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A Swedish biotechnology company, TikoMed AB, has received notice that the U.S. Food and Drug Administration is granting orphan drug designation to its IBsolvMIR® drug for preventing the rejection of transplanted pancreatic islet cells in type 1 patients.
"Orphan drugs" are therapies designed to treat diseases that affect fewer than 200,000 people in the United States. The designation allows a drug developer to enjoy tax benefits, an accelerated review process, and a seven-year U.S. market exclusivity once the drug is approved for sale. The FDA uses the designation as an incentive because drug companies do not stand to profit as much from an orphan drug, given the small number of patients for whom it is developed.
TikoMed is developing IBsolvMIR to counter the immune system rejection that often follows the transplantation of pancreas islet cells into people with severe type 1 diabetes. The transplantations, involving cells from human or animal donors, often produce dramatic results at first, with type 1 patients enjoying a partial or even total restoration of their insulin-producing powers. But subsequent responses by the patients' immune systems often destroys the transplanted tissue.
IBsolvMIR will work in two ways: first, by suppressing the patients' immunological reaction and second, by stimulating growth factors that will abet the spread of the transplanted cells.
Currently the drug is in a phase II clinical study that is partly funded by a $15 million grant from the U.S. National Institutes of Health to Uppsala University in Sweden. Tests with volunteers so far have shown that the drug produces no adverse effects that would limit dosage.
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