Mirava Bio is now live in the Netherlands. 🇳🇱
We are pleased to announce the establishment of Mirava Bio BV, our Dutch entity, which will serve as our European Marketing Authorisation Holder (MAH) platform.
This platform is purpose-built for one type of company: emerging biotech and innovative pharma developing rare disease therapies and ATMPs, with no commercial footprint in Europe. Mirava Bio BV enables companies to access Europe without establishing a legal entity, building an affiliate, or investing in a fixed-cost organisation.
Holding your MAH — and your Orphan Drug Designation
As your partner, Mirava Bio can hold your European Marketing Authorisation (MAH) and, where appropriate, act as your EU Orphan Drug Designation holder — a role that requires an EU-established sponsor. We provide the regulatory, quality, and supply chain infrastructure, while you retain full strategic control, pricing authority, and long-term asset value.
Why it matters
Europe represents more than 40% of global rare disease drug sales, yet only around one-third of FDA-approved orphan drugs ever reach European patients. The challenge is not scientific — it is structural. Mirava Bio exists to remove that barrier.
Our model is simple:
The team behind Mirava Bio helped launch Zolgensma across EMEA and has extensive experience bringing rare disease and advanced therapies to European patients — from regulatory strategy and market access to named-patient programs, supply chain, and commercial execution.
If you’re preparing for Europe — from late Phase II through commercialization — we’d be delighted to discuss how we can help define the right path and execute it.