- CEO Resigns; Executive Team Reorganized; 27% Reduction in Force
- Timelines Revised for ANX-530 and ANX-514
- 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. 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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
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Related links:
http://www.adventrx.com/
CONTACT:
Investor Contact: Ioana C. Hone of ADVENTRX
Pharmaceuticals, +1-858-552-0866
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