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
Date of Report (Date of earliest event reported): December 13, 2006
CELGENE CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 0-16132 22-2711928
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(State or other jurisdiction of (Commission File Number) (IRS Employer
incorporation) Identification No.)
86 Morris Avenue, Summit, New Jersey 07901
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (908) 673-9000
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(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 (see General Instruction A.2. below):
[_] Written communications pursuant to Rule 425 under the Securities Act (17
CFR 230.425)
[_] 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 13, 2006, Celgene Corporation, or the Company, announced that it has
been notified of an Abbreviated New Drug Application (ANDA) filed with the U.S.
Food and Drug Administration (FDA), with a Paragraph IV certification, by Barr
Pharmaceuticals, Inc. This applicant is seeking authorization to market a
generic version of thalidomide 200 mg tablets in the United States for the acute
treatment of cutaneous manifestations of moderate to severe erythema nodosum
leprosum (ENL).
The Company intends to file a complaint alleging infringement of Celgene
patents, within the required forty-five day response period. By bringing suit,
Celgene is entitled to up to a 30-month injunction against the applicant's
marketing of generic thalidomide. The Company has seven issued patents which
cover methods of more safely administering thalidomide through S.T.E.P.S.(R),
an integral part of the FDA approved THALOMID(R) labeling and additional broad
patents protecting methods of using thalidomide in the treatment of
hematological and solid tumor cancers.
Attached hereto as Exhibit 99.1 is the Press Release announcing this event.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS.
Exhibit 99.1 Press Release dated December 13, 2006 announcing the notification
of an ANDA filing for thalidomide.
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CELGENE CORPORATION
Date: December 13, 2006 By: /s/ Robert J. Hugin
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Name: Robert J. Hugin
Title: President and
Chief Operating Officer
EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
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Exhibit 99.1 Press Release dated December 13, 2006 announcing the notification
of an ANDA filing for thalidomide.