0001104659-06-019909.txt : 20060328 0001104659-06-019909.hdr.sgml : 20060328 20060328164556 ACCESSION NUMBER: 0001104659-06-019909 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060323 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060328 DATE AS OF CHANGE: 20060328 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: 06715558 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 a06-7796_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

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 23, 2006

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.)

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 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.

(a) On March 23, 2006, Cephalon, Inc. (the “Company”) issued a press release regarding a United States Food and Drug Administration (“FDA”) Advisory Committee meeting for SPARLON™ (modafinil). The Company hereby incorporates by reference the press release dated March 23, 2006, attached hereto as Exhibit 99.1, and made a part of this Item 8.01.

(b) On March 28, 2006, the Company issued a press release regarding the FDA’s grant of six months of pediatric exclusivity for PROVIGIL® (modafinil). The Company hereby incorporates by reference the press release dated March 28, 2006, attached hereto as Exhibit 99.2, and made a part of this Item 8.01.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Number		Description
99.1		Press Release dated March 23, 2006 titled “FDA Advisory Committee Recommends Against Approval of SPARLON™ for Attention Deficit/Hyperactivity Disorder in Children and Adolescents”
99.2		Press Release dated March 28, 2006 titled “Cephalon Granted Six Months of Pediatric Exclusivity for PROVIGIL®”

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 28, 2006	By:	/s/ John E. Osborn
		John E. Osborn
		Executive Vice President, General Counsel & Secretary

EXHIBIT INDEX

Exhibit Number		Description
99.1		Press Release dated March 23, 2006 titled “FDA Advisory Committee Recommends Against Approval of SPARLON™ for Attention Deficit/Hyperactivity Disorder in Children and Adolescents”
99.2		Press Release dated March 28, 2006 titled “Cephalon Granted Six Months of Pediatric Exclusivity for PROVIGIL®”

EX-99.1 2 a06-7796_1ex99d1.htm EXHIBIT 99

Exhibit 99.1

FDA Advisory Committee Recommends Against Approval of SPARLON(TM) for Attention Deficit/Hyperactivity Disorder in Children and Adolescents

Cephalon 2006 Basic Adjusted Income Per Common Share Guidance Remains Unchanged

FRAZER, Pa., March 23 — Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee voted not to recommend FDA approval of SPARLON(TM) (modafinil) Tablets [C-IV], the company’s investigational medication for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents. The committee voted unanimously that SPARLON is effective for its intended use but recommended that the company collect additional data to support the safety of the drug in children and adolescents with ADHD.

“We are obviously disappointed with the recommendation of the advisory committee. We will continue our discussions with the FDA to determine the next steps in the review of this drug application,” said Dr. Paul Blake, Executive Vice President, Worldwide Medical and Regulatory Operations.

The company’s previously issued 2006 basic adjusted income per common share guidance of $3.80-$4.00 remains unchanged. In light of the advisory committee’s recommendation, the company is reducing its 2006 sales guidance by $100 million to $1.45-1.50 billion; consistent with this reduction, guidance for CNS franchise sales also is reduced by $100 million to $665-715 million.

The advisory committee’s recommendation will be considered by the FDA in its review of the Supplemental New Drug Application that Cephalon submitted for SPARLON, a proprietary dosage form of modafinil, in December 2004. The FDA is not bound by the committee’s recommendation, but takes its advice into consideration when reviewing investigational drugs seeking approval. Cephalon received an approvable letter from the FDA with respect to SPARLON in October 2005.

Cephalon has scheduled a conference call with investors to discuss the outcome of the committee meeting at 6 p.m. EST on March 23, 2006. The conference call may be accessed by dialing 1-913-981-4901. The conference call ID number is 8645966.

SPARLON

SPARLON is a new formulation and proprietary dosage strength of modafinil, the active ingredient in PROVIGIL® (modafinil) Tablets [C-IV], which is approved for the treatment of adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea/hypopnea syndrome and shift work sleep disorder. SPARLON is chemically distinct from currently approved therapies and if approved, would provide a unique

option for ADHD treatment. PROVIGIL is not approved to treat ADHD and is available only in 100 mg and 200 mg strengths. SPARLON should not be used in combination with PROVIGIL® or any other medications that contain modafinil.

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. 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’s European headquarters are located in Maisons-Alfort, France.

The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL® (tiagabine hydrochloride) Tablets, ACTIQ® (oral transmucosal fentanyl citrate) [C-II], and TRISENOX® (arsenic trioxide) injection, and 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, including the results of the SPARLON clinical trials; prospects for final regulatory approval of SPARLON, including the impact of the advisory committee’s recommendation on the FDA’s decision whether to approve the sNDA for SPARLON; manufacturing development and capabilities; market prospects for its products, particularly with respect to SPARLON 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.

EX-99.2 3 a06-7796_1ex99d2.htm EXHIBIT 99

Exhibit 99.2

Cephalon Granted Six Months of Pediatric Exclusivity for PROVIGIL^®

Frazer, Pa. – March 28, 2006 – Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) will apply an additional six months of market exclusivity to PROVIGIL^® (modafinil) Tablets [C-IV]. The extension attaches to the U.S. patent covering PROVIGIL, such that the associated exclusivity now extends until April 6, 2015.

Specifically, the FDA has confirmed that Cephalon met the terms of a written request to provide data from clinical studies examining the effect of PROVIGIL in pediatric patients. The Food and Drug Administration Modernization Act of 1997 enables the FDA to issue written requests for pediatric studies to companies if the agency determines that information related to the use of an approved drug in pediatric patients may produce health benefits.

Cephalon previously announced its settlement with four generic firms of its patent infringement litigation concerning PROVIGIL. Under the terms of the settlements, Cephalon granted to each of the four defendants a non-exclusive royalty-bearing right to market and sell a generic version of PROVIGIL in the United States, that will now become effective in April 2012 (subject to earlier entry in certain circumstances).

Cephalon, Inc.

The company currently markets four proprietary products in the United States: PROVIGIL, GABITRIL^® (tiagabine hydrochloride) Tablets, ACTIQ^® (oral transmucosal fentanyl citrate) [C-II], and TRISENOX^® (arsenic trioxide) injection, and numerous products internationally. Full prescribing information on its U.S. products is available at www.cephalon.com or by calling 1-800-896-5855.

* * *

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. • 41 Moores Road • Frazer, PA 19355 • (610) 344-0200 • Fax (610) 344-0065