-----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, AdEj4sy27D61etFVgkUHZ+SO1wkV4+p5w8yS4udp0pXWpwVwF8t8S8LRFZr9EDt9 jpCBRdljbyb0DjtNlWQzNA== 0000950123-08-008128.txt : 20080721 0000950123-08-008128.hdr.sgml : 20080721 20080721172944 ACCESSION NUMBER: 0000950123-08-008128 CONFORMED SUBMISSION TYPE: 8-K/A PUBLIC DOCUMENT COUNT: 7 CONFORMED PERIOD OF REPORT: 20080721 ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080721 DATE AS OF CHANGE: 20080721 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/A SEC ACT: 1934 Act SEC FILE NUMBER: 001-06571 FILM NUMBER: 08961979 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/A 1 y63200a1e8vkza.htm FORM 8-K/A FORM 8-K/A
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K/A
(Amendment No. 1)
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): July 21, 2008
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))
 
 

 


 

EXPLANATORY NOTE

     Schering-Plough is filing an amendment to its 8-K filed earlier today to furnish, as Exhibit 99.4., a press release issued by The University of Oxford Clinical Trial Service Unit and Epidemiological Studies Unit titled “Independent Analyses of the SEAS, SHARP and IMPROVE-IT Studies of Ezetimibe.” The exhibit was omitted from the 8-K filed earlier today due to technical difficulties.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

     99.4 Press release dated July 21, 2008 titled “Independent Analyses of the SEAS, SHARP and IMPROVE-IT Studies of Ezetimibe”


 

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: July 21, 2008

 


 

Exhibit Index
     
Exhibit    
Number   Description
 
   
 
99.4   Press release dated July, 2008 titled “Independent Analysis of the SEAS, SHARP and IMPROVE-IT studies of Ezetimibe”

 

EX-99.4 2 y63200a1exv99w4.htm EX-99.4: PRESS RELEASE EX-99.4
             
(THE QUEENS ANNIVERSARY PRIZES 2005)
  CTSU   Clinical Trial Service Unit &
Epidemiological Studies Unit
  (UNIVERSITY OF OXFORD SEAL)

Press Release
EMBARGO: 18.00/6pm BST, Monday 21 July 2008
University of Oxford
Nuffield Department of
Clinical Medicine
CTSU, Richard Doll Building,
Old Road Campus,
Roosevelt Drive,
Oxford OX3 7LF, UK
Tel: +44-(0)-1865-743743
Fax: +44-(0)-1865-743985
Website: www.ctsu.ox.ac.uk


Independent analyses of the SEAS, SHARP and IMPROVE-IT studies of ezetimibe
The University of Oxford Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) proposed that the hypothesis-generating results of the SEAS trial of ezetimibe should be tested by reviewing the combined cancer results from the SHARP and IMPROVE-IT trials of ezetimibe, and reporting on the overall findings to the relevant regulatory authorities, independently of the drug manufacturers.
The two hypothesis-testing trials (SHARP and IMPROVE-IT) contain about four times as many cancers as the SEAS trial. They do not confirm the hypothesis raised by the SEAS trial that treatment increases the overall risk of developing cancer. In addition, there is no increase with time in the relative risk (active vs placebo) suggested by the cancer incidence and mortality from all 3 trials together (or just from the pair of hypothesis-testing trials). Consequently, the SEAS, SHARP and IMPROVE-IT trials do not provide credible evidence of any adverse effect on cancer.
Allocation to 5 years of substantial LDL-cholesterol lowering by a statin has been shown previously to have no apparent effect on cancer. The Cholesterol Treatment Trialists’ collaboration has published results (Lancet 2005;366: 1267-78) based on 90,000 patients randomised evenly between statin and control. Based on 5530 patients with cancer onset after randomisation, the statin vs control relative risk was 0.997 (with 95% confidence interval 0.95-1.05; not significant). Of these patients, 2163 died of their cancer during the scheduled follow-up period; the relative risk for cancer death was 1.01 (with 95% confidence interval 0.91-1.12; not significant).
In the final results from the SEAS trial, there appears to be a small increase in total cancer incidence in the group allocated ezetimibe + statin, but this is based on only 102 vs 67 cancer cases (including 39 vs 23 fatal cases) and there is no significant increase in any particular type of cancer.
/more

 


 

Two other large trials of ezetimibe + statin are still in progress: (i) SHARP (ezetimibe + simvastatin vs placebo in 9,000 patients; recruitment completed, but treatment and follow-up continuing) and (ii) IMPROVE-IT (ezetimibe + simvastatin vs placebo + simvastatin in 11,000 patients; recruitment continues towards an eventual target of 18,000 patients). Together, they have already accumulated about four times as many cancers as SEAS (see table). If treatment really did increase total cancer by 50% then this would have been clearly apparent in the hypothesis testing SHARP & IMPROVE-IT trials. Instead, there was no evidence of any increase in cancer (see table).
                 
Cancer events   Active   Control
Hypothesis generator: SEAS
    102       67  
Hypothesis test: SHARP & IMPROVE-IT*
    313       326  
 
*   216 active vs 254 control non-fatal cases and 97 vs 72 fatal cases.
If there were a real adverse effect on cancer incidence or cancer mortality then previous experience with the epidemiology of cancer (ie, with other causes of the disease in humans) strongly suggests that the relative risk (active versus control) should grow bigger with time, but it does not, whether the hypothesis-testing trials are considered separately or all 3 trials are considered together.
Note: The University of Oxford Clinical Trial Service Unit and Epidemiological Studies Unit (CTSU) has decades of experience in cancer epidemiology, in vascular and other trials, and in collaborative meta-analyses of trials. Although CTSU is conducting the SHARP trial, it is doing so independently of the source of funding, and has a policy of not accepting honoraria or consultancy fees. This report to regulatory authorities on the analyses of SEAS, SHARP and IMPROVE-IT was initiated, conducted and interpreted by the CTSU independently of any source of funding.
End
For more information, please, refer to the press release issued by the SEAS investigators today.
Contact: Andrew Trehearne, CTSU, +44 (0)1865-743960, +44 (0)789-404-2600
     
Co-directors: Rory Collins FMed Sci FRCP BHF Professor of Medicine and Epidemiology
  Sir Richard Peto FRS Hon FRCP Professor of Medical Statistics and Epidemiology
                     
Jane Armitage FFPH FRCP
  Colin Baigent FFPH FRCP   Jillian Boreham PhD   John Cairns FRS   Zhengming Chen MBBS DPhil   Michael Clarke DPhil
Reader in Clinical
Epidemiology
  Professor of Epidemiology   Senior Research Fellow   Emeritus Professor of Cancer   Professor of Epidemiology   Professor of Clinical Epidemiology
 
                   
Robert Clarke FFPH FRCP
  Sarah Darby PhD   Christina Davies
BMBCh MSc
  Alison Halliday FRCS   Martin Landray PhD MRCP   Christine Marsden PhD
Reader in Epidemiology
  Professor of Medical Statistics   Senior Research Fellow   Consultant in Vascular Surgery   Reader in Epidemiology   Unit Administrator
 
                   
Sarah Parish DPhil
  Max Parkin MD   Susan Richards DPhil   David Simpson OBE Hon MFPH   Alan Young DPhil   Sarah Clark, Karen Kourellias &
Senior Research Fellow
  Honorary Senior Research Fellow   Senior Research Fellow   Director, IATH   Head of Systems Development   Martin Radley: Lab Management
         
(CANCER RESEARCH UK)   (BRITISH HEART FOUNDATION)   (MRC)

 

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