ADVENTRX Announces Closing of Merger With SD Pharmaceuticals
April 28 2006 - 5:00AM
PR Newswire (US)
SAN DIEGO, April 28 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) announced today the closing of the
merger between the Company and privately-held SD Pharmaceuticals,
Inc. (SD Pharma). ADVENTRX acquired all outstanding shares of SD
Pharma, obtaining worldwide intellectual property rights, excluding
rights for China, Taiwan, Hong Kong and Macau, to a portfolio of
eight oncology and infectious disease therapeutic product
candidates. These candidates include SDP-012 (ANX-530, vinorelbine
emulsion), which was the subject of a prior license agreement
between the companies, announced in October 2005. Most of these SD
Pharma compounds are novel nano-emulsion formulations of currently
available drugs. The nano-emulsion technology was developed by SD
Pharma co-founder, Andrew Chen, Ph.D., Rh.P., in an effort to
address limitations with current drug formulations, such as
injection site reactions and hypersensitivity reactions. "The
closing of this merger is a transformational event for ADVENTRX and
gives the Company exciting new therapeutic product candidates in
the fields of oncology and infectious diseases," said Evan M.
Levine, ADVENTRX president and CEO. "These product candidates fit
well with our mission to develop less toxic drugs that address
specific medical needs and improve patient care. For example, the
novel formulations of paclitaxel and docetaxel were developed
without formulation vehicles Cremophor(R) or polysorbate 80 which
can cause severe hypersensitivity reactions. Furthermore, because
we believe most of these new product candidates may be eligible for
NDA submission under the 505(b)(2) regulatory pathway, we can
potentially advance these rapidly through clinical testing and to
commercialization." Section 505(b)(2) of the Federal Food, Drug
& Cosmetic Act allows the FDA to approve a follow-on drug on
the basis of data in the scientific literature or data used by the
FDA in the approval of other drugs. This procedure potentially
makes it easier for drug manufacturers to obtain rapid approval of
new forms of drugs based on proprietary data of the original drug
manufacturer. ADVENTRX currently plans to file an investigational
new drug (IND) application for ANX-530 (SDP-012, vinorelbine
emulsion) in Q3 2006. ANX-530 is a novel emulsion formulation of
vinorelbine tartrate designed to reduce vein irritation associated
with intravenous delivery of the drug. In addition, the Company
currently plans to request pre-IND meetings with the FDA regarding
proposed 505(b)(2) regulatory paths for the paclitaxel (SDP-013)
and docetaxel (SDP-014) emulsions. SDP-013 is a novel emulsion
formulation paclitaxel (Taxol(R)) designed to be non-allergenic
which may obviate the need for immunosuppressant premedication and
SDP-014 is a novel detergent-free docetaxel (Taxotere(R))
formulation intended to eliminate the need for multiday
immunosuppressant premedication. The Company currently plans to
investigate regulatory strategies for other product candidates
including SDP-015, a novel intravenous formulation of an approved
oral antibiotic in the macrolide family known as clarithromycin;
SDP-016, a novel formulation of vancomycin, a parenteral
glycopeptide antibiotic, which is intended to reduce phlebitis
associated with IV-delivery of the drug, and; SDP-011, an
intranasal/topical antiviral gel intended as a broad spectrum agent
for cold and flu and other viral indications as an over-
the-counter (OTC) product. About ADVENTRX ADVENTRX Pharmaceuticals
is a biopharmaceutical research and development company focused on
introducing treatments for cancer and infectious diseases that
surpass the performance and safety of existing drugs, by addressing
significant problems such as drug metabolism, toxicity,
bioavailability and resistance. More information can be found on
the Company's Web site at http://www.adventrx.com/. Forward-Looking
Statements This press release contains forward-looking statements,
within the meaning of the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995, regarding ADVENTRX. Such
statements are made based on management's current expectations and
beliefs. Actual results may vary from those currently anticipated
based upon a number of factors, including uncertainties inherent in
the drug development process, the timing and success of clinical
trials, the validity of research results, and the receipt of
necessary approvals from the FDA and other regulatory agencies. For
a discussion of such risks and uncertainties, which could cause
actual results to differ from those contained in the
forward-looking statements regarding ADVENTRX, see the section
titled "Risk Factors" in ADVENTRX's last annual report on Form
10-K, as well as other reports that ADVENTRX files from time to
time with the Securities and Exchange Commission. All
forward-looking statements regarding ADVENTRX are qualified in
their entirety by this cautionary statement. ADVENTRX undertakes no
obligation to release publicly any revisions, which may be made to
reflect events or circumstances after the date hereof. DATASOURCE:
ADVENTRX Pharmaceuticals, Inc. CONTACT: Andrea Lynn of ADVENTRX
Pharmaceuticals, Inc., +1-858-552-0866 Web site:
http://www.adventrx.com/ Company News On-Call:
http://www.prnewswire.com/comp/920134.html
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