Inovio Biomedical and VGX Pharmaceuticals Sign Merger
Agreement
Conference call with CEOs of Inovio and VGX
Tuesday, July 8 -- 9am – Eastern Time
US dial in: 877-407-9210
International dial in: 201-689-8049
Presentation link: http://www.investorcalendar.com/IC/CEPage.asp?ID=131832
SAN DIEGO & BLUE BELL, Pa. (Business Wire EON) July 7, 2008 --
Inovio Biomedical Corporation (AMEX:INO), a developer of
electroporation-based DNA vaccine delivery technology, and VGX
Pharmaceuticals, Inc., a privately held DNA vaccine developer, announced
today the signing of a definitive merger agreement, which provides for
the issuance of Inovio Biomedical securities in exchange for all of the
outstanding securities of VGX Pharmaceuticals. Each company’s
board of directors has approved the merger agreement and the all-stock
transaction it contemplates. The transaction is subject to completion of
the registration of the Inovio Biomedical securities to be issued with
the U.S. Securities and Exchange Commission (SEC), receipt of approval
from both companies’ stockholders of the
transaction, and other customary closing conditions. The parties expect
to complete the merger in the fourth quarter of 2008, however, the
actual timing of the transaction will depend on a number of factors,
some of which are beyond either company’s
control. Upon closing, Inovio Biomedical will change its name to VGX
Pharmaceuticals, Inc.
Avtar Dhillon, MD, President and CEO of Inovio Biomedical, said: “Inovio
Biomedical, in collaboration with our research partners, has
successfully demonstrated safety, tolerability, and immunological and
clinical responses from electroporation-delivered DNA vaccines in
humans. While we are pleased with our accomplishments and opportunities,
we also believe the best path to maximizing value for our stockholders
requires us to develop proprietary DNA vaccines. To that end, merging
with VGX Pharmaceuticals immediately adds a broad pipeline of DNA
vaccine candidates and a team of internationally-recognized scientists
with strong DNA vaccine expertise, which we believe will provide the
combined company with the capability to rapidly advance DNA vaccine
candidates into the clinic. We are pleased to join forces with the VGX
team led by Dr. J. Joseph Kim and to become closely associated with Dr.
David Weiner, a VGX co-founder known around the world as a pioneer of
DNA vaccines.
“We are highly confident that the combined
company will advance the potential of developing and delivering new DNA
vaccines that could play a significant role in treating or even
preventing diseases. Leadership of both companies could not forego this
medical and market opportunity,” said Dr.
Dhillon.
J. Joseph Kim, Ph.D., co-founder, president and CEO of VGX
Pharmaceuticals, said: “Significant, growing
evidence indicates that electroporation has a pivotal role to play in
enabling the potency of this promising new generation of vaccines and
VGX has already made a strong commitment to this DNA delivery
technology. Inovio has made tremendous strides in validating
electroporation-based DNA vaccine delivery with human data in the last
year, and we believe that Inovio’s patents and
technology platform, partnerships, and clinical programs will provide
synergy with VGX’s vaccine development focus
and asset base. We look forward to the integration process, working
cooperatively with Inovio’s management,
research and engineering teams, and combining our intellectual property
to aggressively pursue the compelling concept of harnessing the body’s
immune system to tackle cancers and poorly treated infectious diseases.”
Combined Company Profile
The parties believe that the following assets of the combined company
will enable it to advance its integrated DNA vaccine technologies and
generate value for its various stakeholders:
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Internationally recognized scientific expertise in the field of
DNA vaccines complemented by extensive experience with
electroporation technology as a method of DNA delivery.
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A diverse, proprietary pipeline of therapeutic and preventive DNA
vaccine candidates against cancers and infectious diseases, with
one wholly owned agent (for HIV) and one partly owned agent (for
hepatitis C virus) in phase I clinical studies, investigational
new drug (IND) applications that are open for one agent (for
cervical cancer) and under review for avian influenza, and R&D
activities in areas such as universal influenza vaccines and
prostate cancer.
