-----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, REYKkd6z06nM5XQK+ndHgoUq/9wUFucljEKx2bWc4Btt3a9k/Fgs7HCmJ8iGOTYE xQwYNocyu7xHpru62KDRDg== 0000950123-07-000289.txt : 20070110 0000950123-07-000289.hdr.sgml : 20070110 20070110172114 ACCESSION NUMBER: 0000950123-07-000289 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20070104 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070110 DATE AS OF CHANGE: 20070110 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: 07523940 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 y28812e8vk.htm FORM 8-K 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
January 4, 2007
 
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))
 
 

 


TABLE OF CONTENTS

ITEM 1.01. Entry into a Material Definitive Agreement.
ITEM 8.01. Other Events.
SIGNATURE
EX-99.1: PRESS RELEASE
EX-99.2: PRESS RELEASE
EX-99.3: FORM OF NOTICE TO HOLDERS


Table of Contents

ITEM 1.01. Entry into a Material Definitive Agreement.
     On January 4, 2007, Prosidion Limited (“Prosidion”), the U.K. subsidiary of OSI Pharmaceuticals, Inc. (“OSI”) focused on diabetes and obesity, entered into an Exclusive License Agreement (the “License Agreement”) with Eli Lilly and Company (“Eli Lilly”), which grants Eli Lilly an exclusive license in specified territories to PSN010, an oral, small molecule activator of glucokinase with potential applications for the treatment of diabetes, and its back-up molecules, together with related intellectual property (the “Licensed Intellectual Property”). Eli Lilly’s exclusive license includes the right to develop and commercialize products utilizing the Licensed Intellectual Property in specified territories, as well the right to grant sublicenses thereunder. The License Agreement provides for an upfront payment of $25 million, along with up to $360 million in potential development and sales milestones and other payments, plus royalties on sales of any compounds successfully commercialized from the Licensed Intellectual Property.
     The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the License Agreement, a copy of which will be filed as an exhibit to OSI’s next annual report filed with the United States Securities and Exchange Commission.
ITEM 8.01. Other Events.
     On January 5, 2007, OSI announced that it had entered into the License Agreement with Eli Lilly. A copy of OSI’s press release, dated January 4, 2007, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
     On January 9, 2007, OSI announced that its 2.0% Convertible Senior Notes due 2025 (the “Notes”) are now convertible at the option of the holders and will remain convertible through March 30, 2007, the last trading day of the current fiscal quarter, as provided for in the Indenture governing the Notes. A copy of OSI’s press release, dated January 9, 2007, is attached hereto as Exhibit 99.2 and is incorporated herein by reference. A notice setting forth the procedures for converting the Notes has been provided to the holders of the Notes in accordance with the terms of the Indenture and is attached hereto as Exhibit 99.3 and is incorporated herein by reference.
     On January 10, 2007, Genentech, Inc., OSI’s partner for the distribution and sale in the United States of its oncology drug, Tarceva® (erlotinib), announced that the U.S. net sales of Tarceva for the quarter and year ended December 31, 2006 were approximately $107 million and $402 million, respectively.

 


Table of Contents

ITEM 9.01. Financial Statements and Exhibits.
           
 
  Exhibit No.     Description  
 
99.1
    Press release, dated January 5, 2007  
 
99.2
    Press release, dated January 9, 2007  
 
99.3
    Form of Notice to Holders of 2.0% Convertible Senior Notes due 2025  
 

3


Table of Contents

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: January 10, 2007   OSI PHARMACEUTICALS, INC.
 
