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Filing
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 15, 2008 |
ADVENTRX Pharmaceuticals, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)
Delaware | 001-32157 | 84-1318182 |
_____________________ (State or other jurisdiction |
_____________ (Commission |
______________ (I.R.S. Employer |
of incorporation) | File Number) | Identification No.) |
6725 Mesa Ridge Road, Suite 100, San Diego, California | 92121 | |
_________________________________ (Address of principal executive offices) |
___________ (Zip Code) |
Registrants telephone number, including area code: | 858-552-0866 |
Not Applicable
______________________________________________
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 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 15, 2008, ADVENTRX Pharmaceuticals, Inc. (the "Company") issued a press release announcing that it is exploring a range of strategic options, including the sale or disposition of one or more of its product candidate programs, a strategic business merger and other transactions that maximize the value of Company’s assets, and that the Company is currently in discussions with several candidates for both strategic and partnering transactions. The press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The list of exhibits called for by this Item is incorporated by reference to the Exhibit Index filed with this report.
ADVENTRX cautions you that statements information included in this report and the press release attached hereto as Exhibit 99.1 that are not a description of historical facts are forward-looking statements that involve risks and assumptions that, if they materialize or do not prove to be accurate, could cause ADVENTRX’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that ADVENTRX will be unable to consummate a strategic or partnering transaction or will be unable to raise sufficient capital to fund the projects necessary to meet its goals, including funding the continued development and commercialization of its lead product candidates, ANX-530 and ANX 514; the risk that ADVENTRX’s stockholders will not approve a transaction recommended by ADVENTRX’s Board of Directors; the risk the FDA will
determine that ANX-530 and Navelbine® are not bioequivalent; the risk that the on-going study of ANX-514 does not demonstrate pharmacokinetic equivalence or bioequivalence; difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530 and ANX-514, including validating commercial manufacturers and suppliers and the potential for automatic injunctions regarding FDA approval of ANX-514; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings, including prior to the submission or the approval of an NDA for ANX-530 and ANX-514; the risk that the performance of third parties on whom the Company relies to conduct studies or evaluate the data, including clinical investigators, expert data monitoring committees, contract laboratories and contract research organizations, may be substandard, or they may fail to perform as expected; and other risks and uncertainties more fully described in ADVENT
RX’s press releases and periodic filings with the Securities and Exchange Commission. ADVENTRX’s public filings with the Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to update any forward-looking statement included in this report or the press release attached hereto as Exhibit 99.1 to reflect events or circumstances arising after the date on which it was made. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.
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.
ADVENTRX Pharmaceuticals, Inc. | ||||
December 15, 2008 | By: |
/s/ Patrick L. Keran
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Name: Patrick L. Keran | ||||
Title: Vice President, Legal |
Exhibit Index
Exhibit No. | Description | |
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99.1
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Press release, dated December 15, 2008 |
ADVENTRX EXPLORING STRATEGIC OPTIONS
SAN DIEGO December 15, 2008 ADVENTRX Pharmaceuticals, Inc. (Amex: ANX), a biopharmaceutical company focused on in-licensing, developing and commercializing proprietary product candidates primarily for the treatment of cancer, today announced that it is exploring a range of strategic options, including the sale or disposition of one or more of its product candidate programs, a strategic business merger and other transactions that maximize the value of Companys assets. The Company is currently in discussions with several candidates for both strategic and partnering transactions.
Publicly announcing our exploration of strategic alternatives provides the best opportunity to find a partner who wishes to acquire one or both of our late-stage oncology assets, stated Mark Bagnall, the Companys Executive Vice President and Chief Financial Officer. As we expand our horizons, we continue both our on-going discussions with potential pharmaceutical partners and to conduct those activities that maintain the value of our lead programs. We believe that ADVENTRX offers its partners near-term up-side in an otherwise tumultuous market and has the potential to deliver attractive returns by way of its innovative lower-cost, lower-risk business model.
ADVENTRX currently is focused on commercializing two late-stage product candidates in the U.S., both of which are reformulations of currently approved products and are designed to improve the safety profile of the approved product without affecting its efficacy. ANX-514 (docetaxel emulsion) is a reformulation of the blockbuster chemotherapeutic agent, Taxotere®. In 2007, the aggregate worldwide market for Taxotere was in excess of $3 billion. ANX-530 (vinorelbine emulsion) is a reformulation of Navelbine® which, despite being a generic product for a number of years, still sells in excess of $200 million a year world-wide. Both of the Companys product candidates have the potential to be on the market in 2010.
In order to be considered by the Companys Board of Directors, proposals must be presented through a written term sheet that outlines the material terms and conditions of the proposed transaction and sources of funding. In evaluating the terms of a proposed transaction, the Board will focus on the timing of the proposed transaction and closing certainty, including limited closing conditions and financing contingencies. The Company does not intend to disclose developments with respect to this process unless and until the evaluation of all proposals and alternatives has been completed. Interested parties should contact Ioana C. Hone, Director, Investor Relations, at (858) 552-0866, extension 287.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company focused on in-licensing, developing and
commercializing proprietary product candidates primarily for the treatment of cancer. The Company
seeks to improve the performance and commercial potential of existing treatments by addressing
problems associated with these treatment regimens. More information can be found on the Companys
website at www.adventrx.com.
Forward Looking Statements
ADVENTRX cautions you that statements included in this press release that are not a description of
historical facts are forward-looking statements that involve risks and assumptions that, if they
materialize or do not prove to be accurate, could cause ADVENTRXs results to differ materially
from historical results or those expressed or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: the risk that ADVENTRX will be unable to
consummate a strategic or partnering transaction or will be unable to raise sufficient capital to
fund the projects necessary to meet its goals, including funding the continued development and
commercialization of its lead product candidates, ANX-530 and ANX 514; the risk that ADVENTRXs
stockholders will not approve a transaction recommended by ADVENTRXs Board of Directors; the risk
the FDA will determine that ANX-530 and Navelbine® are not bioequivalent; the risk that the
on-going study of ANX-514 does not demonstrate pharmacokinetic equivalence or bioequivalence;
difficulties or delays in manufacturing, obtaining regulatory approval for and marketing ANX-530
and ANX-514, including validating commercial manufacturers and suppliers and the potential for
automatic injunctions regarding FDA approval of ANX-514; the potential for regulatory authorities
to require additional preclinical work or other clinical requirements to support regulatory
filings, including prior to the submission or the approval of an NDA for ANX-530 and ANX-514; the
risk that the performance of third parties on whom the Company relies to conduct studies or
evaluate the data, including clinical investigators, expert data monitoring committees, contract
laboratories and contract research organizations, may be substandard, or they may fail to perform
as expected; and other risks and uncertainties more fully described in ADVENTRXs press releases
and periodic filings with the Securities and Exchange Commission. ADVENTRXs public filings with
the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. ADVENTRX does not intend to update any forward-looking statement as set forth in this press release to reflect events or circumstances arising after the date on which it was made.
Investor Contact:
ADVENTRX Pharmaceuticals
Ioana C. Hone
858-552-0866
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