Oasmia Pharmaceutical AB (NASDAQ: OASM) herewith announces that Apealea was designated as an orphan medicine by the European Commission in 2006 and alongside the procedure of the application for assessing a Market Authorization, the Committee for Orphan Medicinal Products (COMP) carries out in accordance with normal practice an estimation whether the classification as Orphan medicine should be maintained. The designation as an orphan medicinal product is based on the prevalence of the condition (it should occur in less than 5 in 10,000 EU citizens) and the benefit expected from the new formulation. The demographic situation is ever changing and the EU gets an even older population. Women also live longer with the disease and it has been suggested that these changes may increase the prevalence of ovarian cancer. The most recent data from the Nordic countries show that the prevalence is now as high as 17.1 women out of 10,000 women. Considering among other facts this situation and after having had the possibility to present the data to the COMP, Oasmia has decided to withdraw its application for orphan medicine concerning Apealea.
Although the review of the status by the COMP is a routine part of all marketing applications for orphan medicinal products, the companys decision will not impact the review of the application by the Committee for Medicinal Products for Human Use (CHMP) who assess the marketing application.
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