ADVENTRX Signs Definitive Merger Agreement with SD Pharmaceuticals
April 10 2006 - 8:00AM
PR Newswire (US)
SAN DIEGO, April 10 /PRNewswire-FirstCall/ -- ADVENTRX
Pharmaceuticals, Inc. (AMEX:ANX) and SD Pharmaceuticals, Inc. (SD
Pharma), a privately-held company, announced today that the
companies have signed a definitive merger agreement whereby
ADVENTRX will acquire all of the outstanding shares of SD Pharma.
Under the terms of the agreement, ADVENTRX will issue, and SD
Pharma stockholders will receive, approximately 2,100,000 shares of
ADVENTRX common stock. The agreement and plan of merger has been
approved by the boards of directors of both companies and by the
stockholders of SD Pharma. The closing of the merger is subject to
the fulfillment of a number of conditions which the parties
currently expect will be satisfied. SD Pharma co-founder, Andrew
Chen, Ph.D., R.Ph, will continue to collaborate with ADVENTRX as a
consultant. No other organizational changes for ADVENTRX will
result from the merger agreement. Subject to the closing of the
transaction, ADVENTRX will acquire worldwide intellectual property
rights to eight oncology and infectious disease product candidates,
including ex-US rights to SDP-012 (ANX-530, vinorelbine emulsion).
In October 2005, ADVENTRX announced it had licensed US development
and marketing rights to SDP-012 (ANX-530) from SD Pharma. Certain
product candidates that ADVENTRX would acquire as a result of the
merger are based on a nano-emulsion technology for both soluble and
insoluble parenteral drugs. The nano-emulsion technology was
developed by Dr. Andrew Chen and is designed to enable the delivery
of vein irritating or difficult to dissolve drugs without
excipient-induced adverse effects. Many of the product candidates
are based on currently approved drugs and may qualify for the
505(b)(2) regulatory process. Section 505(b)(2) of the US 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. "We believe that this transaction will provide
tremendous value for our stockholders by strengthening our product
pipeline with near-term product candidates in oncology and
infectious disease," said Evan M. Levine, ADVENTRX president and
CEO. "We plan to build on our 505(b)(2) regulatory experience and
our familiarity with Dr. Chen's nano-emulsion technologies and to
apply these skills to compounds with even larger market
opportunities. The integration of these near-term product
candidates can create numerous growth opportunities while allowing
us to remain focused on our core competencies." "ADVENTRX has
several exciting drug development opportunities for cancer and
infectious disease and a proven track record of bringing drugs
through preclinical and clinical development," commented Paul J.
Marangos, Ph.D., SD Pharma chairman, CEO and co-founder. "We
believe ADVENTRX is the right company to further develop these
product candidates based on their rapid progress with ANX-530 which
they licensed from us last year. The SD Pharma portfolio includes
sizeable near-term market opportunities with potentially lower
development costs associated with 505(b)(2) regulatory paths. In
addition, it nicely augments the existing ADVENTRX oncology and
infectious disease pipelines. Development of these compounds will
certainly benefit from ADVENTRX's clinical experience, especially
within the field of oncology." The SD Pharma product portfolio
consists of five anticancer and three anti-infective therapies
which are listed below: * SDP-013 - A non-allergenic, non
cremophor-containing emulsion formulation of paclitaxel (Taxol(R))
designed to eliminate the need for immunosuppressant premedication,
which is recommended for paclitaxel therapy to reduce the incidence
and severity of severe hypersensitivity reaction. Paclitaxel is
approved to treat breast, ovarian and non-small cell lung cancers.
Taxol worldwide sales were approximately $750 million in 2005.
(Source: Bristol-Myers Squibb). * SDP-014 - A novel docetaxel
(Taxotere(R)) formulation not containing polysorbate 80 or other
detergents, intended to eliminate the need for multiday
immunosuppressant premedication, which is recommended for docetaxel
therapy to reduce the incidence and severity of allergic reaction.
Taxotere is approved to treat breast, non-small cell lung, prostate
and gastric cancers. Worldwide Taxotere sales were approximately
$1.6 billion in 2005. (Source: Sanofi-Aventis) * SDP-012
(vinorelbine emulsion) - A novel emulsion formulation of
vinorelbine tartrate designed to reduce vein irritation associated
with the drug. Vinorelbine is approved to treat non-small cell lung
cancer. According to IMS Health, worldwide sales of vinorelbine in
2005 were over $150 million. * SDP-111 - A novel formulation of
beta-elemene, a small molecule anticancer agent belonging to the
triterpene family and currently approved in China for a variety of
cancers. * SDP-112 - An emulsion formulation of alpha-tocopheryl
succinate, a form of vitamin E which has been shown to selectively
facilitate apoptosis, or cell death, in cancer cells. * SDP-015 - A
proprietary intravenous formulation of an approved antibiotic in
the macrolide family known as clarithromycin. Clarithromycin is
approved for mild to moderate bacterial infections such as in
community-acquired pneumonia. Only oral formulations of
clarithromycin are currently available in the US. * SDP-011 - A
broad spectrum intranasal/topical anti-viral gel intended for use
in cold and flu and other viral indications as an over-the- counter
(OTC) product. * SDP-016 - A novel formulation of vancomycin, a
parenteral glycopeptide antibiotic approved to treat gram-positive
bacterial infections. SDP-016 is designed to reduce the vein
irritation and phlebitis associated with the IV-delivered drug.
Certain product candidates to be obtained in the transaction are
being evaluated by ADVENTRX as possible out-licensing
opportunities. About ADVENTRX ADVENTRX Pharmaceuticals is a
biopharmaceutical research and development company focused on
introducing new technologies for anticancer and antiviral
treatments 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/. About
SD Pharma More information on SD Pharma can be found on the
Company's Web site at http://www.sdpharma.com/ . Forward Looking
Statement 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, +1-858-552-0866 Web site: http://www.adventrx.com/
http://www.sdpharma.com/ Company News On-Call:
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