-----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, P3CaEkFr+jnHnDiec/yRANg7SIOiht1J/MdZDQlcYT1V9zdmPZWntjTh69h3hiLg T8I6x3BKiccF+AVs6aHoKg== 0000950123-04-009566.txt : 20040811 0000950123-04-009566.hdr.sgml : 20040811 20040811091248 ACCESSION NUMBER: 0000950123-04-009566 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040811 ITEM INFORMATION: Financial statements and exhibits ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20040811 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: 04965823 BUSINESS ADDRESS: STREET 1: ONE GIRALDA FARMS CITY: MADISON STATE: NJ ZIP: 07940-1000 BUSINESS PHONE: 9738227000 8-K 1 y00125e8vk.htm SCHERING PLOUGH CORP. SCHERING PLOUGH CORP.
Table of Contents



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

August 11, 2004
Date of Report (Date of Earliest Event Reported)

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 offices, including Zip Code)

(908) 298-4000
(Registrant’s telephone number, including area code)



 


TABLE OF CONTENTS

Item 7. Financial Statements and Exhibits.
Item 9. Regulation FD Disclosure.
SIGNATURES
Exhibit Index
SCHERING PLOUGH PIPELINE


Table of Contents

Item 7. Financial Statements and Exhibits.

(c)   Exhibits. The following exhibit is filed with the 8-K:

99.1   Schering-Plough Product Pipeline, updated as of August 2004

Item 9. Regulation FD Disclosure.

Schering-Plough from time to time updates public information about its products in development, also known as its “Product Pipeline.” The information, updated as of August 2004, is now available on the Schering-Plough Website at www.schering-plough.com under “investor relations/investor publications.”

Schering-Plough undertakes no obligation to update the information in the future, and readers should note the date of information when referring to the product pipeline or other historical information available on the Website.

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/Douglas J. Gingerella
Douglas J. Gingerella
Vice President and Controller

Date: August 11, 2004

 


Table of Contents

Exhibit Index

The following exhibits are filed with this 8-K:

99.1 Schering-Plough Product Pipeline, updated as of August  2004

 

EX-99.1 2 y00125exv99w1.htm SCHERING PLOUGH PIPELINE SCHERING PLOUGH PIPELINE
 

Exhibit 99.1

(SCHERING-PLOUGH LOGO)

     
Schering-Plough Product Pipeline
Worldwide Prescription Products
   
 
 
   
Schering-Plough Corporation
   
2000 Galloping Hill Road
  August 2004
Kenilworth, NJ 07033-0530
   


     
  Phase II
 
   
  Adenosine 2a Receptor Antagonist
  Parkinson’s Disease
 
   
4
  CCR5 Receptor Antagonist
  HIV Infection
 
   
  SARASAR
  Leukemia
  Variety of Solid Tumors
 
   
  TEMODAR
  Variety of Tumors
     
  Phase III
 
   
  CLARINEX-D 12 Hour
Seasonal Allergic Rhinitis
 
   
  CLARITIN/Singulair 2
Seasonal Allergic Rhinitis
 
   
4
  Garenoxacin
Variety of Gram-Positive/Gram-Negative Bacterial Infections
 
   
  INTEGRILIN
4
  Early Acute Coronary Syndrome
 
   
  NASONEX
4
  Rhinosinusitis
 
   
  PEG-INTRON
Malignant Melanoma
 
   
  Posaconazole
4
  Prophylaxis
 
   
  REMICADE 1
Psoriasis
Ulcerative Colitis
 
   
  TEMODAR
4
  First-Line Glioblastoma Multiforme
     
  NDA/BLA/PLA/HRD Filed
 
   
  ASMANEX (DPI)
Asthma
4
  Chronic Obstructive Pulmonary Disease (COPD)
 
   
4
  CLARINEX-D 24 Hour
Seasonal Allergic Rhinitis
 
   
  CLARINEX Syrup
Chronic Urticaria
Seasonal Allergic Rhinitis
 
   
  NASONEX
4
  Polyposis
 
   
4
  Posaconazole
Serious Fungal Infections
 
   
  REMICADE 1
4
  Psoriatic Arthritis


4 Phase advance     4 Indication advance     1 International rights only     2 J.V. with Merck      

 


 

                 
Product Name
  Market Size
  Indications
  U.S. Status
  International Status
Adenosine 2a Receptor
Antagonist

Oral formulation
 
Prevalence in major world markets – 1.3 million
Global market – $2.0 billion
 
Treatment of Parkinson’s disease
  Phase II   Phase II
 
               
ASMANEX
Anti-inflammatory steroid
Oral inhaler
 
Oral inhaled steroid market:
U.S. market – $1.0 billion
Int’l market – $1.9 billion
  Dry powder inhaler (DPI)
– Asthma
– COPD
   
Approvable 10/99
Phase III
   
Launched in UK 1/03
Filed in EU
 
               
CCR5 Receptor Antagonist
Oral formulation
 
Market projections premature
 
Treatment of HIV infection
  Phase II   Phase II
 
               
CLARINEX
Nonsedating antihistamine
Oral formulation
 
Oral antihistamine market:
U.S. market – $4.6 billion
Int’l market – $2.5 billion
  Treatment of allergies:
– CLARINEX Syrup
– CLARINEX-D 24 Hour
– CLARINEX-D 12 Hour
   
Approvable 10/01
NDA filed 4/04
Phase III
   
HRD approved 4/02
Filing not planned
Phase III
 
               
CLARITIN/Singulair
Nonsedating antihistamine
leukotriene inhibitor
Oral formulation
 
U.S. allergy market – $6.9 billion
 
Dual-action approach to treating allergies
– Seasonal allergic rhinitis
  J.V. with MRK
 
