Santhera reports net revenues 21% up in 2017 from its lead product Raxone, amid negative opinion by CHMP for it in DMD

January 29, 2018 Off By Dino Mustafić

Santhera Pharmaceuticals has reported an increase of 21% year-on-year in net revenues to CHF 22.9 million (2016: CHF 19.0 million) from sales of its lead product Raxone for the treatment of Leber’s hereditary optic neuropathy (LHON).

Freely available liquid funds by year-end amounted to CHF 58.2 million (December 31, 2016: CHF 49.8 million).

Following the recent negative opinion by the Committee for Medicinal Products for Human Use (CHMP) on its Marketing Authorization Application (MAA) for Raxone in Duchenne muscular dystrophy (DMD), the Company will work with regulators and clinical experts to prepare a refiling as soon as possible. Other development projects progressed according to plan, the company has said.

Thomas Meier, CEO of Santhera, said: “We are pleased about Santhera’s strong commercial progress in 2017. At the same time, we are disappointed about the regulatory decision concerning the approval of Raxone in DMD.” The company’s priorities for 2018 are clear, Meier said, pointing out the company’s focus in bringing Raxone available for DMD patients. “We will work with clinical experts, patient advocacy groups and regulators to prepare for a refiling to enable treatment of patients with abnormal respiratory function and not taking glucocorticoids. In parallel, we will push ahead with the commercialization of Raxone in LHON and the advancement of our development pipeline.”