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SynCon™ technology, used to generate
new clinical product candidates, including consensus sequences and
antigens for some of the currently targeted disease proteins,
offering coverage across different viral sub-types and taxonomic
groups. These antigens are further optimized for gene expression
and induction of a desired immune response.
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An extensive patent portfolio and line of clinical grade devices
and prototypes for electroporation-based DNA delivery, a non-viral
delivery platform that, based on interim clinical data, is
indicating safety, tolerability, and positive immunological and
clinical responses from DNA vaccines delivered using this
technology.
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Interim clinical data from multiple studies assessing DNA vaccines
or DNA-based immunotherapies delivered using the company's
proprietary electroporation technology (ISO 13485-compliant),
which have collectively indicated safety and tolerability,
heightened levels of antibody and T-cell immune responses, and
durable local and systemic tumor responses (melanoma), providing
initial validation of electroporation's ability to enhance DNA
vaccine potency.
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Regulatory approval to use electroporation delivery technology in
conjunction with DNA vaccines in clinical trials in the US (FDA),
Sweden, Italy, and the UK.
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A product line of DNA delivery systems with different design
characteristics:
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-- CELLECTRA® Adaptive Constant Current
Electroporation System
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-- MedPulser® DNA Delivery System
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-- Elgen® DNA Delivery System
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Out-licenses and collaborations with various pharmaceutical,
biotech, academic, government and non-government organizations
include Merck (cancers), Wyeth (infectious diseases), HIV Vaccine
Trial Network (HIV), Vical (metastatic melanoma), Moffitt Cancer
Center (malignant melanoma), University of Southampton (prostate
cancer), National Cancer Institute (HIV), and International AIDS
Vaccine Initiative (HIV), which have already played a pivotal role
in generating valuable preclinical data and proof-of-principle in
humans regarding the utility of electroporation-based delivery of
DNA vaccines. The costs of these studies have largely been borne
by collaborators. Four phase I clinical studies are in progress
and an IND has been filed for a fifth.
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VGX Animal Health, Inc., an 88%-owned subsidiary developing growth
hormone releasing agents and DNA vaccines for various diseases for
cats, dogs, horses, cows and pigs. LifeTide™
SW 5, a product of VGX Animal Health, was recently approved by the
Australian Pesticides and Veterinary Medicines Authority as a
veterinary gene therapy product for treating pigs (aimed at
reducing mortality) making it the first and only DNA therapy
product approved for food animals and only the fourth such product
approved by regulatory agencies for any indication worldwide.
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Thirty percent (30%) ownership interest in VGX International, Inc.
(VI), a Korean company listed on the Korean Stock Exchange, which
has initiated a project to build and operate a 3,000-liter scale
cGMP DNA plasmid manufacturing facility in Korea. VI also operates
a low-volume cGMP DNA plasmid (vaccine) contract manufacturing
facility based in The Woodlands, Texas, including 500-liter and
100-liter fermentors and using a cost-effective manufacturing
process. The combined company would have existing supply
arrangements with VI.
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Representative board of directors, management and research and
development teams, retaining and combining Inovio's public company
and electroporation experience and VGX's vaccine development
experience.
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The combined company is expected to be led by Dr. J. Joseph Kim as
president, CEO and a director, with Dr. Avtar Dhillon serving as a
consultant and a director. The remainder of the combined company’s
board is expected to consist of two directors from each of Inovio’s
and VGX’s current board of directors. Dr.
David B. Weiner is expected to be chairman of the scientific advisory
board, drawing from the wide array of scientific resources currently
available to both companies. The merger agreement provides for a
post-combination management team integrated from both parties’
current management.
The combined company’s headquarters are
anticipated to be located in Blue Bell, Pennsylvania, along with its DNA
vaccine research and development efforts, while maintaining a San Diego,
California operation focused on electroporation R&D and engineering. In
addition, the combined company would continue existing research
operations in The Woodlands, Texas, and Oslo, Norway.
