Neurocrine Biosciences
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date
of Report (Date of the earliest event reported): June 22, 2006
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
(State or other
jurisdiction of
incorporation or
organization)
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0-22705
(Commission File
Number)
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33-0525145
(IRS Employer Identification
No.) |
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12790 El Camino Real
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92130 |
(Address of principal executive offices)
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(Zip Code) |
Registrants telephone number, including area code: (858) 617-7600
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 |
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CFR 240.14d-2 (b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 |
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CFR 240.13e-4 (c)) |
TABLE OF CONTENTS
Item
1.02 Termination of a Material Definitive Agreement
Neurocrine
Biosciences, Inc. announced today that Neurocrine and Pfizer have
agreed to terminate the collaboration agreement to develop and
co-promote indiplon. As a result, Neurocrine will reacquire all
worldwide rights for indiplon capsules and tablets and will
independently develop indiplon for approval and commercialization. As
part of the termination provisions of the agreement, Pfizer will
continue to support indiplon for a period of up to 180 days to ensure
a smooth transition.
Item 9.01 Financial Statements and Exhibits
99.1 Press
Release dated June 22, 2006
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.
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Dated: June 22, 2006 |
NEUROCRINE BIOSCIENCES, INC.
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/s/
MARGARET VALEUR-JENSEN
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Margaret Valeur-Jensen |
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Executive Vice President, General
Counsel |
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Neurocrine Biosciences
Exhibit 99.1
FOR IMMEDIATE RELEASE
Neurocrine Contacts:
Elizabeth Foster or Claudia Woodworth
(858) 617-7600
NEUROCRINE AND PFIZER TERMINATE COLLABORATION AGREEMENT FOR INDIPLON
San Diego,
CA, June 22, 2006 - Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that
Neurocrine and Pfizer have agreed to terminate the collaboration agreement to develop and
co-promote indiplon. As a result, Neurocrine will reacquire all worldwide rights for indiplon
capsules and tablets and will independently develop indiplon for approval and commercialization.
Neurocrine will meet with the Food and Drug Administration (FDA) to finalize development plans for
the resubmissions of each indiplon NDA and plans to commercialize indiplon as quickly as possible
upon approval. The Company plans to review various business and commercial alternatives to expedite
successful commercialization of indiplon. As part of the termination provisions of the agreement,
Pfizer will continue to support indiplon for a period of up to 180 days to ensure a smooth
transition.
While we are disappointed that we will not be working with Pfizer for the commercialization
of indiplon, Neurocrine is fully committed and prepared to develop and commercialize this product.
With the clinical, regulatory and commercial investment we have received from Pfizer coupled with
our experience in conducting the indiplon clinical development program, we are well-positioned to
complete development of this product to secure FDA approval and we anticipate a seamless transition
of responsibility, said Gary A. Lyons, President and CEO of Neurocrine Biosciences. Neurocrine
will reacquire full worldwide rights to this product which we believe has significant commercial
value and we will evaluate commercial alternatives throughout various worldwide markets once our
resubmissions have been made. We believe that full rights to indiplon, together with our R & D
pipeline which is advancing several Phase II products, provides additional value and partnering
opportunities, added Lyons.
In December 2002 Neurocrine entered into an exclusive worldwide collaboration agreement with Pfizer
to develop and commercialize indiplon.
Conference Call and Webcast Today at 5:30 PM Eastern Time
Neurocrine will host a live conference call and Webcast to discuss the plans for indiplon today at
5:30 PM Eastern Daylight Time (EDT)/ 2:30 PM Pacific Daylight Time (PDT). Participants may access
the live Conference Call by dialing 1-800-540-0559 (U.S.) or 785-832-1508 (International) and using
the Conference ID# Neuro. The call can also be accessed via the Webcast through Neurocrines
website at <http://www.neurocrine.com/> or through a link provided by PRNewswire at
<http://www.videonewswire.com/event.asp?id=34432>
Participants may also access a replay of the Conference Call approximately one hour after the
conclusion of the call by dialing 1-800-839-2461 (US) or 402-220-7219 (International). The call
will be archived until Thursday, July 6, 2006.
Neurocrine Biosciences, Inc. is a product-based biopharmaceutical company focused on neurological
and endocrine diseases and disorders. Our product candidates address some of the largest
pharmaceutical markets in the world including insomnia, anxiety, depression, diabetes, irritable
bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news
releases are available through the Companys website via the Internet at http://www.neurocrine.com
In addition to historical facts, this press release may contain forward-looking statements that
involve a number of risks and uncertainties relating to Neurocrines indiplon program that could
cause actual results to differ materially from those indicated in the forward-looking statements.
Specifically, the risks and uncertainties the Company faces with respect to its indiplon program
include, but are not limited to; risk that the Company will not be able to address issues and or
requests set forth in the action letters from the FDA in a timely manner; risk that the Company
will not be able to address issues and or requests set forth in the action letters from the FDA in
a manner acceptable to the FDA; the risk that FDA may reject any future indiplon regulatory filings
or find them incomplete or insufficient; risk that indiplon approval and subsequent
commercialization may be significantly delayed; risks relating to availability of capital; and the
other risks described in Neurocrines annual report on Form 10-K for the year ended December 31,
2005 and quarterly report on Form 10-Q for the quarter ended
March 31, 2006. Neurocrine undertakes
no obligation to update the statements contained in this press release after the date hereof.
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