Oasmia Pharmaceutical has announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMA) for its lead cancer product Apealea (also known as Paclical).
Apealea is a novel formulation of paclitaxel based on the patented excipient platform XR-17, which forms Cremophor®-free micellar nanoparticles with paclitaxel. The indication sought for Apealea is treatment of epithelial ovarian cancer in combination with carboplatin.
”After many years of significant efforts by everyone involved in this project, it is with great satisfaction that we are able to announce the regulatory filing of an application for marketing authorization of Apealea in the EU. Apealea, once approved, we believe would be able to take a share of the market for cytostatics in EU, which currently amounts to more than five billion Euros annually. Besides Abraxane is Apealea / Paclical the only paclitaxel drug which can be given in substantially higher doses”, says Julian Aleksov, Executive Chairman of the Board of Oasmia Pharmaceutical AB.
Standard treatment of ovarian cancer is Taxol® in combination with carboplatin. Taxol is a combination formulation of paclitaxel in Cremophor EL (polyethoxylated castor oil) and ethanol. In order to avoid life threatening acute hypersensitivity reactions to Cremophor EL, treatment with Taxol requires extensive pre-medication with corticosteroids and antihistamines as well as a long infusion time. In the recently published results from Oasmia’s pivotal Phase III study, Apealea showed a positive risk/benefit profile compared to treatment with Taxol; i.e. no need for pre-medication, the infusion time is one hour and possibly a reduced risk of experiencing neuropathy.
This marketing authorization application is based on results from a Phase III study with Apealea on epithelial ovarian cancer conducted in 16 countries. The primary objective of the Phase III clinical study, which consisted of an aggregate of 789 patients, was to show non-inferiority of Apealea (250 mg/m2) versus Taxol (175 mg/m2), both in combination with carboplatin. Tumour response and progression was assessed by external readers in a blinded fashion using computed tomography evaluated through RECIST (standardized response evaluation criteria in solid tumours).
The product has been approved in the Russian Federation since April 2015 and successfully launched by Oasmia’s partner Pharmasyntez.