Indiplon
NBI-34060
Treatment for InsomniaNeurocrine Biosciences Announces Resubmission Status of Indiplon
The Company Also Announces Conference Call and Webcast to Present Fourth Quarter and Year-End 2004 Financial Results
SAN DIEGO, February 07, 2005 -- Neurocrine Biosciences (NASDAQ:NBIX) announced today that it completed its meeting with the FDA regarding the resubmission of its indiplon immediate release and modified release New Drug Applications (NDAs). The company announced that based on the January 26, 2005 meeting with the FDA, it is now expecting to resubmit the immediate release (IR) capsules NDA at end of 1st Quarter / beginning of the 2nd Quarter 2005, followed by the Modified Release (MR) tablets NDA also in the 2nd Quarter 2005.
"Our recent meeting with the FDA regarding the issues related to our NDA submissions was very productive and contained no surprises. The FDA reviewed our reformatting plans and agreed that such plans were sufficient to allow proper FDA navigation of the document. Based on this meeting, we are moving ahead to resubmit our electronic New Drug Applications (NDAs) as quickly as possible, said Gary Lyons, President & CEO of Neurocrine Biosciences. "We will take advantage of the timing of the resubmission of the MR NDA to also incorporate data from the recently completed MR clinical study (404) into the submission rather than amending the application during review. Results of the 404 modified release clinical study in adults with chronic insomnia will be released in mid February. During our fourth quarter conference call we will provide guidance to 2005 earnings and also answer questions relating to our recent regulatory discussions and activities to ensure continued progress toward launch."
Neurocrine Biosciences, Inc. also announced today that the Company will report fourth quarter and year-end 2004 financial results after the NASDAQ market closes on Thursday, February 10, 2005. Neurocrine will also host a live conference call and Webcast to discuss its year-end results and provide a Company update Thursday afternoon, February 10, 2005 at 4:30 PM Eastern Standard Time (EST) / 1:30 PM Pacific Standard Time (PST). The live Conference Call can be accessed by dialing 1-800-905-0392 (U.S.) or 785-832-0201 (International) and using the Conference ID# NBIX. The call can also be accessed via the Webcast through the Company's website at www.neurocrine.com.
If you are unable to attend the Webcast and would like further information on this announcement please contact Claudia Jones or Elizabeth Foster in the Investor Relations Department at Neurocrine Biosciences at 858-617-7600. A replay of the Conference Call will be available by dialing 1-800-839-3607 (US) or 402-220-2970 (International) and will be archived until Thursday, February 24, 2005.
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.
For more information, please visit www.neurocrine.com
Related Articles:
Neurocrine Receives Approvable Letter for Indiplon Capsules with Additional Safety and Efficacy Data Required by FDA - December 13, 2007
Neurocrine Announces PDUFA Action Date of December 12, 2007 for Indiplon Capsules - August 22, 2007
Neurocrine Announces Resubmission of New Drug Application for Indiplon Capsules - June 13, 2007
Neurocrine Reports Results of FDA End-of-Review Meeting on Indiplon Capsules NDA - September 5, 2006
Neurocrine Completes Review of Indiplon Action Letters - June 15, 2006
Neurocrine Receives Approvable Letter for indiplon Capsules and Non-Approvable for indiplon Tablets for the Treatment of Insomnia - May 16, 2006
Neurocrine Announces Acceptance of New Drug Application for Indiplon Tablets - July 26, 2005
Neurocrine Announces Acceptance of New Drug Application for Indiplon Capsules - June 14, 2005
Neurocrine Announces Submission of New Drug Application for Indiplon Tablets - May 26, 2005
Neurocrine Announces Submission of New Drug Application for Indiplon Capsules - April 14, 2005
Neurocrine Biosciences Announces Plans to Resubmit Indiplon Modified Release New Drug Application (NDA) - January 11, 2005
Indiplon IR NDA (New Drug Application) to Be Reformatted Due to Difficulties in Accessing Portions of the Electronic NDA - December 21, 2004
Neurocrine Submits New Drug Application (NDA) for Indiplon Modified Release Tablets for the Treatment of Insomnia - November 22, 2004
Neurocrine Submits New Drug Application (NDA) for Indiplon Immediate Release Capsules for the Treatment of Insomnia - October 19, 2004
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