ADVENTRX Announces Restructuring and Cost Reduction Initiatives
October 20 2008 - 6:00AM
PR Newswire (US)
- CEO Resigns; Executive Team Reorganized; 27% Reduction in Force
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. These changes will not affect the
Company's previously announced plans to submit an NDA for ANX-514
in the third quarter of 2009. Restructuring On October 14, 2008, a
total of nine employees were terminated, consisting of four in
research and development, two in clinical, two in selling, general
and administrative and one in regulatory/quality assurance. After
adjusting to reflect severance costs, these measures will reduce
the Company's compensation expenses in 2009 by approximately
$1,500,000. As part of the reorganization, Mark Erwin, previously
the Company's Vice President of Commercialization, was promoted to
Senior Vice President, Operations. In addition, the Company ended
its employment relationship with its Chief Scientific Officer, Vice
President, Medical Affairs and Vice President, Research and
Development. "This restructuring balances the difficult trade-off
between curtailing spending and conducting those activities that
continue to demonstrate and build the value of ANX-530 and ANX-514,
while efficiently moving towards becoming a commercial
organization," said Mark Bagnall, the Company's Executive Vice
President and Chief Financial Officer. "Our cash conservation
measures will cut our overall burn rate by approximately 50%,"
added Mr. Bagnall. The Company discontinued active work on all
product candidates other than ANX-530 and ANX-514, including its
CoFactor(R) program. Patients currently receiving CoFactor will
continue to receive treatment. With respect to ANX-530 and ANX-514,
until the Company has secured additional funding, it anticipates
focusing primarily on those activities relating to submitting NDAs
and may delay or significantly reduce spending on other work,
including activities related to product launches. Upcoming
Conferences The Company will present its updated corporate outlook
at the 3rd Annual BIOCOM Investor Conference in San Diego on
October 27th, 2008 at 2:30 p.m. Pacific Time, as well as at the 7th
Annual BIOInvestor Forum in San Francisco on October 30th, 2008 at
3:15 p.m. Pacific Time. The presentations will be webcast live via
the "Investors" section of the Company's web site at
http://www.adventrx.com/ under "Events." The webcasts will be
available for replay for 14 days and can be accessed through the
same link. About ANX-530 (vinorelbine emulsion) ANX-530 is a novel
emulsion formulation of the chemotherapy drug vinorelbine. ANX-530
emulsifies vinorelbine into a homogeneous suspension of
nanoparticles that is designed to protect the venous endothelium
during administration into a peripheral vein. Navelbine(R), 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. About ANX-514 (docetaxel emulsion) ANX-514 is a novel
nano-emulsion formulation of the chemotherapy drug docetaxel, which
is marketed under the brand name Taxotere. ANX-514 is formulated
without polysorbate 80 or other detergents and is intended to
reduce the severity and/or incidence of hypersensitivity reactions.
Docetaxel is an anti-cancer agent that acts by disrupting the
cellular microtubular network that is essential for cell division.
Immunosuppressant premedication is recommended for docetaxel
therapy to reduce the incidence and severity of hypersensitivity
reactions. Docetaxel is approved to treat breast, non-small cell
lung, prostate, gastric and head and neck cancers. About ADVENTRX
Pharmaceuticals ADVENTRX Pharmaceuticals is a biopharmaceutical
company focused on in-licensing, developing and commercializing
proprietary product candidates primarily for the treatment of
cancer and infectious disease. The Company seeks to improve the
performance and commercial potential of existing treatments by
addressing problems associated with these treatment regimens. More
information can be found on ADVENTRX's web site at
http://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 involve risks and assumptions that, if they
materialize or do not prove to be accurate, could cause ADVENTRX's
results to differ materially from historical results or those
expressed or implied by such forward-looking statements. These
risks and uncertainties include, but are not limited to: the risk
that ADVENTRX will be unable to raise sufficient capital to fund
the projects necessary to meet its goals, including funding the
continued development and commercialization of ANX-530 or ANX-514;
the risk the FDA will determine that ANX-530 and Navelbine are not
bioequivalent, including as a result of performing pharmacokinetic
equivalence analysis based a patient population other than the
population on which ADVENTRX based its analysis; the risk that the
on-going clinical study of ANX-514 does not demonstrate
pharmacokinetic equivalence or bioequivalence; the risk of
investigator bias in reporting adverse events as a result of the
open-label nature of the ANX-530 bioequivalence clinical study,
including bias that increased the reporting of adverse events
associated with Navelbine and/or that decreased the reporting of
adverse events associated with ANX-530; difficulties or delays in
manufacturing, obtaining regulatory approval for and marketing
ANX-530 and ANX- 514, including validating commercial manufacturers
and suppliers and the potential for automatic injunctions regarding
FDA approval of ANX-514; the potential for regulatory authorities
to require additional preclinical work or other clinical
requirements to support regulatory filings, including prior to the
submission or the approval of an NDA for ANX-530 and ANX-514; the
risk that the performance of third parties on whom ADVENTRX relies
to conduct its studies or evaluate the data, including clinical
investigators, expert data monitoring committees, contract
laboratories and contract research organizations, may be
substandard, or they may fail to perform as expected; 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 http://www.sec.gov/. You are
cautioned not to place undue reliance on these 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 on which it was made. DATASOURCE: ADVENTRX
Pharmaceuticals, Inc. CONTACT: Investor Contact: Ioana C. Hone of
ADVENTRX Pharmaceuticals, +1-858-552-0866 Web site:
http://www.adventrx.com/
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