoints in the study will assess suppression of pituitary
gonadotropins; an important surrogate measurement of efficacy.
"This is an important milestone towards developing a potential new class of
drugs to compete in a $2.5 billion market in women's health and prostate
cancer," said Dr. Henry Pan, Executive Vice President of Clinical Development of
Neurocrine.
Currently available GnRH agonists and antagonists are peptides, which generally
are given as injectable depots. We believe orally active, non-peptide GnRH
antagonists should provide increased dosing flexibility, convenience and greater
patient acceptability over these current treatments. Using high throughput
parallel chemical synthesis of designed libraries, combined with preclinical
safety, pharmacokinetic (PK) and metabolic properties, Neurocrine's approach has
rapidly produced several series of proprietary highly potent, non-peptide
compounds.
"This program has moved very rapidly from basic research through preclinical
studies to Phase I clinical studies and continues to demonstrate the strength of
Neurocrine's integrated drug discovery and development capabilities," said Paul
Conlon, Vice-President of Biology.
-MORE-
Neurocrine recently announced the award of a peer-reviewed Phase II SBIR grant
from the National Institutes of Health (NIH) to fund the development of orally
active GnRH antagonists. This grant will total approximately $1 million over a
two-year period and will support research to discover and evaluate current and
next generation small molecule GnRH receptor antagonists for the treatment of
uterine fibroids, endometriosis, breast cancer, prostate cancer, infertility and
other disorders linked to the endocrine system.
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.
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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 GnRH development program and Neurocrine's business and finances
including, but not limited to, risk that Neurocrine's GnRH antagonist compounds
will not successfully proceed through clinical trials or that later stage
clinical trials will not show that they are effective in treating humans;
determinations by regulatory and governmental authorities; dependence on
corporate collaborators who could terminate their relationships with the Company
at any time; 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 report on Form 10K for the year ended December 31, 2000 and the
Company's quarterly report on Form 10Q 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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