Tuesday March 14, 7:30 am Eastern Time
Company Press Release
SOURCE: Neurocrine Biosciences, Inc.
Neurocrine Biosciences, Inc. Announces Small
Molecule GnRH Antagonist Program Targeting Women's Health
Program Awarded National Institutes of Health (NIH) Grant
SAN DIEGO, March 14 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - news) announced today that the
Neurocrine GnRH small molecule antagonist program has accomplished two significant milestones. The company announced
that it has developed small molecule GnRH antagonist compounds for the treatment of endometriosis, uterine fibroids,
prostate/breast cancer and other related diseases and plans to be in human clinical trials within one year. In addition, the
company has been awarded an NIH Phase I grant supporting Neurocrine's research and development efforts. In contrast to
currently marketed GnRH peptide agonists which must be administered via depot injection, such as Lupron(TM) and
Zoladex(TM), Neurocrine's GnRH program is focused on the development of orally active small molecule GnRH antagonists.
In addition to the obvious advantages of oral vs. injectable therapy, antagonism of GnRH has been shown it leads to a more
rapid suppression of gonadotropins without the flare associated with agonists. Currently marketed GnRH peptides that treat a
variety of indications where shutdown or partial inhibition of the reproductive endocrine system is beneficial, generate annual
sales in excess of $1.5 billion. These indications include uterine fibroids, endometriosis, prostate cancer, breast cancer and
assisted reproductive therapy among others.
GnRH is a ten amino acid peptide whose principal action is to stimulate the secretion of the pituitary gonadotropins. The
gonadotropins, in turn, regulate steroid production and gametogenesis in the gonads. Peptide drugs that mimic or inhibit the
action of GnRH have proven extremely useful in regulating the hypothalamic-pituitary-gonadal axis and are now routinely used
for medical oophorectomy and in a variety of assisted reproductive therapy approaches. Small molecule, orally active GnRH
antagonists may provide substantial advantages over existing peptide drugs.
``The GnRH program represents a natural progression of the company's broad research platform enabling the rapid
development of small molecule antagonists against G-protein coupled receptors (GPCR),' said Wylie Vale, Professor, The
Salk Institute of La Jolla and co-founder of Neurocrine, a leading researcher in neuropeptides, including CRF and GnRH.
``Neurocrine researchers have repeatedly demonstrated their ability to develop GPCR ligands that show promise for the
treatment of a number of central nervous, immune and endocrine systems disorders,' said Vale. ``This particular project builds
upon the in-house biological expertise of Dr. Nick Ling, Senior Director Peptide Chemistry, who had worked on the original
isolation and characterization of the GnRH peptide in the laboratory of Nobel laureate, Dr. Roger Guillemin.' Dr. Ling is a
recipient of the 1994 Sydney H. Ingbar Distinguish Service Award in the Field of Endocrinology given by The Endocrine
Society and co-authored over 450 papers during his distinguished career.
Neurocrine scientists, led by project leader Dr. Scott Struthers, using the Company's GPCR focused, high throughput synthesis
and biological assay technologies, have rapidly developed multiple families of potent small molecule antagonists with high affinity
for the human receptor.
``This is yet another example of the strength of Neurocrine's core GPCR platform. The GnRH program capitalizes on this
platform and the power of the integrated research and development approach underlying Neurocrine's programs. We feel that
receipt of the NIH award provides peer review validation of the program as well as funding through outside sources,' said Paul
W. Hawran, Senior Vice President and CFO. ``We expect to bring a small molecule GnRH antagonist compound into clinical
trials in 2001.'
Neurocrine Biosciences is a leading neuroscience company focused on the discovery and development of novel therapeutics for
neuropsychiatric, neuroinflammatory and neurodegenerative diseases and disorders. The Company's neuroscience, endocrine
and immunology disciplines provide a unique biological understanding of the molecular interaction between central nervous,
immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, insomnia, stroke,
malignant brain tumors, multiple sclerosis, obesity and diabetes.
Neurocrine Biosciences, Inc. news releases are available free of charge through PR Newswire's Company News On-Call fax
service. For a menu of Neurocrine's previous releases, or to receive a specific release via fax call: (800) 758-5804, ext.
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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 research and development programs and business and
finances including, but not limited to, risks and uncertainties associated with, or arising out of, drug discovery, pre-clinical and
clinical development of products including risk that research may not generate development candidates, development
candidates will not successfully proceed through early clinical trials or that in later stage clinical trials will not show that they are
effective in treating humans; determinations by regulatory and governmental authorities; changes in relationships with strategic
partners and dependence upon strategic partners for performance of clinical and commercialization activities under
collaborative agreements including potential for any collaboration agreement to be terminated without any product success;
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 Form 10K for December 31, 1998. Neurocrine undertakes no obligation to update the
statements contained in this press release after the date hereof.
SOURCE: Neurocrine Biosciences, Inc. |
