Under the terms of the agreement, ExCEEd Orphan will have exclusive rights to seek reimbursement, distribute and market Sialanar® within its paediatric indication in 8 CEE countries – Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia. It is estimated that approximately 2,850 children with neurodisabilities suffer from sialorrhea in the CEE region.
Sialanar® (320 mcg/ml glycopyrronium, oral solution) received a European Paediatric Use Marketing Authorisation (PUMA) on 15th September 2016 for the symptomatic treatment of severe sialorrhea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders (https://www.ema.europa.eu/en/medicines/human/EPAR/sialanar®#product-information-section).
Jiri Hermanek, Chief Executive Officer and Founding Partner of ExCEEd Orphan, commented:
“We are really pleased to announce partnership with Proveca to bring Sialanar to children with neurodisabilities suffering from sialorrhea in CEE countries. Sialanar addressing this serious unmet medical need fits 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 Proveca to make Sialanar available to as many patients as possible through our partnership with leading Paediatric Neurology centres in our countries.”
Dr Simon Bryson, CEO and founder of Proveca Ltd, commented:
“We are delighted to announce this agreement with ExCEEd Orphan to make Sialanar available to children with neurodisabilities who suffer from sialorrhea. As in many countries there is such an unmet need to manage this condition and improve quality of life to patients and their carers. We are looking forward to working with ExCEEd Orphan who have a strong track record of launching orphan medicines within this region. As Sialanar is now available for patients in many countries in Europe, this agreement is in line with our commercialisation strategy in order to optimise global market access for our products outside the large European markets”
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 Proveca Ltd.
Proveca Ltd is a European pharmaceutical company specialising in the development and licensing of medicines to address the unmet medical needs of children. The team at Proveca are seeking to improve the lives of children, many of whom require long-term drug treatment for chronic conditions. Working with clinicians, parents, carers and children, Proveca are leading the way in providing licenced, clinically proven, medicines that are tailored to the specific needs of children.
For further information about Proveca Pharma, please visit www.proveca.com