FDA GRANTS TM-400 ORPHAN DRUG DESIGNATION FOR MOBILIZATION OF STEM CELLS USED TO TREAT HEMATOLOGIC CANCER IN THE US.

FDA GRANTS TM-400 ORPHAN DRUG DESIGNATION FOR MOBILIZATION OF STEM CELLS USED TO TREAT HEMATOLOGIC CANCER IN THE U.S.

U.S. Orphan Drug Designation Follows Recent Orphan Drug Designation in Europe

Viken, Sweden–July 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.”

About Hematopoietic Stem cell transplantation

HSCT is the most common cell transplantation and is routinely used with more than 50,000 patients treated every year in the U.S. and Europe together. It is most commonly used for the treatment of hematological cancers and other severe diseases, successful transplantation may contribute to curing 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 to patients after ablation. The transplantation is often managed through harvesting of stem cells from the bloodstream of the donor and thereafter transfused to the patient. The market for the treatment has been assessed to be larger than $400 million.

About Orphan Designation

The FDA’s orphan drug designation is reserved for new therapies being developed to treat diseases or conditions that affect fewer than 200,000 people in theU.S.The orphan drug designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the U.S. after product approval. Hence, TM-400 will not meet any generic competition during this period and can also receive FDA assistance without user fees for the design of clinical trials.

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 of Swedish Red-Cross and Q-Med, Jan Sandström, previously Vice President Business Development at AstraZeneca and Gillis Johnsson, previously Medical Director at AstraZeneca. 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 II study is ongoing and has received a grant of $15 million by National Institutes of Health (NIH), US. In 2009 it was granted Orphan Status in the U.S. and Europe.
• TM-120, an apheresis product for sepsis and other inflammatory diseases. It binds and down and regulates pro-inflammatory cells and chemokines. There is a high unmet need for improved treatments of sepsis. Death from sepsis is as common as from myocardial infarction and there are currently limited effective treatments available.
• TM-400, which is developed for HSCT, can contribute to 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