By Vincent Lévêque, Co-Founder & CEO, Mirava Bio
The Essence of Mirava
For my first article here, I cannot write about anything other than the sense of purpose behind Mirava Bio , the very reason we founded it. After decades building commercial infrastructures for emerging biotechs,we came to a simple realization: great science alone isn’t enough.
If patients never receive the therapy, the innovation remains incomplete. That belief became the essence of Mirava: bridging life-changing science with the patients who need it most.
The Challenge: Great Science, Limited Reach
Over the last 20 years, breakthroughs in ATMPs and gene and cell therapies have transformed what is possible for patients with rare diseases. Yet, despite record numbers of FDA and EMA approvals, around 70 % of orphan therapies never reach patients outside the US.
For most emerging biotechs, the obstacle isn’t science , it’s commercial execution.
Launching a single therapy across multiple healthcare systems demands years of setup, complex licensing, and heavy fixed investment. For companies with only one or two assets, the economics simply don’t work.
As a result, patients in Europe, the Middle East, and Eurasia (EMEE) often wait years for access to approved treatments, while biotechs lose valuable time and revenue potential.
The Insight: A Missing Model Between “Go-Alone,” Out-Licensing, and Distribution
Traditional paths each have their limits:
- Going Alone offers full control but requires creating an entire local footprint , legal entities, staff, supply chain, and compliance , with high upfront cost and risk.
- Out-Licensing removes execution pressure but permanently transfers regional rights to another company. As a result, the biotech loses the market value of the EMEE region in any future exit or acquisition, since that geography is no longer part of its commercial potential.
- Distribution ay seem easier, but in practice it still requires the biotech to hold (or establish through a partner) the regulatory responsibilities for its product — including Orphan Drug Designation (ODD), Marketing Authorisation (MA), and the corresponding legal entity in the EU with qualified personnel (Responsible Person, Qualified Person) and the necessary licenses (MIA, WDA) supported by a compliant Quality Management System (QMS). The result is faster access in appearance only, yet minimal strategic control and limited influence on brand, pricing, and market access decisions.
What was missing was a hybrid model , one that preserves ownership and valuation while eliminating the burden of building local infrastructure.
That’s the gap Mirava Bio fills: a license-ready, one-contract model enabling biotechs to enter Europe, the Middle East, and Eurasia efficiently, compliantly, and without diluting long-term value.
The Solution: Mirava Bio’s Integrated, License-Ready Platform
Mirava Bio’s license-ready commercialization platform allows biotechs to expand into EMEE under a single contract, leveraging pre-existing legal entities, regulatory licenses, and qualified experts (MAH, GDP, GMP, QP, QA, QPPV).
The result:
- Immediate launch readiness once approval is granted.
- No affiliate build-out or upfront infrastructure.
- Controlled, performance-linked cost structure.
- Faster patient access across multiple geographies.
This model turns commercialization from a fixed-cost burden into a scalable, risk-mitigated growth engine.
Financial Discipline Meets Rare-Disease Focus
Rare-disease therapies face unique launch dynamics: high initial investment, small patient populations, and rapid market saturation.
Mirava Bio integrates financial discipline, milestone-based planning, and early-revenue pathways (through Early Access and Named-Patient Programs) into every expansion plan.
By aligning regulatory, access, medical, supply-chain, and commercial functions, we ensure biotechs deploy capital only where it creates measurable value.
Shared Infrastructure, Shared Success
At its core, Mirava’s model mutualizes infrastructure across partners and products.
This shared-services approach reduces duplication, strengthens local expertise, and builds long-term relationships with payers, regulators, and patient communities.
Our performance-based margin structure means we succeed only when our partners do.
Why It Matters
For patients, it means faster access to life-changing therapies.
For biotechs, it means global expansion without dilution, delay, or disproportionate cost.
For investors, it means a capital-efficient, scalable route to value creation.
As the rare-disease landscape evolves, Mirava Bio offers a new model , one that blends purpose with precision, flexibility with compliance, and innovation with impact.
About Mirava Bio
Mirava Bio is a Swiss-based biocommercial partner helping rare-disease and ATMP innovators expand across Europe, the Middle East, and Eurasia.
Through its two-pillar model , Strategic Go-to-Market Advisory & Support and a License-Ready Integrated Commercialization Platform , Mirava Bio empowers emerging biotechs to bring transformative therapies to patients faster, with less risk and greater control.