We will continue to work closely with Chiesi Group in the coming months to ensure a smooth transition and a seamless supply of Raxone to LHON patients,' said Thomas Meier, PhD, Chief Executive Officer of Santhera.
The VF testing is essential for making a diagnosis and monitoring the visual function of all optic neuropathies, including LHON. Moreover, VF defects can be the only clinical manifestation of LHON, with no fundoscopic changes.
These increases reflect the expansion of Santhera's operations, especially the commercial activities, the ongoing roll-out of Raxone for LHON across Europe and market entry preparations for Raxone for DMD.
"As an organization historically present in Eastern European and Baltic countries with a specific focus on niche indications and diseases with high unmet medical need, we are very excited to have an opportunity to team upwith Santhera to offer for the first time a treatment to patients with LHON," said Alain Staub , CEO and Chairman of the Board of Ewopharma.
Based on the recent announcement that its pivotal phase III DELOS trial demonstrated that treatment with Raxone/Catena delays respiratory function loss in patients not using steroids, ValuationLAB expects Santhera to prioritize a new drug application (NDA) for DMD in the US and apply for a variation on the LHON label once approved in the EU.