-----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, UYAFy00dfTNa0TgblOWECeNxnI3rZM5OXvk8pgU5eb2a9ZKjyHutFHhIv8OScusC vge2krnJl60uIRIlD++60g== 0001104659-07-079098.txt : 20071102 0001104659-07-079098.hdr.sgml : 20071102 20071102092439 ACCESSION NUMBER: 0001104659-07-079098 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20071023 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071102 DATE AS OF CHANGE: 20071102 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: 071208791 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 a07-28240_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 23, 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.

 

(a)           On October 23, 2007, Cephalon, Inc. (the “Company”) announced positive results from a Phase 3 clinical trial of TREANDA® (bendamustine HCl) in patients with indolent non-Hodgkin’s lymphoma (NHL) whose cancer is no longer responsive to treatment with rituximab. The Company hereby incorporates by reference the press release dated October 23, 2007, attached hereto as Exhibit 99.1, and made a part of this Item 8.01.

 

(b)           On November 1, 2007, the Company announced that Valli F. Baldassano, Esq., had been appointed to the new position of Executive Vice President and Chief Compliance Officer. The Company hereby incorporates by reference the press release dated November 1, 2007, attached hereto as Exhibit 99.2, 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 October 23, 2007

99.2

 

Press Release dated November 1, 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: November 1, 2007

By:

/s/ John E. Osborn

 

 

 

John E. Osborn

 

 

 

Executive Vice President, General Counsel and
Secretary

 

3



 

EXHIBIT INDEX

 

Exhibit

 

 

Number

 

Description

99.1

 

Press Release dated October 23, 2007

99.2

 

Press Release dated November 1, 2007

 

4


EX-99.1 2 a07-28240_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 from Its Pivotal Study of
TREANDA in Patients with Non-Hodgkin’s Lymphoma

 

Company on Target to File Second New Drug Application for TREANDA by End of 2007

 

Frazer, Pa. – October 23, 2007 – Cephalon, Inc. (Nasdaq: CEPH) today announced positive results from a Phase 3 clinical trial of TREANDA® (bendamustine HCl) in patients with indolent non-Hodgkin’s lymphoma (NHL) whose cancer is no longer responsive to treatment with rituximab. The study met its primary endpoints of overall response rate and median duration of response, while demonstrating a manageable tolerability profile. According to the National Cancer Institute, an estimated 30,000 people in the United States will be diagnosed in 2007 with indolent NHL, a serious and slow growing cancer of the lymphatic system that is difficult to treat because patients are prone to relapse after treatment.

 

The Phase 3, multicenter, single-arm study evaluated the efficacy and safety of single-agent TREANDA in 100 patients with relapsed, rituximab-refractory NHL. The overall response rate, as assessed by an independent radiological committee, was 75% (p<0.0001) and the median duration of response was 40 weeks (or 9.2 months). The overall response rate includes the percent of patients in the trial who had a complete, unconfirmed complete or partial response to treatment. The most common side effects included nausea, fatigue, neutropenia, diarrhea and vomiting. The company anticipates that the results of this study will be released at the upcoming American Society of Hematology (ASH) annual meeting in December 2007.

 

“We are encouraged that these results replicate those seen in our Phase 2 study, confirming the substantial efficacy in this difficult to treat population,” said Dr. Lesley Russell, Executive Vice President, Worldwide Medical and Regulatory Operations. “Based on these positive results, we are on track to file a New Drug Application in the fourth quarter for TREANDA in patients with indolent NHL who have failed treatment with rituximab.”

 



 

The protocol for the NHL pivotal trial received special protocol assessment (SPA) approval from the U.S. Food and Drug Administration (FDA) in February 2006. The SPA process allows for FDA evaluation and acceptance of a clinical trial protocol, including trial size, clinical endpoints and/or data analysis, which will be used as the basis of an efficacy claim to support a New Drug Application (NDA).

 

In September 2007, Cephalon submitted an NDA requesting approval of TREANDA for the treatment of patients with chronic lymphocytic leukemia (CLL), for which the FDA has granted orphan drug status.

 

About TREANDA

 

TREANDA is a rationally designed purine analog/alkylator hybrid. Preclinical data demonstrate that TREANDA 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.

 

Cephalon holds exclusive rights to market and develop TREANDA in the United States. TREANDA is licensed from Astellas Deutschland 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 market and sell bendamustine HCl in Japan and selected Asian countries.

 

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.

 

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.

 


EX-99.2 3 a07-28240_1ex99d2.htm EX-99.2

Exhibit 99.2

 

 

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 Appoints Valli F. Baldassano as Executive Vice

President and Chief Compliance Officer

 

Frazer, Pa. – November 1, 2007 – Cephalon, Inc. (Nasdaq: CEPH) announced today that Valli F. Baldassano, Esq., has been appointed to the new position of Executive Vice President and Chief Compliance Officer. In this role, Ms. Baldassano reports directly to Chairman and CEO, Frank Baldino Jr., Ph.D., with dotted line reporting to the audit committee of the board of directors.

 

“Valli brings a unique perspective on compliance issues as she has represented both corporations in the pharmaceutical industry and the U.S. government, “ said  Frank Baldino, Jr., Ph.D., Chairman and CEO. “We are pleased to have her guide us through this increasingly challenging regulatory environment. Moreover, our decision to make the chief compliance officer position an executive officer of the company underscores the importance of compliance in our organization.”

 

Ms. Baldassano has 21 years experience of legal experience with a strong background in healthcare fraud and compliance issues. Most recently she served as a Partner with Fox Rothschild LLP in Philadelphia where she was a member of the Litigation Department. Her corporate law experience includes eight years in the pharmaceutical industry in senior level compliance positions at Schering-Plough and the former Pharmacia. While at Schering, she negotiated and managed the implementation of two corporate integrity agreements with the Department of Health and Human Services, Office of Inspector General.

 

- more -

 



 

Previously, Ms. Baldassano was an Assistant United States Attorney in the Criminal Division of the United States Attorney’s Office for the Eastern District of Pennsylvania, where she investigated and tried federal criminal cases involving healthcare fraud and public corruption.

 

Ms. Baldassano received her Juris Doctor degree from Syracuse University and holds a Bachelor of Arts from Georgetown University.

 

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: AMRIX™ (cyclobenzaprine hydrochloride extended-release capsules), PROVIGIL® (modafinil) Tablets [C-IV], FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX® (arsenic trioxide) injection, 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, interpretation of clinical results, prospects for regulatory approval, 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.

 

# # #

 

SOURCE:  Cephalon, Inc. 41 Moores Road Frazer, PA  19355 (610) 344-0200 Fax (610) 344-0065

 

2


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-----END PRIVACY-ENHANCED MESSAGE-----