On March 25, 2020 Elevar Therapeutics, Inc., a fast-growing biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, reported an agreement with Swedish-based Oasmia Pharmaceutical AP to obtain global rights for Apealea, except in Nordics, Russia, and certain countries in Eastern Europe (Press release, LSK BioPharma, MAR 25, 2020, View Source [SID1234555812]).
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Apealea is a non-cremophor formulation of the well-known chemotherapeutic agent paclitaxel. It 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. Apealea has been launched in certain Nordic countries as well as Russia. Oasmia and Elevar are in the process of selecting a European partner to commercialize Apealea in Europe, UK and Switzerland. The companies are also in discussions with the FDA to determine the best route for a New Drug Application (NDA) in the US.
"We are excited for the opportunity to help make this chemotherapy drug available globally," said Alex Kim, CEO of Elevar, "The utility of paclitaxel in oncology is well-known and we strongly believe that Apealea may significantly contribute to the patients’ fight against cancer while improving the quality of life."
Ovarian cancer is the seventh most commonly diagnosed cancer in women globally, with an estimated 230,000 newly diagnosed patients annually and approximately 150,000 deaths annually from the disease.
"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.
Elevar and Oasmia have created a joint development committee for Apealea to expand approvals in Ovarian cancer worldwide while driving development in additional indications. Although the full terms of the deal have not been disclosed, Oasmia will receive an upfront payment of $20M and up to $658M in additional regulatory and sales milestones.