Cancer drug Apealea submitted to EMA
A new ovarian cancer drug has been submitted for marketing authorization to the European Medicines Agency (EMA) by Swedish firm Oasmia Pharmaceutical.
Oasmia (Nasdaq: OASM) has made the application for its lead cancer product Apealea (also known as Paclical). Apealea is a formulation of paclitaxel based on the patented excipient platform XR-17, which forms micellar nanoparticles with paclitaxel.
Oasmia executive chairman Julian Aleksov said: "After many years of significant efforts by everyone involved in this project, it is with great satisfaction that we are finally 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 5 billion euros [$5.57 billion] annually."
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