On March 25, 2020 Oasmia Pharmaceutical AB and US based Elevar Therapeutics Inc. reported that they have signed a global strategic partnership deal regarding the commercialization of Oasmia’s anticancer product Apealea (Press release, Oasmia, MAR 25, 2020, View Source [SID1234556577]). The agreement includes milestone payments with a potential of up to USD 678 million depending on Elevar’s achievement of future sales milestones, clinical development milestones and regulatory approval milestones. Elevar will also pay Oasmia double-digit royalties on sales of Apealea. Oasmia will also receive USD 20 million as an upfront payment.
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The worldwide partnership between Oasmia and Elevar grants Elevar the exclusive right to commercialize Apealea, a proprietary formulation of paclitaxel, in all global territories, with the exception of countries in which Oasmia and its partners are already present including Nordics, Baltics, Russia and some other CIS countries[1] in which Oasmia and its partners will continue to drive the commercialization of the product. The arrangement gives Elevar the right to sub-license Apealea to other strategic partners, including, for example, in Europe.
Elevar will be responsible for all regulatory application processes in its territory, including the submission of the approval application to the FDA in the US.
The collaboration between the two companies will include a joint steering committee and working teams in order to optimize the global development, launch and commercialization processes. The partnership will build upon Oasmia’s product development strategy for Apealea, and exploring possible new indications.
Oasmia will remain in sole control over, and will continue to develop, its proprietary technology platform XR17, for use with active pharmaceutical ingredients other than paclitaxel.
"This first major commercial partnership for Oasmia demonstrates both its clinical & regulatory capabilities in getting Apealea approved for the EU and its commercial capabilities by successfully negotiating a global partnership agreement with a US-based company for global exploitation of that product. This is a great achievement. Clinical studies have demonstrated that Apealea is an effective cancer treatment with strong benefits for cancer patients. We will capitalize on this partnership to move Oasmia to its next level of growth by continuing to develop the other compounds in our pipeline. We will also be looking to add new complementary assets. I believe by implementing this partnership, Oasmia has achieved a significant milestone and is on track to become a major oncology player, says Francois R Martelet, CEO at Oasmia.
"At Elevar, we are thrilled to take this exciting anti-cancer drug to the market. We see great potential to commercialize Apealea on a global scale and to develop it further, creating new tools for patients and health care professionals to fight cancer", says Alex Kim, CEO of Elevar.
"This is a great step forward for Oasmia on our way to truly capitalize on the proprietary XR17 technology that has been developed by our company. This deal, together with a lot of hard work the last year, has created a very good platform for the future growth of Oasmia. We have a lot more to achieve", says Jörgen Olsson, Chairman of the Board in Oasmia.
About Apealea
Apealea is a patented, water-soluble, intravenously injectable formulation of paclitaxel, developed using Oasmia’s proprietary technology platform – XR17 – 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.