-----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, KPe4CwAKO1rvF6vdKTP1YHE2mNcpVJxSySiRpX/KRLAlXDnXPIcw0NwpGeMB/03C nvuOS+/w6o+CHh142dAV0w== 0001104659-09-022770.txt : 20090406 0001104659-09-022770.hdr.sgml : 20090406 20090406134508 ACCESSION NUMBER: 0001104659-09-022770 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090406 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090406 DATE AS OF CHANGE: 20090406 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: 09734546 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 a09-9502_18k.htm 8-K

 

 

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)  April 6, 2009

 

Cephalon, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

0-19119

 

23-2484489

(State or Other Jurisdiction

 

(Commission

 

(IRS Employer

of Incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

41 Moores Road

 

 

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:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ 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 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 



 

Item 8.01                                             Other Events.

 

On April 6, 2009, Cephalon, Inc. (the “Company”) announced positive results from a phase three clinical trial of NUVIGIL® (armodafinil) Tablets [C-IV] as a treatment for excessive sleepiness associated with jet lag disorder.  Based on these findings, the Company will file a supplemental New Drug Application with the U.S. Food and Drug Administration to expand the indications for NUVIGIL during the third quarter of 2009.  The Company hereby incorporates by reference the press release dated April 6, 2009, attached hereto as Exhibit 99.1, and made a part of this Item 8.01.

 

Item 9.01               Financial Statements and Exhibits.

 

(d)

 

Exhibits.

 

 

 

 

 

Exhibit No.

 

Description of Document

 

 

99.1

 

Press Release dated April 6, 2009

 

2



 

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: April 6, 2009

By: 

/s/ Gerald J. Pappert

 

 

Gerald J. Pappert

 

 

Executive Vice President, General Counsel and Secretary

 

3



 

EXHIBIT INDEX

 

Exhibit

 

 

Number

 

Description

99.1

 

Press Release dated April 6, 2009

 

4


EX-99.1 2 a09-9502_1ex99d1.htm EX-99.1

Exhibit 99.1

 

For Immediate Release

 

Contacts:

 

Media:

 

Investor Relations:

Candace Steele

 

Chip Merritt

610-727-6231 (office)

 

610-738-6376 (office)

csteele@cephalon.com

 

cmerritt@cephalon.com

 

Cephalon Announces Positive Results from a

Phase Three Study of NUVIGIL in Jet Lag Disorder

 

Company to Submit a Supplemental New Drug Application to Expand the NUVIGIL® Label

 

FRAZER, Pa., April 6, 2009 — Cephalon, Inc. (NASDAQ: CEPH) today announced positive results from a phase three clinical trial of NUVIGIL® (armodafinil) Tablets [C-IV] as a treatment for excessive sleepiness associated with jet lag disorder.  Based on these findings, Cephalon® will file a supplemental New Drug Application with the U.S. Food and Drug Administration to expand the indications for NUVIGIL during the third quarter of this year.

 

The efficacy and safety of NUVIGIL as a potential treatment for acute excessive sleepiness associated with jet lag disorder were evaluated over the course of three days in a randomized, double-blind, placebo-controlled study of 427 healthy adults who had experienced jet lag symptoms during the previous five years.  Participants in the study traveled eastbound from the United States to France where they were then examined at a sleep facility.  Clinical efficacy was evaluated using two primary endpoints: an objective assessment — the Multiple Sleep Latency Test (MSLT), and a subjective assessment — the Patient Global Impression of Severity (PGI-S).  Patients taking NUVIGIL (150 mg) showed a statistically significant improvement over placebo as measured by the MSLT [p<0.0001] and the PGI-S [p<0.05].  The results of this study will be submitted for presentation at a future medical meeting.

 

“After flying the subjects over the Atlantic, we objectively evaluated those receiving placebo versus those receiving NUVIGIL,” said Dr. Lesley Russell, Chief Medical Officer and Executive Vice President at Cephalon. “We discovered that those on placebo were as excessively sleepy as narcoleptics and that the treatment effect for those on NUVIGIL was the largest we have seen to date.  We are pleased that this positive study will allow us to file our first sNDA for an acute use of NUVIGIL.”

 

NUVIGIL was generally well-tolerated in the study.  The adverse events reported in this study of acute use are consistent with chronic use in the current NUVIGIL label. The most common adverse events in the study, observed more frequently with NUVIGIL use, included headache, anxiety, nausea, palpitations and fatigue.

 



 

Jet lag disorder is an acute circadian rhythm sleep disorder that results from rapid travel across several time zones.  This disorder affects approximately 70 million American travelers annually and gradually resolves once a person adjusts to the new local time.

 

Circadian rhythm sleep disorders are disruptions in a person’s internal body clock, which controls sleep patterns.  When the internal body clock is disrupted, certain symptoms may develop affecting a person’s ability to sleep, stay awake and function normally. Circadian rhythm sleep disorders can be caused by many factors, including shift work, time zone changes and medications.

 

Cephalon is preparing to launch NUVIGIL, the longer-lasting isomer of modafinil, in the third quarter of 2009.  NUVIGIL is not approved for the treatment of jet lag disorder or its associated symptoms.  The U.S. Food and Drug Administration-approved prescribing information for NUVIGIL, including bolded warnings, is available at www.NUVIGIL.com.

 

About Cephalon, Inc.

 

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and commercialization of many unique products in four core therapeutic areas: central nervous system, inflammatory diseases, pain and oncology. A member of the Fortune 1000 and the S&P 500 Index, Cephalon currently employs approximately 3,000 people in the United States and Europe. U.S. sites include the company’s headquarters in Frazer, Pennsylvania, and offices, laboratories or manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota.

 

Cephalon has a growing presence in Europe, the Middle East and Africa.  The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris.  Key business units are located in England, Ireland, France, Germany, Italy, Spain, the Netherlands for the Benelux countries, and Poland for Eastern and Central European countries.  Cephalon Europe markets more than 30 products in four areas: central nervous system, pain, primary care and oncology.

 

The company’s proprietary products in the United States include: AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), TREANDA® (bendamustine hydrochloride) for Injection, FENTORA® (fentanyl buccal tablet) [C-II], PROVIGIL® (modafinil) Tablets [C-IV], TRISENOX® (arsenic trioxide) injection, GABITRIL® (tiagabine hydrochloride), NUVIGIL and ACTIQ® (oral transmucosal fentanyl citrate) (C-II).  The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.

 

# # #

 

In addition to historical facts or statements of current condition, this press release may contain forward-looking statements.  Forward-looking statements provide Cephalon’s current expectations or forecasts of future events.  These may include statements

 



 

regarding anticipated scientific progress on its research programs, development of potential pharmaceutical products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, sales and earnings guidance, and other statements regarding matters that are not historical facts.  You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning.  Cephalon’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, regulatory and political conditions affecting the biotechnology and pharmaceutical industries as well as more specific risks and uncertainties facing Cephalon such as those set forth in its reports on Form 8-K, 10-Q and 10-K filed with the U.S. Securities and Exchange Commission.  Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect.  Therefore, you should not rely on any such factors or forward-looking statements.  Furthermore, Cephalon does not intend to update publicly any forward-looking statement, except as required by law.  The Private Securities Litigation Reform Act of 1995 permits this discussion.

 


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