ADVENTRX Pharmaceuticals Submits ANX-530 New Drug Application Print E-mail
By Staff and Wire Reports   
Monday, 04 January 2010 07:31

Just after some traders had given up on the company's promise to submit their New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) announced on Monday that it had done just that.

ADVENTRX is seeking approval of ANX-530 for the same indications as Navelbine®, a branded formulation of vinorelbine, including non-small cell lung cancer.




Presentation on ANX-530


Now, shares of the company are expected to rally on the news in the days ahead, especially given the fact that ADVENTRX submitted the NDA as a 505(b)(2) application, which relies in part on the FDA's findings of safety and effectiveness of a reference drug (see presentation on right). 

The Company's 505(b)(2) NDA submission includes data from one clinical bioequivalence study designed to assess the pharmacokinetic equivalence of ANX 530 and Navelbine, the reference drug. 

"I congratulate our development team for achieving this important milestone on schedule in December, as planned.  ANX-530 has the potential to offer important benefits to cancer patients, and we look forward to working with FDA towards its approval," said Brian M. Culley, Principal Executive Officer of ADVENTRX. "The ANX-530 NDA submission is a key step in our strategy to create valuable products that improve the performance of currently approved drugs."

ANX-530 is ADVENTRX's proprietary emulsion formulation of vinorelbine.  Vinorelbine is a vesicant and venous irritant, and these adverse effects can limit its tolerability.  ANX-530 was designed to be bioequivalent to the reference drug while reducing the incidence and severity of vein irritation associated with intravenous delivery of the drug.  In a clinical bioequivalence study, ANX 530 and the reference drug were determined to be bioequivalent.

ADVENTRX acquired ANX-530 in 2006 and retains exclusive worldwide rights to ANX-530, other than in China, Hong Kong, Macau and Taiwan.

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.




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