Details of the Proposed Transaction
VGX Pharmaceuticals is a privately held company, predominantly owned by
founders, current and former members of management and other private
investors and institutions. Inovio is a publicly traded company
(AMEX:INO). At the time of closing of the merger, a wholly-owned
acquisition subsidiary of Inovio Biomedical will merge into VGX
Pharmaceuticals, with VGX Pharmaceuticals surviving as a wholly-owned
subsidiary of Inovio Biomedical. Concurrently, Inovio Biomedical will
issue shares of Inovio common stock in exchange for all of the
outstanding shares of VGX common stock based on an exchange ratio
derived from the comparative fully diluted share capitalization of the
companies, excluding the shares of VGX common stock underlying $5.5
million of VGX convertible debt. Inovio will also assume all outstanding
VGX options and warrants and a portion of VGX convertible debt, which
will be adjusted based on the exchange ratio and become exercisable or
convertible, as applicable, for Inovio common stock. The $5.5 million of
VGX convertible debt excluded from calculation of the exchange ratio
will be assumed at closing and the principal outstanding at closing
immediately converted into shares of Inovio common stock at $1.05 per
share.
Due to the structure of the exchange ratio calculation, it is not
possible for the parties to state with certainty at this time the total
number of shares of Inovio common stock, options, and warrants to be
issued at closing of the merger. However, the exchange ratio is designed
to result in the legacy holders of Inovio and VGX securities each
holding on an aggregate basis 50% of the combined company’s
fully-diluted equity interests, excluding the $5.5 million of VGX
convertible debt. Inovio anticipates that post-closing, the combined
company would continue to have some other outstanding convertible debt,
which it expects would be fully retired by April 2009 from deferred
proceeds relating to the sale of VGX Pharmaceuticals’
plasmid production facility in Texas in June 2008. Based on current
capitalization information, the parties anticipate that legacy Inovio
equity interest holders and legacy VGX equity interest holders will
share voting power over the combined company 49% and 51%, respectively.
However, the exact percentage split of the equity interests in and
voting power over the combined company will depend on a number of
factors, including Inovio’s pre-closing
capitalization and VGX’s pre-closing
capitalization, thus these projected percentages may change prior to
closing.
Inovio is required to use commercially reasonable efforts to register
the securities to be issued in the merger under the Securities Act of
1933, as amended, on a registration statement on Form S-4 to be filed
with the Securities and Exchange Commission. Registered shares of Inovio
common stock received in the transaction by certain significant holders
of VGX common stock and certain affiliates and all employees of VGX and
shares of Inovio common stock held by all affiliates and employees of
Inovio at the time of consummation of the transaction will be subject to
lock-up arrangements that will provide for 25% of the shares initially
subject to the lock-up per individual to be released from such
restrictions upon each six-month anniversary of the closing date of the
transaction, such that all shares will be released from the lock-up
arrangements upon the two-year anniversary of the closing date of the
transaction. The lock-up restrictions will also apply to the shares of
Inovio common stock issued upon assumption and conversion of VGX
convertible debt for six-months after the closing date of the
transaction, and will provide for 50% of the shares initially subject to
the lock-up to be released upon the three-month anniversary of the
closing date of the transaction. Inovio anticipates listing the
securities to be issued in the merger with the American Stock Exchange.
The merger requires approval of the stockholders of both Inovio
Biomedical and VGX Pharmaceuticals. Inovio expects to file a proxy
statement and supporting materials as part of its Form S-4, and will
hold a special meeting of stockholders to seek approval of the merger
and related stockholder proposals.
Oppenheimer & Co. Inc. provided certain financial advisory services to
Inovio Biomedical in connection with the merger. KL Gates, LLP is acting
as Inovio Biomedical’s outside legal counsel.
Needham & Company, LLC provided certain advisory services to VGX
Pharmaceuticals in connection with the merger. Duane Morris LLP is
acting as VGX Pharmaceuticals’ outside legal
counsel.
VGX and Inovio urge their investors and the public to read the
relevant registration, proxy solicitation and consent solicitation
related documents to be filed with the SEC before making any investment
and/or voting decision related to the merger because they contain
important information about the companies, the merger, the Inovio
securities to be issued and the expectations for the combined company.
