-----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, Q4rXDstMz9PXvfrF55SWGi/s+dvX7x6mDSqsWqVZS4jcg/rEJlD8+at2zHDbaoZw TjKR/ddhGKXmmDqtdEQuHw== 0000912057-02-037751.txt : 20021004 0000912057-02-037751.hdr.sgml : 20021004 20021004131642 ACCESSION NUMBER: 0000912057-02-037751 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20021003 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20021004 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: 02781774 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 a2090641z8-k.htm FORM 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)  October 3, 2002

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.)
145 Brandywine Parkway   19380
West Chester, Pennsylvania   (Zip Code)
(Address of Principal Executive Offices)    


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 October 3, 2002, Cephalon, Inc. (the "Registrant"), publicly announced that it has reacquired rights to its cancer pain product ACTIQ® (oral transmucosal fentanyl citrate) [C-II] in 12 countries, principally in Europe, from Elan Pharma International Limited, a subsidiary of Elan Corporation, plc.

        The Registrant hereby incorporates by reference the press release dated October 3, 2002 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: None

    (b)
    Pro Forma Financial Information: None

    (c)
    Exhibits

Number
  Description
99.1   Press Release—Cephalon Reacquires Rights to ACTIQ® in Key European Markets


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: October 3, 2002

 

By:

 

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


EXHIBIT INDEX

Exhibit
Number

  Description
99.1   Cephalon Reacquires Rights to ACTIQ® in Key European Markets



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Registrant's telephone number, including area code (610) 344-0200
SIGNATURES
EXHIBIT INDEX
EX-99.1 3 a2090641zex-99_1.htm EXHIBIT 99.1
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EXHIBIT 99.1

LOGO   News
    Contact:
Robert W. Grupp (Media)
610-738-6402
rgrupp@cephalon.com
    Robert S. (Chip) Merritt (Investors)
610-738-6376
cmerritt@cephalon.com

For Immediate Release


Cephalon Reacquires Rights to ACTIQ® in Key European Markets
Deal Further Strengthens International Marketing Presence

        WEST CHESTER, PA—October 3, 2002—Cephalon, Inc. (Nasdaq: CEPH), an international biopharmaceutical company, announced today that it has reacquired all rights to its cancer pain product ACTIQ® (oral transmucosal fentanyl citrate) [C-II] in 12 countries, principally in Europe, from Elan Pharma International Limited, a subsidiary of Elan Corporation, plc (NYSE: ELN).

        Under the agreement, Cephalon reacquired rights to ACTIQ in Austria, Belgium, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Switzerland, United Kingdom, Philippines, and Taiwan and paid Elan $50 million in cash. Cephalon already markets ACTIQ in the United States and will market the drug directly in the UK, Germany, and France.

        ACTIQ was granted marketing authorization in 16 European countries in June 2001 via the EU Mutual Recognition Procedure. ACTIQ had been marketed by Elan in the United Kingdom since January 2001 and in Germany and Ireland since early 2002. Elan acquired ACTIQ marketing rights from Anesta Corp. in December 1999. Cephalon acquired Anesta in October 2000.

        "By reacquiring ACTIQ rights, we achieve another milestone in our strategy of consolidating worldwide rights to our key products," said Frank Baldino, Jr., Chairman and CEO of Cephalon. "Our experience with ACTIQ will enable us to effectively position the product in these European territories. We believe ACTIQ will be an important product for our European business."

        In the United States, prescriptions and sales of ACTIQ are projected to double this year compared to 2001, making ACTIQ one of the fastest growing drugs in Cephalon's product portfolio. For the six months ended June 30, 2002, Cephalon reported sales of ACTIQ were $47.8 million, a 193 percent increase over sales of $16.3 million in the first half of 2001.

        In the past year, Cephalon has expanded its international business and now holds European and Asian rights to all three of its U.S. products: PROVIGIL |(modafinil) tablets [C-IV], ACTIQ, and GABITRIL | (tiagabine hydrochloride). In January 2002, Cephalon acquired worldwide rights to GABITRIL (excluding Canada, Latin America, and Japan). In December 2001, Cephalon purchased Laboratoire L. Lafon and acquired control of worldwide rights to its flagship product PROVIGIL.

    ACTIQ

        ACTIQ is the first drug approved for the management of breakthrough pain. ACTIQ is indicated for patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. ACTIQ utilizes a novel oral transmucosal system (OTS) that delivers the potent pain reliever fentanyl using a soluble lozenge that is attached to a handle and


rubbed by patients on the inside of their cheeks. Side effects are typical of all opioid products and include somnolence, nausea, vomiting, and dizziness.

    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 more than 1,200 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's major European offices are located in Guildford, England, Munich, Germany, and at Laboratoire L. Lafon in Maisons-Alfort, France.

        The company currently markets three proprietary products in the United States: PROVIGIL, ACTIQ, and GABITRIL, 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 contains 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, including its ability to favorably position ACTIQ in Europe, sales and earnings projections, the importance of ACTIQ to Cephalon's European territories and other statements regarding matters that are not historical facts. 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 such as those set forth below and 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 ultimately 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 U.S. Private Securities Litigation Reform Act of 1995 permits this discussion.

        # # #




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Cephalon Reacquires Rights to ACTIQ® in Key European Markets Deal Further Strengthens International Marketing Presence
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