Soligenix Inc (SNGX)

[io_io]

Standard Review (only).........


(but at least we didn't get an RTF, which the stock price would seem to infer)


FDA Accepts DOR BioPharma's NDA Filing for orBec(R)
Tuesday November 21, 8:01 am ET


MIAMI, FL--(MARKET WIRE)--Nov 21, 2006 -- DOR BioPharma, Inc. (OTC BB:DORB.OB - News) ("DOR" or the "Company") announced today that the U.S. Food and Drug Administration ("FDA") has accepted the Company's New Drug Application ("NDA") for orBec® (oral beclomethasone dipropionate) for the treatment of gastrointestinal Graft-versus-Host disease ("GI GVHD"). The FDA has granted the orBec® NDA application a standard review designation and established a target action date of July 21, 2007 for completion of review of the NDA in accordance with The Prescription Drug User Fee Act ("PDUFA"). The FDA's Acceptance of the filing indicates the FDA has determined that the NDA is sufficiently complete to permit a substantive review.

Christopher J. Schaber, Ph.D., President and Chief Executive Officer of DOR, stated, "We are proud to announce FDA acceptance of our NDA for orBec®, which is an important milestone for our company. We believe the data included in this filing clearly demonstrate the clinical benefit of orBec® in treating patients suffering from GI GVHD. We are now within sight of a possible approval of orBec®, and are looking forward to productive interactions with the FDA."

GI GVHD is the most common life-threatening complication of allogeneic hematopoetic stem cell transplantation ("HSCT"). Currently, there are no FDA approved treatments for GI GVHD, rendering this often fatal disease an area of unmet medical need. orBec® is a two-pill system containing the highly potent, topically active corticosteroid, beclomethasone dipropionate, designed to specifically target and treat upper and lower GI GVHD with reduced systemic immunosuppressive side effects. Although not approved by the FDA for this indication, systemic immunosuppressive agents, such as prednisone, are currently the standard treatment for GI GVHD despite being associated with high rates of mortality due to infection and debility.

The data provided in the NDA submission demonstrate that orBec® safely provides a lower risk of mortality compared with the current standard of care, and a lower exposure to systemic corticosteroids following allogeneic HSCT transplantation. The NDA filing is supported by data from two randomized, double-blinded, placebo-controlled clinical trials. The first was a 129 patient pivotal Phase 3 clinical trial for orBec® conducted at 16 bone marrow/stem cell transplant centers in the U.S. and France. The second trial was a 60 patient Phase 2 clinical trial conducted at the Fred Hutchinson Cancer Research Center. While orBec® did not achieve statistical significance in the primary endpoint of its pivotal trial, namely time to treatment failure through Day 50 (p-value 0.1177), orBec® did achieve statistical significance in other key outcomes such as median time to treatment failure through Day 80 (p-value 0.0226), and, most importantly, it demonstrated a statistically significant survival advantage in comparison to placebo. In the pivotal Phase 3 trial, analysis of patient survival at the pre-specified endpoint of 200 days post-transplant showed a clinically meaningful and statistically significant 66% reduction (p-value 0.0139) in mortality among patients randomized to orBec®. The mortality benefit in favor of orBec® was corroborated earlier this year in a retrospective analysis of the Phase 2 study in which there was a 55% reduction in mortality at 200 days post transplant. At one year after randomization, there were relatively consistent 51% and 45% reductions in the risk of mortality among patients randomized to orBec® in both the Phase 3 and Phase 2 studies, respectively. In the pivotal Phase 3 trial, a subgroup analysis also revealed that patients dosed with orBec® who had received stem cells from unrelated donors had a 94% reduction in the risk of mortality at Day 200.

"There are more than 10,000 allogeneic stem cell transplants in the U.S. each year," added Dr. Schaber. "It is estimated that allogeneic transplants will increase by as much as 20% annually over the next several years, with cord-blood and reduced intensity conditioning regimens, known as 'mini-transplants,' in the elderly fueling much of this growth. Unfortunately, more than half of these patients will go on to develop GI GVHD that requires treatment. We believe that orBec®, if approved, will potentially provide transplant physicians with an effective and much-needed tool to treat their GI GVHD patients and to improve survival. If approved, it is our intention to commercialize orBec® on our own in the United States, and to partner it in Europe and the rest of the world."

DOR filed a Marketing Authorization Application (MAA) via the centralized procedure with the European Medicines Agency (EMEA) on November 7, 2006 for orBec for the treatment of GI GVHD. orBec® has been granted orphan drug status by the EMEA which provides for ten (10) years of marketing exclusivity in European member countries.