Oasmia Pharmaceutical AB is launching its product, Apealea® 60 mg, in Sweden, Denmark and Finland. The first batch of the drug has been shipped to distributors in these countries.
Apealea® is a patented, water-soluble, intravenously injectable formulation of paclitaxel, developed using Oasmia’s proprietary technology platform – XR-17- which facilitates the solubility of paclitaxel. Paclitaxel is a chemotherapy medication used to treat a number of types of cancers. Apealea® has been authorized for marketing by the European Commission. Apealea® in combination with Carboplatin is approved for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.
“The launch of Apealea in the Nordic countries enables therapeutic potential for patients in need of innovative cancer treatment. This is an important milestone for Oasmia in its transition towards becoming a fully integrated pharmaceutical company. As a second step, we intend to continue our efforts of engaging strategic partners for Apealea in other territories”, comments Sven Rohmann, acting CEO of Oasmia.
“Oasmia has fulfilled all the regulatory requirements required for launch of the drug in the EU. The next intended step for us is to prepare for the submission for a regulatory approval from the United States Food and Drug Administration to obtain access to the U.S. market“, says Nina Heldring, Chief Medical Officer at Oasmia.
Oasmia will participate as official sponsor of the 41st EORTC-PAMM Winter Meeting in Stockholm between February 13th – 15th 2020. The Winter Meeting is organized under the umbrella of the European Organization for Treatment of Cancer (EORTC) intended to provide opportunities for interdisciplinary and international exchange of knowledge on optimizing cancer treatment.