           
    By:   /s/ Barbara A. Wood
         
 
      Name:   Barbara A. Wood
 
      Title:   Vice President, General Counsel and Secretary


Table of Contents

EXHIBIT INDEX
           
 
  Exhibit No.     Description  
 
99.1
    Press release, dated January 5, 2007  
 
99.2
    Press release, dated January 9, 2007  
 
99.3
    Form of Notice to Holders of 2.0% Convertible Senior Notes due 2025  
 

EX-99.1 2 y28812exv99w1.htm EX-99.1: PRESS RELEASE EX-99.1
 

     Exhibit 99.1
(OSI LOGO)
NEWS RELEASE
Contact:
         
 
  OSI Pharmaceuticals, Inc.   Eli Lilly and Company
 
  Kathy Galante (Investors/Media)   Mark E. Taylor
 
  Senior Director   317-276-5795
 
  631-962-2043    
 
  Kim Wittig (Media)    
 
  Director    
 
  212-824-3204    
OSI PHARMACEUTICALS LICENSES ITS GLUCOKINASE
ACTIVATOR PROGRAM FOR THE TREATMENT OF TYPE 2
DIABETES TO ELI LILLY AND COMPANY
MELVILLE, NEW YORK — January 5, 2007 — OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) and Eli Lilly and Company (NYSE:LLY) announced today that OSI’s diabetes and obesity subsidiary, Prosidion Limited, has entered into a licensing agreement granting Lilly exclusive rights to its Glucokinase Activator (GKA) program, which includes the lead compound PSN010. Under the terms of the agreement, OSI will receive an upfront fee of $25 million, up to $360 million in potential development and sales milestones and other payments plus royalties on sales of any compounds successfully commercialized from the program.
“We believe this licensing arrangement with a global leader in the field of diabetes like Lilly is an important validation of our diabetes and obesity research portfolio,” stated Colin Goddard, Ph.D., Chief Executive Officer, OSI Pharmaceuticals. “Under Anker Lundemose’s leadership, our UK-based subsidiary, Prosidion, has established a portfolio of innovative drug candidates and demonstrated an ability to rapidly and effectively advance drug candidates to a clinical proof-of-concept.”
David Moller, M.D., Lilly, Vice President, Endocrine and Cardiovascular Research and Clinical Investigation commented, “This in-licensing agreement will help bolster Lilly’s early stage pipeline and will augment one of our core therapeutic areas. We are committed to maintaining our leadership role in diabetes care, including addressing the increasing prevalence of type 2 diabetes. We will continue to seek out innovative molecules to add to our diabetes portfolio in order to best respond to the growing health crisis posed by diabetes worldwide.”

 


 

GKAs represent a new approach to diabetes therapy. GKAs like PSN010 are designed to attenuate hyperglycemia by rapidly lowering blood glucose levels through a dual mechanism of increasing glucose uptake in the liver and potentiating insulin secretion from the pancreas. PSN010 is currently in Phase I clinical trials. PSN010 was discovered and developed in-house through OSI’s diabetes and obesity research efforts. The project arose from a research collaboration with the Vanderbilt University Diabetes Center and Tanabe Seiyaku Co. Ltd. and is part of an innovative pipeline of diabetes and obesity research assets being pursued through Prosidion.
About Diabetes
According to the International Diabetes Federation, diabetes affects more than 230 million people worldwide and is expected to affect 350 million by 2025. In 2003, the five countries with the largest number of people with diabetes were India, China, the United States, Russia and Japan. Each year a further 7 million people develop diabetes and each year over 3 million deaths are tied directly to diabetes making it the fourth leading cause of death by disease globally.
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. For additional information about OSI, please visit <http://www.osip.com>.
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 y28812exv99w2.htm EX-99.2: PRESS RELEASE EX-99.2
 

Exhibit 99.2
(OSI LOGO)
NEWS RELEASE
     
Contacts:
   
OSI Pharmaceuticals, Inc.
  Burns McClellan, Inc. (representing OSI)
Kathy Galante (investors/media)
  Justin Jackson (media)/Laura Siino (investors)
631-962-2000 
  212-213-0006 
OSI Pharmaceuticals Announces Conversion Period for Convertible Notes
MELVILLE, NY — January 9, 2007 — OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that its 2.0% Convertible Senior Notes due 2025 (the “notes”) are now convertible at the option of the holders and will remain convertible through March 30, 2007, the last trading day of the current fiscal quarter, as provided for in the Indenture governing the notes.
The notes became convertible as the Company’s common stock closed at or above $35.32 per share for twenty trading days within the thirty trading day period ending on December 29, 2006. As a result, during the conversion period commencing January 1, 2007 and continuing through and including March 30, 2007, holders of the notes may, if they elect, convert the notes into shares of common stock, subject to the terms of the related Indenture. The notes are convertible at the conversion rate of 33.9847 shares per $1,000 principal amount of each Note or an effective conversion price of $29.43 per share. There is currently outstanding $115 million principal amount of the notes.
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. For additional information about OSI, please visit <http://www.osip.com>.

