-----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, FFe+mk/ajkmc+H0oQ3U/TpYr3scVb7CBA0aSqI8hilA7/PhhLAMFOdZG5XrS0+hJ o6prsJ9E1YBb63w8W7hmHQ== 0000950123-08-002012.txt : 20080222 0000950123-08-002012.hdr.sgml : 20080222 20080222172807 ACCESSION NUMBER: 0000950123-08-002012 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080222 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080222 DATE AS OF CHANGE: 20080222 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: 08637541 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 y50274e8vk.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): February 22, 2008
SCHERING—PLOUGH CORPORATION
(Exact Name of Registrant as Specified in its Charter)
         
New Jersey   1-6571   22-1918501
(State or Other Jurisdiction of
Incorporation)
  (Commission File Number)   (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 February 22, 2008, 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
(d) Exhibits
99.1 February 22, 2008 Frequently Asked Questions and Answers
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.
         
Schering-Plough Corporation    
 
       
 
       
 
       
By:
  /s/ Steven H. Koehler    
 
       
 
  Steven H. Koehler    
 
  Vice-President and Controller    
 
       
 
       
 
       
Date: February 22, 2008

 


 

Exhibit Index
Exhibit    
Number   Description
99.1 February 22, 2008 Frequently Asked Questions and Answers

 

EX-99.1 2 y50274exv99w1.htm EX-99.1: FREQUENTLY ASKED QUESTIONS AND ANSWERS EX-99.1
 

Exhibit 99.1
    February 22, 2008 — 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   What are the IMS prescription volumes for VYTORIN and ZETIA?
 
A    
                 
U.S. Total Prescription Volume (000’s)
      January 2008
Cholesterol Management Market
          20,363  
Total Merck/Schering-Plough Franchise
          3,194  
VYTORIN
          1,832  
ZETIA
          1,362  
    Source: IMS’ National Prescription Audit Plus (NPA+)
 
Q   Will you provide international presciption data for VYTORIN and ZETIA?
 
A   Prescription data from international markets are not as robust as U.S. data and their availability varies country to country. As a result, we will not report data from international markets.
 
Q   Will additional ENHANCE data be presented at ACC?
 
A   Yes, the American College of Cardiology (ACC) has accepted the ENHANCE abstract for presentation on Sunday, March 30, 2008, following the ACC Presidential address.
 
Q   What is the status of sugammadex?
 
A   Sugammadex was filed with regulatory authorities in the U.S., EU and Japan in 2007.
 
    The U.S. Food & Drug Administration (FDA) has assigned priority review status to the company’s New Drug Application (NDA) for sugammadex.
 
    The FDA has scheduled an advisory meeting to discuss sugammadex on March 11, 2008.
 
    Sugammadex is specifically designed to reverse the effects of certain muscle relaxants, marketed in the United States as ZEMURON(R) (rocuronium bromide) and vecuronium bromide. Muscle relaxants are used as part of general anesthesia during surgical procedures. If approved, sugammadex will be the first in a new class of drugs known as selective relaxant binding agents that work in an entirely new and unique way to encapsulate the muscle relaxant molecule and render it inactive.

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Q   What is the status of the Peg-Interferon filing for malignant melanoma?
 
A   Schering-Plough submitted a supplemental Biologics License Application (sBLA) for Peg-Interferon alfa-2b to the U.S. FDA and has been granted Priority Review status for the adjuvant treatment of patients with Stage III melanoma. This was announced on January 31, 2008.
 
    The Priority Review designation is intended to expedite the review process for therapies that provide a significant improvement in the treatment of serious or life-threatening diseases. Based on this Priority Review status, the FDA reviews the application with the goal of taking action within six months of the sponsor’s submission of the sBLA.
 
    Originally, the application was to be discussed by the FDA Oncology Drugs Advisory Committee on March 12, 2008. That meeting has been postponed and a new date is still to be determined.
 
    DISCLOSURE NOTICE: The information in this frequently asked questions document includes certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the ENHANCE clinical trial and its presentation. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough’s forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details about these and other factors that may impact the forward-looking statements, see Schering-Plough’s Securities and Exchange Commission filings, including Part II, Item 1A. “Risk Factors” in Schering-Plough’s 8-K, filed February 12, 2008.

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