-----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, SgsbW7YZ8OjAZHCP/hM1IjHBOmcGpynLWcSz3Ta5bp32qNulRxRNc0XvhTG1Qrl/ BrpmXWdkussQn9TyuU+fmw== 0001104659-07-024548.txt : 20070402 0001104659-07-024548.hdr.sgml : 20070402 20070402083458 ACCESSION NUMBER: 0001104659-07-024548 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070330 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070402 DATE AS OF CHANGE: 20070402 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: 07735739 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 a07-9589_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)  March 30, 2007

 

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 March 30, 2007, Cephalon, Inc. (the “Company”) provided an update related to the Company’s NUVIGIL™ (armodafinil) Tablets [C-IV] new drug application.  The Company hereby incorporates by reference the press release dated March 30, 2007, 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 Exhibit

 

 

 

 

99.1

 

Press Release dated March 30, 2007

 




 

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 30, 2007

 

By:

 

/s/ John E. Osborn

 

 

 

 

John E. Osborn

 

 

 

 

Executive Vice President, General Counsel &

 

 

 

 

Secretary

 




EXHIBIT INDEX

Exhibit No.

 

Description of Exhibit

 

 

 

 

99.1

 

Press Release dated March 30, 2007

 



EX-99.1 2 a07-9589_1ex99d1.htm EX-99.1

Exhibit 99.1

 

News

 

 

Contacts:

 

 

Media:

 

 

Jenifer Antonacci

 

 

610-738-6674

 

 

jantonac@cephalon.com

 

 

 

 

 

Investors

 

 

Robert (Chip) Merritt

 

 

610-738-6376

 

 

cmerritt@cephalon.com

 

FOR IMMEDIATE RELEASE

Cephalon Provides Update Related to NUVIGILTM New Drug Application

Frazer, Pa. — March 30, 2007 — Cephalon, Inc. (Nasdaq: CEPH) today announced that it has received an approvable letter, together with draft labeling, from the U.S. Food and Drug Administration (FDA) for its new drug application (NDA) for NUVIGIL (armodafinil) Tablets [C-IV] for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS) and shift work sleep disorder (SWSD).

The draft labeling includes a proposed bolded warning section that characterizes the potential occurrence of skin rash and hypersensitivity in patients taking modafinil and armodafinil. As expected, the agency also has indicated that it will request similar language in the label for PROVIGIL® (modafinil) Tablets [C-IV].  The proposed labeling is subject to final approval by the FDA.

“We have worked diligently with the FDA over the past six months on this issue, and they have now informed us that their review is complete. We are very pleased that the proposed warning language appropriately describes the product’s safety profile,” said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations.

Among other things, the agency has requested that the company provide a standard safety update from clinical trials conducted since the last update in June 2006, and introductory promotional materials to be used for the product. The company’s response will be submitted within 30 days and will be considered a Class I response; the agency is expected to complete its review within 60 days thereafter. The agency has not requested any additional studies prior to final approval of NUVIGIL.

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SOURCE:  Cephalon, Inc.    41 Moores Road    Frazer, PA 19355    (610) 344-0200    Fax (610) 344-0065




 “While we fully appreciate that this regulatory review has been difficult and lengthy for  stockholders and others interested in the outcome, we are convinced that in this unusual situation where multiple products may be affected, the final result will prove to be worth the investment of time and effort,” said Frank Baldino Jr., Ph.D., Chairman and CEO.

About NUVIGIL

NUVIGIL is a single-isomer formulation of modafinil, the active pharmaceutical ingredient contained in PROVIGIL which is FDA-approved for the treatment of excessive sleepiness associated with narcolepsy, OSAHS and SWSD.  The NUVIGIL NDA is based on positive results of four double-blind, randomized, placebo-controlled studies in patients with excessive sleepiness associated with either narcolepsy, SWSD or OSAHS. In these studies, NUVIGIL was generally well tolerated. The most common side effects were mild to moderate in intensity and included nausea, headaches, dizziness, diarrhea, decreased appetite and upset stomach.

The company submitted its NDA for NUVIGIL to FDA in March 2005 and received an initial approvable letter in April 2006.

Cephalon also plans to conduct clinical trials evaluating the use of NUVIGIL as a treatment for serious medical conditions such as bipolar depression, cognition associated with schizophrenia, and excessive sleepiness and fatigue in conditions such as Parkinson’s disease and cancer.

NUVIGIL is protected by a U.S. patent expiring in 2023 that claims the Form 1 polymorph of armodafinil.

About Cephalon, Inc.

Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction. Cephalon currently employs approximately 3,000 people in the United States and Europe. Cephalon’s U.S. headquarters are located in Frazer, Pennsylvania, with offices, laboratories and manufacturing facilities in West Chester, Pennsylvania, Salt Lake City, Utah, and suburban Minneapolis, Minnesota. Cephalon’s European headquarters are located in Maisons-Alfort, France.

The company currently markets six proprietary products in the United States: PROVIGIL, FENTORA® (fentanyl buccal tablet) [C-II], ACTIQ® (oral transmucosal fentanyl citrate) [C-II], GABITRIL® (tiagabine hydrochloride), TRISENOX® (arsenic trioxide) injection, and VIVITROL® (naltrexone for extended-release injectable suspension). Full prescribing information on its U.S. products is available at http://www.cephalon.com or by calling 1-800-896-5855.

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2




 

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, including future clinical development plans for NUVIGIL; interpretation of clinical results, particularly with respect to the NUVIGIL Phase 3 trials; prospects for regulatory approval of NUVIGIL, including the likelihood of receiving final approval from FDA and the characterization of serious skin rash, among other things, in the final approved labeling for NUVIGIL; 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.

# # #

 

3



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