AB Science Granted MUMS Status by FDA for Masivet
AB Science announces that the U.S. Food and Drug Administration has granted Minor Use in Major Species (MUMS) status to its Masivet® treatment for the treatment of mast cell tumors in dogs. This designation paves the way for an expansion of the group's veterinary franchise in the American market.
Strategic Implications of MUMS Status for Masivet
Masivet®, a targeted treatment that inhibits juxtamembrane mutations of the c-kit gene responsible for canine mast cell tumors, has been granted MUMS status. This designation, similar to the orphan drug status in human medicine, grants the promoter seven years of exclusive marketing rights upon approval in the United States. AB Science notes that this designation is 'an encouragement to develop Masivet® in the United States'. The product is already registered and marketed in Europe, where it is profitable, but remains unapproved in the American market.
Expansion Plans for Veterinary Franchise
AB Science announces its intention to expand its profitable veterinary franchise and is engaging in discussions with various partners for distribution and marketing agreements. Targeted areas include European countries not yet covered (Norway, Denmark, Sweden, Finland, and Lithuania), Latin America (Brazil, Argentina, and Mexico), Asia (Japan and Taiwan), MENA regions, and South Africa. Should American approval be obtained, the company anticipates that the EBITDA generated from product sales will contribute to its self-financing and risk reduction.
