-----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, BmL22+XAX6wsRE/wuKFpx7/onTvXgDHpuTNpXBMlpaUuPn15habdnFM78uFxRcTI WDlWoqSKP2ZAUOnfXidl5A== 0001104659-04-025398.txt : 20040824 0001104659-04-025398.hdr.sgml : 20040824 20040824115758 ACCESSION NUMBER: 0001104659-04-025398 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040819 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20040824 DATE AS OF CHANGE: 20040824 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: 04993386 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 a04-9892_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)    August 19, 2004

 

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
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)

 

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.

 

On August 19, 2004, the Registrant issued a press release announcing results from three multi-center clinical trials of proprietary once-daily dosage forms of modafinil for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

 

The Registrant hereby incorporates by reference the press releases dated August 19, 2004 attached hereto as Exhibit 99.1, and made a part of this Item 8.01.

 

ITEM 9.01.  FINANCIAL STATEMENTS 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 Announces Positive Results with a New Modafinil Formulation for the Treatment of Children with Attention Deficit Hyperactivity Disorder

 

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: August 24, 2004

By:

/s/  J. Kevin Buchi

 

 

 

J. Kevin Buchi

 

 

Senior Vice President & Chief Financial Officer

 

3



 

EXHIBIT INDEX

 

Exhibit
Number

 

Description

 

 

 

99.1

 

Press Release – Cephalon Announces Positive Results with a New Modafinil Formulation for the Treatment of Children with Attention Deficit Hyperactivity Disorder

 

4


EX-99.1 2 a04-9892_1ex99d1.htm EX-99.1

EXHIBIT 99.1

 

 

News

 

 

 

 

 

Contacts:

 

 

Media:

 

 

Sheryl Williams

 

 

610-738-6493

 

 

swilliam@cephalon.com

 

 

 

 

 

Investors:

 

 

Robert (Chip) Merritt

 

 

610-738-6376

 

 

cmerritt@cephalon.com

 

For Immediate Release

 

Cephalon Announces Positive Results with a New Modafinil Formulation for the Treatment of Children with Attention Deficit Hyperactivity Disorder

 

Results with New Pediatric Doses Were Highly Significant in all Three Studies;

 

Regulatory Filing Accelerated to Late 2004

 

West Chester, PA – August 19, 2004 – Cephalon, Inc. (Nasdaq: CEPH) today announced results from three multi-center clinical trials, which show that new proprietary once-daily dosage forms of modafinil significantly improve symptoms of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

 

In three nine-week, double-blind, placebo-controlled studies, 600 children and adolescents between the ages of six and 17 with ADHD were randomized to either placebo or an optimized new proprietary dosage form of modafinil.  The primary endpoint in all studies was the teacher-completed school version of the ADHD Rating Scale IV.  All of the modafinil treated groups showed a highly statistically significant improvement on the primary endpoint compared to placebo (p<0.0001).  Modafinil was generally well tolerated, and the most common side effects observed in these studies were consistent with those observed in other studies of this compound and included insomnia, headache and loss of appetite. The complete Phase III study data are expected to be presented at major medical meetings over the next 12 months.

 

“Because children metabolize modafinil differently from adults, our clinical efforts focused on identification of optimal doses of modafinil for these studies,” said Dr. Paul Blake, MB, FRCP, Senior Vice President of Clinical Research and Regulatory Affairs at Cephalon.  “The result was the development of proprietary dosage strengths of 340 and 425 milligrams, which in these Phase III studies demonstrated robust symptom improvement in children and adolescents with ADHD.  The most encouraging aspects of these results were the strength and consistency of the effects of modafinil across the three studies and the robust effects of modafinil on both the inattentive and hyperactive symptoms of ADHD.”

 

 — more —

 

 

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

 



 

Based upon the demonstrated strength of the study results, the company plans to accelerate the filing of its application with the Food and Drug Administration from the first quarter of 2005 to the fourth quarter of 2004.

 

Frank Baldino Jr., Ph.D., Chairman and CEO of Cephalon, said, “We are excited about these data and the promise they hold for the ADHD community.  We expect this product, once approved, to command a substantial presence in this large and growing market that today exceeds several billion dollars.  With its excellent clinical profile and strong intellectual property protection for use in ADHD, we anticipate this product will be an important contributor to Cephalon’s revenue growth for many years to come.”

 

Modafinil

Modafinil (PROVIGIL® C-IV Tablets) is currently available in 100 and 200 milligrams and is indicated for the treatment of excessive sleepiness associated with narcolepsy, obstructive sleep apnea and shift work sleep disorder. Modafinil for the treatment of children and adolescents with ADHD will be manufactured as smaller, film-coated tablets in unique dosage strengths.

 

Attention Deficit Hyperactivity Disorder

According to the National Institutes of Mental Health, ADHD is one of the most common psychiatric disorders among children, affecting three to five percent of American children.  ADHD is associated with dysfunction in the prefrontal cortex area of the brain.  The most common ADHD behaviors fall into three categories: inattention, hyperactivity, and impulsivity.  A diagnosis of ADHD is generally made when these behaviors become excessive, long-term, and pervasive.

 

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 2,000 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 and Eden Prairie, Minnesota.  Cephalon’s major European offices are located in Guildford, England, Martinsried, Germany, and Maisons-Alfort, France.

 

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.

 

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, interpretation of clinical results, including the results of the three multi-center clinical trials of modafinil in ADHD, prospects for regulatory approval of modafinil for ADHD and the anticipated timetable for filing a marketing application for the use of modafinil in ADHD, manufacturing development and capabilities, market prospects for its products, particularly with respect to the Company’s ability to effectively compete in the ADHD marketplace with modafinil, 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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