-----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, I7/v1lmqJJ3husaEaFt+sbDoMfvyevdtBJRpPMmqkQmWRolQl7tUTrgoHu3H28yR Huna3zSECHLsinF7PxnfXw== 0001104659-07-065535.txt : 20070828 0001104659-07-065535.hdr.sgml : 20070828 20070828160318 ACCESSION NUMBER: 0001104659-07-065535 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070823 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070828 DATE AS OF CHANGE: 20070828 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: 071084035 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 a07-22783_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 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 1.01               Entry into a Material Definitive Agreement.

On August 23, 2007, Anesta AG, an indirect wholly-owned subsidiary of Cephalon, Inc. (the “Registrant”), and E. Claiborne Robins Company, Inc., a privately-held company d/b/a ECR Pharmaceuticals (“ECR”), entered into an Asset Purchase Agreement (the “Agreement”) under which Anesta AG agreed to acquire all assets (the “Acquisition”) related to AMRIX™ (cyclobenzaprine hydrochloride extended-release capsules), a once-daily muscle relaxant, for $100 million cash.  In addition to the up-front cash payment, the Agreement provides for future cash payments to ECR upon the achievement of certain cumulative net sales milestones.  The Registrant has agreed to guaranty to ECR all obligations of Anesta AG, including payment obligations, under the Agreement.  The Acquisition closed on August 28, 2007; the purchase price of the Acquisition was funded from existing cas h on hand.

AMRIX was approved in February 2007 by the U.S. Food and Drug Administration (FDA) for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.  Anesta AG’s right to market and sell AMRIX in the United States derives from a Development, License and Manufacturing Agreement with Eurand, Inc., the exclusive supplier of AMRIX.

There are no material relationships between ECR and the Registrant, Anesta AG or any of the Registrant’s other affiliates, directors or officers (or any associate of any such director or officer), other than by virtue of the Agreement.

The Registrant hereby inc orporates by reference the press release dated August 23, 2007, attached hereto as Exhibit 99.1, and made a part of this Item 1.01.

Item 8.01   Other Events.

The Registrant hereby incorporates by reference the information contained in Item 1.01 hereof.

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 August 23, 2007.

 




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 28, 2007

 

By:

/s/ J. Kevin Buchi

 

 

 

J. Kevin Buchi

 

 

 

Executive Vice President and Chief Financial Officer

 




EXHIBIT INDEX

Exhibit
Number

 

Description

 

 

99.1

 

Press Release dated August 23, 2007.

 



EX-99.1 2 a07-22783_1ex99d1.htm EX-99.1

Exhibit 99.1

 

 

News

 

Contacts:

 

 

 

Media:

 

Sheryl Williams

 

 

610-738-6493

 

 

swilliams@cephalon.com

 

 

 

 

 

Investors:

 

 

Robert (Chip) Merritt

 

 

610-738-6376 office

 

 

cmerritt@cephalon.com

 

For Immediate Release

Cephalon, Inc. Announces Agreement to Acquire AMRIX,

A Once-Daily Extended-Release Muscle Relaxant

 FDA Approved Product Will Accelerate Growth of Pain Franchise

Frazer, Pa — August 23, 2007 — Cephalon, Inc. (Nasdaq: CEPH) announced today it has signed an agreement to acquire the North American rights to AMRIX® (cyclobenzaprine hydrochloride extended-release capsules) from ECR Pharmaceuticals, a privately held company.  Two dosage strengths of AMRIX (15 mg and 30 mg) were approved in February 2007 by the U.S. Food and Drug Administration (FDA) for short-term use as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions.  The product is not yet available commercially in the United States; however, Cephalon expects to launch the product early in the fourth quarter.

Under the agreement, which is expected to close on or about August 28, 2007, Cephalon will acquire the rights to AMRIX for $100 million cash.  The company also could make future cash payments to ECR upon the achievement of certain cumulative net sales milestones.  The company anticipates that the transaction will be modestly dilutive in the fourth quarter due to product launch costs; despite this, the company is reaffirming its existing 2007 sales and adjusted income per common share guidance.  The transaction is expected to be accretive in 2008 and thereafter.

“AMRIX is an excellent strategic fit with our current sales organization, providing us with a second product that is complementary to many pain relievers used today,” said Robert Roche, Executive Vice President, Worldwide Pharmaceutical Operations.  “Cyclobenzaprine HCl is the most widely prescribed muscle relaxant in the United States, representing 37 percent of the 45 million prescriptions for muscle relaxants written in 2006, according to IMS.  AMRIX has convenient once-daily dosing and a side effect profile that includes very low rates of sedation which will provide physicians and patients an attractive alternative to current therapies.”




About AMRIX

AMRIX is a once-a-day, extended-release version of cyclobenzaprine hydrochloride, the active ingredient in the brand Flexeril®*.  AMRIX is indicated for relief of muscle spasm associated with acute, painful musculoskeletal conditions.  AMRIX is intended for short-term use  (up to two or three weeks) because adequate data for more prolonged use are not available and because muscle spasm associated with acute, painful musculoskeletal conditions is generally of short duration and specific therapy for longer periods is seldom warranted.

With convenient, once-daily dosing, AMRIX provides relief from muscle spasm comparable to that with cyclobenzaprine hydrochloride taken three times daily.  In Phase 3 clinical trials, once daily dosing of AMRIX at 15 mg and 30 mg resulted in somnolence rates of one and two percent respectively.  The most common side effects of AMRIX in Phase 3 clinical trials (greater than or equal to three percent) were dry mouth, dizziness, fatigue, constipation, nausea and dyspepsia.

AMRIX is contraindicated in patients concomitantly using monoamine oxidase (MAO) inhibitors or within 14 days after their discontinuation; in patients during acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block conduction disturbances or congestive heart failure; and in patients with hyperthyroidism.  AMRIX is not recommended for use in the elderly or in those with hepatic impairment.

AMRIX currently has market exclusivity until the first quarter of 2010.  There also is a pending U.S. patent application that contains claims directed to the formulation of the product.

Full prescribing information is available on the FDA website at http://www.fda.gov/cder/foi/label/2007/021777lbl.pdf.

About 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 has delivered a seven-year compound annual growth rate (CAGR) greater than 75 percent and 2006 revenue of $1.760 billion.  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® (arsenic trioxide) injection, VIVITROL® (naltrexone for extended-release injectable suspension), GABITRIL® (tiagabine hydrochloride), ACTIQ® (oral transmucosal fentanyl citrate) [C-II], and




NUVIGIL™ (armodafinil) Tablets [C-IV]. 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 the acquisition of AMRIX, including the strategic fit of the product with Cephalon’s organization, the attractiveness of AMRIX to physicians and patients compared with current therapies, the timing of the expected closing of the transaction and the potential impact the acquisition, if consummated, may have on  sales and earnings in 2007 and beyond; 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.

# # #


* Flexeril is the registered trademark of Johnson & Johnson

 



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