ADVENTRX Provides Update on Strategic Transaction Process
10 Februar 2009 - 3:00PM
PR Newswire (US)
Evaluation of multiple proposals for strategic transactions
on-going SAN DIEGO, Feb. 10 /PRNewswire-FirstCall/ -- 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 Company's
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(R). 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(R), 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 Company's
assets. More information can be found on ADVENTRX's web site at
http://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 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 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/delays 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
ADVENTRX's leadership by a committee of executive officers will
negatively impact ADVENTRX'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 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 ADVENTRX's stockholders
will not approve a strategic or capital-raising transaction
recommended by ADVENTRX's Board of Directors; and other risks and
uncertainties more fully described in ADVENTRX'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 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. DATASOURCE: ADVENTRX Pharmaceuticals,
Inc. CONTACT: Investors, Ioana C. Hone of ADVENTRX Pharmaceuticals,
+1-858-552-0866 Web site: http://www.adventrx.com/
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