TikoMed receives FDA Orphan Drug Designation for TM-400 to treat hematological cancers

Jul 26 2011

TikoMed AB, a biotechnology company focused on the development and commercialization of innovative treatments of immune diseases and transplantation therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted TM-400 Orphan Drug Designation for the mobilization of stem cells prior to stem cell transplantation treatment.

TM-400 is in development to improve the outcome of hematopoietic stem cell transplantation (HSCT) by increasing the number of cells available for transplantation and thereby the success rate of engraftment and outcome for the patient. Studies support that TM-400 has a favorable profile as compared to current treatment. TM-400 can be used for a variety of hematological cancers and other severe diseases, where HSCT is a treatment option, such as Multiple Myeloma and Non-Hodgkins Lymphoma and may contribute to curing patients from their cancer.

"To receive Orphan Drug Designation for stem cell transplantation in the U.S. is a commercial breakthrough for TM-400 and TikoMed," said Anders Waas, CEO of TikoMed. "With the backing of both European and U.S. Orphan Designations, we have secured commercial exclusivity for more than 75 percent of the global market for the product."

"Our second Orphan Designation in the U.S. confirms that TikoMed's development team is highly effective and it underscores our strong dedication to orphan and severe diseases," said Adam Bruce, Chairman of TikoMed. "The Orphan Designation endorses that we have a product which can improve treatment for patients. Market exclusivity for this indication will be valuable in our negotiations with partners for development and commercialization."

Source: TikoMed AB