Ascelia Pharma: Wrap up from interview with Deputy CEO Julia Waras Brogren

Ascelia Pharma participated in an event with HCA Capital on Monday June 17th to discuss its future partner strategy and how to launch Orviglance once it has been approved. At the event Deputy CEO Julie Waras Brogren once again made a thorough and confident presentation signaling that the company remains on track and are well prepared to submit the regulatory application (NDA) for an FDA approval of Orviglance by mid 2025 based on the full data from the completed phase 3 SPARKLE study as these data become available in the 4th quarter of 2024.

At the event, Julie Waras Brogren explained that at this point in the submission preparation process, Ascelia Pharma has all the necessary competencies allocated to the regulatory application and that the company has the time and flexibility to find the right partner and doesn’t need a partner to prepare and make the regulatory submission. Importantly, Ascelia Pharma also explained that the company has fully compliant, high quality and scalable manufacturing in place already.

With regards to finding the right partner, among other things, Julie Waras Brogren described the de-risked nature of the commercial opportunity for Orviglance as being one of the most important features. For example, clinical development for Orviglance has been completed with strong efficacy and safety results, including in the Phase 3 study. A clear unmet need and validation through extensive market research and data is in place, suggesting an attractive proposition and high ‘launch readiness’ for a potential partner.

To see the whole interview and further comments on the balance between up front milestones versus royalty-based partnerships etc.

Watch full interview here: Interview with Julie Waras Brogren

Disclaimer: HC Andersen Capital receives payment from Ascelia Pharma for a Digital IR/Corporate Visibility subscription agreement. /Claus Thestrup 10:45 AM 18-06-2024