-----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, QA3++nOUQF2cmJo1TgSwcQ59iOkuRkyXk3ZRN5i1nbxj9ATDPxcd+1oWtoEG1bVb K9S7hGyqLHcuJIjDq3UcvQ== 0001104659-10-010303.txt : 20100226 0001104659-10-010303.hdr.sgml : 20100226 20100226163823 ACCESSION NUMBER: 0001104659-10-010303 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20100223 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100226 DATE AS OF CHANGE: 20100226 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: 10639939 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 a10-4764_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)    February 23, 2010

 

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 February 23, 2010, Cephalon, Inc. (the “Company”) issued a press release announcing that it has exercised its option to acquire Ception Therapeutics, Inc, following receipt of positive data from a Phase II clinical study on Ception’s lead compound, CINQUIL™ (reslizumab) in adults with eosinophilic asthma.  The Company hereby incorporates by reference the press release dated February 23, 2010,  attached hereto as Exhibit 99.1, and made a part of this Item 8.01.

 

Item 9.01               Financial Statements and Exhibits.

 

(d)           Exhibits.

 

Exhibit No.

 

Description of Document

99.1

 

Press Release dated February 23, 2010

 

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: February 26, 2010

By:

/s/ Gerald J. Pappert

 

 

Gerald J. Pappert

 

 

Executive Vice President, General Counsel and Secretary

 

3



 

EXHIBIT INDEX

 

Exhibit

 

 

Number

 

Description

99.1

 

Press Release dated February 23, 2010

 

4


EX-99.1 2 a10-4764_1ex99d1.htm EX-99.1

 

Exhibit 99.1

 

 

 

For Immediate Release

 

Cephalon Exercises its Option to Acquire Ception Therapeutics

 

Ception Delivers Positive Results from a Phase II Study

of CINQUIL in Adult Eosinophilic Asthma

 

FRAZER, PA, and MALVERN, PA (February 23, 2010) — Cephalon, Inc. (Nasdaq: CEPH) announced today that it has exercised its option to acquire Ception Therapeutics, Inc, following receipt of positive data from a clinical study in adults with eosinophilic asthma.  A Phase II clinical trial of Ception’s lead compound, CINQUIL™ (reslizumab), in 106 patients demonstrated improved asthma control in adult patients with moderate to severe asthma and eosinophilic airway inflammation, as measured by the primary study endpoint, a change in Asthma-Control -Questionnaire or ACQ score (p=0.054). In addition, an analysis of the FEV1, a measure of lung function, showed a statistically significant improvement with CINQUIL compared to placebo (p= 0.002).

 

“This study showed a strong treatment signal and compelling internal consistency on the effect of CINQUIL on measurements of asthma and lung function,” said Dr. Lesley Russell, Chief Medical Officer at Cephalon.  “These data provide confidence that CINQUIL shows a meaningful treatment effect in this patient population.  We look forward to advancing CINQUIL into Phase three clinical trials.”

 

Based on these Phase II results, Cephalon exercised its option to acquire Ception on February 22, 2010.  Following the exercise of its option, Cephalon’s obligation to enter into a merger agreement relating to the acquisition is subject to Cephalon’s rights under, and Ception’s satisfaction of certain conditions set forth in, the option agreement.  The merger agreement is subject to customary closing conditions, including expiration of applicable antitrust waiting periods.  Upon the closing of the merger, Cephalon would purchase all of the outstanding capital stock of Ception for $250 million, subject to adjustment for any third party debt held by Ception.  Ception shareholders could receive additional payments related to clinical and regulatory milestones.

 

“The acquisition of Ception is consistent with our strategy to diversify into biologics and provides us with an important Phase three asset for further development,” said Frank Baldino, Jr., Ph.D., Chairman and CEO of Cephalon.

 



 

“Today marks an important milestone for Ception, as well as the asthma community,” said Stephen Tullman, President and CEO, Ception Therapeutics.  “These encouraging results will allow the advancement of this novel therapeutic for the many people suffering from this severe, poorly controlled form of asthma.  The Ception team has done an excellent job, and I am extremely thankful for the support provided by Cephalon and our investors.”

 

 

About the Study

 

The four-month, double-blind, placebo-controlled Phase II clinical trial assessed the efficacy and safety of CINQUIL in the treatment of patients with poorly controlled eosinophilic asthma.  In this study, 106 adults patients received CINQUIL (3mg/kg) or placebo administered intravenously once every 28 days for four cycles.  Patients entering the study were required to have persistent asthma symptoms, despite high doses of inhaled corticosteroids, and elevated eosinophils in their sputum.  The primary study endpoint was improvement in asthma control as assessed by the change in Asthma-Control-Questionnaire (ACQ) score at week 15.  Patients on CINQUIL showed an improvement on the ACQ compared to placebo (p=0.054).  In this clinical study, CINQUIL was generally well tolerated with an adverse event profile comparable to placebo.  The most commonly observed side effect associated with CINQUIL versus placebo was nasopharyngitis.

