Question 1

Can Mirava Bio act as the Marketing Authorisation Holder (MAH) in Europe?

Accepted Answer

Yes. Through Mirava Bio BV, our Dutch entity in The Hague, Mirava Bio can hold your European Marketing Authorisation (MAH) and, where appropriate, act as your EU Orphan Drug Designation sponsor — a role that requires an EU-established sponsor. You access Europe without setting up a legal entity or affiliate, while retaining ownership, pricing authority and strategic control.

Question 2

What is a European Operating Partner for biotech and pharma?

Accepted Answer

A European Operating Partner is a fully outsourced European team that plans and executes market entry on a company behalf — covering regulatory affairs, MAH and ODD sponsorship, quality, supply chain, market access, medical affairs and commercial execution under one contract. Mirava Bio serves innovative biotech and pharma companies with no commercial footprint in Europe.

Question 3

How can a US biotech launch in Europe without building local affiliates?

Accepted Answer

Through a partner-based commercialisation model. Mirava Bio integrates as an outsourced European team covering regulatory affairs, market access and HTA, quality and compliance, CMC and supply chain, medical affairs, early access programs, patient advocacy and commercial readiness — under one contract, while the biotech retains ownership, pricing authority and strategic control.

Question 4

When should a biotech start planning its European market entry?

Accepted Answer

At late Phase 2. European regulatory (EMA), HTA / Joint Clinical Assessment and early-access timelines run in parallel with US development. Starting at the Phase 2 readout protects option value and avoids costly rework — without committing to structural investment before the data warrants it.

Question 5

What is the pathway from Phase 2 readout to a European pricing agreement?

Accepted Answer

A sequence of ten decision gates (G1–G10): readiness and scenario planning, orphan drug designation and PRIME strategy, Joint Scientific Consultation and PIP alignment, CMC bridging and QP designation, pricing architecture, early access programs, MAA submission with parallel Joint Clinical Assessment, CHMP opinion and EU marketing authorisation, national HTA dossiers, and signed pricing and reimbursement agreements.

Question 6

Can a rare disease drug generate European revenue before EU approval?

Accepted Answer

Yes. France’s Accès Précoce, Italy’s Law 648/96, Germany’s §2 SGB V and Switzerland’s Art. 71a-d KVV allow chargeable early access before marketing authorisation — generating first EU revenue while real-world evidence feeds later HTA submissions.

Question 7

Why do so few FDA-approved orphan drugs reach European patients?

Accepted Answer

Only around 260 orphan drugs are approved in the EU versus roughly 880 in the US — about 30%. Fragmented markets, high upfront affiliate costs, complex regulatory pathways and country-by-country pricing negotiations deter emerging biotechs, even though Europe represents over 40% of global rare disease drug sales.

Question 8

Does the biotech keep control of its product and strategy?

Accepted Answer

Yes. The engagement is decision-gated and reversible: stop, go or defer at every milestone. Vendor contracts, operational systems and institutional knowledge transfer to the biotech’s team whenever it is ready to internalise. Pricing, strategy, IP and ownership always stay with the company.

Beyond advice: one senior team, from assessment to execution.