-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, RqaDqtLjMSBqTUlQKz3u8yBVk57h2Ngu1bxeun5Fuh60P45gpnB7uVDG5qgJKqPO uEVEYSxGi1z2hnhR9o7H7A== 0001104659-06-018405.txt : 20060322 0001104659-06-018405.hdr.sgml : 20060322 20060322091057 ACCESSION NUMBER: 0001104659-06-018405 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20060322 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20060322 DATE AS OF CHANGE: 20060322 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEPHALON INC CENTRAL INDEX KEY: 0000873364 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 232484489 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-19119 FILM NUMBER: 06702577 BUSINESS ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 BUSINESS PHONE: 6103440200 MAIL ADDRESS: STREET 1: 41 MOORES ROAD CITY: FRAZER STATE: PA ZIP: 19355 8-K 1 a06-7308_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

UNITED STATES

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 earliest event reported)  March 22, 2006

 

Cephalon, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

0-19119

 

23-2484489

(State or Other Jurisdiction
of Incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

 

 

 

 

41 Moores Rd.
Frazer, Pennsylvania

 

19355

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code   (610) 344-0200

 

Not Applicable

(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))

 

 


 

Item 7.01               Reulation FD Disclosure.

 

On March 22, 2006, the Psychopharmacologic Drugs Advisory Committee (“PDAC”) of the Food and Drug Administration (“FDA”) posted on the FDA website a briefing document with respect to Cephalon’s New Drug Application (“NDA”) for SPARLON™ (modafinil) (“SPARLON”) for the treatment of ADHD in children and adolescents between the ages of six through 17.

 

The briefing document, which will be reviewed by the PDAC at its meeting on March 23, 2006, details the chronology of events leading up to the issuance by the FDA of an approvable letter for SPARLON including the following notable events:

 

•      On September 26, 2006, the original clinical review of the NDA was completed by Glenn Mannheim, M.D., in the Division of Psychiatric Products (“DPP”) of the FDA. In this review Dr. Mannheim concluded that modafinil should not be approved for ADHD.

•      On October 12, 2005, Paul J. Andreason, M.D., the Acting Deputy Director of the DPP recommended an approvable action for modafinil for ADHD.

•      On October 19, 2005, Thomas P. Laughren, M.D., the Director of the DPP recommended an approvable action for modafinil for ADHD.

•      On October 20, 2005, the FDA issued an approvable letter to Cephalon for SPARLON, along with a proposal for labeling.

 

Cephalon has scheduled an investor conference call on March 23, 2006, beginning at 6:00 p.m. EST, to discuss the results of the PDAC meeting on March 23. The public may access a live webcast of the conference call from the Events page of the Investor Information section of Cephalon’s website (http://www.cephalon.com) by clicking on the link and following the prompts for registration and access.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

CEPHALON, INC.

 

 

 

 

Date: March 22, 2006

By:

/s/ J. Kevin Buchi

 

 

 

J. Kevin Buchi

 

 

Executive Vice President &
Chief Financial Officer

 

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