ADVENTRX Receives Refuse to File Letter from FDA on ANX-530 New Drug Application
March 01 2010 - 12:00AM
PR Newswire (US)
SAN DIEGO, March 1 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that it
received a refuse to file letter from the U.S. Food and Drug
Administration (FDA) regarding its New Drug Application (NDA) for
ANX-530 (vinorelbine injectable emulsion). In the letter, the FDA
indicated that the data included in the initial submission from the
intended commercial manufacturing site was insufficient to support
a commercially-viable expiration dating period. FDA identified only
the one chemistry, manufacturing and controls (CMC) reason for the
refusal to file. ADVENTRX plans to meet with the FDA as soon as
possible to discuss its response. To support a commercially-viable
expiration dating period, the stability data provided in the
ANX-530 NDA met ICH filing requirements for a new drug.
Site-specific stability data from lots manufactured at the intended
commercial manufacturing site also were submitted in the NDA. "We
believed, following discussions with the FDA at a pre-NDA meeting,
the stability data package included in our initial submission
supported both NDA acceptance and appropriate expiration dating.
However, we now expect FDA will require additional site-specific
stability data to accept our application. Although we plan to
discuss the particular filing requirements with the reviewing
chemists, site-specific stability studies are already ongoing and
our recent financings provide us the capital to continue this work
and, we expect, resubmit the application," said Brian M. Culley,
Chief Executive Officer at ADVENTRX. "We will work closely with the
Agency to understand its new requirements and define the path to a
successful resubmission at the earliest possible time," Mr. Culley
continued. ADVENTRX submitted the NDA for ANX-530 on December 30,
2009. Based on current regulations, once an NDA is submitted to the
FDA, FDA has 60 days to preliminarily review the NDA submission and
assess whether the NDA is sufficiently complete to permit a
substantive review. If it determines that the NDA is not
sufficiently complete, the FDA issues a refuse to file letter to
the applicant. ADVENTRX plans to request a meeting with the FDA as
soon as possible to discuss its comments on the NDA submission and
to reach an understanding on what would be required for the ANX-530
NDA to be accepted for review. Conference Call and Webcast ADVENTRX
will hold a conference call on Monday, March 1, 2010 beginning at
9:00 a.m. Eastern time to review the developments discussed in this
news release. Individuals interested in listening to the conference
call may do so by dialing (866) 305-6438 for domestic callers, or
(706) 679-7161 for international callers, or from the webcast on
the investor relations section of the Company's Web site at
http://www.adventrx.com/. A 48-hour telephone replay will be
available approximately one hour after the conclusion of the call
by dialing (800) 642-1687 for domestic callers, or (706) 645-9291
for international callers, and entering reservation code 60223016.
The webcast will be available on the Company's Web site for 14 days
following the completion of the call. 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: FDA's
requirements for the 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, including as a result of performing
pharmacokinetic equivalence analyses based on a patient population
other than the population on which ADVENTRX based its analysis; 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; ADVENTRX's reliance on third parties to assist with
its bioequivalence trials, regulatory submissions, manufacturing
and other important aspects of the ANX-530 development program, and
the risk that FDA approval may be delayed if their performance is
found to have been substandard; the possibility that patent claims
covering ANX-530 will not issue or, if they do, that such claims,
which likely will be limited to a specific intravenous emulsion
formulation of vinorelbine, will not be sufficient to preclude
development of other formulations of vinorelbine by competitors;
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; the risk that
ADVENTRX will have insufficient capital to support its operations
during the FDA review of the ANX-530 NDA, including as a result of
FDA requesting or ADVENTRX providing additional information or
clarification with respect to such submission or the FDA not
completing its review by the ANX-530 "PDUFA date," 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 the 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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