 

Secondary endpoints and analysis of a subgroup of patients in the study showed the following:

 

·                  A significant reduction in sputum eosinophil counts for CINQUIL compared to placebo (p=0.006).

 

·                  A significant improvement in FEV1 and FVC for CINQUIL compared to placebo (p=0.002 and p=0.004 respectively).  FEV1 and FVC are indices for assessing airway obstruction, bronchoconstriction or bronchodilation.

 

·                  In a subset of patients with both asthma and nasal polyps (n= 38), patients on CINQUIL compared to placebo showed a significant mean improvement in ACQ (p=0.011) and FEV1 (p=0.046).

 

·                  Fewer patients on CINQUIL compared to placebo experienced clinical asthma exacerbations.  Clinical asthma exacerbations were defined as a 20 percent decrease in FEV1 from baseline, emergency treatment or hospital admission and treatment for three or more days of oral corticosteroids.

 

Cephalon will further evaluate the study data and work with the FDA to determine the necessary and appropriate steps to move clinical development of CINQUIL forward to Phase III.

 

About CINQUIL

 

CINQUIL is an investigational humanized monoclonal antibody (mAb) against interleukin-5 (IL-5).  IL-5 has been shown to play a crucial role in the maturation, growth and chemotaxis (movement) of eosinophils, which are inflammatory white blood cells implicated in a

 



 

number of allergic diseases including asthma.  This investigational agent is currently administered as an intravenous injection; a subcutaneous formulation is being developed.

 

About Eosinophilic Asthma

 

Eosinophilic asthma is a type of severe asthma with persistent inflammation of the airways associated with increased levels of eosinophils (a type of white blood cell).  There is an increasing body of evidence that asthma is a heterogeneous disease, with eosinophilic airway inflammation a common feature among phenotypes.  Many patients with asthma respond well to inhaled corticosteroids.  However, there is a subgroup of patients with severe asthma in whom eosinophilic airway inflammation persists despite therapy with high doses of inhaled corticosteroids.  Patients with eosinophilic asthma may experience changes in their airways, impaired lung function, more frequent asthma exacerbations, and near-fatal asthma attacks.  Such patients are in need of additional anti-inflammatory therapies to address persistent high levels of eosinophils and associated poor prognosis.

 

About Cephalon, Inc.

 

Cephalon is an international biopharmaceutical company dedicated to discovering, developing and bringing to market medications for difficult to treat and rare conditions.  Since its inception in 1987, Cephalon has brought first-in-class and best-in-class medicines to patients around the world in several therapeutic areas.  Cephalon has the distinction of being one of the world’s fastest-growing biopharmaceutical companies, now among the Fortune 1000 and a member of the S&P 500 Index, employing approximately 3,000 people worldwide.

 

Cephalon has a growing presence in Europe, the Middle East and Africa.  The Cephalon European headquarters and pre-clinical development center are located in Maisons-Alfort, France, just outside of Paris.  Operational subsidiaries are located in the United Kingdom, France, Germany, Italy, Spain, the Netherlands (which covers the entire Benelux region), and Poland (which covers Eastern Europe and Scandinavia).  Cephalon Europe markets more than 30 products in 50 countries in four therapeutic areas: central nervous system, pain, primary care and oncology.

 

The company’s proprietary products in the United States include: NUVIGIL® (armodafinil) Tablets [C-IV], TREANDA® (bendamustine hydrochloride) for Injection, AMRIX® (cyclobenzaprine hydrochloride extended-release capsules), FENTORA® (fentanyl buccal tablet) [C-II], TRISENOX® (arsenic trioxide) injection, GABITRIL® (tiagabine hydrochloride), PROVIGIL® (modafinil) 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.

 



 

About Ception Therapeutics, Inc.

 

Ception Therapeutics, Inc., is a privately held biopharmaceutical company focused on the discovery and development of novel products to address areas of unmet medical need.  The company’s pipeline includes CINQUIL in clinical development for certain eosinophil-mediated conditions and an established program to discover small molecule, orally-active, anti-TNF (tumor necrosis factor) receptor agents.  For further information, visit www.ceptiontx.com.

 

* * *

 

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 whether Cephalon will complete the acquisition of Ception, anticipated scientific progress on its research programs, development of, and prospects for, potential pharmaceutical products such as CINQUIL, 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., and Ception Therapeutics, Inc.

 

Contacts:

 

Cephalon

 

Media:

 

Investor Relations:

Sheryl Williams

 

Chip Merritt

610-738-6493 (office)

 

610-738-6376 (office)

610-457-5257 (cell)

 

cmerritt@cephalon.com swilliam@cephalon.com

 



 

Ception

 

Media:

 

Mike Beyer - Sam Brown Inc. 
773- 463-4211 (office)

beyer@sambrown.com

 

#  #  #

 


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