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Soligenix (SNGX): A Key Player in the Biodefense Space

03/13/2017
By Grant Zeng, CFA

NASDAQ:SNGX

Soligenix to Present Results from its Ricin Toxin Vaccine Program at the Society of Toxicology 56th Annual Meeting 

On March 10, 2017, Soligenix (NASDAQ:SNGX) announced that it will present results from its ricin toxin vaccine (RiVax™) development program on March 15 at the Society of Toxicology 56th Annual Meeting. The meeting is being held on March 12-16, 2017 in Baltimore, MD.

The poster is titled: Verification of Lethal Doses of Inhaled Ricin in Rhesus Macaques to Support Vaccine Development.

RiVax™ is the Company's proprietary vaccine candidate for the prevention of exposure to ricin toxin that utilizes a unique antigen that is completely devoid of the toxic activity of ricin. When formulated with Soligenix's proprietary vaccine heat stabilization technology, ThermoVax®, RiVax™ has demonstrated significantly enhanced thermostability and 100% protection in preclinical ricin aerosol challenge models.

The poster presentation focuses on the further optimization of the primate ricin challenge model that is important to facilitating future approval of RiVax™ under the US Food and Drug Administration (FDA) "Animal Rule".

This work was funded by the National Institute of Allergy and Infectious Disease (NIAID) via Contract #HHSN272201400039C.

A Potential Biodefense Priority Review Voucher (PRV) for Soligenix

With the advance of its ricin vaccine program, Soligenix may receive a biodefense Priority Review Voucher (PRV). A PRV can be utilized in future programs or sold. If the company choose to sell its PRV, it could be worth as much as $350 million.

Since 2007, the FDA has issued a handful of special "priority review" vouchers which allow its recipient to expedite the review of any one of its new drug products. The PRV can also be sold to other companies.

Sarpeta Therapeutics sold its PRV to Gilead for $125 million, speeding up the FDA approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months. Gilead also purchased PaxVax’s PRV for about $200 million and Knight Therapeutics’ PRV for $125 million, which Gilead used to gain approval for its HIV drug Odefsey.

The most expensive PRV was sold by United Therapeutics to AbbVie for $350 million in August 2015.

With the recent enactment of the 21st Century Cures Act in late 2016, FDA approval of RiVax™ has the potential to position the vaccine for a biodefense Priority Review Voucher (PRV), which may be utilized in future programs or sold.

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