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VGX Pharmaceuticals announces an agreement with VGX International
to build a large scale cGMP DNA manufacturing plant in Korea
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Bell, PA – October 29, 2007 – |
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VGX Pharmaceuticals, Inc.,
a leading developer of novel drugs and vaccines, announced today that
it has signed a collaboration and license agreement with VGX International,
Inc. The Agreement provides the technical support and manufacturing process
technology necessary for VGX International to construct and operate a
large-scale cGMP, DNA plasmid manufacturing facility in Korea - its first
in Asia. The agreement will also allow VGX Pharmaceuticals additional
supply of Phase II clinical through commercial-scale production of cGMP-grade
DNA plasmids to meet the increasing demand for its own products and those
of its contract manufacturing client organizations around the world.
VGX Pharmaceuticals currently operates a 500-liter scale fermentor in
its cGMP, DNA plasmid manufacturing facility in The Woodlands, Texas,
and is conducting IND-enabling pre-clinical toxicology studies for three
of its DNA plasmid-based product candidates. The candidates include: vaccines
for human papilloma virus as a treatment for cervical cancer (VGX-3100);
a therapeutic based on human growth hormone releasing hormone (VGX-3200)
for cancer-related cachexia; and vaccines for avian influenza (VGX-3400).
The Company expects to file Investigational New Drug Applications (INDs)
for all three products by June 2008. Additional product candidates are
in its robust R&D pipeline.
“Our agreement with VGX International represents the next phase
in the expansion of our capabilities to manufacture DNA plasmids for clinical
and eventually commercial applications,” said Dr. J. Joseph Kim,
President and CEO of VGX Pharmaceuticals. “We will continue to operate
world-class manufacturing facilities to meet the increasing demand for
our own DNA-based vaccine and therapy product candidates as well as those
of our clients.”
Under the terms of the agreement, VGX Pharmaceuticals will license its
patented DNA plasmid manufacturing process and cGMP expertise to VGX International
exclusively in Asia. VGX Pharmaceuticals will also provide necessary technical
support and training for what is planned to be the largest cGMP, DNA manufacturing
facility in Asia. The design phase for this facility will commence before
the end of 2007.
Cautionary
Factors That May Affect Future Results - Materials in this
Web site contain information that includes or is based upon forward-looking
statements within the meaning of the Securities Litigation Reform
Act of 1995. Forward-looking statements relate to expectations or
forecasts of future events. You can identify these statements by the
fact that they do not relate strictly to historical or current facts.
They use words such as "anticipate," "estimate,"
"expect," "project," "intend," "plan,"
"believe," and other words and terms of similar meaning
in connection with a discussion of potential future events, circumstances
or future operating or financial performance. In particular, these
include statements relating to future actions, prospective products
or product approvals, future performance or results of current and
anticipated products, sales efforts, expenses, the outcome of contingencies
such as legal proceedings, and financial results. Any or all of our
forward-looking statements here or in other publications may turn
out to be wrong. They can be affected by inaccurate assumptions or
by known or unknown risks and uncertainties. Many such factors will
be important in determining our actual future results. Consequently,
no forward-looking statement can be guaranteed, and forward-looking
statements may be adversely affected by factors, including general
market conditions, competitive product development, product availability,
current and future branded and generic competition, federal and state
regulations and legislation, manufacturing issues, timing of the elimination
of trade buying, patent positions, litigations and investigations.
Our actual results may vary materially, and there are no guarantees
about the performance or valuation of VGX stock. It is also important
to read the disclosure notice contained in many of the individual
VGX documents available on this Web site as many contain important
information on such cautionary factors as of the date of the individual
document. We undertake no obligation to correct or update any forward-looking
statements, whether as a result of new information, future events
or otherwise. You are advised, however, to consult any further disclosures
we make on related subjects in our reports. |
About VGX Pharmaceuticals
VGX Pharmaceuticals is a biopharmaceutical company with small molecule
and biologic product candidates for the treatment of infectious diseases,
cancer, and inflammatory diseases. The Company's clinical development
programs include PICTOVIR™ for HIV infection, which is in Phase
II clinical trials, and PENNVAX™-B, a DNA vaccine for HIV infection,
which is in 2 separate Phase I clinical trials. The Company’s lead
compound for inflammatory diseases, VGX-1027, is also in Phase I clinical
trials. VGX's research pipeline includes a new generation of SynCon™
DNA vaccines and therapeutics as well as the CELLECTRA™ electroporator,
a patented DNA delivery device. The product candidates and technology
programs are protected by the Company's extensive global intellectual
property portfolio. More information about VGX can be found at www.vgxp.com.
About VGX International
VGX International, a publicly-traded global biopharmaceutical company
listed on Korean Stock Exchange. VGX International is a member of the
KOSPI 200 index and is headquartered in Seoul, Korea. The Company is dedicated
to developing revolutionary new drug candidates for the treatment of cancer
and inflammatory diseases, providing the most advanced cGMP solutions
for better facilities, and supplying high-end biopharmaceutical products
to global clients. The Company's clinical development programs include
VGX-1027 for type 1 diabetes and VGX-100 for gastric cancer, which are
both currently in pre-clinical stages. The Company provides cGMP manufacturing
solutions to other pharmaceutical companies in Asia for new construction
of GMP facilities and its related fields. The Company also provides contract
manufacturing services dedicated to supplying biopharmaceutical products
to global institutions and companies working on DNA therapies. More information
about VGX International can be found at www.vgxi.com.
About VGXI Inc.
VGXI Inc. is a leading manufacturer of DNA plasmids, and its cGMP and
non-cGMP products have passed rigorous reviews by several international
regulatory agencies. VGXI offers a wide variety of contract manufacturing
services to outside client organizations. The Company’s cGMP manufacturing
facility in The Woodlands, Texas is a flexible, purpose-built facility
used for research, development, and clinical supply. The site includes
500-liter and 100-liter fermentors and incorporates a cost-effective process.
VGX International also has initiated a project to build and operate a
3000-liter scale cGMP, DNA plasmid manufacturing facility in Asia.
Company Contact:
Henry Hebel
Vice President, Manufacturing and Operations
Tel. 281.296.7300
Fax 281.296.7333
E-mail: hhebel@vgxii.com
www.vgxii.com
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