Santhera Pharmaceuticals will receive CHF 105m ($104.5m) in return for the licensing agreement, whilst it also retains the rights for the treatment in the US and Canada.
The deal includes CHF 50m in upfront cash, with up to CHF 55m held in near- to mid-term sales milestone payments. According to Santhera, Chiesi Farmaceutici also has the option to fully acquire Raxone (idebenone) upon the completion of reimbursement and post-regulatory commitments on its part.
Raxone is a treatment for Leber’s hereditary optic neuropathy (LHON), which is a heritable genetic disease that causes vision loss and blindness. Clinical trials have shown that up to 50% of patients using the treatment are protected from vision loss or experience relevant recovery of visual acuity.
Regarding its decision to out-license the product, Santhera stated that the transaction would enable it to focus on its long-term strategy of developing its neuromuscular and pulmonary clinical programs.
Thomas Meier, CEO of Santhera, further explained, “This license agreement for Raxone in LHON, our sole neuro-ophthalmology asset, will allow us to create significant value for our shareholders as it provides financial resources enabling us to focus on delivering innovation to patients with neuromuscular and pulmonary diseases of great unmet medical need.”
Santhera’s pipeline includes ibedonone for Duchenne muscular dystrophy, currently in pivotal trials, omigapil for congenital muscular dystrophy, which has completed a Phase I study, and POL6014 for various pulmonary diseases.
In its full-year 2018 financial report, Santhera stated that Raxone had reached sales of CHF 31.7m, representing growth of 38% year-on-year and predicted it would maintain double-digit growth figures in 2019.
The deal is expected to close in the third quarter of 2019.