RiVax granted orphan drug designation

The US Food and Drug Administration has granted orphan drug designation to Soligenix, Inc., for RiVax, the company's vaccine for the prevention of ricin intoxication.

The orphan drug designation will allow Soligenix access to certain regulatory and financial benefits.

The US Orphan Drug Act was put in place to encourage companies to create effective and safe therapies to treat rare disorders and disease that affect less than 200,000 individuals in the United States. Orphan drug designation gives Soligenix a seven year term of market exclusivity for RiVax pending FDA approval and allows the company access to grants to conduct clinical trials. Additionally, it allows Soligenix access to several government and tax benefits.

"The FDA's decision to grant RiVax orphan drug designation for the prevention of ricin intoxication marks another important step forward in our biodefense pipeline," Christopher J. Schaber, president and CEO of Soligenix, said. "Marketing exclusivity through Orphan Drug Designation adds significantly to the existing patent estate surrounding RiVax. We are enthusiastic about the prospects of developing a ricin vaccine to anticipate civilian and biodefense requirements and for potential government stockpiling."

Ricin is believed to be a possible bioterror threat due to its high potency, its stability and the large worldwide reservoir created as a by-product of the production of castor oil. RiVax has been shown in clinical trials to induce a protective immune response in both animal and human trials.