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Neurocrine Biosciences, Inc.
Table of Contents

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): July 26, 2005

NEUROCRINE BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)
         
Delaware   0-22705   33-0525145
(State or other
jurisdiction of
incorporation or
organization) 		  (Commission File
Number) 		  (IRS Employer Identification No.)
         
12790 El Camino Real
   92130
(Address of principal executive offices)
   (Zip Code)

Registrant’s 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:

     
o
  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
    
o
  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
    
o
  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2 (b))
 
    
o
  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4 (c))

 

TABLE OF CONTENTS

ITEM 8.01 OTHER EVENTS.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
SIGNATURES
EXHIBIT 99.1

Table of Contents

ITEM 8.01 OTHER EVENTS.

     On July 26, 2005 Neurocrine Biosciences, Inc. announced that the U.S. Food and Drug Administration had accepted its new drug application for indiplon tablets for review for the treatment of insomnia. The full text of the press release issued with this announcement is filed as Exhibit 99.1 to this Current Report on Form 8-K.

ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.

     (c) EXHIBITS. The following exhibits are filed herewith:

     
Exhibit    
Number
   Description of Exhibit
99.1
  Press Release dated July 26, 2005

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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: July 27, 2005  NEUROCRINE BIOSCIENCES, INC.
 		  
  /s/ PAUL W. HAWRAN    
  Paul W. Hawran   
  Executive Vice President and Chief Financial Officer   
 

2

Exhibit 99.1
 

Exhibit 99.1
Investor Contacts:
Elizabeth Foster or Claudia Jones of Neurocrine Biosciences
(858) 617-7600
Media Contact: Liz Frank of Cohn & Wolfe
(212) 798-9734
NEUROCRINE ANNOUNCES ACCEPTANCE OF NEW DRUG APPLICATION
FOR INDIPLON TABLETS
Indiplon NDA Filing Process Complete – Both Capsule and Tablet Filings Now Under Formal Review
San Diego, CA, July 26, 2005 — Neurocrine Biosciences, Inc. (NASDAQ:NBIX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for indiplon tablets for review for the treatment of insomnia in both adult and elderly patients.
“This is an exciting milestone for Neurocrine and represents the company’s first completed NDA filing,” said Gary A. Lyons, President and CEO of Neurocrine Biosciences. “Data from these two submissions is supported by one of the most comprehensive clinical trial programs in insomnia and demonstrates the long-term safety and efficacy profile of indiplon in helping patients with sleep onset and sleep maintenance problems.”
Indiplon is a unique non-narcotic, non-benzodiazepine agent that acts on a specific site of the GABA-A receptor. Indiplon has been shown to bind selectively to the specific subtype of GABA-A receptors within the brain believed to be responsible for promoting sleep. Indiplon was developed to address different types of sleep problems. Upon approval, indiplon will be copromoted in the US with Pfizer.
Insomnia is a prevalent condition in the United States. According to the National Sleep Foundation’s (NSF) Sleep in America Poll 2005 approximately half of America’s adults report that they experienced at least one symptom of insomnia a few nights a week or more in the past year. Sleep loss has been found to impair the ability to perform tasks involving memory, learning, and logical reasoning, yet few people understand the importance of sufficient sleep.
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, multiple sclerosis, irritable bowel syndrome, eating disorders, pain, and autoimmunity. Neurocrine Biosciences, Inc. news releases are available through the Company’s 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. 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 business and finances in general including, but not limited to, risk and uncertainties associated with the Company’s indiplon program and planned regulatory activities including, but not limited to; risk that regulatory authorities find our regulatory submissions incomplete or insufficient or otherwise unapprovable; and the other risks described in the Company’s report on Form 10-K for the year ended December 31, 2004 and report on Form 10-Q for the quarter ended March 31, 2005. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.
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