Phase III/Evaluating clinical program
  U.S. only
 
               
Garenoxacin
Quinolone antibiotic
Oral, injectable formulations
 
Worldwide antibiotic market – $25.5 billion
 
Treatment of a variety of gram-positive/gram-negative bacterial infections
  Phase III   Phase III
 
               
INTEGRILIN
Glycoprotein IIb/IIIa platelet aggregation inhibitor
Injectable formulation
 
Total U.S. patients with ACS – 550 million
 
Treatment of early acute coronary syndrome (ACS)
  Phase III   Primarily U.S. rights

 


 

                 
Product Name
  Market Size
  Indications
  U.S. Status
  International Status
NASONEX
Anti-inflammatory steroid
Nasal inhaler
 
Nasal inhaled steroid market:
U.S. market – $2.3 billion
Int’l market – $726 million
  Treatment of allergies:
– Polyposis
– Rhinosinusitis
   
NDA filed 2/04
Phase III
   
Phase III
Phase III
 
               
PEG-INTRON
Long-acting antiviral/biological
response modifier
Injectable formulation
 
Worldwide interferon market – in excess of $1 billion
  Cancer indications:
– Malignant melanoma
   
Phase III
   
Phase III
 
               
Posaconazole
Triazole antifungal
Oral formulation
 
Worldwide antifungal market – in excess of $4.0 billion
 
– Treatment of serious fungal infections
– Prophylactic treatment of serious fungal infections
  NDA filed 5/04
 
Phase III
  Filed in EU
 
Phase III
 
               
REMICADE
Monoclonal antibody
Injectable formulation
 
Prevalence in int’l markets:
Rheumatoid arthritis – 4 million
Psoriasis – 6.3 million
Psoriatic arthritis – 650,000
Ulcerative colitis – 200,000
 
Treatment of inflammatory diseases:
– Psoriatic arthritis
– Psoriasis
– Ulcerative colitis
  International only    
 
CHMP recomm. app. 7/04
Phase III
Phase III
 
               
SARASAR
Farnesyl transferase inhibitor
Oral formulation
 
Market projections premature
  Treatment of cancer:
– Leukemia
– Variety of solid tumors
   
Phase II
Phase II
   
Phase II
Phase II
 
               
TEMODAR
Cytotoxic chemotherapeutic agent
Oral formulation
  Alkylating agent market:
U.S. market – $192 million
Int’l market – $141 million
 
– First-line glioblastoma multiforme
– Treatment of a variety of tumors
  Phase III 
 
Early Phase
  Phase III 
 
Early Phase

 


 

Pipeline Updates / August 2004

Phase II
Pure Anti-Estrogen

In light of changing research and development priorities, a decision was made to seek outside partners for the future development of a pure anti-estrogen. Post-menopausal studies in Phase II had been on hold pending the outcome of FDA guidance on hormone replacement therapy products. This agent will no longer appear on the company’s Product Pipeline.

CCR5 Receptor Antagonist for HIV infection has advanced to Phase II on the Product Pipeline.

Phase III
ASMANEX (MDI)

Development of the ASMANEX MDI formulation in Phase III has been discontinued. This formulation will no longer appear on the company’s Product Pipeline.

Garenoxacin

In June, Schering-Plough signed a definitive license agreement with Toyama Chemical Co. Ltd. for garenoxacin, Toyama’s proprietary quinolone antibacterial agent in late-stage development. As previously disclosed, the company is proceeding with its review of the product dossier and implementation of technology transfer steps, and expects to be in a position to file a U.S. NDA by late 2005.

The following compounds or indications have advanced to Phase III on the Product Pipeline: INTEGRILIN for early acute coronary syndrome, Posaconazole for prophylactic treatment of serious fungal infections and TEMODAR for first-line glioblastoma multiforme.

NDA/HRD Filed

U.S. regulatory submissions have been accepted as filed for the following compounds: CLARINEX-D 24 Hour for seasonal allergic rhinitis, NASONEX for polyposis and Posaconazole for serious fungal infections.

International regulatory submissions have been accepted as filed for the following compounds: REMICADE for psoriatic arthritis, ASMANEX DPI for COPD and Posaconazole for serious fungal infections.

Note:

As part of the current Phase II program for the Adenosine 2a Receptor Antagonist in Parkinson’s disease, the company is reviewing several back up compounds to determine whether they offer a better profile than the original compound.

CLARINEX-D 12 Hour is listed in Phase III on the Product Pipeline. As previously reported, based on an analysis of an October 2001 “approvable” letter, SGP has determined that it intends to reformulate the product and seek approval for a new version with improved stability.

Recent Approvals

VYTORIN2 (ezetimibe/simvastatin)
Cholesterol lowering [U.S. 7/04, Germany, Mexico 4/04]

REMICADE1
Early rheumatoid arthritis [EU 6/04]

REMICADE1
Maintenance of fistulizing Crohn’s disease [EU 10/03]

PEG-INTRON REDIPEN
Hepatitis C [U.S. 10/03]

REBETOL oral solution
Pediatric use [U.S. 7/03]

REMICADE1
Ankylosing spondylitis [EU 5/03]

CAELYX1
Metastatic breast cancer [EU 1/03]

1 International rights only       2 J.V. with Merck

The SGP Product Pipeline is solely intended to provide to investors general information regarding Schering-Plough products in development and, for this reason, the information is not represented to be complete. Due to market factors and the nature of the development and approval process, the information – including the status of these products – is subject to change.

“International Status” does not necessarily imply that the company will be marketing the compound in all major countries.

The trademarks indicated by CAPITAL LETTERS are the property of, licensed to, promoted or distributed by Schering-Plough, its subsidiaries or related companies.



 

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