ADVENTRX Provides Update on Strategic Transaction Process
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.