Under the terms of the agreement, ExCEEd Orphan will have exclusive rights to seek reimbursement, distribute and market Filsuvez® in 17 CEE countries – Albania, Bosnia & Herzegovina, Bulgaria, Croatia, Czech Republic, Estonia, Hungary, Kosovo, Latvia, Lithuania, Montenegro, North Macedonia, Poland, Romania, Serbia, Slovakia and Slovenia.
The European Commission (EC) approved Filsuvez® for the treatment of partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients 6 months and older on June 21, 2022. Filsuvez® will be the first and only approved treatment for EB patients.
The EC approval of Filsuvez® is supported by Phase 3 data from the EASE trial which was the largest ever global trial conducted in patients with EB, performed across 58 sites in 28 countries.
Jiri Hermanek, Chief Executive Officer and Founding Partner of ExCEEd Orphan, commented:
“We are really pleased to announce partnership with Amryt to bring Filsuvez® to EB patients in CEE countries. It perfectly fits to our long-term strategy of focusing on launching innovative medications for rare diseases in CEE region. We are looking forward to working with Amryt to make Filsuvez® available to all patients in needs in our countries!”
Martina Peper, Vice President and General Manager DACH and CEE of Amryt, commented:
“We are delighted to be working with ExCEEd and value their focus on rare diseases. This partnership will allow us to bring the first and only approved treatment for EB to patients in Central and Eastern Europe as soon as possible. It supports our mission to bring hope to patients that suffer from this rare and devastating disease.”
About Epidermolysis Bullosa
Epidermolysis Bullosa (EB) is a rare and devastating group of hereditary disorders of the skin, mucous membranes, and internal epithelial linings characterized by extreme skin fragility and blister development. Patients with severe forms of EB suffer from severe, chronic blistering, ulceration and scarring of the skin, mutilating scarring of the hands and feet, joint contractures, strictures of the esophagus and mucous membranes, a high risk of developing aggressive squamous cell carcinomas, infections and risk of premature death.
About ExCEEd Orphan s.r.o.
ExCEEd Orphan was founded in 2018 by five rare disease experts from multiple Central and Eastern European (CEE) countries. The Company is focusing on innovative treatments for rare diseases and has extensive experience in launching innovative medicines in this field. The portfolio of ExCEEd Orphan includes products in therapeutic areas like haematology, neurology, immunology, and metabolic diseases. For further information about ExCEEd Orphan, visit www.exceedorphan.com.
Amryt is a global commercial-stage biopharmaceutical company focused on acquiring, developing and commercializing innovative treatments to help improve the lives of patients with rare and orphan diseases. Amryt comprises a strong and growing portfolio of commercial and development assets.
For further information about Amryt, please visit www.amryt.com.