Santhera licenses LHON drug to Chiesi for €93m

Santhera has announced it is licensing its LHON drug Raxone (idebenone) to Chiesi Group for an upfront payment of €44 million and milestone payments of up to €49 million, as it looks to focus more on neuromuscular and pulmonary programmes.

Chiesi will gain the rights to Raxone in LHON and all other ophthalmological indications worldwide except the US and Canada, where Santhera retains rights.

Following the completion of certain reimbursement and post-regulatory commitments on the part of Santhera, Chiesi also has the option to fully acquire Santhera’s Raxone business.

In an interim phase Santhera will continue to provide medical, technical, logistical and scientific support with regard to ongoing market authorisation activities and/or market access undertakings for several months.

The companies have agreed that Santhera will continue to commercialise Raxone for LHON in France until ongoing pricing and reimbursement negotiations have been finalised.

Santhera will also be responsible to complete the ongoing Post Authorization Measures, expected by 2021, in conjunction with the centralised European Marketing Authorization granted in 2015.

Santhera said that the transaction enables them to focus on "the business areas core to its long-term growth strategy" by advancing its clinical-stage neuromuscular and pulmonary programmes.

Santhera plans to submit a marketing authorisation application for Duchenne muscular dystrophy (DMD) drug Puldysa (idebenone) to the EMA this year. Meanwhile, Pivotal study data for vamorolone as treatment of younger, still ambulatory DMD patients is expected in 2020.

The company also recently acquired clinical-stage asset POL6014, which has the potential to treat cystic fibrosis (CF) and other pulmonary diseases.

Other pipeline elements include strategies to treat congenital muscular dystrophies.

LHON is a neurodegenerative disease targeting the optic nerve and characterised by sudden vision loss. For more information see pharmaphorum's disease spotlight.