-----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, QyOyAWYyIVBXt0r3o734X5KMJMShVopZNqhei1WcXhRMyiYTpMWDUrrYQKVSUy4h VW1x9NFE6Hc+FOiHuWWNzA== 0000950123-08-003378.txt : 20080326 0000950123-08-003378.hdr.sgml : 20080326 20080326161400 ACCESSION NUMBER: 0000950123-08-003378 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080314 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080326 DATE AS OF CHANGE: 20080326 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OSI PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000729922 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 133159796 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15190 FILM NUMBER: 08712286 BUSINESS ADDRESS: STREET 1: 41 PINELAWN ROAD CITY: MELVILLE STATE: NY ZIP: 11747 BUSINESS PHONE: 631-962-2000 MAIL ADDRESS: STREET 1: 41 PINELAWN ROAD CITY: MELVILLE STATE: NY ZIP: 11747 FORMER COMPANY: FORMER CONFORMED NAME: ONCOGENE SCIENCE INC DATE OF NAME CHANGE: 19920703 8-K 1 y52266e8vk.htm FORM 8-K 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
March 14, 2008
 
Date of Report (Date of earliest event reported)
OSI PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   0-15190   13-3159796
         
(State or other jurisdiction of
incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)
41 Pinelawn Road
Melville, NY 11747

(Address of principal executive offices)
(631) 962-2000
(Registrant’s telephone number, including area code)
N/A
(Former name or former address,
if changed since last report.)
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 8.01.   Other Events.
     On March 14, 2008, OSI Pharmaceuticals, Inc. (“OSI”) announced that it had reached a preliminary agreement to settle a class action lawsuit filed on or about December 16, 2004 against OSI, certain of its current and former executive officers and certain of its current and former members of its Board of Directors. A copy of OSI’s press release, dated March 14, 2008, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
     On March 18, 2008, OSI announced that the decision of the European Patent Office to revoke one of OSI’s dipeptidyl peptidase IV patents, EP0896538, was upheld on appeal. A copy of OSI’s press release, dated March 18, 2008, is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01.   Financial Statements and Exhibits.
     
Exhibit No.   Description
   
 
99.1  
Press Release dated March 14, 2008.
99.2  
Press Release dated March 18, 2008.

 


 

SIGNATURE
     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.
         
Date: March 26, 2008   OSI PHARMACEUTICALS, INC.
 
 
  By:   /s/ Barbara A. Wood    
    Barbara A. Wood   
    Senior Vice President, General Counsel and Secretary   
 

-2-


 

EXHIBIT INDEX
     
Exhibit No.   Description
   
 
99.1  
Press Release dated March 14, 2008.
99.2  
Press Release dated March 18, 2008.

-3-

EX-99.1 2 y52266exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
 

Exhibit 99.1
(OSI PHARMACEUTICALS LOGO)
NEWS RELEASE
     
Contacts:
   
OSI Pharmaceuticals, Inc.
  Burns McClellan, Inc. (representing OSI)
Kathy Galante (investors/media)
  Justin Jackson (media)
Senior Director
  Kathy Nugent
Kim Wittig (media)
  (212) 213-0006
Director
   
631-962-2000
   
OSI PHARMACEUTICALS ANNOUNCES PRELIMINARY
AGREEMENT TO SETTLE CLASS ACTION LAWSUIT
MELVILLE, NEW YORK – March 14, 2008 – OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that it has reached a preliminary agreement to settle a putative class action lawsuit filed on or about December 16, 2004 in the U.S. District Court for the Eastern District of New York against OSI, certain of its current and former executive officers and current and former members of its Board of Directors. Under the terms of the settlement, the pending action will be dismissed with prejudice and without any admission of liability on the part of the Company or any of the individually named defendants. The amount of the settlement is $9 million. Approximately, $500,000 will be paid by OSI, and the balance of the settlement will be paid by OSI insurer. The settlement will have no impact on the Company’s 2008 financials. The terms of the settlement are subject to court approval.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to “shaping medicine and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products designed to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity. The Company’s oncology programs are focused on developing molecular targeted therapies designed to change the paradigm of cancer care. OSI’s diabetes/obesity efforts are committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva® (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients in certain settings. OSI markets Tarceva through partnerships with Genentech, Inc. in the United States and with Roche throughout the rest of the world.
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA and other foreign review processes and other governmental regulation, OSI’s and its collaborators’ abilities to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors described in OSI Pharmaceuticals’ filings with the Securities and Exchange Commission.
###

