Within the veterinarian field, Oasmia sees many opportunities based on the core technology XR17. Oasmia has two drug candidates in the field, Paccal Vet and Doxophos Vet.
Paccal Vet is a new XR17-based formulation of paclitaxel and is intended for use in dogs. Paccal Vet was Oasmia’s first product candidate in the field of veterinary oncology and is identical to Apealea for human use. In February 2014, Oasmia received conditional approval of Paccal Vet under designation status for Minor Use and Minor Species (MUMS) in the US for treatment of non-operable mammary tumours in stages III, IV or V and operable and non-operable squamous cell carcinoma, each in dogs that have not received previous chemotherapy or radiotherapy.
Oasmia withdrew its conditional approval in January 2017 in order to improve the side-effect profile. Preparations for the planning of a new study for future development are ongoing. The outcome of the study will serve as basis for future registration strategies both in Europe and US. In addition to the commercialization and development of Paccal Vet for dogs, there is also an option to investigate the use of Paccal Vet for cats.
Doxophos Vet is a patented formulation of doxorubicin in combination with XR17. Oasmia is developing Doxophos Vet for the treatment of lymphoma, one of the most common forms of cancer in dogs.
Oasmia has conducted a phase I study on Doxophos Vet to determine the dosage for the clinical program. In February 2015, a phase II study was initiated whose primary objective was response frequency in treated dogs. In October 2018, the results from the study were compiled in a clinical study report. These showed that treatment with Doxophos Vet was well tolerated and that the study had thus achieved its objective. The two study reports for the phase I and phase II studies will form part of the application to the FDA for conditional approval.
As for the portfolio within human health, Oasmia intends to bring these key product candidates in the veterinary portfolio towards market authorization in the United States and then establish partnerships around these product candidates or products. Oasmia believes that market access in the United States will be greatly facilitated by an already established partner who has an existing distribution network for these products. In the next few months, Oasmia will finalize its plans for the United States and initiate a discussion with the FDA.