Attached files
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EX-99.3 - PRESS RELEASE DATED DECEMBER 29, 2009. - OSI PHARMACEUTICALS INC | v170891_ex99-3.htm |
EX-99.1 - PRESS RELEASE DATED DECEMBER 16, 2009. - OSI PHARMACEUTICALS INC | v170891_ex99-1.htm |
EX-99.2 - PRESS RELEASE DATED DECEMBER 22, 2009. - OSI PHARMACEUTICALS INC | v170891_ex99-2.htm |
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
December
16, 2009
______________________
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:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17
CFR230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act(17 CFR
240.14d-2(b))
¨ 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 December 16, 2009, OSI
Pharmaceuticals, Inc. (“OSI”) and Genentech, Inc., a wholly owned
member of the Roche Group, announced that the U.S. Food and Drug
Administration Oncologic Drugs Advisory Committee voted 12 to one recommending
against approval of Tarceva® (erlotinib) for first-line maintenance
use in people with advanced or metastatic non-small cell lung cancer whose
cancer has not progressed following first-line treatment with platinum-based
chemotherapy. A copy of OSI’s press release, dated
December 16, 2009, is attached hereto as Exhibit
99.1 and is incorporated
herein by reference.
On December 22, 2009, OSI provided an update to the preliminary
revenue and adjusted earnings per share growth rate guidance provided to investors at
OSI’s recent analyst
R&D day meeting on December 3, 2009. A copy of OSI’s press release, dated December
22, 2009, is attached hereto as Exhibit
99.2 and is incorporated
herein by reference. The information in this paragraph of Item 8.01 (including Exhibit 99.2) is being “furnished” and shall not be
deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of
that section, nor shall it be deemed incorporated by reference in any filing
under the Securities Act of 1933, as amended, or the Exchange Act, whether made
before or after the date of this report, except as shall be expressly set forth
by specific reference in such filing.
On December 29, 2009, OSI announced that the U.S. Patent &
Trademark Office has granted reissue patent RE41,065, replacing Tarceva's
composition of matter patent (formerly No.5,747,498). A copy of OSI’s press release, dated
December 29, 2009, is attached hereto as Exhibit
99.3 and is incorporated
herein by reference.
This
Current Report on Form 8-K contains “forward-looking statements” that do not
convey historical information, but relate to predicted or potential future
events, such as statements of our plans, strategies and intentions. These
statements can often be identified by the use of forward-looking terminology
such as “believe,” “expect,” “intend,” “may,” “will,” “should,” or “anticipate”
or similar terminology. All statements other than statements of historical facts
included in this Current Report on Form 8-K, including statements regarding the
updated guidance for investors, are forward-looking statements. All
forward-looking statements speak only as of the date of this Current Report on
Form 8-K. Except for OSI’s ongoing obligations to disclose material information
under the federal securities laws, OSI undertakes no obligation to update or
revise any forward-looking statements, whether as a result of new information,
future events or otherwise. In addition to the risks and uncertainties of
ordinary business operations and conditions in the general economy and the
markets in which OSI competes, the forward-looking statements of the Company
contained in this Current Report on Form 8-K are also subject various risks and
uncertainties, including those set forth in Item 1A, “Risk Factors”, in OSI’s
Annual Report on Form 10-K, for the fiscal year ended December 31, 2008, and in
its subsequent filings made with the Securities and Exchange
Commission.
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Item 9.01.
Financial Statements and Exhibits.
Exhibit
No.
|
Description
|
99.1
|
Press
Release dated December 16, 2009.
|
99.2
|
Press
Release dated December 22, 2009.
|
99.3
|
Press
Release dated December 29, 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.
Date: January 8, 2010 | OSI PHARMACEUTICALS, INC. | ||
|
By:
|
/s/ Barbara A. Wood | |
Barbara A. Wood | |||
Senior Vice President, General Counsel and Secretary | |||
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EXHIBIT
INDEX
Exhibit
No.
|
Description
|
99.1
|
Press
Release dated December 16, 2009.
|
99.2
|
Press
Release dated December 22, 2009.
|
99.3
|
Press
Release dated December 29, 2009.
|
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