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8-K - LIVE FILING - Savara Inc | htm_40442.htm |
ADVENTRX PHARMACEUTICALS RECEIVES PDUFA DATE FOR EXELBINE NDA
SAN DIEGO January 19, 2011 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 FDAs 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 FDAs 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 November2027.
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 Companys
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 ADVENTRXs 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 ADVENTRXs 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;
ADVENTRXs 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 ADVENTRXs competitors; ADVENTRXs 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 ADVENTRXs press releases and periodic filings with the Securities and Exchange
Commission. ADVENTRXs 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.
Company Contact:
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Investor Contact: | |
ADVENTRX Pharmaceuticals Ioana C. Hone (ir@adventrx.com) 858-552-0866 Ext. 303 |
Lippert/Heilshorn & Associates, Inc. Don Markley (dmarkley@lhai.com) 310-691-7100 |
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