-----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, BWbHqyFsA4XwrV37VM/k4yKcNE4j0gxXPBN9Ndf/VVSLtT1/yg9FMWUpwpRiiIP6 fAJkrjfqVJimKug2DVum9Q== 0001104659-09-056154.txt : 20090924 0001104659-09-056154.hdr.sgml : 20090924 20090924160640 ACCESSION NUMBER: 0001104659-09-056154 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20090924 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090924 DATE AS OF CHANGE: 20090924 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: 091085118 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 a09-27814_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) September 24, 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:

 

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 8.01               Other Events.

 

On September 24, 2009, Cephalon, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (FDA) granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV].  The Company filed the sNDA in June 2009 seeking marketing approval for NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel.  The Company hereby incorporates by reference the press release dated September 24, 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 September 24, 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: September 24, 2009

By:

/s/ J. Kevin Buchi

 

 

J. Kevin Buchi

 

 

Executive Vice President and

 

 

Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit

 

 

Number

 

Description

 

 

 

99.1

 

Press Release dated September 24, 2009

 

4


EX-99.1 2 a09-27814_1ex99d1.htm EX-99.1

Exhibit 99.1

 

Cephalon Announces that FDA Grants Priority Review of its
Supplemental New Drug Application for NUVIGIL as a Treatment for
Excessive Sleepiness Associated with Jet Lag Disorder

 

FRAZER, Pa., September 24, 2009 — Cephalon, Inc. (Nasdaq: CEPH) today announced the U.S. Food and Drug Administration (FDA) has granted a priority review for its supplemental New Drug Application (sNDA) for NUVIGIL(R) (armodafinil) Tablets [C-IV], which was filed in June of this year. The FDA decision on approval of NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel is expected by December 29, 2009. There currently is no FDA-approved treatment for jet lag disorder.

 

The NUVIGIL sNDA is based on data from a Phase III pivotal study that evaluated the efficacy and safety of NUVIGIL (50 or 150 mg/day) in 427 healthy adults over three days during travel from the United States to Europe.  These data were presented earlier this year at the SLEEP 2009 23rd Annual Meeting of the Associated Professional Sleep Societies.

 

About NUVIGIL

 

NUVIGIL, the longer-lasting isomer of modafinil, was launched in the United States in June 2009 and is indicated to improve wakefulness in patients with excessive sleepiness associated with treated obstructive sleep apnea, shift work sleep disorder, also known as shift work disorder (SWD), and narcolepsy.  NUVIGIL is not approved as a treatment for jet lag disorder or its associated symptoms.  The NUVIGIL label includes a bolded warning for serious or life-threatening rash, including Stevens-Johnson syndrome, that has been reported in adults and children taking modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil, the active ingredient in NUVIGIL).  NUVIGIL is not approved for use in pediatric patients for any indication.

 

The most common adverse events in controlled clinical trials (five percent or greater) were headache, nausea, dizziness and insomnia.  Full prescribing information for NUVIGIL 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: NUVIGIL, TREANDA(R) (bendamustine hydrochloride) for Injection, AMRIX(R) (cyclobenzaprine hydrochloride extended-release capsules), FENTORA(R) (fentanyl buccal tablet) [C-II], TRISENOX(R) (arsenic trioxide) injection, GABITRIL(R) (tiagabine hydrochloride), PROVIGIL(R) (modafinil) Tablets [C-IV], and ACTIQ(R) (oral transmucosal fentanyl citrate) (C-II). The company also markets numerous products internationally. Full prescribing information on its U.S. products is available at 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, clinical development of NUVIGIL, timing of FDA decisions, 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.

 

###

 

Contacts:

 

Media
Sheryl Williams

610-738-6493

swilliam@cephalon.com

 



 

Investor Relations
Chip Merritt
(610) 738-6376

cmerritt@cephalon.com

 

Source: Cephalon, Inc.

 

Web Site:

www.cephalon.com

 


-----END PRIVACY-ENHANCED MESSAGE-----