DOR BioPharma, Inc, a late-stage biopharmaceutical company developing products to treat the life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines against certain bioterrorism agents, announced that the Therapeutics Goods Administration (TGA) of Australia has designated orBec as an Orphan Drug for the treatment of patients with gastrointestinal Graft-Versus-Host-Disease (GI GVHD) following allogeneic haematopoietic cell transplantation.
The Australian Orphan Drug Programme was launched in 1998 by the TGA and is intended to encourage sponsors to market orphan drugs in Australia to ensure the availability of a greater range of treatments for rare diseases (those with a prevalence of 2,000 or fewer patients/subjects annually in the Australian population). Once orphan designation is granted, the TGA waives evaluation fees and sets up a priority evaluation pathway for processing orphan drugs.
"The TGA's decision to grant Orphan Designation to orBec is extremely exciting and validates the potential of this therapy to provide a therapeutic option to patients who are afflicted with GI GVHD," said John Michailidis, general manager of Orphan Australia. "We look forward to working with DOR to make this product available within Australia, as well as in New Zealand and South Africa."
"We are pleased with the TGA's decision to grant orBec Orphan Drug Designation for the treatment of GI GVHD," stated Christopher J Schaber, president and CEO of DOR BioPharma. "This bolsters our intellectual property position in Australia, which already includes issued and pending patents covering orBec in GI GVHD. It also potentially provides for a quicker path to regulatory approval in Australia once we have successfully completed our confirmatory phase-3 clinical trial of orBec."
Dr Schaber added, "We have also launched our orBec Named Patient Access Programme in Australia and have booked our first sales pursuant to this important program. We look forward to a prosperous relationship with Orphan Australia Pty Ltd, and with their assistance hope to help as many GI GVHD patients in Australia as possible."
orBec represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic.
DOR BioPharma is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.