Xlucane is still on track towards regulatory approval ahead of Lucentis patent expiration in EU July 2022 despite the impact of COVID-19 on the phase III-study Xplore
Xbrane Biopharma AB (publ) (?Xbrane? or the "Company?) (Nasdaq Stockholm: XBRANE) today announces the following update on the ongoing phase III-study Xplore:
- As of today, Xlucane is still on track towards regulatory approval ahead of Lucentis? patent expiration in EU July 2022.
- Despite the global Corona crisis, Xplore remains open for recruitment of new patients and treatment for patients currently in the study.
- Xbrane is continuously taking all necessary steps to comply with the new COVID-19 guidance from local authorities and the European Medicines Agency ("EMA") and the US Food and Drug Administration ("FDA") with patient and clinic personnel safety as first priority.
- Currently approximately 60% of the planned 580 patients are recruited into Xplore.
- However, the rapid development of the COVID-19 pandemic makes forecasting of future recruitment rate challenging at this stage.
- Patients in Xplore are treated for a critical eye-disease, age related macular degeneration, which if not treated leads to significant vision impairment and in worst case blindness and despite the risk of contamination of COVID-19 and local restrictions there is a desire from patients to be treated.
- Participation in Xplore does not lead to significantly more visits to a clinic than if the patients would receive standard treatment outside of a clinical trial.
- Over 50% of clinics are private eye-clinics located separately from general hospitals and therefore with lower risk of contamination of patients and clinic personnel in relation to patient visits.
Contacts
Martin ?mark, CEO/ IR M: +46 (0) 763-093 777 E:?martin.amark@xbrane.com Susanna Helgesen, CFO M: +46 (0) 708-278 636 E:?susanna.helgesen@xbrane.com
Martin ?mark, CEO/ IR M: +46 (0) 763-093 777 E:?martin.amark@xbrane.com Susanna Helgesen, CFO M: +46 (0) 708-278 636 E:?susanna.helgesen@xbrane.com
About Us
Xbrane is a commercial phase Swedish biopharmaceutical company that develop and produces biosimilars. Xbrane has a patented protein production platform for development of biosimilars and world leading expertise in biosimilars. Xbrane?s headquarter is located in Solna outside of Stockholm and the company?s in-house research and development facilities are in Sweden and Italy. Xbrane is listed at Nasdaq Stockholm since September 2019 with the ticker XBRANE. For more information please visit?www.xbrane.com.
Xbrane is a commercial phase Swedish biopharmaceutical company that develop and produces biosimilars. Xbrane has a patented protein production platform for development of biosimilars and world leading expertise in biosimilars. Xbrane?s headquarter is located in Solna outside of Stockholm and the company?s in-house research and development facilities are in Sweden and Italy. Xbrane is listed at Nasdaq Stockholm since September 2019 with the ticker XBRANE. For more information please visit?www.xbrane.com.