DOR BioPharma Obtains Fast Track Designation For DOR201 In The Prevention Of Acute Radiation Enteritis

Ewing, NJ – January 6, 2009 – DOR BioPharma, Inc. (DOR or the Company) (OTCBB: DORB) today announced that its program for the development of DOR201 (oral beclomethasone dipropionate) for the prevention of acute radiation enteritis has received "Fast Track" designation from the U.S. Food and Drug Administration (FDA).

Fast Track is a designation that the FDA reserves for a drug intended to treat a serious or life- threatening condition and one that demonstrates the potential to address an unmet medical need for the condition. Fast track designation is designed to facilitate the development and expedite the review of new drugs. For instance, should events warrant, DOR will be eligible to submit a new drug application (NDA) for DOR201 on a rolling basis, permitting the FDA to review sections of the NDA prior to receiving the complete submission. Additionally, NDAs for fast track development programs ordinarily will be eligible for priority review, which implies an abbreviated review time of six months.

“There are no FDA approved therapies to prevent acute radiation enteritis,” stated Christopher J. Schaber, PhD, President and Chief Executive Officer of DOR. “The FDA's action in granting fast track designation is an indication of DOR201's potential to address this serious, unmet medical need with over 100,000 patients at risk annually.

source: DOR Biopharma