Santhera closes of licensing transaction with Chiesi Group

“We are pleased to have closed the transaction so quickly and efficiently. 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. “As previously announced, the agreement with Chiesi Group enables us to focus on business areas core to our long-term growth strategy through advancing our clinical-stage neuromuscular and pulmonary programs.”

With the closing, Santhera has licensed its rights for the development, commercialization and distribution of Raxone for the treatment of LHON and any other potential ophthalmological indications to Chiesi Group for all territories worldwide except the US and Canada. In an interim phase, Santhera will provide support services to Chiesi Group to enable a seamless handover of the business and will continue to commercialize Raxone for LHON in France.

About Leber’s Hereditary Optic Neuropathy and the Therapeutic Use of Raxone

Leber’s hereditary optic neuropathy (LHON) is a heritable genetic disease causing profound vision loss and blindness. The disease presents predominantly in young, otherwise healthy adult males as rapid, painless loss of central vision, usually leading to permanent bilateral blindness within a few months of the onset of symptoms. About 95% of patients harbor one of three pathogenic mutations of the mitochondrial DNA, which cause a defect in the complex I subunit of the mitochondrial respiratory chain. This defect leads to decreased cellular energy (ATP) production, increased reactive oxygen species (ROS) production and retinal ganglion cell dysfunction, which cause progressive loss of visual acuity and blindness.

Raxone (idebenone), a synthetic short-chain benzoquinone and a cofactor for the enzyme NAD(P)H:quinone oxidoreductase (NQO1), circumvents the complex I defect, reduces and scavenges ROS, restores cellular energy levels in retinal ganglion cells and promotes recovery of visual acuity. Current data demonstrate that a majority of patients benefit from treatment and are protected from progression of visual acuity loss or experience a clinically relevant recovery of visual acuity. Raxone for the treatment of LHON was granted orphan drug status in the EU, US, Switzerland and South Korea.