Within the next few days, Adventrx Pharmaceuticals Inc. (ANX) is expected to submit its New Drug Application for ANX-530, a novel emulsion formulation of chemotherapy drug Navelbine (vinorelbine). If submitted, the filing will mark the first NDA submission for Adventrx' drug.
Navelbine, a branded formulation of vinorelbine, is approved in the U.S. to treat advanced non-small cell lung cancer as a single agent or in combination with cisplatin, and approved in the European Union to treat non-small cell lung cancer and advanced or metastatic breast cancer. According to the company, Navelbine, which, despite being a generic product for a number of years, still sells in excess of $200 million a year world-wide. Adventrx is planning to seek approval of ANX-530 for the same indications as Navelbine.
Adventrx has yet another late-stage product candidate ANX-514 (docetaxel emulsion for injection), a reformulation of the blockbuster chemotherapeutic agent, Taxotere.
Incorporated under the name Victoria Enterprises, Inc. in December 1995, the company began operations in 1996. The name was subsequently changed to "BioQuest, Inc." then to "Biokeys Pharmaceuticals, Inc." and finally to "ADVENTRX Pharmaceuticals, Inc." in May 2003. The company's common stock trades on the American Stock Exchange (Amex).
The company has incurred annual net losses since inception and has not generated any revenue from product sales to date. As mentioned earlier, the NDA for ANX-530 will be the first for the company if it is successfully filed.
As of September 30, 2009, the company had cash and cash equivalents of $3.2 million and in October raised $6 million from equity financing. The company, which has zero debt, believes that its cash on hand will be sufficient to permit it to continue operations through 2010.
ANX, which has been trading in the range of $0.07-$0.25 over the past twelve months, closed Friday's trading at $0.19.
by RTT Staff Writer
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