ExCEEd Orphan announces partnership with SERB to exclusively distribute Voraxaze® and DigiFab® in Central and Eastern Europe (CEE)

Under the terms of the agreement, ExCEEd Orphan will have exclusive rights to seek reimbursement, distribute and market Voraxaze® within its indications in 13 CEE countries – Albania, Bosnia & Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Kosovo, Montenegro, North Macedonia, Romania, Serbia, Slovakia and Slovenia. ExCEEd Orphan will also supply DigiFab® on an unlicensed basis to patients in these countries.

Voraxaze® (glucarpidase) received EMA approval on January 11th, 2022, for lowering the level of methotrexate in the blood of adults and children older than 28 days at risk of methotrexate toxicity. Voraxaze® received an orphan medicine designation in February 2003. (https://www.ema.europa.eu/en/medicines/human/EPAR/voraxaze-0)

DigiFab® (Digoxin Immune Fab) is used for the treatment of life-threatening or potentially life-threatening digoxin toxicity or overdose. DigiFab® is supplied in Eastern European countries through a Named Patient Program, allowing physicians to treat patients who, otherwise, would have no effective treatment options available to them. (https://digifab.health/getmedia/6f38d7ed-1832-4b7d-863a-9c71905e4d02/SmPC_DigiFab_Dec17.pd)

Jiri Hermanek, Chief Executive Officer and Founding Partner of ExCEEd Orphan, commented:
“We are really pleased to announce partnership with SERB to bring Voraxaze and Digifab to patients suffering from toxicity of methotrexate and digitoxin in CEE countries. Both products are effectively addressing those serious medical conditions hence protecting patients from serious health consequences. Those products fit perfectly long-term strategy of ExCEEd Orphan focusing on launching innovative medications for rare diseases in CEE region. We are looking forward to working with SERB to make both products available to all patients in needs in our countries!”

Antoine Bernasconi, EMEA Chief Commercial Officer of SERB, commented:
“We are delighted to be working with a company that is highly specialized in rare diseases. This partnership will allow us to make these two important, life-saving rescue therapies available to patients in Central and Eastern Europe.”

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, please visit www.exceedorphan.com

About SERB S.A.S.
SERB, together with BTG Specialty Pharmaceuticals and Veriton, are a growing specialty pharmaceutical group and a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain.

For further information about SERB, please visit www.serb.eu.

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