PRINCETON, N.J., Aug. 4 /PRNewswire-FirstCall/ -- DOR BioPharma, Inc., (OTC Bulletin Board: DORB) (DOR or the Company), a late-stage biopharmaceutical company, announced today that the Office of Orphan Products Development of the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Oral BDP (beclomethasone 17,21-dipropionate, or orBec((R))) for the treatment of gastrointestinal symptoms associated with chronic Graft-versus-Host disease (cGVHD) in patients who have undergone allogeneic hematopoietic cell transplantation.
The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. In addition to providing a seven-year term of market exclusivity for orBec((R) )upon final FDA approval, orphan drug designation also positions DOR to be able to take advantage of a wide range of financial and regulatory benefits, including government grants for conducting clinical trials, waiver of expensive FDA user fees for the potential submission of a New Drug Application for orBec((R)), and certain tax credits.
orBec((R) )is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP, the active component of orBec((R)), has been marketed in the United States and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. orBec((R)) and oral BDP are currently in development by DOR for the treatment and prevention of GVHD, the prevention of acute radiation enteritis and the treatment of Crohn's disease.
"The FDA's decision to grant orBec((R)) Orphan Drug Designation for the treatment of GI symptoms of cGVHD marks another step in the expansion of our orBec((R))/oral BDP pipeline," stated Christopher J. Schaber, PhD, President and CEO of DOR Bio
|SOURCE DOR BioPharma, Inc.|
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