Chiesi Farmaceutici, an international research-focused healthcare group (Chiesi Group), announces the closing of the licensing transaction with Santhera Pharmaceuticals. As per the agreement, Chiesi Group is in-licensing a product whose active principle is idebenone for the treatment of Leber’s hereditary optic neuropathy (LHON) and the initial payment of CHF 50 million (EUR 44 million) of the total consideration of up to CHF 105 million (EUR 93 million) becomes due.
With the closing, Santhera is licensing 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 idebenone 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.
Santhera Pharmaceuticals (SIX: SANN) is a Swiss specialty pharmaceutical company focused on the development and commercialization of innovative medicines for rare neuromuscular and pulmonary diseases with high unmet medical need. Santhera is building a leading Duchenne muscular dystrophy (DMD) franchise. A marketing authorization application for Puldysa® (idebenone) is currently under review by the European Medicines Agency. Santhera has an option to license vamorolone, a first-in-class dissociative steroid currently investigated in a pivotal study in patients with DMD to replace standard glucocorticoids. The clinical stage pipeline also includes POL6014 to treat cystic fibrosis (CF) and other neutrophilic pulmonary diseases, as well as omigapil and an exploratory gene therapy approach targeting congenital muscular dystrophies. Santhera out-licensed ex-North American rights to its first approved product, Raxone® (idebenone), for the treatment of Leber's hereditary optic neuropathy (LHON) to Chiesi Group. For further information, please visit www.santhera.com.
Raxone® and Puldysa® are trademarks of Santhera Pharmaceuticals.
About Chiesi Group
Based in Parma, Italy, Chiesi Farmaceutici is an international research-oriented group with over 80 years’ experience in the pharmaceutical sector, and is present in 27 countries. The group researches, develops and commercialises innovative medicines in the respiratory disease, special care and rare disease therapeutic areas. The Group’s Research & Development centre is based in Parma (Italy) and integrated with 6 other important research and development groups in France, the USA, the UK and Sweden, to promote its pre-clinical, clinical and registration programmes. The Group employs around 5,700 people.