Santhera, Chiesi Group Enter Raxone License Agreement

Santhera Pharmaceuticals has entered into an exclusive license agreement with Chiesi Group Farmaceutici, under which Chiesi will in-license Raxone for the treatment of LHON for a total consideration of as much as €93 million, comprising an upfront payment of €44 million and near- to mid-term sales milestone payments of as much as €49 million. 
 
Chiesi Group is in-licensing the rights to Raxone in LHON and all other ophthalmological indications worldwide except the U.S. and Canada, where Santhera retains rights. Following the completion of certain reimbursement and post-regulatory commitments on the part of Santhera, Chiesi has the option to fully acquire Santhera's Raxone business. The transaction enables Santhera to focus on the business areas core to its long-term growth strategy by advancing its clinical-stage neuromuscular and pulmonary programs.
 
"Since the approval in 2015 we have successfully launched Raxone in Europe and reported strong year-on-year sales increases. In the past eighteen months we also strategically diversified our pipeline. 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," said Thomas Meier, Ph.D., chief executive officer of Santhera. 
 
"We have built a strong portfolio in neuromuscular and pulmonary rare disease areas with last year's acquisition of option-rights to vamorolone for Duchenne muscular dystrophy (DMD) and other inflammatory diseases, and the acquisition of POL6014 for cystic fibrosis and other pulmonary disorders. Major upcoming inflection points will be our marketing authorization application for Puldysa in DMD in Europe, and results of the pivotal trial with vamorolone in DMD. We are delighted to be working with Chiesi Group, a global company with an established commercial infrastructure and a strong reputation for delivering innovation in rare diseases and areas of special care, including ophthalmology. We will work closely with Chiesi Group to ensure a smooth handover of the Raxone business and a seamless supply of this only approved medication for the treatment of this devastating form of vision loss to patients in need."      
 
The closing of the transaction, subject to customary approvals, is currently expected in the third quarter 2019.

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