ROCKVILLE, Md. and SAN FRANCISCO, Aug. 8,
2012 /PRNewswire/ -- Synthetic Biologics, Inc. (NYSE
Amex: SYN), a developer of synthetic biologics and innovative
medicines for unmet medical needs, and Intrexon Corporation
(Intrexon), a synthetic biology company that utilizes its
proprietary technologies to provide control over cellular function,
today entered into a second worldwide exclusive channel
collaboration through which Synthetic Biologics intends to develop
and commercialize a series of monoclonal antibody (mAb) therapies
for the treatment of certain infectious diseases not adequately
addressed by existing therapies. Utilizing Intrexon's comprehensive
suite of proprietary technologies, including the mAbLogix™ platform
for rapid discovery of fully human mAbs, Synthetic Biologics'
initial efforts will target three infectious disease
indications. The collaboration may optionally be expanded to
include up to an additional five infectious disease indications.
Synthetic Biologics intends to disclose selected indications from
time to time as business and commercial considerations dictate.
Jeffrey Riley, Chief Executive
Officer of Synthetic Biologics, Inc., stated, "Through this second
worldwide exclusive collaboration, we are pleased to strengthen our
relationship with Intrexon and develop new therapeutics for unmet
medical needs, in an effort to build value for our shareholders.
Intrexon has state-of-the-art technologies and efficient processes
that have tremendous potential for the production of a broad
spectrum of fully human antibodies. This expanded relationship
gives us access to this paradigm-changing platform."
Saiid Zarrabian, President of
Intrexon's Protein Production Division, said, "We are very pleased
to expand our relationship with Synthetic Biologics. Intrexon is
committed to building a molecular toolkit and the scientific
expertise needed to take on the challenges of developing new
treatments for unmet medical needs. Intrexon's collaboration with
Synthetic Biologics represents the culmination of important
acquired and internally developed technologies. Intrexon's
core technology, the UltraVector® platform for design,
construction, and testing of genetic components, integrated with
the mAbLogix™ platform for in vitro B‑cell library
production and the LEAP™ cell processing station, will allow for
the rapid end-to-end development from fully human antibody
discovery to therapeutic."
Mr. Riley concluded, "We look forward to applying Intrexon's
competencies to the development of a series of monoclonal
antibodies for the treatment of infectious diseases that take a
tremendous worldwide toll on human life, and to disclosing more
about our discovery targets in the near future."
Under terms of the transaction agreements:
- Synthetic Biologics will have broad access within the target
indications to Intrexon's comprehensive suite of proprietary
technologies, including UltraVector®, DNA and RNA MOD
engineering, protein engineering, transcription control chemistry,
genome engineering, mAbLogix™ human antibodies, LEAP™-based cell
processing and cell system engineering.
- Synthetic Biologics will issue to Intrexon approximately 3.6
million shares of its common stock as a technology access fee upon
execution of the agreement; together with previously issued shares,
immediately following this transaction Intrexon will own
approximately 18% of Synthetic Biologics.
- Synthetic will pay to Intrexon an additional fee, in cash or
additional shares of common stock, should it elect to broaden the
collaboration beyond the three initial disease indications.
- Upon certain milestones (i.e., the filing of an Investigational
New Drug application with the FDA and governmental approval/the
initiation of commercial sales), Synthetic Biologics will pay
Intrexon a milestone fee in cash or additional shares of common
stock.
- Subject to certain expense allocations, Synthetic Biologics
will pay Intrexon quarterly royalties in cash on annualized
worldwide net sales.
If the NYSE Amex approval of the issuance of the securities
described above is not received within 120 days of the date of the
execution of the exclusive channel agreement, Intrexon has the
right to terminate the exclusive channel collaboration.
Joint Synthetic Biologics/Intrexon Corporation
Conference Call
Synthetic Biologics and Intrexon will hold a conference call
this afternoon, Wednesday, August 8,
2012, at 5:00pm
(ET)/2:00pm (PT). Jeffrey Riley, Chief Executive Officer of
Synthetic Biologics and Saiid
Zarrabian, President of Intrexon's Protein Production
Division and Senior Vice President will host the call. Mr. Riley
and Mr. Zarrabian will discuss the second worldwide exclusive
channel collaboration through which Synthetic Biologics intends to
develop and commercialize a platform of mAbs for the treatment of
certain serious infectious diseases.
