September 9, 2020
During the first quarter, we continued to work to deliver the strategic vision we set out following the announcement of the global partnership with Elevar Therapeutics to commercialize our anti-cancer therapy Apealea®. Oasmia retains the rights to Apealea in the Nordic and Baltic countries under the agreement with Elevar and is now making the product commercially available. The Covid-19 pandemic has inevitably impacted the ability of our medical scientific liaison team to meet oncologists during the quarter. An easing of lockdown restrictions will allow the team to resume medical activities during the rest of the year.
Elevar entered into an agreement with Tanner Pharma Group in July 2020 to establish a named-patient program that will facilitate patient access to Apealea in countries outside the USA, where it is not yet commercially available. The goal of the program is to assist ovarian cancer patients who have no alternative therapeutic options to gain access to the drug. Apealea is the only solvent-free paclitaxel approved in Europe for use in combination with carboplatin for the treatment of adults with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. Our XR-17™-based paclitaxel formulation is free of conventional solvents. The initial target population is first relapse of platinum-sensitive ovarian cancer patients. For prescribing information, please visit the European Agency’s website here.
The collaboration with Elevar that started in 2020, as well as the transfer of all commercial manufacturing of Apealea® to Baxter at the end of 2018, were important developments in realigning our growth strategy, enabling us to focus resources where they can bring the best return for shareholders.
The Board’s long-term vision is to build a cash flow-positive specialty pharmaceutical company. To help achieve this, we have implemented a strategic reorganization of Oasmia to focus on R&D and Business Development and to reduce unnecessary expenditure. With a proven technology in XR- 17™, a highly promising approved anti-cancer product, Apealea®, and a global commercialization agreement worth up to $678 million plus royalties, we are well positioned to grow through M&A and licensing deals for late-stage and marketed products. We will seek further opportunities to apply our proprietary XR-17™ solubility-enhancing technology platform, primarily in oncology but also in other therapeutic areas. We are also looking at the potential to out-license the technology in non-core applications. We are already in the process of reviewing strategic options for our Animal Health business.
We will continue to drive the development of our pipeline of XR-17™-based products and leverage the Company’s manufacturing expertise for R&D. Current promising lead programs include docetaxel micellar in metastatic prostate cancer. In June, we signed an agreement with the Swiss research group SAKK to conduct the first clinical trial of docetaxel micellar in advanced prostate cancer. Oasmia’s docetaxel micellar formulation is based on XR-17™, which enables greater use of otherwise water-insoluble cancer drugs while reducing the side effects or need for additional medications associated with traditional solubility enhancers. In addition, we continue the assessment of XR-19, the dual encapsulation technology platform.
During the rest of 2020 we will continue to advance key areas of our growth strategy, including working closely with Elevar to deliver key milestones for Apealea® and support efforts to identify the most appropriate commercial partners for the product in Europe and China. The appointment of Peter Selin as Chief Business Officer, announced a few weeks ago, together with our strong cash position, will be invaluable as we continue to pursue growth through M&A and in- and out-licensing opportunities that complement our technology and business model.
I look forward to keeping you updated on our progress. Please accept my thanks for your patience and continued support as we further transform Oasmia into a sustainable and profitable growth business with long-term potential. Above all, we are here to help patients to better manage their cancer diseases.
Dr. Francois Martelet, M.D., CEO of Oasmia