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Synthetic Biologics, Intrexon enter pact to develop and commercialize mAb therapies for infectious diseases

Rockville, MarylandThursday, August 9, 2012, 09:00 Hrs  [IST]

Synthetic Biologics, Inc., 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, have entered into a second worldwide exclusive channel collaboration.  Under the collaboration 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 tool kit 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."

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.

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.

UltraVector, mAbLogix, and LEAP are registered trademarks of Intrexon Corporation.

 
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