-----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, JGtoD86KBiLogdRhii39/KXdUAMHwluAHTB7YTLfbue//YgBPFaT+UWzmvvUW9Lh 0+2A+48cV2c1Ks4K16tkMg== 0001104659-09-059990.txt : 20091022 0001104659-09-059990.hdr.sgml : 20091022 20091022164754 ACCESSION NUMBER: 0001104659-09-059990 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20091020 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091022 DATE AS OF CHANGE: 20091022 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: 091132888 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 a09-31998_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) October 20, 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 October 21, 2009, Cephalon, Inc. (the “Company”) issued a press release regarding the receipt of a paragraph IV certification notice letter on October 20, 2009 by the Company relating to an abbreviated new drug application submitted to the U.S. Food and Drug Administration by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of NUVIGIL® (armodafinil) Tablets [C-IV].  The Company hereby incorporates by reference the press release dated October 21, 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 Exhibit

 

 

 

99.1

 

Press Release dated October 21, 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: October 22, 2009

By:

/s/ Gerald J. Pappert

 

 

Gerald J. Pappert

 

 

Executive Vice President and General Counsel

 

3



 

EXHIBIT INDEX

 

Exhibit No.

 

Description of Exhibit

 

 

 

99.1

 

Press Release dated October 21, 2009

 

4


EX-99.1 2 a09-31998_1ex99d1.htm EX-99.1

EXHIBIT 99.1

 

News Release

 

For Immediate Release

 

Cephalon Notified of

Generic Filing for Armodafinil Tablets

 

FRAZER, Pa., October 21, 2009 – Cephalon, Inc. (Nasdaq: CEPH) today announced receipt of a Paragraph IV Certification Notice Letter on October 20, 2009 regarding an Abbreviated New Drug Application (ANDA) submitted to the U.S. Food and Drug Administration (FDA) by Teva Pharmaceuticals USA, Inc. requesting approval to market and sell a generic version of the 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths of NUVIGIL® (armodafinil) Tablets [C-IV].  In the Notice Letter, Teva alleges that U.S. Patent Nos. 7,132,570 (the “’570 Patent”), 7,297,346 (the “’346 Patent”) and RE37,516 (the “’516 Patent”) issued to Cephalon are invalid, unenforceable and/or will not be infringed by Teva’s manufacture, use or sale of the product described in Teva’s ANDA submission.

 

Cephalon is currently reviewing the Notice Letter. By statute, if Cephalon initiates a patent infringement lawsuit against Teva within 45 days of Cephalon’s receipt of the Notice Letter, then the FDA would be automatically precluded from approving the Teva ANDA until the earlier of entry of a district court decision finding the patents invalid or not infringed or 30 months from the receipt of the Notice Letter by Cephalon.

 

Cephalon has a three-year period of marketing exclusivity for NUVIGIL that extends until June 15, 2010.  In addition, including the six-month pediatric extension, the ‘516 Patent, the ‘346 Patent, and the ‘570 Patent expire on April 6, 2015, May 29, 2024, and June 18, 2024, respectively.  Teva’s Notice Letter does not challenge Orange Book-listed U.S. Patent No. 4,927,855 (the “’855 Patent”), which provides additional protection until October 22, 2010, the expiration date of the ‘855 Patent.

 

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® (bendamustine hydrochloride) for Injection, AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), FENTORA® (fentanyl buccal tablet) [C-II], PROVIGIL® (modafinil) Tablets [C-IV], TRISENOX® (arsenic trioxide) injection, GABITRIL® (tiagabine hydrochloride), 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; legal matters, including whether the company will initiate a patent infringement lawsuit against Teva; market prospects for its products; 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.

 

Contacts:

 

Media:

Investor Relations:

Sheryl Williams

Chip Merritt

610-738-6493 (office)

610-738-6376 (office)

610-457-5257 (cell)

cmerritt@cephalon.com

swilliam@cephalon.com

 

 


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