Oasmia gains MUMS designation for dog lymphoma treatment

Oasmia Pharmaceutical AB (STO: OASM) has received Minor Use designation (MUMS) for its investigational canine cancer drug candidate Doxophos® Vet (doxorubicin) in dogs presenting with lymphoma by the U.S. FDA. This allows Oasmia to request conditional approval after efficacy data has been collected and then market the drug for five years while collection data on the drug’s safety. Following an FDA approval, the drug would enjoy seven years of market exclusivity. Oasmia considers the decision very important for the company and the stock has responded positively in early trading.

The Minor Use/Minor Species (MUMS) use in the United States is governed by the Minor Use and Minor Species Animal Health (MUMS) Act. It applies to new animal drugs intended for minor species or minor uses (for diseases that occur infrequently or in limited geographic areas and in only a small number of animals annually) in major species (those are horses, dogs, cats, cattle, pigs, turkeys and chickens, all other animals belong to minor category). The law aims to make it easier for companies to bring innovative treatments for these small indications that would not otherwise be commercially viable Advantages such as conditional approval before attaining all the necessary data, the animal equivalent of an orphan drug designation and indexing in very rare species are given.