December 9, 2020
The last quarter at Oasmia has seen us focusing on building on the solid foundations we have laid so far this year following the implementation of recommendations highlighted by the strategic review initiated following my appointment as CEO in March. Since then, we have focused our activities on R&D and lab testing in line with our new strategy and reduced our rate of cash burn as the consequence of the rightsizing of our Company. Throughout the period we have continued to make progress on delivering our vision of creating a sustainable specialty pharma company.
In early December Elevar Therapeutics, our global strategic partner shared an update on the development plan for Apealea® (paclitaxel micellar) in ovarian cancer. Following interactions with the FDA Elevar has decided to complete two new studies with Apealea which will be initiated in the first half of 2021 before filing the new drug application (NDA). These studies of Apealea may potentially help to secure a successful registration in the U.S. and provide new data to support a strong product label.
Over the period we have also been working with Elevar to support their partnering efforts for Apealea® in key global territories. In October, Elevar announced an agreement with Taiba Middle East FZ LLC for the commercialization of Apealea® in the Middle East and North Africa region. This is the first regional partnership deal for Apealea® and Elevar is in late stage discussions with a number of potential partners for other regions around the world. Most recently, Elevar and Tanner Pharma Group announced the launch of a global Named Patient program to provide access to Apealea® in areas outside of the United States and Middle East North Africa (MENA) where Apealea® is not yet commercially available.
As previously communicated Oasmia retains marketing rights for Apealea® in the Nordic countries and has made the product commercially available earlier this year. The COVID-19 pandemic continues to significantly impact the ability of our medical scientific liaisons to meet oncologists in the Nordics. However, we are pleased to report that as of November we have started to record initial sales in Finland. In Sweden a positive interest for Apealea has been shown in a few centres in a highly competitive oncology ward environment that is mostly closed to any face-to-face interactions with the Industry. In Denmark, against a negative outcome from the health technology assessment submission we are working on alternatives to generate clinical data.
A central pillar of our new strategy is to explore licensing and partnering opportunities for our existing assets. To drive this process forward in a timely manner I have appointed consultancy firms that will aid us in finding and selecting partners for our Animal Health division as well as the wider XR-17™ platform.
To maximise the value of our platform we have hired a strategic firm to assist Oasmia and facilitate analysis, selection and engagement with potential partners related to licensing/M&A. A four-step project has therefore been initiated with developing a positioning analysis of the XR-17 ™ platform against competing alternatives based on identification and validation of perceived industry needs among potential licensees.
I have also appointed an international investment bank focusing on healthcare with animal health experts to provide us strategic advisory services related to our Animal Health portfolio.
Our pipeline of development programmes continues to progress well. Docetaxel micellar is poised to enter on time in clinical development for advanced prostate cancer with the renowned Swiss Group for Clinical Cancer Research (SAKK). We are also working on adding a novel product candidate in pre-clinical development, using our XR-17™ technology. I hope to be able to disclose further details soon provided a positive outcome.
Protecting intellectual property is critical at any innovative company in our sector, and during the period we worked to bolster our already strong position in this area. In October we announced that our XMeNa patent was approved in India and will soon to be approved in Australia. The XMeNa patent protects an improved method for producing our technology platform XR-17™, which is a unique carrier system for anticancer drugs. We have also secured new trademark registrations for Apealea® in Switzerland, Israel, South Africa, Malaysia and Indonesia during the year.
A key objective for Oasmia is to ensure that we have the right people in place to execute our plans and deliver success. We have made several senior level executive appointments over the last few months including the appointment of two senior scientists to our technical operations team. We believe that investing in this crucial area of the business will enable us to further develop and potentially upgrade our XR-17 platform.
In September we announced that Peter Selin would be joining us as Chief Business Officer and he is now on board since the start of November. His expertise in business development and strategy in the life sciences sector will be invaluable to Oasmia as we continue to pursue growth by seeking M&A and licensing opportunities that complement our technology and business model. Another key addition to the team, announced in October, was the appointment of Fredrik Järrsten as Chief Financial Officer. He has over 25 years of experience across the financial, medical technology and life sciences sectors in the Nordic region and internationally. I know that Fredrik will be an incredible asset to Oasmia when he joins us early next year.
With this experienced new senior team in place I look forward to the remainder of 2020 and beyond with confidence and optimism. Oasmia is in great shape to deliver our strategic objectives as a business and I look forward to keeping you up to date on our progress.
Dr. Francois Martelet, M.D., CEO of Oasmia