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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
CURRENT REPORT
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Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of the earliest event reported): April 5, 2000
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
CALIFORNIA 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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ITEM 5. OTHER EVENTS
On April 5, 2000, Neurocrine Biosciences, Inc. announced that Janssen
Pharmaceutica, N.V. intends to substitute its lead CRF antagonist (R121919) with
a Neurocrine/Janssen back-up compound resulting from the expanded research
collaboration entered into during 1999. The decision to discontinue further
development of R121919 was based on observations of reversible increases in
liver enzymes in two volunteers participating in an expanded safety trial
conducted in the United Kingdom. Approximately 250 subjects to date have been
treated in various clinical trials with no other observed safety issues.
A copy of the press release issued by the Registrant on April 5, 2000
concerning the foregoing transactions are filed herewith as Exhibits 99.1 and is
incorporated herein by reference.
ITEM 7. FINANCIAL STATEMENTS, PRO-FORMA FINANCIAL INFORMATION AND EXHIBITS
(a) FINANCIAL STATEMENTS OF BUSINESS ACQUIRED. Not applicable.
(b) PRO-FORMA FINANCIAL INFORMATION. Not applicable.
(c) EXHIBITS. The following exhibits are filed herewith:
99.1 Press Release of Registrant, dated April 5, 2000,
announcing Janssen Pharmaceutica's replacement of R121919
with a back-up compound
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: 04/05/00 By:/s/ Paul W. Hawran
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Paul W. Hawran
Senior Vice President and Chief Financial Officer
(Principal Financial and Accounting Officer)
EXHIBIT INDEX
Exhibit Number Description
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99.1 Press Release of Registrant, dated April 5, 2000, announcing
Janssen Pharmaceutica's replacement of R121919 with a
back-up compound
EXHIBIT 99.1
FOR IMMEDIATE RELEASE:
Contact at Neurocrine Biosciences:
Claudia Jones or Paul Hawran
(858) 658-7600
NEUROCRINE ANNOUNCES THAT JANSSEN PHARMACEUTICA INTENDS TO REPLACE
R121919 WITH A BACK-UP COMPOUND
NEUROCRINE CRF PROGRAM ON TRACK FOR PHASE I TRIALS TO BEGIN 2ND HALF 2000
WITH UNPARTNERED CRF ANTAGONIST COMPOUND FOR ANXIETY/DEPRESSION
San Diego, CA, April 5, 2000 - Neurocrine Biosciences, Inc. (Nasdaq: NBIX)
announced today that Janssen Pharmaceutica intends to substitute its lead CRF
antagonist (R121919) with a Neurocrine/Janssen back-up compound resulting from
the expanded research collaboration entered in 1999. The decision to discontinue
further development of R121919 was based on observations of reversible increases
in liver enzymes in two volunteers participating in an expanded safety trial
conducted in the United Kingdom. Approximately 250 subjects to date have been
treated in various clinical trials with no other observed safety issues.
Separately, Neurocrine also confirmed that Phase I clinical trials are scheduled
to begin in the 2nd half of 2000 for its unpartnered CRF antagonist compound for
anxiety/depression.
"Janssen remains committed to the CRF technology. This technology continues to
be important to us," said Rolondo Gutierrez, M.D., Global Product Leader
Antidepressants and Anxiolytics of Janssen Pharmaceutica. "We have learned a
great deal about the CRF mechanism from our preclinical and clinical experience
with this compound. We believe this knowledge will help us to accelerate the
clinical development of future potential CRF antagonist compounds."
"Recently, considerable evidence from preclinical and clinical investigations
have provided even more support for the CRF hypothesis of depression," said
Charles Nemeroff, M.D., Ph.D., Chairman and Professor of the Department of
Psychiatry and Behavioral Sciences at Emory University School of Medicine. "One
piece of this expanding database is the promising results with the CRF1 receptor
antagonist, R121919. This safety issue which appears unrelated to the CRF
receptor mechanism unfortunately precludes further clinical development of this
compound. I have little doubt that this novel class of
antidepressants/anxiolytics will represent a breakthrough in the treatment of
these devastating disorders."
Neurocrine also confirmed today that the clinical development of its unpartnered
CRF antagonist compound for anxiety/depression is scheduled to begin human
clinical trials in the 2nd half 2000. This proprietary compound is from a novel
chemical series which is distinct from R121919. Based on preclinical studies the
Neurocrine proprietary compound has demonstrated improved specificity and
greater potency together with excellent pharmacokinetic properties.
"The results of an unrelated open label Phase IIa study conducted at the Max
Planck Institute have provided encouraging results regarding the validity of the
CRF mechanism as a potential therapeutic target for anxiety and depression,"
said Florian Holsboer, M.D., Ph.D., and Director at the Max Planck Institute fur
Psychiatrie in Munich, Germany. "There is no indication of a causal relationship
between the pharmacology of the compound and the safety concerns that have
arisen by the two volunteers in the expanded safety study in the United
Kingdom."
"While we are disappointed by these developments, the Janssen work has generated
valuable knowledge with respect to the CRF mechanism which will guide our future
development," said Gary Lyons, President & CEO. "In addition to our unpartnered
CRF program, our expanded collaboration with Janssen has produced multiple
back-up compounds from which the next series of clinical candidates will be
selected. We look forward to continuing and perhaps expanding our collaboration
with Janssen in this field."
CRF was first identified and cloned by Neurocrine co-founder, Dr. Wylie Vale and
his colleagues at the Salk Institute. Neurocrine holds the patent rights to the
CRF family of receptors and has developed multiple series of selective, potent,
small molecule antagonists for these receptors. CRF functions as a
neurotransmitter in the brain and plays a critical role in coordinating the
body's responses to stress. The CRF1 receptor subtype largely mediates these
effects. In preclinical models, selective CRF1 receptor antagonists block stress
responses providing evidence that this novel mechanism may result in improved
anti-anxiety and anti-depressant drugs. CRF1 antagonists have not shown evidence
of sexual dysfunction or addictive properties in preclinical models. In
addition, some data suggest that CRF1 antagonists may have a more rapid onset of
action compared to the currently marketed anti-depressants.
Including R121919, Neurocrine has now advanced five programs into clinical
trials. Neurocrine is conducting several Phase II trials with NBI-34060 for
insomnia, a Phase I/II with NBI 3001 for glioblastoma and a Phase I with NBI
6024 with Altered Peptide Ligand for Type I diabetes. In addition, as the
company has recently announced, Neurocrine is planning a Phase II clinical trial
of its APL compound for multiple sclerosis following positive results from an
earlier Phase II trial.
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 http://www.neurocrine.com.
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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 CRF antagonist development programs including, but
not limited to, risks and uncertainties associated with, or arising out of,
clinical development of products including risk that 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, 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, 1999. Neurocrine undertakes no obligation to update the statements contained
in this press release after the date hereof.
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