The registration statement/proxy statement to be filed on Form S-4 and
other merger-related documents will be available, when filed, without
charge, from the SEC’s web site (www.sec.gov)
or can be obtained, free of charge, by requesting such documents,
including any items incorporated by reference, from Inovio Biomedical
Corporation.
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. VGX’s
clinical development programs include PENNVAX™-B
for HIV infection, which is in two separate Phase I clinical trials, and
VGX-1027 for inflammatory diseases and VGX-3100, a DNA therapeutic
vaccine for cervical cancer, both of which are in Phase I clinical
trials. In addition, VGX has filed INDs for VGX-3200, a novel DNA
therapy that utilizes GHRH for the treatment of cancer cachexia and
anemia and for VGX-3400, a DNA preventative vaccine for avian influenza.
VGX has established a vertically-integrated DNA Vaccines and Therapies
Platform with extensive capabilities including SynCon™
DNA-based product candidates, the CELLECTRA®
delivery device, and access to efficient cGMP plasmid manufacturing.
Vertical control over key aspects of product development has enabled VGX
to consistently develop multiple product candidates, from bench-to-IND
filing, within one year. The product candidates and technology programs
are protected by the VGX’s extensive global
intellectual property portfolio. More information about VGX can be found
at www.vgxp.com, the contents of which
are not incorporated by reference herein.
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX:INO) is focused on developing multiple
DNA-based immunotherapies and DNA vaccines. Inovio is a leader in
developing human applications of electroporation, using brief,
controlled electrical pulses to increase cellular uptake of a useful
biopharmaceutical. Human data has shown that Inovio’s
electroporation-based DNA delivery technology can significantly increase
gene expression and immune responses from DNA vaccines. Inovio’s
technology is protected by an extensive patent portfolio covering in
vivo electroporation. More information is available at www.inovio.com,
the contents of which are not incorporated by reference herein.
This press release contains certain forward-looking statements
relating to plans for the merger of Inovio Biomedical Corporation and
VGX Pharmaceuticals and the parties’ intent
to develop their electroporation-based drug and gene delivery
technologies and DNA vaccines. Actual events or results may differ from
the expectations set forth herein as a result of a number of factors,
including the uncertainties inherent in complex commercial transactions
like the proposed merger; uncertainties inherent in clinical trials and
product development programs (including, but not limited to, the fact
that pre-clinical and clinical results referenced in this release may
not be indicative of results achievable in other trials or for other
indications and that results from one study may not necessarily be
reflected or supported by the results of other similar studies), the
availability of funding to support continuing research and studies in an
effort to prove safety and efficacy of electroporation technology as a
delivery mechanism or develop viable DNA vaccines, the availability or
potential availability of alternative therapies or treatments for the
conditions targeted by the parties or their collaborators, including
alternatives that may be more efficacious or cost-effective than any
therapy or treatment that the parties and their collaborators hope to
develop, evaluation of potential opportunities, issues involving patents
and whether they or licenses to them will provide the parties with
meaningful protection from others using the covered technologies,
whether such proprietary rights are enforceable or defensible or
infringe or allegedly infringe on rights of others or can withstand
claims of invalidity and whether the combined company can finance or
devote other significant resources that may be necessary to prosecute,
protect or defend them, the level of corporate expenditures, assessments
of the companies’ combined technology by
potential corporate or other partners or collaborators, capital market
conditions, evaluation of the transaction by the American Stock
Exchange, which may impact the current and/or additional listing of
Inovio’s securities, and other factors set
forth in Inovio’s Annual Report on Form 10-K
for the year ended December 31, 2007, its 10-Q for the three months
ended March 31, 2008 and other regulatory filings from time to time,
including, but not limited to, the registration statement/proxy
statement and related consent solicitation materials to be filed by
Inovio under Form S-4 pursuant to the merger agreement. There can be no
assurance that any product in Inovio’s, VGX’s
or the projected combined company’s product
pipeline will be successfully developed or manufactured, that final
results of clinical studies will be supportive of regulatory approvals
required to market licensed products, or that any of the forward-looking
information provided herein will be proven accurate.
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