 


 

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 review process 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-99.3 4 y28812exv99w3.htm EX-99.3: FORM OF NOTICE TO HOLDERS EX-99.3
 

Exhibit 99.3
OSI Pharmaceuticals, Inc.
41 Pinelawn Road
Melville, NY 11747
T. 631.962-2000 F. 631.752-3880
www.osip.com
(OSI LOGO)
     
To:
  Holder of 2% Convertible Senior Subordinated Notes Due 2025 of
 
  OSI Pharmaceuticals, Inc. CUSIP No’s. 671040AE3 and 671040AF0
From:
  Michael G. Atieh, Chief Financial Officer
 
   
Date:
  January 9, 2007
 
   
Subject:
  Notice of Convertibility
 
     Pursuant to Section 4.2(j) of the Indenture, by and between OSI Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and The Bank of New York, a New York banking corporation, as Trustee and Conversion Agent, dated as of December 21, 2005 (the “Indenture”), notice is hereby given of the occurrence of the event (“Triggering Event”) specified in Section 4.1(a)(i) of the Indenture triggering the convertibility of the 2% Convertible Senior Subordinated Notes due 2025 (the “Notes”) into shares of common stock, $.01 par value, of the Company (“Common Stock”). As a result, the Notes are convertible, during the period commencing January 1, 2007, and terminating March 30, 2007, at the rate of 33.9847 shares of Common Stock for each $1,000 principal amount of the Notes, subject to the terms of the Indenture. Capitalized terms used in this notice and not otherwise defined herein shall have the respective meanings ascribed thereto in the Indenture.
     Section 4.1(a)(i) of the Indenture provides that the Notes shall become convertible prior to December 15, 2020, if, during any fiscal quarter (beginning with the quarter ending after March 31, 2006), the Closing Sale Price of the Common Stock for at least 20 Trading Days during the last 30 consecutive Trading Days of the immediately preceding fiscal quarter (the “Measurement Period”) exceeds 120% of the Conversion Price in effect on the last Trading Day of such Measurement Period.
     No adjustment to the Conversion Rate pursuant to Section 4.13 of the Indenture has taken effect as a result of the Triggering Event.
     The following sets forth the procedures Holders must follow to convert their Notes:
          To surrender a Note for conversion, a Holder must comply with the Applicable Procedures of The Depositary Trust Company currently in effect.

 


 

          No payment or adjustment will be made for accrued and unpaid interest (including Additional Interest, if any) or dividends on the shares of Common Stock, except as provided in the Indenture.
          Unless the Company elects to satisfy its Conversion Obligation wholly or in part in Cash (as described below), the Notes will be convertible into fully paid and nonassessable shares (calculated to the nearest 1/100th of a share) of Common Stock at the rate of 33.9847 shares of Common Stock for each $1,000 principal amount of the Notes.
          The Company will not issue any fraction of a share of Common Stock in connection with any conversion of Notes, but instead will make a Cash payment equal to such fraction multiplied by the Relevant Average Price per Share of the Common Stock.
          On conversion by a Holder, such Holder will also receive the rights under the Company’s stockholder rights plan.
          Except as provided below with respect to an election by the Company to satisfy its Conversion Obligation wholly or partially in Cash, a Notice of Conversion will not be retractable.
          From and after the close of business on the Conversion Date of a Note, the person in whose name any certificate representing Common Stock issued pursuant to Section 4.2 of the Indenture, if any, is to be registered will be treated as a stockholder of record of the Company, and all rights of the Holder of such Note will terminate, other than the right to receive the Common Stock upon conversion of such Note as provided herein.
          If a Holder converts more than one Note at a time, the number of full shares of Common Stock issuable upon such conversion, if any, will be based on the aggregate principal amount of the Notes converted.
          If a Holder elects to convert all or any portion of a Security into shares of Common Stock, the Company may choose to satisfy all or any portion of the Conversion Obligation in Cash. Upon such election, the Company will notify such Holder through the Trustee of the dollar amount to be satisfied in Cash at any time on or before the date that is two Business Days following the Conversion Agent’s receipt of the Conversion Notice (such period, the “Cash Settlement Notice Period”). If the Company elects to pay Cash for any portion of the shares of Common Stock otherwise issuable to the Holder (other than after an irrevocable election as described in Section 4.2(b)(v) of the Indenture), the Holder may retract the Conversion Notice at any time during the two Business Day period beginning on the day after the final day of the Cash Settlement Notice Period (the “Conversion Retraction Period”); no such retraction can be made (and a Conversion Notice will be irrevocable) if the Company does not elect to deliver Cash in lieu of shares of Common Stock (other than Cash in lieu of fractional shares). If the Company elects to satisfy all or a portion of its Conversion Obligation in Cash and the Notice of Conversion has not been retracted, then settlement (in Cash or a combination of