Interested parties should call toll free 1-800-860-2442 (U.S.)
or 1-866-605-3852 (Canada), or
from outside North America +1
412-858-4600, fifteen minutes before the start of the call to
register and identify themselves as registrants of the 'Synthetic
Biologics' Conference Call. Any registered caller on the toll free
line may ask to be placed in the queue for the Question &
Answer session. The call will be simulcast on the web at
http://www.videonewswire.com/event.asp?id=88858. If you are unable
to participate during the live conference call, the webcast will be
available for replay at the same URL
(http://www.videonewswire.com/event.asp?id=88858) for 30 days after
the call.
About Monoclonal Antibodies
Acting as the body's army, antibodies are proteins generally
found in the blood that detect and destroy invaders, such as
viruses and bacteria and their associated toxins. Monoclonal
antibodies (mAbs) are designed and made utilizing protein
engineering and recombinant production technologies. The mAbs being
developed under this collaboration are intended to supplement a
patient's immune system by providing infected individuals with the
means to specifically and rapidly neutralize and/or clear specific
pathogens and toxins of interest in a process known as "passive
immunity". Many infectious diseases are innately resistant to, or
over time have developed increased resistance to, antibiotics and
other drugs. Synthetic Biologics intends to utilize Intrexon's
comprehensive suite of proprietary mAb design and recombinant
protein production technologies to efficiently create potent
candidate mAbs for human testing and use to specifically treat
certain infectious diseases for which current therapies are
unavailable or inadequate.
About Intrexon Corporation
Intrexon Corporation is a privately held biotechnology company
focused on the industrial engineering of synthetic biology.
Intrexon is deploying its extensive capabilities to rapidly design
and produce novel and enhanced biological products and processes
across multiple industry sectors, including: human therapeutics,
protein production, industrial products, agricultural
biotechnology, and animal science. The Company's advanced
bioindustrial engineering platform enables Better DNA™ technology
by combining revolutionary DNA control systems with corresponding
advancements in modular transgene design, assembly, and
optimization to enable unprecedented control over the function and
output of living cells. More information about the Company is
available at www.dna.com.
About Synthetic Biologics, Inc.
Synthetic Biologics is a biotechnology company focused on the
development of product candidates to address serious diseases and
unmet medical needs. Synthetic Biologics is developing the
following synthetic biologic candidates: a series of monoclonal
antibodies (mAbs) for the treatment of infectious diseases
not adequately addressed by existing therapies and a synthetic
DNA-based therapy for the treatment of pulmonary arterial
hypertension (PAH) in collaboration with Intrexon. The Company is
also developing drug candidates for the treatment of
relapsing-remitting multiple sclerosis (MS), cognitive dysfunction
in MS, amyotrophic lateral sclerosis (ALS) and fibromyalgia
(partnered with Meda AB). For more information, please visit
Synthetic Biologics' website at www.syntheticbiologics.com.
UltraVector®, mAbLogix™, and LEAP™ are registered trademarks of
Intrexon Corporation.
This release includes forward-looking statements on Synthetic
Biologics' current expectations and projections about future
events. In some cases forward-looking statements can be identified
by terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are based
upon current beliefs, expectations and assumptions and are subject
to a number of risks and uncertainties, many of which are difficult
to predict and include statements regarding Synthetic Biologics'
intent to develop and commercialize multiclonal antibody therapies
for infectious diseases and Synthetic Biologics' belief that the
new product opportunity and collaboration will build shareholder
value. The forward-looking statements are subject to risks and
uncertainties that could cause actual results to differ materially
from those set forth or implied by any forward-looking statements.
Important factors that could cause actual results to differ
materially from those reflected in Synthetic Biologics'
forward-looking statements include, among others, a failure of
Synthetic Biologics' monoclonal antibodies for the treatment of
infectious diseases to be successfully developed or commercialized,
a failure of the Intrexon's intellectual property to create
potent candidate mAbs, an inability to obtain regulatory approval
of the infectious disease product candidates, a failure of the
results of clinical trials to support Synthetic Biologics' claims,
a failure of the preclinical or clinical trials to proceed on
schedules that are consistent with Synthetic Biologics' current
expectations or at all, Synthetic Biologics' inability to protect
its intellectual property and freedom to operate without
interference of the patents of others, inability to maintain the
effectiveness of the exclusive collaboration agreement, its
reliance on third parties to develop its product candidates, the
insufficiency of existing capital reserves to fund continued
operations for a particular amount of time and uncertainties
regarding Synthetic Biologics' ability to obtain additional
financing to support its operations thereafter and other factors
described in Synthetic Biologics' report on Form 10-K/A for the
year ended December 31, 2011 and any
other filings with the SEC. The information in this release is
provided only as of the date of this release, and Synthetic
Biologics undertakes no obligation to update any forward-looking
statements contained in this release on account of new information,
future events, or otherwise, except as required by law.
SOURCE Synthetic Biologics, Inc.