European Medicines Evaluation Agency Grants Tikomed Orphan Drug Designation for IBSOLVMIR
"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