 


 

     Cash and shares of Common Stock) will occur on the third Business Day following the Cash Settlement Averaging Period. If the Company elects to satisfy the entire Conversion Obligation in shares of Common Stock, then settlement will occur on the third Business Day following the Conversion Date. With respect to any Conversion Notice received by the Company and not retracted, the “Conversion Settlement Distribution” for any Security subject to such Conversion Notice will consist of Cash, Common Stock or a combination thereof, as selected by the Company as set forth below:
     (1) if the Company elects to satisfy the entire Conversion Obligation in shares of Common Stock, the Conversion Settlement Distribution will be a number of shares of Common Stock for each $1,000 principal amount of the Securities to be converted equal to the Conversation Rate, plus Cash for any fractional shares;
     (2) if the Company elects to satisfy the entire Conversion Obligation in Cash, the Conversion Settlement Distribution will be Cash for each $1,000 principal amount of the Securities in an amount equal to the product of:
     (A) the applicable Conversion Rate, and
     (B) the average of the Applicable Cash-Settlement Stock Price of the Common Stock for the 10 Trading Days beginning on the Trading Day immediately following the final day of the Conversion Retraction Period (the “Cash Settlement Averaging Period”); and
     (3) if the Company elects to satisfy a fixed portion (other than 100%) of the Conversion Obligation in Cash, the Conversion Settlement Distribution will consist of such Cash amount (“Cash Amount”) and a number of shares, for each $1,000 principal amount of the Securities, equal to the applicable Conversion Rate minus the number of shares of Common Stock equal to the Cash Amount divided by the average of the Applicable Cash-Settlement Stock Price of the Common Stock during the Cash Settlement Averaging Period (plus Cash for any fractional shares); provided, however, the number of shares of Common Stock will not be less than zero; provided, further, that the Company will pay Cash for any fractional shares.
         
    OSI PHARMACEUTICALS, INC.
 
       
 
  By:    
 
       
 
      Michael G Atieh
Executive Vice President and Chief
Financial Officer

 


 

CONVERSION NOTICE
          To convert this Note, check the box: ¨
          To convert only part of this Note, state the principal amount to be converted (must be $1,000 or an integral multiple of $1,000): $ .
          If you want the Cash paid to another person or the stock certificate, if any, made out in another person’s name, fill in the form below:
 
(Insert assignee’s soc. sec. or tax I.D. no.)
 
 
 
(Print or type assignee’s name, address and zip code)
     
 
  Your Signature:
 
   
Date:
   
 
   
 
  (Sign exactly as your name appears on the
other side of this Note)
 
   
*Signature guaranteed by:
   
 
   
By:
   
 
   
 
   
 
    * The signature must be guaranteed by an institution which is a member of one of the following recognized signature guaranty programs: (i) the Securities Transfer Agent Medallion Program (STAMP); (ii) the New York Stock Exchange Medallion Program (MSP); (iii) the Stock Exchange Medallion Program (SEMP); or (iv) such other guaranty program acceptable to the Trustee.

 

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