insomnia.....
anxiety/depression......
Monday November 29, 5:40 pm Eastern Time
Company Press Release
SOURCE: Neurocrine Biosciences, Inc.
Neurocrine Biosciences, Inc. Reports Positive Phase II
Results With New Insomnia Drug
SAN DIEGO, Nov. 29 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - news) today announced results from
a Phase II clinical trial demonstrating that NBI-34060 is a robust sedative hypnotic as demonstrated by a highly statistically
significant and clinically relevant effect in inducing sleep when compared to placebo. These data confirm that NBI-34060 is safe
and effective in helping subjects with transient insomnia achieve rapid sleep induction without next day residual effects
associated with most currently marketed sleep hypnotics.
The results indicate statistical significance was reached for the primary clinical endpoint (Latency to Persistent Sleep-LPS), the
required regulatory endpoint for approval. In this study, which enrolled 228 transient insomnia subjects, those subjects receiving
NBI-34060 the mean time to LPS was 16 minutes compared to 34 minutes in the placebo group (p less than .001). In
addition, the data indicated that a majority of subjects in the treated group fell asleep within 9 minutes as indicated by the
median time to LPS as compared to 23 minutes in the placebo group.
''An ideal sedative does not exist in the market today,'' said Dr. Thomas Roth, Chief, Division Head, Sleep Disorders and
Research Center, Henry Ford Hospital. ''By successfully combining efficacy (on multiple measures) with safety (low side
effects, hangover, abuse liability), NBI-34060 will address the market need expressed by both physicians and consumers for
an ideal sedative.''
The Phase II clinical trial was a randomized-double blinded placebo controlled, multi-center Phase II clinical trial of
NBI-34060 in 228 subjects with transient insomnia. The study was conducted in a sleep laboratory setting employing objective
polysomnographic assessments. The safety findings indicate that NBI-34060 was safe and well tolerated at doses up to 30 mg.
There were no serious adverse events reported in this clinical trial. Overall there was a low incidence of adverse effects which
was comparable to that observed in the placebo group with no residual next day hangover effects.
''We are pleased with these robust efficacy findings. By successfully combining better efficacy and safety, we believe
NBI-34060 will become the first choice for treating insomnia by prescribing physicians and those who suffer from insomnia,''
said Gary A. Lyons, President and Chief Executive Officer of Neurocrine Biosciences. ''These results confirm that NBI-34060
has the potential to compete effectively in the $1 billion sleep hypnotic market.''
Lyons added that ''Neurocrine is moving rapidly to expand clinical development of NBI-34060 and plans to initiate a
dose-response, randomized-placebo controlled, multi-center Phase II study in over 550 subjects in the 2nd Quarter 2000.
These studies will be conducted in subjects with chronic insomnia and will include other subject sub-groups. Neurocrine is also
designing a large scale pivotal Phase III program in more than 1500 subjects scheduled to begin in late 2000.''
In addition at an investor conference this week, Florian Holsboer, M.D., PhD of the Max Planck Institute for Psychiatry in
Germany presented preliminary safety and efficacy results on 20 subjects in an open-label Phase II study with a CRF receptor
antagonist (R121919/NBI-30775). This compound is being developed by Neurocrine and Janssen Pharmaceutica for
anxiety/depression. Results indicated a statistically significant improvement in widely accepted measures of anxiety and
depression. Comprehensive findings from this trial will be finalized and Dr. Holsboer will present a full analysis in early 2000.
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,
insomnia, stroke, malignant brain tumors, 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 previous releases, or to receive a specific release via fax call: (800) 758-5804, ext.
604138, or use the Internet via prnewswire.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 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 the year ended December 31, 1998 and the current 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.
SOURCE: Neurocrine Biosciences, Inc. |
