-----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, TNgL7BjUtEWumY/WKPDtT8sEwSb6LXKMYlGqbaa6nILlOeRn3mUZvduGPwShWVZe 41/oIrjaoro14nqErj6LhA== 0000950123-05-011724.txt : 20050930 0000950123-05-011724.hdr.sgml : 20050930 20050930162250 ACCESSION NUMBER: 0000950123-05-011724 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050930 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050930 DATE AS OF CHANGE: 20050930 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: 051114471 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 y13258e8vk.htm FORM 8-K FORM 8-K
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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): September 30, 2005
SCHERING—PLOUGH CORPORATION
(Exact Name of Registrant as Specified in its Charter)
         
New Jersey   1-6571   22-1918501
(State or Other Jurisdiction of   (Commission File Number)   (IRS Employer
Incorporation)       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))
 
 

 


TABLE OF CONTENTS

Item 7.01 Regulation FD Disclosure.
Item 9.01 Financial Statements and Exhibits
SIGNATURE(S)
Exhibit Index
EX-99.1: 9/30/05 FREQUENTLY ASKED QUESTIONS AND ANSWERS


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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. The most recent FAQs, dated September 30, 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 September 30, 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: September 30, 2005

 


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Exhibit Index
The following exhibits are furnished with this 8-K:
99.1 September 30, 2005 Frequently Asked Questions and Answers

 

EX-99.1 2 y13258exv99w1.htm EX-99.1: 9/30/05 FREQUENTLY ASKED QUESTIONS AND ANSWERS EX-99.1
 

Exhibit 99.1
September 30, 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
  What is the status of the work related to the Consent Decree?
 
   
A
  Schering-Plough continues steady progress in fulfilling consent decree obligations with the U.S. Food and Drug Administration (FDA), including completing the revalidation programs for bulk active pharmaceutical ingredients by Sept. 30, 2005 as required. The deadline for completing revalidation programs for bulk active pharmaceutical ingredients was reported by the company in previous SEC filings, including the company’s 10-Q filed in July 2005. The obligations and requirements fulfilled by the Company under the Consent Decree are subject to certification by an external third party and FDA review and approval.
 
   
Q
  How many of the significant steps have been completed to date?
 
   
A
  An update on the status of significant steps will be provided when earnings are reported on Oct. 24, 2005. As reported in Schering-Plough’s earnings release on July 21, 2005, 183 of 212 significant steps and 27 of 30 validation actions had been completed as of June 30, 2005 without incurring any additional payments for missed deadlines.
 
   
Q
  Is the company on track to meet the deadline on Dec. 31, 2005 for revalidation of finished drug products?
 
   
A
  The company continues steady progress in fulfilling consent decree obligations with the FDA. As noted in the company’s 10-Q filed in July 2005, requirements under the Consent Decree require Schering-Plough to complete the revalidation for finished drugs by Dec. 31, 2005 and the company is working toward that goal.
 
   
Q
  Once the significant steps are completed, does this mean the Consent Decree is lifted?
 
   
A
  No. All of the obligations and requirements fulfilled by the Company under the Consent Decree are subject to certification by an external third party and FDA review and approval. The Company cannot predict at this time when or how long FDA may take to complete a review of the Company’s completion of its cGMP Work Plans and validation program requirements under the Decree.
 
   
 
  The Consent Decree contains a sunset provision that permits the Company to petition the Court to dissolve the Decree if, during any five year period following the entry of the Decree (May 20, 2002), FDA has not notified the Company that there has been a significant violation of FDA law, regulations, or the Decree. If these conditions are satisfied, the Decree states that FDA will not oppose the Company’s petition. The earliest the Company would be in a position to submit such a petition would be May, 2007 (five years after the entry of the Decree).

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Q
  Has Schering-Plough started the Phase III program for vicriviroc, the CCR5 receptor antagonist for the treatment of HIV?
 
   
A
  Schering-Plough’s CCR5 receptor antagonist compound, vicriviroc, is being studied in ongoing Phase II clinical trials in both treatment-naïve and treatment-experienced HIV patients. The Phase II program was initiated in Spring 2004.
 
   
  Schering-Plough is currently working to initiate worldwide Phase III clinical studies with vicriviroc in treatment-experienced HIV patients. Site initiation is ongoing. Pending completion of discussions with the U.S. FDA, patient dosing will begin.
 
   
Q
  Are there any safety concerns with vicriviroc?
 
   
A
  The Phase II studies are each monitored by independent Data and Safety Monitoring Boards (DSMB). Additionally, for the treatment-naïve study being conducted by Schering-Plough, our project physicians review all laboratory data in real time, without knowledge of treatment assignment, and we continue to share available safety data with the U.S. FDA. The treatment-experienced trial is being conducted by the U.S. AIDS Clinical Trials Group (ACTG), and data are monitored according to their well established standards. Schering-Plough maintains regular communication with the ACTG with the goal of maintaining patient safety.
 
   
 
  With these ongoing careful reviews of vicriviroc clinical studies, Schering-Plough will continue to monitor progress carefully to ensure the safety of patients in these studies.
 
   
 
  It is important to note that while CCR5 receptor antagonists represent a potential new class of HIV drugs with a similar mechanism of antiviral activity, the individual compounds currently undergoing clinical study are unique molecules that may exhibit different safety and efficacy profiles.
Disclosure Notice
The information in this FAQ contains certain “forward-looking” statements, including statements relating to the timing of clinical trials and the status of the completion of work required under the FDA Consent Decree. 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 second quarter 2005 10-Q. The company does not assume the obligation to update any forward-looking statement.

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