Oasmia Pharmaceutical announces that Elevar Therapeutics and Taiba Middle East FZ LLC have entered into an exclusive agreement under which Taiba will commercialize and distribute Apealea (micellar paclitaxel) in certain countries throughout the Middle East and North African (MENA) region.
Under the terms of the agreement, Taiba will also be responsible for managing named-patient requests through which physicians can legally and ethically prescribe Apealea for patients prior to commercial availability.
Apealea is a patented formulation of paclitaxel in combination with Oasmia’s XR-17 technology which encapsulates individual active pharmaceutical ingredients (APIs) in a layer of micelles, making the API and micelle formulation water soluble and therefore usable in water based intravenous injections. Apealea has been approved by the European regulatory authorities for use 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.
Potential milestone payments of up to USD 678 million
In March 2020, Oasmia signed a global strategic partnership with Elevar Therapeutics for the commercialization of Apealea, making Oasmia eligible for potential milestone payments of up to USD 678 million- and double-digit royalties on sales.
“It is great to see Elevar secure a quality regional partner for the MENA region which will initiate the process of obtaining regulatory approvals and commercialization. If regulatory approval is obtained, Apealea will be the first Cremophor-free formulation of paclitaxel approved for use in ovarian cancer in the Middle East and North Africa region and offer many cancer patients a therapeutic option with far less side effects,” says François Martelet, CEO of Oasmia.
Photo of François Martelet, CEO, Oasmia