Inceptua receives formal approval of the transfer of Oasmia’s marketing authorization for Apealea®

On December 10, 2021 Oasmia Pharmaceutical AB (Oasmia), an oncology-focused specialty pharmaceutical company, reprted that the transfer of its marketing authorization for Apealea (paclitaxel micellar) to Inceptua AB has received approval from the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA) (Press release, Oasmia, DEC 10, 2021, View Source [SID1234596759]).

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As the new marketing authorization holder, Inceptua will assume full regulatory responsibility for Apealea in the EU, Norway, Iceland, Liechtenstein and the UK.

Apealea is approved in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

Francois Martelet, Chief Executive Officer, Oasmia, commented: "This marketing authorization transfer is in line with Oasmia’s strategy, to commercially launch Apealea through partners and build a diversified pipeline focused on hard-to-treat and late-stage cancers using different mechanisms of action. We anticipate receiving our first royalties on Apealea sales during 2022 following commercial product launches in several key European markets."