The FDA's orphan drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in the U.S. The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the U.S. after product approval. Hence, IBsolvMIR will not meet any generic competition during this period and can also without user fees receive FDA assistance in the design of clinical trials.
"Receiving U.S. orphan drug designation for IBsolvMIR is extremely gratifying as there is an acute need for more treatment options for patients with severe type 1 diabetes with unstable diabetic conditions," said Adam Bruce, Chairman of TikoMed. "Aside from the opportunity to improve quality of life for these patients, the designation provides free assistance for the execution of clinical studies, so we are making significant progress towards commercialization on the U.S. market."
IBsolvMIR is in development to improve islet cell transplantation for patients with severe type 1 diabetes. An ongoing phase II clinical study has gained a $15 million grant from the National Institutes of Health (NIH) through Uppsala University, Sweden. IBsolvMIR has the ability to improve the transplantation outcome through avoiding destruction of the insulin producing islet cells by the immune system. Successful islet transplantation has the potential to make severe type 1 diabetics insulin independent and avoid hypoglycemic crises. In a previous phase I study, IBsolvMIR was well tolerated by healthy volunteers, with no dose-limiting adverse effects documented.
"The orphan drug designation strengthens TikoMed's competitive position as exclusive marketing rights in the U.S. are very valuable," said Anders Waas, CEO of TikoMed. "This is a complement to our patent portfolio, adding value in our discussions for collaborations to develop and commercialize IBsolvMIR in the U.S."
Swedish-based TikoMed is an innovation driven biotechnology company focused on the development and commercialization of novel treatments for cell transplantation and immune diseases. Currently, TikoMed has three products in development:
For more information, please visit www.tikomed.com.