-----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, KmdEBg9IC1lVy81mgnEq+tDoY0RjUB5SmK74X+lruYrmii0z8y4WDqAnyVDKyyL0 HvagtDHsnWesgeeYdAtroQ== 0000950123-07-006073.txt : 20070426 0000950123-07-006073.hdr.sgml : 20070426 20070426170217 ACCESSION NUMBER: 0000950123-07-006073 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070420 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070426 DATE AS OF CHANGE: 20070426 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: 07792095 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 y34054e8vk.htm FORM 8-K FORM 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
April 20, 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))
 
 

 


 

ITEM 1.01. Entry into a Material Definitive Agreement.
     On April 20, 2007 (the “Effective Date”), (OSI) Eyetech, Inc., a wholly-owned subsidiary of OSI Pharmaceuticals, Inc. (the “Company”), and Pfizer Inc. agreed to terminate a Collaboration Agreement, dated as of December 17, 2002, between the parties with respect to the co-promotion of Macugen® (pegaptanib sodium injection) in the United States. (OSI) Eyetech and Pfizer also agreed to amend and restate a License Agreement, dated as of December 17, 2002 (as amended and restated, the “Amended and Restated License Agreement”), pursuant to which (OSI) Eyetech had originally granted to Pfizer a number of exclusive licenses or sublicenses to patents and other intellectual property related to Macugen on a world-wide basis. Under the terms of the Amended and Restated License Agreement, Pfizer has agreed to return to (OSI) Eyetech all rights to develop and commercialize Macugen in the United States, and (OSI) Eyetech has granted to Pfizer an exclusive right to develop and commercialize Macugen in the rest of the world. The parties have also agreed to provide each other with certain transitional services following the Effective Date. As previously disclosed by the Company, (OSI) Eyetech has restructured its relationship with Pfizer to help facilitate a successful divestiture of the Company’s eye disease business.
     The foregoing description of the Amended and Restated License Agreement does not purport to be complete and is qualified in its entirety by reference to the Amended and Restated License Agreement, a copy of which will be filed with the United States Securities and Exchange Commission as an exhibit to the Company’s next quarterly report on Form 10-Q.
Item 8.01. Other Events.
     On April 25, 2007, the Company issued a press release announcing that results published in the Journal of Clinical Oncology showed that adding Tarceva to gemcitabine chemotherapy improved survival when administered as first-line therapy to patients with advanced pancreatic cancer. A copy of the press release, dated April 25, 2007, is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
ITEM 9.01 Financial Statements and Exhibits.
(d) Exhibits.
     
Exhibit No.   Description
99.1
  Press release, dated April 25, 2007

 


 

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: April 26, 2007   OSI PHARMACEUTICALS, INC.
 
 
  By:   /s/ Barbara A. Wood    
    Barbara A. Wood   
    Vice President, General Counsel and Secretary   

 


 

         
EXHIBIT INDEX
     
Exhibit No.   Description
99.1
  Press release, dated April 25, 2007

 

EX-99.1 2 y34054exv99w1.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)   Lauro Siino (Investors)
 
  Senior Director   212-213-0006 
 
  631-962-2043    Kathy Nugent (Media)
 
  Kim Wittig (Media)   205-401-0260 
 
  Director    
 
  631-962-2135     
OSI PHARMACEUTICALS ANNOUNCES PIVOTAL PHASE III TARCEVAâ
STUDY PUBLISHED IN THE JOURNAL OF CLINICAL ONCOLOGY SHOWED
SURVIVAL IMPROVEMENT IN PATIENTS WITH PANCREATIC CANCER
MELVILLE, NY — April 25, 2007 — OSI Pharmaceuticals, Inc. (Nasdaq: OSIP) announced today that results published yesterday in the Journal of Clinical Oncology show that adding Tarcevaâ (erlotinib) to gemcitabine chemotherapy significantly improves survival when administered as first-line therapy to patients with advanced pancreatic cancer. Data from this study, conducted by the National Cancer Institute of Canada (NCIC), formed the basis of both the U.S. and European approvals for Tarceva in this patient population.
“This study is important because it shows the benefit of a new approach to treat this deadly disease,” said Dr. Malcolm Moore, Study Chair and Chief of Medical Oncology and Hematology at Princess Margaret Hospital, University of Toronto. “This is the first study in ten years to demonstrate an improvement in survival in pancreatic cancer, and as a physician I’m delighted to have additional treatment options for my patients.”
In November 2005, the U.S. Food and Drug Administration (FDA) approved the use of Tarceva (100 mg) in combination with gemcitabine for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in patients who have not received previous chemotherapy. The approval was based on this pivotal Phase III study, which demonstrated a 23% improvement in overall survival with gemcitabine plus Tarceva versus gemcitabine alone. In January 2007, the European Commission granted marketing authorization for Tarceva in combination with gemcitabine for the treatment of metastatic pancreatic cancer. This indication for Tarceva is also approved in 15 other countries worldwide.
- more -

 


 

About Pancreatic Cancer
Pancreatic cancer affects more than 216,000 people worldwide, according to the World Health Organization. In the US, pancreatic cancer accounts for just two percent of new cancer cases each year, but is the fifth leading cause of cancer death. Pancreatic cancer is difficult to treat, as it is often resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body, leading to its high mortality and short life expectancy.
The main risk factors for the disease include advanced age, cigarette smoking, a high-fat diet, diabetes mellitus, chronic inflammation of the pancreas (pancreatitis) — especially hereditary pancreatitis — and a family history of pancreatic cancer. The symptoms vary depending upon the location of the tumor in the pancreas, but include weight loss, abdominal pain and jaundice.
Additional Tarceva Information
Tarceva (150 mg) was approved by the FDA in November 2004 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one chemotherapy regimen. Results from two earlier large, randomized, placebo-controlled Phase III clinical trials in first-line advanced NSCLC patients showed no clinical benefit with concurrent administration of Tarceva with doublet platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and cisplatin) and its use is not recommended in that setting. Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (HER1) pathway, one of the factors critical to cell growth in NSCLC and other solid tumors. HER1, also known as EGFR, is a component of the HER signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signaling pathway inside the cell, which may block tumor cell growth. Tarceva is the only HER1/EGFR-targeted therapy proven to significantly prolong survival in second-line NSCLC as a single agent, and in pancreatic cancer when added to gemcitabine.
For Tarceva full prescribing information, please call 1-877-TARCEVA or visit http://www.tarceva.com.
Tarceva Safety Profile
There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer, or other advanced solid tumors. In the pancreatic cancer trial, other serious adverse events associated with Tarceva, and which may have included fatalities, were myocardial infarction/ischemia, cerebrovascular accident, and microangiopathic hemolytic anemia with thrombocytopenia. The most common side effects in patients with pancreatic cancer receiving Tarceva (100 mg) plus gemcitabine were fatigue, rash, nausea, anorexia, and diarrhea. Severe rash (5%) and severe diarrhea (5%) each resulted in dose reductions in 2% of patients, and discontinuation in up to 1% of patients. The most common side effects in patients with NSCLC receiving Tarceva monotherapy (150 mg) were mild to moderate rash (9%) and diarrhea (6%) which resulted in 1% of Tarceva-treated patients discontinuing therapy. When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding.

 


 

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.
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