Pharmanovia will hold exclusive rights for the commercialisation of elamipretide in the EU, other European countries including Switzerland, Norway, Iceland and the UK, and the Middle East and northern Africa region.
The agreement allows Stealth to receive upfront and future payments linked to the achievement of regulatory, development and commercial milestones, and royalties on net sales of elamipretide in the licensed territories.
Pharmanovia CEO James Burt stated: “Only 5% of rare diseases have an approved treatment option, therefore we share a common goal of wanting to meet unmet patient needs and we’re excited to have the opportunity to bring to market a potential first specific treatment option for those living with Barth syndrome.”
Stealth’s elamipretide tetrapeptide drug is an investigational mitochondrial protective agent that binds to cardiolipin in dysfunctional mitochondria.
In preclinical studies, it was demonstrated to enhance mitochondrial structure and function.
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The investigational product candidate has concluded Phase III development as a treatment option for Barth syndrome.
Stealth CEO Reenie McCarthy stated: “While we work with the FDA toward a potential US approval pathway, we remain committed to expanding access to elamipretide to individuals living with Barth syndrome in Europe and beyond.”