-----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, MBsaR73FGL7Z4yHvud8UZYFisBJqAbiwnaG9dcVuWCTY/i116b5ZZbv70QkciJ9u p3c+kC5+ak0mGDkRX88/Dg== 0001047469-03-004241.txt : 20030206 0001047469-03-004241.hdr.sgml : 20030206 20030206145837 ACCESSION NUMBER: 0001047469-03-004241 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20030205 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030206 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: 03542412 BUSINESS ADDRESS: STREET 1: 145 BRANDYWINE PKWY CITY: WEST CHESTER STATE: PA ZIP: 19380 BUSINESS PHONE: 6103440200 MAIL ADDRESS: STREET 1: 145 BRANDYWINE PARKWAY CITY: WEST CHESTER STATE: PA ZIP: 19380 8-K 1 a2102561z8-k.htm 8-K
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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) February 5, 2003

Cephalon, Inc.
(Exact Name of Registrant as Specified in Charter)

Delaware
(State or Other Jurisdiction
of Incorporation)
  0-19119
(Commission
File Number)
  23-2484489
(I.R.S. Employer
Identification No.)


145 Brandywine Parkway West Chester, Pennsylvania 19380
(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)





ITEM 5. OTHER EVENTS.

        On February 5, 2003, Cephalon, Inc. (the "Registrant"), publicly announced that it has learned of a generic modafinil filing.

        The Registrant hereby incorporates by reference the press release dated February 5, 2003 attached hereto as Exhibit 99.1, and made a part of this Item 5.


ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS.

    (a)
    Financial Statements of Business Acquired: Not applicable

    (b)
    Pro Forma Financial Information: Not applicable

    (c)
    Exhibits

Number
  Description

99.1   Press Release—Cephalon, Inc. Learns of Generic Modafinil Filing

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: February 6, 2003

 

By:

/s/  
JOHN E. OSBORN      
John E. Osborn
Senior Vice President and General Counsel

3



EXHIBIT INDEX

Exhibit
Number

  Description

99.1   Press Release—Cephalon, Inc. Learns of Generic Modafinil Filing



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SIGNATURES
EXHIBIT INDEX
EX-99.1 3 a2102561zex-99_1.htm EXHIBIT 99.1
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EXHIBIT 99.1

GRAPHIC   News
    Contact:
Media: Robert Grupp
610-738-6402
rgrupp@cephalon.com

 

 

Investors: Robert S. (Chip) Merritt
610-738-6376
cmerritt@cephalon.com


Cephalon, Inc. Learns of Generic Modafinil Filing

Company Intends to Vigorously Defend the Product's 2014 Patent

West Chester, PA—February 5, 2003—Cephalon, Inc. (Nasdaq: CEPH) reported today that the U.S. Food and Drug Administration (FDA) has accepted an abbreviated new drug application (ANDA) for a generic form of modafinil, the active ingredient found in the company's PROVIGIL® Tablets [C-IV].

        Even if an ANDA application eventually is approved by the FDA, it will be years before a generic equivalent modafinil product can be sold in the United States. PROVIGIL is protected in the United States by a patent that does not expire until 2014 and that covers the pharmaceutical composition of the form of modafinil contained in PROVIGIL. PROVIGIL also was granted orphan drug exclusivity that prevents the approval of any ANDA for a modafinil product prior to June 2006, provided the FDA grants the company a six-month extension to the December 2005 orphan drug exclusivity upon completion of a pediatric study.

        "We have anticipated the possibility of a filing for some time, and we believe that our patent position for this product is strong," said John E. Osborn, Senior Vice President and General Counsel of Cephalon. "We will thoroughly evaluate any filing when it becomes available to us, and we are prepared to vigorously protect our intellectual property rights."

        PROVIGIL was approved by the FDA for the treatment of excessive daytime sleepiness associated with narcolepsy in December 1998 and was launched in the United States by Cephalon in February 1999. In December 2002, the company filed a Supplemental New Drug Application with the FDA seeking to expand its U.S. labeling to cover the treatment of excessive sleepiness associated with disorders of sleep and wakefulness in adults.

—more—



SOURCE: Cephalon, Inc. • 145 Brandywine Parkway •West Chester, PA 19380-4245 • (610) 344-0200 • Fax (610) 344-0065

Cephalon, Inc.

        Founded in 1987, Cephalon, Inc. is an international biopharmaceutical company dedicated to the discovery, development and marketing of innovative products to treat sleep and neurological disorders, cancer and pain.

        Cephalon currently employs approximately 1,500 people in the United States and Europe. U.S. sites include the company's headquarters in West Chester, Pennsylvania, and offices and manufacturing facilities in Salt Lake City, Utah. Cephalon also has European operations in the United Kingdom, France and Germany.

        The company currently markets three proprietary products in the United States: PROVIGIL, GABITRIL® (tiagabine hydrochloride) and ACTIQ® (oral transmucosal fentanyl citrate) [C-II] and more than 20 products internationally. Further information about Cephalon and 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 potential generic competition and our responses thereto, the strength of the PROVIGIL patent position, 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.

# # #


SOURCE: Cephalon, Inc. • 145 Brandywine Parkway •West Chester, PA 19380-4245 • (610) 344-0200 • Fax (610) 344-0065



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Cephalon, Inc. Learns of Generic Modafinil Filing
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