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EMEA grants TikoMed orphan drug designation for IBsolvMIR in the treatment of diabetes patients

TikoMed AB announced recently that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection during pancreatic islet transplantation by the Committee for Orphan Medicinal Products of the EMEA.

IBsolvMIR could transform islet cell transplantation into a widely used cure for severe type 1 diabetes patients with unstable diabetic conditions. IBsolvMIR is in development to improve insulin-producing 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 can improve the transplantation outcome by 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.

‘Receiving orphan drug designation for IBsolvMIR in the treatment of severe diabetes is extremely gratifying as we now have an improved opportunity to provide these patients with a chance for a better life,’ said Anders Waas, CEO of TikoMed, a biotechnology company focused on the development and commercialization of treatments for immune diseases and cell therapies. ‘This designation is a significant step towards commercialization of IBsolvMIR in Europe. With the U.S. orphan drug application in place and plans to start additional clinical studies, we are continuing to make progress towards the commercialization of IBsolvMIR in the major European and U.S. markets.’

Orphan drug designation is granted by the European Medicines Agency (EMEA) to promote the development of products that might offer therapeutic benefits for diseases affecting less than five in 10,000 people in the EU. The EMEA's orphan medicinal product designations are based on several criteria that include the rarity and seriousness of the condition and the availability of other effective therapies. Orphan drug designation provides opportunities for free protocol assistance, fee reductions for access to the centralized community procedures before and after marketing authorization and ten years of market exclusivity after drug approval. The EMEA represents 27 EU countries, including major markets such as France, Germany, Italy, Spain and the United Kingdom. For more information, please visit the EMEA website.

‘The exclusive marketing right is the key benefit of an orphan drug designation,’ said Adam Bruce, Chairman of TikoMed. ‘It is a significant complement to our patent portfolio and allows us to build an exclusive commercialization platform.’

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