SALT LAKE CITY, March 25, 2020 /PRNewswire/ -- Elevar Therapeutics, Inc., a fast-growing biopharmaceutical company focused on promising therapies for unmet medical needs in cancer, announced today an agreement with Swedish-based Oasmia Pharmaceutical AP to obtain global rights for Apealea®, except in Nordics, Russia, and certain countries in Eastern Europe.
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 $678M in additional regulatory and sales milestones.
About Elevar Therapeutics
Elevar Therapeutics (formerly LSK BioPharma) is a fast-growing biopharmaceutical company with offices in Utah, California, and South Korea. The Company focuses on promising therapies for unmet needs in cancer. Elevar Therapeutics' lead proprietary drug candidate is rivoceranib, a selective VEGFR-2 inhibitor which has demonstrated clinical efficacy in a variety of solid tumors. Elevar Therapeutics is developing rivoceranib for the treatment of patients with gastric cancer, colorectal cancer, hepatocellular carcinoma, and adenoid cystic carcinoma. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. Elevar is a US corporation and wholly owned subsidiary of HLB Co., LTD., a Korean conglomerate traded on the KOSDAQ (028300.KQ). Elevar Therapeutics can be found on the web at www.elevartherapeutics.com.
Apealea® is a patented, water-soluble, intravenously injectable formulation of paclitaxel, developed using Oasmia's proprietary technology platform – XR17 – which facilitates the formulation of paclitaxel without cremophor. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and esophageal cancer, as well as other types of solid tumor cancers. Apealea® has been authorized for marketing by the European Commission for use in combination with carboplatin in adult patients with a first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. It is Europe's first non-cremophor formulation of paclitaxel approved for use in ovarian cancer.
About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures and markets new generations of drugs in the field of human and veterinary oncology. The company's product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatic which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company's product development is based on its proprietary in-house research and company patents. Oasmia is listed on Nasdaq Stockholm (OASM) and Frankfurt Stock Exchange (OMAX.GR). www.oasmia.com
Phone: +46 18-50 54 40
E-mail: [email protected]
SOURCE Elevar Therapeutics