ADVENTRX Narrows Prior Guidance on NDA Submission Timeline
August 04 2009 - 4:05PM
Business Wire
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced
that it intends to submit an NDA for ANX-530 (vinorelbine emulsion)
by the end of 2009. The Company successfully completed the final
manufacturing activities required for the NDA submission, which
activities were re-started following the Company’s June 2009 equity
financing.
“Our recently completed manufacturing activities represented the
last major hurdle before our NDA submission,” said Brian M. Culley,
Principal Executive Officer at ADVENTRX. “While we continue to
evaluate the bioequivalence and preclinical data, we have begun the
substantial process of compiling the information required for a
submission, which we expect to take place by the end of this
year.”
About ANX-530 (vinorelbine emulsion)
ANX-530 is a novel emulsion formulation of the chemotherapy drug
vinorelbine. 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. Worldwide sales
of Navelbine and its generic equivalents in 2006 were in excess of
$200 million. The ANX-530 formulation emulsifies vinorelbine into a
homogeneous suspension of nanoparticles that may reduce exposure of
the venous endothelium during administration of the drug.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a biopharmaceutical company whose
product candidates are designed to improve the safety of existing
cancer treatments. More information can be found on the Company’s
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
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 raise sufficient additional
capital on a timely basis to submit an NDA for ANX-530, to fund
operations during the FDA review period if an NDA is submitted, or
to conduct pre-launch activities should an NDA for ANX-530 be
submitted or launch activities should an NDA for ANX-530 be
approved; the risk that ADVENTRX will be unable to raise sufficient
additional capital on a timely basis to continue as a going
concern; the risk that ADVENTRX will seek protection under the
provisions of the U.S. Bankruptcy Code; the risk that ADVENTRX will
reassess the results of the ANX-530 bioequivalence study and
determine to conduct additional bioequivalence studies of ANX-530,
including in humans; the potential for regulatory authorities to
require additional preclinical work and/or clinical activities to
support regulatory filings, including prior to the submission or
the approval of an NDA for ANX-530, which activities may increase
the cost and timeline to NDA submission or approval; the risk the
FDA will determine that ANX-530 and Navelbine® are not
bioequivalent, including as a result of performing pharmacokinetic
equivalence analysis based on a patient population other than the
population on which ADVENTRX based its analysis; 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, including
validating commercial manufacturing processes and manufacturers, as
well as suppliers; 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; 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
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.
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