Ascelia Pharma AB (publ), a biotech focused on improving the life of people living with rare cancer conditions, announced the filing of a new patent application for its first-in-class orphan liver imaging drug Orviglance.In line with the strategy for Orviglance, the company has turned manufacturing knowledge and innovations into a patent application that, subject to approval and granting, further strengthens the market protection for Orviglance until 2046.
Also Read: CDSCO Clears MSN Labs' Abiraterone 1000mg for Phase IV TrialMagnus Corfitzen, CEO of Ascelia Pharma comments: “For both Ascelia Pharma and future commercialization partners, this patent has the potential to strengthen the commercial opportunity and lifetime value of Orviglance.”Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumours) in patients with reduced kidney function.
These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA). A clinical programme of nine studies, including the pivotal global Phase 3 study SPARKLE, has successfully been completed with strong and consistent efficacy and safety results. The New Drug Application (NDA) has been submitted to the FDA.Ascelia Pharma is a biotech company focused on orphan oncology treatments. We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway.