ADVENTRX Receives Brand Name Acceptance for ANX-530
March 12 2010 - 8:00AM
PR Newswire (US)
SAN DIEGO, March 12 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the
U.S. Food and Drug Administration (FDA) has accepted the proposed
proprietary name "Exelbine(TM)" for the Company's product candidate
ANX-530 (vinorelbine injectable emulsion). "We are pleased with the
FDA's response to our proprietary name request and look forward to
continued regulatory progress on ANX-530," said Brian M. Culley,
Chief Executive Officer of ADVENTRX. Following completion of its
review process, the FDA concluded that "Exelbine" is acceptable
provided the information presented by ADVENTRX regarding the safety
of interchanging ANX-530 with other vinorelbine injectable products
is confirmed during review of an ANX-530 New Drug Application
(NDA). As previously announced, the Company submitted an NDA for
ANX-530 to the FDA in December 2009. In March 2010, the Company
announced that it had received a refusal-to-file letter from the
FDA regarding its ANX-530 NDA submission. In the letter, the FDA
indicated that the data included in the December 2009 NDA
submission from the intended commercial manufacturing site was
insufficient to support a commercially-viable expiration dating
period. The FDA identified only this one chemistry, manufacturing
and controls (CMC) reason for the refusal to file. ADVENTRX has
requested a face-to-face meeting with the FDA to understand its
requirements and define the path to a successful filing of an
ANX-530 NDA at the earliest possible time. About ADVENTRX
Pharmaceuticals ADVENTRX Pharmaceuticals is a specialty
pharmaceutical company whose product candidates are designed to
improve the performance of existing cancer treatments by addressing
limitations associated principally with their safety and use. More
information can be found on the Company'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 FDA determines that there is a safety concern related to
interchanging ANX-530 with other vinorelbine injectable products;
the risk that the FDA's requirements for an ANX-530 NDA to be
accepted for review do not justify continued development of
ANX-530; ADVENTRX's dependence on the success of ANX-530, and
increased uncertainty as to whether ANX-530 will receive regulatory
approval or be commercialized successfully; the potential that FDA
may not accept a resubmitted ANX-530 NDA for review, or that the
bioequivalence data and other information included in the ANX-530
NDA may not adequately support bioequivalence with Navelbine; the
potential that changes made in transferring the manufacturing
process for ANX-530 may result in a lack of comparability between
the commercial product and the material used in clinical trials,
and that FDA may require ADVENTRX to perform additional
non-clinical or clinical studies; the potential for FDA to impose
other requirements to be completed before or after approval of the
ANX-530 NDA; the risk that ADVENTRX will have insufficient capital
to support its operations during the FDA review of an ANX-530 NDA,
should a resubmitted ANX-530 be accepted; the risk that ADVENTRX
will pursue development activities at levels or on timelines, or
will incur unexpected expenses, that shortens the period through
which its operating funds will sustain it; the risk that ADVENTRX
will be unable to raise sufficient additional capital to
commercialize ANX-530, if an ANX-530 NDA is approved; 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: Brian Culley, Chief Executive
Officer of ADVENTRXPharmaceuticals, +1-858-552-0866; or investors,
Don Markley ofLippert/Heilshorn & Associates, Inc.,
+1-310-691-7100, dmarkley@lhai.com, forADVENTRX Pharmaceuticals Web
Site: http://www.adventrx.com/
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