SAN DIEGO, July 9 /PRNewswire/ -- Neurocrine Biosciences (Nasdaq: NBIX)
announced today that it has signed an exclusive worldwide licensing agreement
with DOV Pharmaceuticals, Inc. for a compound in clinical development for the
treatment of insomnia. The compound, NBI-34060, works through the activation
of the benzodiazepine site on GABA receptors. It is through this mechanism
that the currently marketed benzodiazepines produce their sleep-promoting
effects. However, NBI-34060, a next generation compound, is chemically
distinct from the benzodiazepines with an improved pharmacokinetic profile and
receptor subtype selectivity, giving it the potential to reduce the side
effects characteristic of the currently marketed benzodiazepines. A Phase I
clinical trial evaluating NBI-34060 in normal patients indicated that
therapeutic doses appear to be safe and well tolerated with the most commonly
noted effect being drowsiness. Neurocrine plans to further evaluate NBI-34060
in a Phase Ib trial this year and to initiate comprehensive Phase II clinical
trials in 1999.
While the clinical efficacy of benzodiazepines has been established,
significant troublesome side effects are associated with this class of
compounds, including interaction with alcohol, development of rapid tolerance,
potential for abuse and withdrawal symptoms, next-day hangover effects, and
impairment of psychomotor performance and memory. Like the benzodiazepines,
NBI-34060 works through potentiation of the effects of the inhibitory
neurotransmitter GABA. However, it binds differentially to the GABA Type I
site, suggesting a more selective action. Preclinical and clinical studies
have generated data suggesting that NBI-34060 may produce a more rapid onset
of sleep and lack of next-day hangover effects compared to zolpidem
(Ambien(R)) and other currently marketed products. Similarly, studies have
also demonstrated that NBI-34060 has minimal interaction with alcohol and does
not produce rapid tolerance or amnesia at effective sleep promoting doses.
Under the terms of the licensing and development agreement, Neurocrine will
become the exclusive licensee of NBI-34060 for insomnia and all therapeutic
indications and will be responsible for worldwide development and
commercialization of this compound. Neurocrine has made an equity investment
in DOV Pharmaceutical and will pay milestones based upon attainment of certain
clinical development and regulatory accomplishments. DOV Pharmaceutical will
also receive royalties on the worldwide sales by Neurocrine of approved
products resulting from the collaboration.
"We are encouraged by the development potential of this next generation
compound for insomnia which works through a proven mechanism. NBI-34060 is an
excellent fit with our therapeutic pipeline. We will now have five compounds
in clinical development for CNS-related diseases and disorders," said Gary A.
Lyons, CEO and president of Neurocrine Biosciences, Inc.
"Considerable preclinical development and an initial Phase I study have
provided supportive evidence that NBI-34060 is a potent and rapid sleep-
promoter with improved pharmacokinetics over the current generations of
benzodiazepines. This indication has clear and well-defined clinical
endpoints, which will allow us to aggressively pursue the therapeutic
potential of this product," added Stephen G. Marcus M.D., senior vice
president, clinical and regulatory affairs and chief medical officer for
Neurocrine Biosciences.
DOV Pharmaceutical, Inc. is a drug development company whose primary strategic
goal is to license and further develop drugs that already have been advanced
to the clinical testing stage. DOV is currently developing several novel
pharmacotherapeutics in the areas of central nervous system and cardiovascular
diseases, where it has also developed a drug candidate using its own in-house
expertise.
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, Alzheimer's disease, Parkinson's disease, stroke,
traumatic brain injury, multiple sclerosis, obesity and diabetes.
Neurocrine Biosciences, Inc. news releases are available free of charge though
PR Newswire's Company News On-Call fax service. For a menu of Neurocrine's
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800-758-5804, ext. 604138, or use the Internet via http://www.prnewswire.com.
The statements in this press release that relate to the development of
NBI-34060 as a potential product by the Company, the expected dates of
initiation of such compound into clinical trials, and the potential efficacy
of such compound and potential reduction in side effects associated with such
compound are forward looking statements. Such forward looking statements
involve risks and uncertainties, including without limitation, that compounds
which demonstrate efficacy or limited side effects in pre-clinical studies may
not prove to be effective for treatment in humans, that development,
candidates which have progressed through pre-clinical and early stage clinical
trials will not successfully proceed through later stage clinical trials, that
the regulatory clearances required for clinical testing, manufacturing and
marketing of products may not be received in a timely manner, and the
potential adverse impact of competitive technologies and potential products.
For discussion of other risks and uncertainties potentially impacting the
Company's business, see the Company's form 10-K for the year ending December
31, 1997. Actual results and timing of certain events could differ materially
from those indicated in the forward looking statements as a result of these
and other factors.
SOURCE Neurocrine Biosciences, Inc.
CO: Neurocrine Biosciences, Inc.; DOV Pharmaceuticals, Inc.
ST: California
IN: MTC
SU: LIC
07/09/98 08:44 EDT http://www.prnewswire.com