Uppsala, Sweden – November 3, 2009 – TikoMed AB, a biotechnology company focused on development and commercialization of innovative treatments of immune diseases and cell therapies, today announced 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 (COMP) of the European Medicines Agency (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 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.
“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. “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 EMEA to promote the development of products that may offer therapeutic benefits for diseases affecting less than five in 10,000 people in the European Union (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 10 years of market exclusivity following 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 http://www.emea.europa.eu/htms/human/orphans/intro.htm
“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.”
About TikoMed 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: • IBsolvMIR, which in addition to islet cell transplantation also has the potential to improve the outcome of other transplantations, such as liver and bone marrow transplantations. • TM-110, is an oral product which can eliminate IP-10, a pro-inflammatory chemokine. It provides an opportunity for safe and effective treatment of severe autoimmune diseases, where there is a high unmet need. Ongoing studies are documenting the product utility for inflammatory bowel disease (ulcerative colitis and Crohn´s disease), a $3 billion market. • TM-120, is an apheresis product for autoimmune and inflammatory diseases. It binds and down regulates IP-10, a pro-inflammatory chemokine. It will first be developed for rheumatoid arthritis. The market for treatment of rheumatism is more than $8 billion and there is a significant unmet need for improved treatments. For more information, please visit www.tikomed.com.
About NIH The National Institutes of Health (NIH) — The U.S. Medical Research Agency — includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, please visit www.nih.gov.
Contacts/TikoMed: Anders Waas (CEO) anders.waas@tikomed.com +46-734-04 5141
