SAN DIEGO, Jan. 19, 2011 /PRNewswire/ -- ADVENTRX
Pharmaceuticals, Inc. (NYSE Amex: ANX) announced today that the
U.S. Food and Drug Administration (FDA) has established a
Prescription Drug User Fee Act (PDUFA) date of September 1, 2011 for the review of the Exelbine
(ANX-530) New Drug Application (NDA). The acceptance of the
Exelbine NDA is the FDA's determination that the application is
sufficiently complete to permit a substantive review, and the PDUFA
date is the goal date for the FDA to complete its review of the
NDA.
"With a September PDUFA date established in the Day 74 letter
from the FDA, we look forward to working closely with the Agency on
moving Exelbine toward approval this year," said Brian M. Culley, Chief Executive Officer of
ADVENTRX.
About Exelbine
ADVENTRX is seeking approval of Exelbine for the same
indications as Navelbine®, a branded formulation of vinorelbine,
including non-small cell lung cancer. ADVENTRX submitted the
NDA as a 505(b)(2) application that relies in part on the FDA's
findings of safety and effectiveness of a reference drug. The
Exelbine NDA includes data from one clinical bioequivalence study
designed to assess the pharmacokinetic equivalence of Exelbine and
Navelbine, the reference drug. In this clinical
bioequivalence study, Exelbine and the reference drug were
determined by ADVENTRX to be bioequivalent.
ADVENTRX retains exclusive worldwide rights to Exelbine, other
than in South Korea, China, Hong
Kong, Macau and
Taiwan. In March 2010, the FDA conditionally accepted
"Exelbine" as the proposed proprietary name for ANX-530. The
United States Patent and Trademark Office has allowed patent claims
related to Exelbine, which claims issued in January 2011 and will expire in November 2027.
About ADVENTRX Pharmaceuticals
ADVENTRX Pharmaceuticals is a specialty pharmaceutical company
whose product candidates are being developed to improve the
performance of existing anti-cancer drugs 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 are based on ADVENTRX's current
expectations and assumptions. Such forward-looking statements
include, but are not limited to, statements regarding the timing
and receipt of regulatory approval of Exelbine based on the
505(b)(2) NDA accepted for filing, working with the FDA in the
regulatory review process and the bioequivalence of Exelbine and
Navelbine. Actual events or results may differ materially from
those expressed or implied by the forward-looking statements in
this press release due to a number of risks and uncertainties,
including, without limitation: the risk that ADVENTRX does not
receive FDA approval of Exelbine on a timely basis, or at all; the
potential for the FDA to determine that the bioequivalence data and
other information included in the Exelbine NDA does 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 Exelbine may result in a lack of
comparability between the commercial product and the material used
in the bioequivalence trial; the risk that results of future
stability testing on samples of Exelbine do not support
comparability between ADVENTRX's prior and intended commercial
manufacturing sites or a commercially-viable expiration dating
period; the potential for the FDA to impose other requirements to
be completed before or after approval of the Exelbine NDA,
including that the FDA may require ADVENTRX to perform additional
nonclinical, bioequivalence or clinical studies; ADVENTRX's
reliance on third parties to assist with its bioequivalence trials,
regulatory submissions, manufacturing and other important aspects
of the Exelbine development program, and the risk that FDA approval
may be delayed if their performance is found to have been
substandard; the risk that any patent issued to ADVENTRX may not
provide sufficient protection and market exclusivity for Exelbine
and may be challenged, invalidated, infringed or circumvented by
third parties, including by ADVENTRX's competitors; ADVENTRX's
dependence on the success of Exelbine as its first product
candidate to be submitted for regulatory approval; the potential
that ADVENTRX may require substantial additional funding to obtain
FDA approval for and commercialize Exelbine, and the risks inherent
in these activities; the potential for ADVENTRX to enter into a
commercial partnership or other strategic transaction relating to
Exelbine and that such partnership or transaction may not succeed
in commercializing Exelbine; 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 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 hereof, except as may be required by
law.
SOURCE ADVENTRX Pharmaceuticals, Inc.