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.

Oasmia pulls European marketing application, shares tank

Oasmia Pharmaceutical AB (STO: OASM) has decided to withdraw its MA for its Paccal Vet drug candidate for mastocytoma in dogs. European Medicines Agency asked for more data to assess the risk benefit profile of the paclitaxel reformulation.

The company says that the on-going approval process for the product in the USA is not affected. Oasmia develops new generation of drugs for human and veterinary oncology use. The stock has retreated 33% in early trading.

Oasmia up on interim analysis data from ovarian cancer clinical trial

Oasmia Pharmaceutical AB (STO: OASM, DE: OMAX) announced interim analysis from a Phase III study with Paclical® in ovarian cancer. The company says that the interim analysis based on 400 or so patients points toward a favourable efficacy of Paclical® compared to Taxol® (active compound in both is paclitaxel). Both drugs are given in a combination with Carboplatin.

Dose for Paclital is 250 mg/m2 and no pre-medication is needed. The dose for Taxol is 175 mg/m2 and the patients received the recommended pre-treatment. Oasmia says the lack of intensive pre-treatment stemming from the fact that Paclical is water-soluble is a great advantage for Paclical. The study plans to recruit 650 patients.

Oasmia’s method of evaluating efficacy involves the use of a biomarker CA 125, which is a novel method. The company says that study design is in accordance with the scientific advice received from the European Medicines Agency, EMA, in 2008. According to the company’s analysis Paclical reduces the level of CA 125 to the same level as Taxol. The study continues to collect data on time to progression and on overall survival.

Oasmia says it will apply for MA within the European Union and in some emerging markets for the indication. It also says the study will form a basis for the company application for market authorization in the USA. The stock is up 15% for the day.