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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): | February 10, 2009 |
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 February 10, 2009, ADVENTRX Pharmaceuticals, Inc. (the "Company") issued a press release announcing, among other things, that it has received written indications of interest from numerous companies representing a range of strategic transactions and currently is evaluating all proposals and options. The Company also indicated that continued cost-containment measures may impact the timeline of its regulatory filings. A copy of the press release is attached as Exhibit 99.1 and 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 Current Report on Form 8-K.
This current report on Form 8-K contains forward-looking statements, including, but not limited to, statements related to the Company’s on-going strategic transaction process and its corporate timelines. These forward-looking statements are based on the Company’s current estimates and expectations and inherently involve significant risks and uncertainties. The Company’s actual results could differ materially from those anticipated in such forward-looking statements as a result of those risks and uncertainties, which include, without limitation, the risk that the Company will be unable to consummate a strategic or partnering transaction or raise sufficient capital to fund the projects necessary to meet its goals, including funding the continued development and commercialization of ANX-530 or ANX-514; the risk that the Company’s recent cost-containment measures, as well as any future workforce reductions and/or reductions/dela ys in spending, will further impact the Company’s development and commercialization plans, including its ability to achieve on time its previously stated goals; the risk that the departure of the Company’s former Chief Executive Officer and President and Executive Vice President and Chief Financial Officer and/or the Company’s leadership by a committee of executive officers will negatively impact the Company’s ability to execute its business plan or to maintain effective disclosure controls and procedures or internal control over financial reporting; the risk the FDA will determine that ANX-530 and Navelbine® are not bioequivalent, including as a result of performing pharmacokinetic equivalence analysis based a patient population other than the population on which the Company based its analysis; the risk that the bioequivalence study of ANX-514 does not demonstrate pharmacokinetic equivalence or bioequivalence to Taxotere®; the risk of investigator bias in reporting adve rse events as a result of the open-label nature of the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events associated with Navelbine and/or that decreased the reporting of adverse events associated with ANX-530; 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 its 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; the risk that the Company’s stockholders will not approve a strategic or capital-raising transaction recommended by the Company’s Board of Directors; and other risks and uncertainties more fully described in the Company’s periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this current report. The Company does not intend to update any forward-looking statement in this current report to reflect events or circumstances arising after the date on which it is filed with the Securities and Exchange Commission.
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. | ||||
February 10, 2009 | 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 of ADVENTRX Pharmaceuticals, Inc. dated February 10, 2009 |
ADVENTRX PROVIDES UPDATE ON STRATEGIC TRANSACTION PROCESS
Evaluation of multiple proposals for strategic transactions on-going
SAN DIEGO February 10, 2009 ADVENTRX Pharmaceuticals, Inc. (NYSE Alternext US: ANX) announced today that it has received written indications of interest from numerous companies representing a range of strategic transactions. The Company currently is evaluating all proposals and options. In December 2008, the Company announced that it was 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 the Companys assets.
We are pleased with the number and breadth of opportunities presented to us and are currently negotiating with interested parties, stated Brian M. Culley, Chief Business Officer of ADVENTRX. In order to provide sufficient flexibility to consummate a transaction on appropriate terms, we continue to curtail our spending. While this may impact the timelines of our regulatory filings, it is likely that a future partner would make the final decision on the timing of each NDA submission. However, we still remain on track to announce pharmacokinetic data from our bioequivalence study of ANX-514 in the second quarter.
About ANX-514 (docetaxel emulsion)
ANX-514 is a novel nano-emulsion formulation of the chemotherapy drug docetaxel, a formulation of
which is marketed under the brand name Taxotere®. ANX-514 is formulated without polysorbate 80 or
other detergents and is intended to reduce the severity and incidence of hypersensitivity
reactions. Docetaxel is an anti-cancer agent that acts by disrupting the cellular microtubular
network that is essential for cell division. Immunosuppressant premedication is recommended for
docetaxel therapy to reduce the incidence and severity of hypersensitivity reactions. Docetaxel is
approved to treat breast, non-small cell lung, prostate, gastric and head and neck cancers.
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drug vinorelbine. ANX-530 emulsifies
vinorelbine into a homogeneous suspension of nanoparticles that is designed to protect the venous
endothelium during administration into a peripheral vein. Navelbine®, a branded formulation of
vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent
or in combination with cisplatin, and approved in the European Union to treat non-small cell lung
cancer and advanced or metastatic breast cancer.
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. In December 2008, the Company 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 the Companys assets. More information can be found on ADVENTRXs web site 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 raise sufficient capital to fund the projects
necessary to meet its goals, including funding the continued development and commercialization of
ANX-530 or ANX-514; the risk that the Companys recent cost-containment measures, as well as any
future workforce reductions and/or reductions/delays in spending, will further impact the Companys
development and commercialization plans, including its ability to achieve on time its previously
stated goals; the risk that the departure of the Companys former Chief Executive Officer and
President and Executive Vice President and Chief Financial Officer and/or ADVENTRXs leadership by
a committee of executive officers will negatively impact ADVENTRXs ability to execute its business
plan or to maintain effective disclosure controls and procedures or internal control over financial
reporting; the risk the FDA will determine that ANX-530 and Navelbine are not bioequivalent,
including as a result of performing pharmacokinetic equivalence analysis based a patient population
other than the population on which ADVENTRX based its analysis; the risk that the bioequivalence
study of ANX-514 does not demonstrate pharmacokinetic equivalence or bioequivalence to Taxotere;
the risk of investigator bias in reporting adverse events as a result of the open-label nature of
the ANX-530 bioequivalence study, including bias that increased the reporting of adverse events
associated with Navelbine and/or that decreased the reporting of adverse events associated with
ANX-530; 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 ADVENTRX relies to conduct its
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; the risk that ADVENTRXs stockholders will not approve a strategic or
capital-raising transaction recommended by ADVENTRXs Board of Directors; 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 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 revise or update any forward-looking statement 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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