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Soligenix’s Orphan Drug For Pediatric Crohn’s Disease Receives FDA Fast Track Designation

November 9, 2012

       Soligenix announces on November 8, 2012, that orphan drug SGX203 (beclomethasone 17,21-diproprionate or oral BDP) for the treatment of mild-to-moderate pediatric Crohn’s Disease (CD), receives FDA “Fast Track” designation. SGX203 receives FDA Orphan Drug Designation (ODD) on December 18, 2007.     

       There are 4 Products with FDA Orphan Designation in Soligenix’s Pipeline. 

       SGX203 Facts

–  Contains BDP, an active corticosteroid for inflamed tissue

–  Is a 2 tablet delivery system (immediate & delayed release) of BDP 

–  Designed for delivery of BDP throughout small bowel and the colon. 

       FDA “Fast Track” Designation

–  Is intended for a drug that treats “a serious or life-threatening condition and that shows the potential to address an unmet medical need” 

–  Is for the purpose of accelerating the review of new drugs 

–  Soligenix is eligible to submit a FDA new drug application (NDA) for SGX203 on a “rolling basis” (permits the FDA to review sections of the NDA prior to receiving the complete NDA submission) 

–  NDAs under this program, “typically are eligible for priority review, which implies a shorter review period of 6 months”. 

References 

 Crohn’s & Colitis Foundation of America (CCFA)  

PBR Regulatory Affairs November 9, 2012 article titled, “Soligenix pediatric Crohn’s disease therapy wins FDA fast track status” 

ProactiveInvestors.co.uk November 8, 2012 Article titled, ”Soligenix shares pop after pediatric Crohn’s drug gets fast track designation from FDA” 

Copyright © 2012-2013, Orphan Druganaut Blog.  All rights reserved.

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