-----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, QoIJG2105vLScXBCND3bLpf1q3Jof0fcXm+9sFI0S7LAvsdEAdLtKls6i+v/DmsI MpE73NiJ/cosbToM3rbHBQ== 0001104659-07-087165.txt : 20071205 0001104659-07-087165.hdr.sgml : 20071205 20071205165922 ACCESSION NUMBER: 0001104659-07-087165 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071203 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071205 DATE AS OF CHANGE: 20071205 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: 071287227 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 a07-30776_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)  December 3, 2007

 

 

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 December 3, 2007, Cephalon, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (FDA) had accepted and granted priority review designation to the TREANDA® (bendamustine HCl) New Drug Application (NDA) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL).  The Company hereby incorporates by reference the press release dated December 3, 2007, 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.

 

 

 

 

 

None

 

 

 

(b)

 

Pro forma Financial Information.

 

 

 

 

 

None

 

(c)

 

Exhibits.

 

 

 

 

 

Exhibit No.

 

Description of Document

 

 

99.1

 

Press Release dated December 3, 2007

 

 

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: December 5, 2007

By:

/s/ J. Kevin Buchi

 

 

 

J. Kevin Buchi

 

 

Executive Vice President and Chief Financial

 

 

Officer

 

 

3



 

EXHIBIT INDEX

 

Exhibit

 

 

Number

 

Description

99.1

 

Press Release dated December 3, 2007

 

 

4


EX-99.1 2 a07-30776_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

News

 

 

 

Contacts:

 

 

Media

 

 

Candace Steele

 

 

610-727-6231

 

 

csteele@cephalon.com

 

 

 

 

 

Investors

 

 

Robert (Chip) Merritt

 

 

610-738-6376

 

 

cmerritt@cephalon.com

 

For Immediate Release

 

TREANDA New Drug Application for the Treatment of Chronic Lymphocytic
Leukemia Granted Priority Review Status by FDA

 

 

Frazer, PA — December 3, 2007 — Cephalon, Inc. (Nasdaq: CEPH) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review designation to the TREANDA® (bendamustine HCl) New Drug Application (NDA) for the first-line treatment of patients with chronic lymphocytic leukemia (CLL).  CLL is a slowly progressing blood and bone marrow disease with an estimated 15,000 new cases diagnosed every year in the United States. Cephalon filed the TREANDA NDA for CLL in September 2007 and the FDA will make a review decision by the end of March 2008.

 

“If approved, TREANDA will make a meaningful difference as the first new CLL treatment option approved by the FDA since 2001 and could be available as soon as the second quarter of 2008,” said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations.

 

The FDA assigns priority review to drugs that, if approved, would offer major advances in treatment or would provide treatment to patients where no adequate therapy exists. Priority review reduces the targeted NDA review time from 10 months to six months. FDA granted orphan drug status for TREANDA for CLL in August 2007, which would entitle Cephalon to a seven-year period of marketing exclusivity in the United States, if the product is approved for this indication.

 

About TREANDA

 

TREANDA is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that this rationally designed hybrid acts in two ways to kill cancer cells. TREANDA damages the DNA in cancer cells, which leads to the normal path of cell death (apoptosis).  It also stops cancer cells from dividing to create new cancer cells. This dual-action of TREANDA may be attributable to its unique chemical design.

 

- more -

 

 

 

SOURCE:  Cephalon, Inc. l 41 Moores Road l Frazer, PA  19355 l (610) 344-0200 l Fax (610) 344-0981

 



 

 

Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Pharma GmbH.  Bendamustine HCl, the active ingredient in TREANDA, is marketed in Germany by Astellas’ licensee, Mundipharma International Corporation Limited, under the tradename RIBOMUSTIN®. In Germany, RIBOMUSTIN is indicated as a single-agent or in combination with other anti-cancer agents for indolent NHL, multiple myeloma, and CLL. SymBio Pharmaceuticals Ltd holds exclusive rights to develop and market bendamustine HCl in Japan and selected Asian countries.

 

TREANDA in CLL

 

The TREANDA NDA for the treatment of patients with CLL is based on a large, international multi-center Phase 3 clinical trial that evaluated the safety and efficacy of bendamustine HCl, the active ingredient in TREANDA, compared to chlorambucil in patients who were not previously treated for their disease. Chlorambucil, a chemotherapy drug, is FDA-approved as a first-line therapy for patients with CLL. In the pivotal trial, bendamustine HCl met both primary endpoints — overall response rate and progression-free survival — and demonstrated a manageable tolerability profile. The company anticipates that results from this study will be released at the American Society of Hematology (ASH) annual meeting, which begins on December 8, 2007 in Atlanta, Georgia.

 

TREANDA in NHL

 

The company has also studied TREANDA for the treatment of patients with indolent non-Hodgkin’s lymphoma (NHL) whose cancer is no longer responsive to treatment with rituximab.  This study also met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile. The company anticipates filing an NDA in the fourth quarter of 2007 for TREANDA in patients with indolent NHL who failed treatment with rituximab.  In addition, Cephalon has studied TREANDA in combination with rituximab in patients with relapsed indolent and mantle cell NHL. Results from these studies of TREANDA as monotherapy and in combination will be presented at medical meetings later this year.

 

About Cephalon Oncology

 

Cephalon Oncology is a strategic business unit focused on the development and commercialization of oncology products and resources for patients and healthcare providers. The Cephalon Oncology portfolio includes a number of promising investigational and marketed compounds.  In addition to TREANDA, the Cephalon Oncology therapeutic portfolio in the United States includes TRISENOX® (arsenic trioxide) Injection, a product approved in the United States for the treatment of patients with relapsed or refractory acute promyelocytic leukemia, and CEP-701, an oral small molecule inhibitor of tyrosine kinases including FLT-3, TRK and JAK-2, in phase 3 development for acute myeloid leukemia.

 

In Europe, Cephalon markets three additional oncology products in 19 countries.

 

 

2



 

About Cephalon, Inc.

 

Cephalon, Inc. is an international biopharmaceutical company, recently inducted into the World Economic Forum Community of Global Growth Companies. For 20 years, the company has been dedicated to the discovery, development and commercialization of innovative products in four core therapeutic areas: central nervous system, pain, oncology and addiction.  A member of the Fortune 1000, 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’s proprietary products in the United States include: PROVIGIL® (modafinil) Tablets [C-IV], FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX, AMRIX™ (cyclobenzaprine hydrochloride extended-release capsules), VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), NUVIGIL™ (armodafinil) Tablets [C-IV] 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, including the results of any clinical programs with respect to TREANDA or the timing or acceptance of any current or future filings for regulatory approval of TREANDA or other Cephalon Oncology compounds;  interpretation of clinical results, particularly with respect to the TREANDA clinical trials; 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.

 

# # #

 

3


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