Viken, Sweden – May 19, 2011 – TikoMed AB, a biotechnology company focused on development and commercialization of innovative treatments of immune diseases and transplantation therapies, today announced that TM-400 has been granted orphan drug designation for treatment to mobilize progenitor cells prior to stem cell transplantation by the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA).
TM-400 is a product, which 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, short and long term outcome for the patient. Studies support that TM-400 can be an improvement for patients compared to current treatment. TM-400 can be useful 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 contribute to curing of patients from cancer.
-To receive orphan drug designation for TM-400 for stem-cell transplantation is a breakthrough for us as a company. TM-400 can contribute to treatment of patients with severe diseases such as Multiple Myeloma. Orphan designation endorses that we have a product which can improve treatment for patient and this is important for us as we enter into discussions and negotiations with partners for development and commercialization,” said Anders Waas, CEO of TikoMed.
“This is our 2nd product achieving orphan designation, and is a manifestation of our dedication to severe diseases. The exclusive marketing right is the key benefit of an orphan drug designation. It is a significant complement to our patent portfolio and allows us to build an exclusive commercialization platform,"said Adam Bruce, Chairman of TikoMed.
About Orphan drug designation
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 EMA’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 EMA 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
About Hematopoietic Stem cell transplantation
HSCT is the most common cell transplantation and is routinely used with more than 50 000 patients treated yearly in US and Europe together. It is mostly used for the treatment of hematological cancers and other severe diseases and successful transplantation can contribute to cure patients from cancer. It is used for patients with cancers such as Multiple Myeloma and Non-Hodgkins Lymphoma. HSCT is a transplantation of hematological stem cells from the bone marrow. The transplantation is often managed trough harvesting of stem cells from the bloodstream which thereafter are transfused to the patient.
About TikoMed
Swedish-based TikoMed is an innovation driven Biotechnology Company focused on the development and commercialization of novel treatments for transplantation therapies and immune diseases. The board includes Anders Milton, former chairman at Q-Med, Jan Sandström, previously VP BD at Astra Zeneca and Gillis Johnsson, previously Medical Director at Astra Zeneca. TikoMed has three main products in development:
- IBsolvMIR/Diabetes, for severe diabetes, by improving the outcome of transplantation of insulin producing beta cells. A phase 2 study is ongoing and has received a grant of $15m by National institutes of Health (NIH), US. In 2009 it was granted Orphan Status in US and EU.
- TM-120, is an apheresis product for sepsis and other inflammatory diseases. It binds and down regulates a pro-inflammatory cells and chemokines. There is a high unmet need for improved treatments of sepsis. Death from sepsis is as common as of myocardial infarction and there are currently limited effective treatments available.
- TM-400, which is developed for HSCT, and can contribute in the treatment and curing of patients with hematological cancers, such as Multiple Myeloma and Non-Hodgkins Lymphoma.
For more information, please visit www.TikoMed.com.
Contacts/TikoMed:
Anders Waas (CEO)
anders.waas@TikoMed.com
+46-734-04 5141
Adam Bruce (Chairman)
adam.bruce@TikoMed.com
+46-708-238444
