Uppsala, Sweden, December 28, 2020 – Oasmia Pharmaceutical AB, an innovation-focused specialty pharmaceutical company, today announces that its partner Elevar Therapeutics has signed a licensing agreement with Inceptua Group for the commercialization of Apealea® (paclitaxel micellar) in Europe. Apealea is 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. Under the terms of the agreement, Inceptua will have exclusive rights to distribute and commercialize Apealea in Europe, excluding the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland).
Oasmia signed a global strategic partnership with Elevar Therapeutics in March 2020 for the commercialization of Apealea, under which Oasmia will be eligible for potential milestone payments of up to USD 678 million- and double-digit royalties on sales.
François Martelet, M.D., CEO of Oasmia, commented: “We congratulate Elevar on securing this agreement, which marks an important milestone in Apealea’s commercialization plan. With regulatory approval already granted in Europe, we hope that the product can rapidly be made available to patients that are in need of a cremophor free formulation of paclitaxel. We look forward to working closely with Elevar and Inceptua and to seeing further commercial agreements in other key regions in 2021.”
Alex Kim, CEO of Elevar Therapeutics, added: “We are very pleased to announce our partnership with Inceptua to make Apealea® (paclitaxel micellar) available to patients with ovarian cancer in Europe. Apealea is the only non-Cremophor based paclitaxel treatment approved in Europe for ovarian cancer. Inceptua’s proven capabilities to develop and commercialize oncology and orphan treatments in Europe make them the ideal partner to accelerate access to Apealea in this important region. This agreement further propels progress for Apealea development and commercialization, an important step in Elevar’s strategy to optimize the value of its portfolio in global markets.”
About Oasmia Pharmaceutical AB
Oasmia is a specialty pharma company dedicated to improving the lives of patients by enhancing the intravenous delivery of established and novel drugs in significant diseases, including cancer. Product development is based on the Company’s proprietary drug delivery technology platform XR-17™ which can be applied to medicines used in many therapeutic areas, to develop water soluble formulations of drugs that currently require chemical solubilizers for dissolution. The first product approved using this technology is Apealea (paclitaxel micellar). Apealea has received market authorization in the European Union and several other territories for the treatment of first relapse in platinum-sensitive ovarian cancer, in combination with carboplatin. The Company is making Apealea accessible to patients through its partnership with Elevar Therapeutics, together with its existing commercial operations in the Nordic region. Oasmia’s shares are traded on the Nasdaq Stockholm stock exchange (ticker: OASM). To find out more about Oasmia please visit www.vivesto.com.
About Elevar Therapeutics
Elevar Therapeutics (formerly LSK BioPharma) is a rapidly growing, fully integrated biopharmaceutical company built on the promise of elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options. Elevar’s lead proprietary drug candidates include rivoceranib (apatinib) and Apealea® (paclitaxel micellar). Rivoceranib is the first small-molecule tyrosine kinase inhibitor (TKI) to be approved in gastric cancer (China, Dec 2014). It has been granted Orphan Drug designation in the U.S., Europe and South Korea and has been clinically tested in over 1,000 patients worldwide in numerous cancer indications.
Apealea® (paclitaxel micellar) is a non-Cremophor EL based formulation of paclitaxel that received market authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor EL formulation of paclitaxel approved for use in ovarian cancer. Elevar Therapeutics has offices in Utah, California and South Korea, and additional information is available at www.elevartherapeutics.com.
About Inceptua Group
Inceptua is a specialty pharmaceutical company and a premium global service partner. Inceptua Pharma commercializes and markets orphan and specialty care products and have the expertise and capabilities to supply unlicensed medicines globally. Inceptua Services supports pharma and biotech companies with global clinical trial comparator sourcing, packaging, and labelling solutions, pre-approval and medicines access programs and consulting
Inceptua partners with life science companies of all sizes, drawing on over 20 years of industry experience, and has global operations with local offices across Europe, North America, China and Japan. Additional information is available at www.inceptua.com.
For More Information:
Oasmia Pharmaceutical AB
Francois Martelet, Chief Executive Officer
Phone: +46 18-50 54 40
E-mail: IR@oasmia.com
Consilium Strategic Communications (For Oasmia)
Jonathan Birt, Chris Welsh, Ashley Tapp
Phone: +44 (0)20 3709 5700
E-mail: oasmia@consilium-comms.com