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
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.
SOURCE ADVENTRX Pharmaceuticals, Inc.
04/28/2006
CONTACT: Andrea Lynn of ADVENTRX Pharmaceuticals, Inc., +1-858-552-0866
Company News On-Call: http://www.prnewswire.com/comp/920134.html
Web site: http://www.adventrx.com
(ANX)