-----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, KWau4cZ0iyUElMpAtm9ofoYyMRBOhdWzLCKzsfdz05rAUPu9794gVuCEhLNfZ2tk xvUrGiXfXni2PQHMlvfOFw== 0000950123-05-014895.txt : 20051219 0000950123-05-014895.hdr.sgml : 20051219 20051216190844 ACCESSION NUMBER: 0000950123-05-014895 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20051216 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051219 DATE AS OF CHANGE: 20051216 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCHERING PLOUGH CORP CENTRAL INDEX KEY: 0000310158 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 221918501 STATE OF INCORPORATION: NJ FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-06571 FILM NUMBER: 051270986 BUSINESS ADDRESS: STREET 1: 2000 GALLOPING HILL ROAD CITY: KENILWORTH STATE: NJ ZIP: 07033 BUSINESS PHONE: 9082984000 MAIL ADDRESS: STREET 1: 2000 GALLOPING HILL ROAD CITY: KENILWORTH STATE: NJ ZIP: 07033 8-K 1 y15765e8vk.htm FORM 8-K FORM 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 16, 2005
SCHERING–PLOUGH CORPORATION
(Exact Name of Registrant as Specified in its Charter)
         
New Jersey
(State or Other Jurisdiction of
Incorporation)
  1-6571
(Commission File Number)
  22-1918501
(IRS Employer
Identification Number)
2000 Galloping Hill Road
Kenilworth, NJ 07033
(Address of Principal Executive Office)
Registrant’s telephone number, including area code: (908) 298-4000
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 7.01 Regulation FD Disclosure.
Schering-Plough Corporation from time to time issues Frequently Asked Questions and Answers (FAQs) that are believed to be of interest to investors. The most recent FAQs, dated December 16, 2005, are furnished as Exhibit 99.1 to this 8-K and are posted on the Schering-Plough Website at www.schering-plough.com under “investor relations/investor FAQs.”
Schering-Plough undertakes no obligation to update the FAQs and readers should note the date of information when referring to the FAQs or other historical information available on the website.
Item 9.01 Financial Statements and Exhibits
The following exhibits are furnished with this 8-K:
99.1 December 16, 2005 Frequently Asked Questions and Answers
SIGNATURE(S)
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.
Schering-Plough Corporation
By: /s/ Douglas J. Gingerella
Douglas J. Gingerella
Vice President and Controller
Date: December 16, 2005

 


 

Exhibit Index
The following exhibits are furnished with this 8-K:
99.1 December 16, 2005 Frequently Asked Questions and Answers

 

EX-99.1 2 y15765exv99w1.htm EX-99.1: DECEMBER 16, 2005 FREQUENTLY ASKED QUESTIONS AND ANSWERS EX-99.1
 

Exhibit 99.1
     
 
  December 16, 2005 — Frequently Asked Questions and Answers — (FAQ’s)
 
   
 
  From time to time, Investor Relations will provide FAQs on various topics of interest. The following is a compilation of recent FAQs.
 
   
Q
  Has NOXAFIL been launched in Europe?
 
   
A
  On October 27, 2005, Schering-Plough announced that it had received European Union approval to market NOXAFIL in 25 EU member states, as well as Iceland and Norway, for the treatment of certain serious invasive fungal infections in adult patients refractory to or intolerant of certain commonly used antifungal agents.
 
   
 
  In November, NOXAFIL was launched in Germany. Launches are anticipated in other EU markets during 2006.
 
   
Q
  What is the status of NOXAFIL in the U.S.?
 
   
A
  Schering-Plough received an approvable letter from the U.S. FDA in June 2005 and plans to file a complete response to the FDA in 2006.
 
   
 
  In addition, data from two pivotal trials in the prophylaxis of serious fungal infections has been presented recently. These studies have demonstrated that NOXAFIL reduced the incidence of serious fungal infections in hematopoietic stem cell transplant recipients with graft versus host disease and patients with acute leukemia or myelodysplastic syndrome. The Company plans to submit an NDA for prophylaxis to the FDA and a variation to our European Marketing authorization by the end of 2006.
 
   
Q
  What is the status of the TEMODAR brain metastases trial?
 
   
A
  The Phase III trial of temozolomide for the treatment of brain metastases from non-small cell lung cancer (NSCLC) is being modified and amended to a smaller Phase II randomized trial. The change is based upon lagging enrollment rates and the trial design. Patients enrolled in the trial who are responding to treatment will continue on the study.
 
   
 
  The decision was not based on safety- or efficacy-related issues. Schering-Plough remains committed to identifying the optimal way to use temozolomide in this setting. We will work with our investigators to develop new studies.
 
   
Q
  Does Schering-Plough or the Merck/Schering-Plough Joint Venture have any rights to combination products developed by Merck?
 
   
A
  This is a complicated issue. Schering-Plough is committed to maximize the value of VYTORIN and ZETIA through the Joint Venture.

 


 

Disclosure Notice
The information in this FAQ contains certain “forward-looking” statements, including statements relating to the timing of clinical trials and the timing of anticipated launches. Forward-looking statements relate to expectations or forecasts of future events. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements. The forward-looking statements may be affected by general market and economic factors, uncertainties in the regulatory approval process, federal and state regulations and legislation, and other uncertainties described in the company’s Securities and Exchange Commission filings under the heading “Disclosure Notice” including the company’s third quarter 2005 10-Q. The company does not assume the obligation to update any forward-looking statement.

 

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