Lund 12 April 2017 – Active Biotech AB (Nasdaq Stockholm:ACTI) announces today that Active Biotech has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for its investigational novel agent tasquinimod, for the treatment of multiple myeloma.
The FDA Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnoses or prevention of rare diseases or disorders that effect fewer than 200,000 people in the U.S. This designation provides for a seven year marketing exclusivity period against competition, as well as certain incentives.
Tasquinimod is an immunomodulatory, anti-metastatic and anti-angiogenic compound that affects the tumor’s ability to grow and spread. Tasquinimod acts on immunosuppressive cells that play a key role in tumor progression in multiple myeloma due to their capability to promote immune-escape, angiogenesis, and metastasis. Robust results have been achieved with tasquinimod in animal models for multiple myeloma. Tasquinimod has patent protection in multiple myeloma until 2035. The development of tasquinimod has previously been focused on the treatment of prostate cancer with clinical proof of concept and a good safety profile shown in Phase 2 and 3 studies. Active Biotech is seeking a partner for the continued development of tasquinimod in multiple myeloma.
About Multiple myeloma
Multiple myeloma is an incurable form of blood cancer where the plasma cells in the bone marrow grow uncontrollably while other blood forming cells such as white and red blood cells and blood platelets are suppressed. This leads to anemia, infections, destruction of bone tissue and kidney problems since normal plasma cells are an important part of the body’s immune defense and the production of antibodies. Despite new treatments that have greatly improved prognosis and survival of MM patients, the biological heterogeneity of the disease and the emergent drug resistance is a big challenge and the medical need remains high.