 

EX-99.2 3 y52266exv99w2.htm EX-99.2: PRESS RELEASE EX-99.2
 

Exhibit 99.2
(OSI PHARMACEUTICALS LOGO)
     
   
NEWS RELEASE
Contacts:
   
OSI Pharmaceuticals, Inc.
  Burns McClellan, Inc. (representing OSI)
Kathy Galante (investors/media)
  Justin Jackson (media)
Senior Director
  Kathy Nugent (media)
Kim Wittig (media)
  (212) 213-0006
Director
   
631-962-2000
   
OSI Pharmaceuticals Announces that the Prior Revocation of its
European DP-IV Patent has been Upheld
- No Impact on DP-IV Patent Estate Revenue Guidance for 2008 -
MELVILLE, NEW YORK – March 18, 2008 — OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced today that the decision of the European Patent Office (EPO) to revoke one of the Company’s dipeptidyl peptidase IV (DP-IV) patents, EP0896538, claiming the use of DP-IV inhibitors to treat type II diabetes and related indications, has been upheld in appeal proceedings brought by the Company.
“We are disappointed with the outcome of the appeal proceedings. However, since the revocation applies to only one patent within our licensed DP-IV patent portfolio, any short-term loss in royalty revenue in Europe should be mitigated as additional licensed patents within the portfolio progress through the EPO examination procedure to grant,” stated Anker Lundemose, M.D., Ph.D., President of (OSI) Prosidion. “The Company’s DP-IV patent estate includes licensed rights to patents and patent applications claiming combinations of DP-IV inhibitors with other oral anti-diabetes drugs such as metformin.”
“The Company anticipates that the vast majority of DP-IV sales in 2008 and 2009 are likely to take place in the US, therefore the financial implications of losing this patent in Europe are relatively insignificant and do not impact our prior DP-IV revenue guidance for 2008,” stated Michael G. Atieh, Executive Vice President and Chief Financial Officer.
Background
OSI through its U.K. subsidiary, Prosidion Limited, owns or has licensing rights to issued and pending patents and patent applications with claims covering DP-IV as a target for anti-diabetes therapy and related indications. The patents which are subject of these DP-IV licenses will expire between 2017 and 2019. Thirteen pharmaceutical companies, including

 


 

Merck & Co., Inc., Novartis AG and Bristol-Myers Squibb Company have taken licenses to this patent estate.
About OSI Pharmaceuticals
OSI Pharmaceuticals is committed to “shaping medicine and changing lives” by discovering, developing and commercializing high-quality and novel pharmaceutical products designed to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity. The Company’s oncology programs are focused on developing molecular targeted therapies designed to change the paradigm of cancer care. OSI’s diabetes/obesity efforts are committed to the generation of novel, targeted therapies for the treatment of type 2 diabetes and obesity. OSI’s flagship product, Tarceva® (erlotinib), is the first drug discovered and developed by OSI to obtain FDA approval and the only EGFR inhibitor to have demonstrated the ability to improve survival in both non-small cell lung cancer and pancreatic cancer patients in certain settings. OSI markets Tarceva through partnerships with Genentech, Inc. in the United States and with Roche throughout the rest of the world.
This news release contains forward-looking statements. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. Factors that might cause such a difference include, among others, challenges to OSI’s intellectual property, any adverse litigation decisions, competition from other pharmaceutical companies, the ability to effectively market products, OSI’s and its collaborators’ abilities to successfully develop and commercialize drug candidates, the completion of clinical trials, the FDA review process and other governmental regulation, and other factors described in OSI Pharmaceuticals’ filings with the Securities and Exchange Commission.
###

 

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