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8 Feb 2016

Oasmia submits MAA to the EMA for its lead cancer product Apealea

The indication sought for Apealea is treatment of epithelial ovarian cancer in combination with carboplatin.

Apealea is a novel formulation of paclitaxel based on the patented excipient platform XR-17, which forms 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 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 five billion Euro annually," 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. To avoid life threatening acute hypersensitivity reactions to Cremophor EL, treatment with Taxol requires extensive pre-medication as well as a long infusion time. In 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.

The product has been approved in the Russian Federation since April 2015 and successfully launched by Oasmia's partner Pharmasyntez.

The two leading paclitaxel-based products on the market are Taxol and Abraxane. Taxol generated $1.6 billion in sales in 2000 alone, prior to losing its patent protection in 2001. In 2013, Taxol generated $92 million in post-patent sales. Abraxane generated $759 million in worldwide annual sales in 2013 and $979 million in 2014.

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