UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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): March 3, 2005
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CYTOGEN CORPORATION
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(Exact Name of Registrant as Specified in Charter)
Delaware 000-14879 22-2322400
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(State or Other Jurisdiction (Commission File Number) (I.R.S. Employer
of Incorporation) Identification No.)
650 College Road East, CN 5308, Suite 3100, Princeton, NJ 08540
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(Address of Principal Executive Offices) (Zip Code)
Registrant's telephone number, including area code: (609) 750-8200
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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 March 3, 2005, Advanced Magnetics, Inc. and Cytogen Corporation
announced that the U.S. Food and Drug Administration's Oncologic Drugs Advisory
Committee (ODAC) voted 15 to 4 to not recommend approval of the proposed
indication for Combidex(R), Advanced Magnetics' investigational functional
molecular imaging agent. In making its recommendation, the committee cited
insufficient clinical data to support a broad indication for use of Combidex to
differentiate metastatic from non-metastatic lymph nodes across all cancer
types.
Combidex (ferumoxtran-10) consists of iron oxide nanoparticles for use in
conjunction with magnetic resonance imaging (MRI) to aid in the differentiation
of cancerous from non-cancerous lymph nodes.
Combidex received an approvable letter, subject to certain conditions, from
the FDA in June 2000. In September 2004, Advanced Magnetics submitted a complete
response to the approvable letter. A decision by the FDA on Combidex is expected
by the FDA-designated user fee goal date of March 30, 2005.
The full text of the March 3, 2005 press release issued in connection with
the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K,
and is incorporated herein by reference. The foregoing description is qualified
in its entirety by reference to such Exhibit.
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits.
Exhibit No. Description
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99.1 Press Release of Advanced Magnetics and Cytogen dated
March 3, 2005
SIGNATURES
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.
CYTOGEN CORPORATION
By: /s/ William J. Thomas
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William J. Thomas
Senior Vice President and General Counsel
Dated: March 3, 2005
EXHIBIT INDEX
Exhibit No. Description
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99.1 Press Release of Advanced Magnetics and Cytogen dated
March 3, 2005