- Current report filing (8-K)
March 24 2009 - 12:31PM
Edgar (US Regulatory)
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 19, 2009
Date of Report (Date of earliest event reported)
OSI
PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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0-15190
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13-3159796
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(State or other jurisdiction of
incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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41 Pinelawn Road
Melville, NY 11747
(Address of principal executive offices)
(631) 962-2000
(Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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TABLE OF CONTENTS
Item 8.01. Other Events.
On March 19, 2009, OSI Pharmaceuticals, Inc. (OSI) together with Genentech, Inc.
(Genentech), OSIs collaborator for the distribution and sale in the United States of its
oncology drug, Tarceva
®
(erlotinib), announced that OSI has submitted a supplemental New Drug
Application to the U.S. Food and Drug Administration for the use of Tarceva as a first-line
maintenance therapy for people with advanced non-small cell lung cancer who have not progressed
following first-line treatment with platinum-based chemotherapy. Additionally, OSI and Genentech
announced that Roche, their international collaborator for Tarceva, filed an application in Europe
with the European Medicines Agency. A copy of OSIs press release, dated March 19, 2009, is
attached hereto as Exhibit 99.1 and is incorporated herein by reference.
On March 20, 2009, OSI announced that it filed two lawsuits in U.S. District Court in Delaware
against Teva Pharmaceuticals USA, Inc. and Mylan Pharmaceuticals, Inc. for infringement of three
patents associated with Tarceva: U.S. Patent Nos. 5,747,498, 6,900,221 and 7,087,613. A copy of
OSIs press release, dated March 20, 2009, is attached hereto as Exhibit 99.2 and is incorporated
herein by reference.
Item 9.01. Financial Statements and Exhibits.
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Exhibit No.
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Description
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99.1
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Press release, dated March 19, 2009.
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99.2
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Press release, dated March 20, 2009.
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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.
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Date: March 24, 2009
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OSI PHARMACEUTICALS, INC.
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By:
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/s/ Barbara A. Wood
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Barbara A. Wood
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Senior Vice President, General Counsel
and Secretary
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EXHIBIT INDEX
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Exhibit No.
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Description
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99.1
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Press release, dated March 19, 2009.
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99.2
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Press release, dated March 20, 2009.
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-3-
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