SAN DIEGO, March 26 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that it will
meet the U.S. Food and Drug Administration (FDA) in Washington D.C. during the last week of
April 2010 to review the Company's
New Drug Application (NDA) for ANX-530 (vinorelbine injectable
emulsion) and the FDA's refusal-to-file letter.
ADVENTRX had 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.
"We look forward to meeting with the agency next month to
clarify the necessary steps for filing the ANX-530 NDA this year,"
said Brian M. Culley, Chief
Executive Officer of ADVENTRX.
ADVENTRX submitted an NDA for ANX-530 to the FDA in December 2009. The Company announced on
March 1, 2010 that it had received a
refusal-to-file letter from the FDA regarding that 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. No clinical or
nonclinical issues were identified.
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 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 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 the
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 the bioequivalence trial, and that the FDA may require ADVENTRX
to perform additional nonclinical or clinical studies; the
potential for the FDA to impose other requirements to be completed
before or after approval of the ANX-530 NDA; 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 re-submitted, accepted
for filing and ultimately 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 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.
SOURCE ADVENTRX Pharmaceuticals, Inc.