Lund, Sweden (Press Release) – 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.

About Tasquinimod

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.

About Active Biotech

Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a bio­technology com­pany with focus on Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a bio­technology com­pany with focus on neuro­degenerative / in­flam­ma­tory dis­eases and cancer. Laquinimod, an orally admin­istered small mol­e­cule with unique immuno­modu­la­tory properties, is in pivotal Phase 3 devel­op­ment for the treat­ment of relapsing remitting mul­ti­ple sclerosis. Also, laquinimod is in Phase 2 devel­op­ment for the treat­ment of pri­mary progressive mul­ti­ple sclerosis and Huntington's dis­ease. Fur­ther­more, com­mer­cial ac­­tiv­i­ties are con­ducted for the tasquini­mod, paquinimod och SILC projects. Please visit www.activebiotech.com for more in­­for­ma­tion.

Source: Active Biotech.