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Neurocrine Biosciences, Inc. Presents GnRH Small Molecule Orally Active Antagonist Program at International Research Meeting (PR Newswire)..., immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes....- Feb 08 7:32 AM ET

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Posted on: 02/08/2001

"Yahoo - Neurocrine Biosciences, Inc. Presents GnRH Small Molecule Orally Active Antagonist Program at International Research Meeting"
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Press Release

SOURCE: Neurocrine Biosciences, Inc.

Neurocrine Biosciences, Inc. Presents GnRH Small Molecule Orally Active Antagonist Program at International Research Meeting

Company Also Reports on Conference Call and Webcast Held To Summarize 2001 Expectations

SAN DIEGO, Feb. 8 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX - news) presented data on its GnRH small molecule antagonist program at the Sixth International Symposium on GnRH Analogues in Cancer and Human Reproduction in Geneva, Switzerland. In this presentation, Neurocrine scientists reported that they have developed potent orally active compounds for the modulation of gonadotropin releasing hormone (GnRH), a hormone that regulates key reproductive hormones. Neurocrine is evaluating these small molecule compounds in preclinical development for the treatment of certain reproductive disorders, such as endometriosis and prostate cancer. The Company expects to initiate Phase I clinical studies later this year.

"An orally active small molecule has a great potential to dominate the market place which is currently held by injectable peptides with annual worldwide sales in excess of $2 billion," said Gary Lyons, President & CEO.

Currently available GnRH agonists and antagonists are peptides, which generally are given as depots. Orally active GnRH small molecule antagonists should provide increased dosing flexibility and convenience over these current treatments. Using high throughput parallel synthesis of designed libraries combined with very early evaluation of pharmacokinetic (PK) properties, Neurocrine's approach has rapidly produced several patented series of potent compounds both in vitro and in vivo. Four advanced leads, all with molecular weights below 500 kilodaltons, are currently undergoing detailed preclinical evaluation and have high affinity for the human receptor with Ki's in the range 0.1 - 4 nM. They are stable when exposed to human liver homogenate. In macaques, the most studied compound is 30% orally bioavailable which projects into a >70% level for humans based on this and other PK data. In addition, clearance data would predict a half life in humans in excess of 6 hours. This same compound when given at 10 mg/kg orally to castrated macaques reduces leutinizing hormone (LH) levels by 40% and reduces testosterone to control levels -- both measures seen as convincing markers of efficacy. These compounds are scheduled to begin human clinical testing later this year. "These results support our continued research effort to design small molecule ligands, both agonists and antagonists, of G-protein coupled receptors, like the GnRH receptor, for the treatment of a variety of debilitating diseases," said Dr. John Saunders, Vice President Chemistry at Neurocrine Biosciences.

In a year-end conference call and Webcast held on Friday, February 2, 2001, members of senior management reviewed the Company's 2001 financial expectations and clinical development programs. Gary Lyons, President and CEO provided an overview of Neurocrine's objectives and upcoming 2001 milestones. The Webcast is being archived on the Company's website

Commenting on the Company's five clinical programs as well as the preclinical development program, Lyons stated, "We are on track or ahead on our milestones for the year 2001. I am pleased with the progress to date and with our goals and strategic plans clearly in place, I believe we will remain on target and continue to advance our programs into their next clinical phase."

    Neurocrine's upcoming 2001 milestones include:
    --  Completion of multiple Phase II clinical trials for insomnia leading
        to the initiation of Phase III clinical trials later in 2001;
    --  Initiation of a Phase I clinical trial for CRF in anxiety and
        depression as well as the selection of a backup compound ready for
        Phase I clinical trials by year's end;
    --  Initiating a Phase IIb trial with APL, NBI-5788, for multiple
        sclerosis with a corporate partner
    --  Initiating a Phase I/II clinical trial as well as two Phase II/III
        clinical trials with APL, NBI-6024,  in pediatrics and adults for Type
        I diabetes.
    --  The selection of a development compound and back-up compound for GnRH
        (Gonadotrophin-releasing hormone) for initiation into Phase I clinical
        trials in endometriosis, uterine fibroids and prostate cancer later in
        the year.
    --  Complete two research or development collaborations

Paul Hawran, Executive Vice President and CFO reviewed the year-end earnings and provided additional details for the Company's 2001 financial expectations. He noted that operating expenses would increase due to the expanding clinical and pre-clinical activity as the Company continues its drug development. However, the net operating expenses would be reduced significantly in the event of a new collaboration.

Dr. Bruce Campbell, Senior Vice President of Development reviewed the Company's clinical pipeline and provided a summary on each of the clinical programs. "It has been a very exciting year at Neurocrine and with our five clinical programs currently underway and the positive results demonstrated thus far, we continue to be optimistic with our clinical development progress."

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 through the Company's website via the Internet at

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 small molecule antagonist program and business and finances including, but not limited to, risk that the GnRH program will not successfully proceed to Phase I clinical trials or that in later stage clinical trials will not show that it is 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 Form 10K for the year ended December 31, 2000, as amended, the current form 10Q and its most recent registration statement, as filed with the Securities and Exchange Commission, 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.

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