ADVENTRX Announces Restructuring and Cost Reduction Initiatives
- Company to Present Updated Corporate Outlook at Conferences in October
SAN DIEGO, Oct. 20 /PRNewswire-FirstCall/ -- ADVENTRX Pharmaceuticals, Inc. (Amex: ANX) announced today that it has implemented a restructuring designed to reduce operating costs while continuing advancement towards the Company's near term goals. ADVENTRX will focus its resources solely on the continued development and regulatory approvals of ANX-530 (vinorelbine emulsion) and ANX- 514 (docetaxel emulsion). The restructuring reduced the Company's staff by a total of nine employees, or approximately 27% of its workforce. These changes will allow the Company to retain the appropriate personnel to submit New Drug Applications (NDAs) for both ANX-530 and ANX-514, and are expected to provide ADVENTRX with cash sufficient to fund operations until mid-2009. In addition, the Company announced that it is revising its timelines for ANX-530 and ANX- 514. Additional information regarding the restructuring and program timelines are provided below.
ADVENTRX also announced that Evan M. Levine has resigned his positions as Chief Executive Officer and President, effective October 17, 2008, to pursue other opportunities. Mr. Levine will continue to serve on the Company's Board of Directors. The Company intends to conduct a search for a replacement Chief Executive Officer. In the interim, consistent with the Company's CEO succession plan, ADVENTRX will be led by a committee of executive officers.
'We thank Evan for his leadership and contributions to the Company and wish him the best in his future endeavors,' stated Jack Lief, Chair of the Company's Board of Directors. 'While the decision to let go employees, particularly those who have been with the Company for many years, was difficult, the changes announced today give the Company the opportunity to advance its lead product candidates towards commercialization and to demonstrate their value, which we believe has been underappreciated by the market,' added Mr. Lief.
ANX-530 and ANX-514 Timelines
ADVENTRX has entered into an agreement with a new contract manufacturer to conduct process development and scale-up activities for both ANX-530 and ANX- 514. Last week, the Company attended a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss its NDA submission for ANX-530. The FDA requested additional information regarding the Company's new manufacturer, and as a result, ADVENTRX anticipates the submission of its NDA for ANX-530 will take place in the second quarter of 2009.
ADVENTRX also announced that it anticipates completing patient enrollment in its registrational bioequivalence clinical study of ANX-514 in the first quarter of 2009. The Company expects to announce results from this study in the second quarter of 2009.