Our Business Models
Out Licensing
Offering partners fully developed and commercialized assets, reducing time-to-market and risk.
Co-Development
Advancing development to a defined stage, to partner with companies that provide investment and commercialization
Development under contract
Leveraging proven compounds and creating differentiated solutions through transdermal technologies.
Out-licensing
Our out-licensing model offers immediate access to validated, market-ready products with complete dossiers and reliable supply agreements.
Partners benefit from reduced time-to-market, lower investment risk, and flexible production volumes.
Supported by monthly S&OP, KPIs, and audit-ready documentation, Amarin ensures continuity, predictability, and cost efficiency.
This model allows seamless integration of proven assets into partner portfolios, maximizing value throughout the product lifecycle.
Market-ready products, backed by expertise
We offer a portfolio of already commercialized products, with a complete dossier and supply agreements that prioritize continuity, predictability, and control. Licensees receive a fully traceable technical package and a supply plan aligned with their forecast.
Our versatile plant supports campaign-based and variable-scale production, enabling pilot batches, commercial series, ramp-ups, and buffers for demand peaks. Management is our differential: one point of contact, monthly S&OP, agreed service levels, realistic MOQs, compliance KPIs, and a clear change control process to ensure stability and cost efficiency.
The objective is to integrate a validated asset into the portfolio with limited risk, well-maintained documentation, and a seamless logistics chain throughout the product’s lifecycle.
Benefits: access to a validated asset, lower initial investment, flexible volumes thanks to plant versatility, assured supply continuity with KPIs and S&OP, documentation ready for audits.
Steps: CDA, product selection and dossier review, demand and service level alignment, supply agreement with MOQs and KPIs, supply plan and first shipment.
Co-Development
Amarin’s co-development model accelerates market entry by sharing R&D risk and aligning incentives.
Starting from a clear TPP and technical plan, we integrate formulation, analytics, regulatory design, and flexible manufacturing.
With milestone-based execution and continuous molecule screening, we deliver projects with realistic approval probability and balanced risk–return, transforming proof of concept into commercialized products ready to scale globally.
Partnerships that turn innovation into impact
We work through alliances that accelerate time-to-market, sharing R&D risks and leveraging complementary capabilities. Each project starts with a clear Target Product Profile (TPP) and a technical plan that integrates formulation, analytical development, IVRT and IVPT studies, PK/BE study design, and regulatory planning by territory. Manufacturing is carried out at our facility as the preferred route, with technology transfer when strategically required.
Our pipeline is fueled by continuous molecule screening and rigorous selection based on technical feasibility, patent landscape, therapeutic rationale, and market potential.
In our co-development model, we do not sell lab hours—we build a business case focused on capturing value once the product reaches the market. Execution is close and agile, with milestone-based decision structures and clear advancement criteria.
The result is a project with realistic approval probability and a balanced risk–return equation for both parties, from proof of concept to dossier submission and market adoption.
Benefits: aligned incentives, faster execution, leveraged experience and track record, technical and commercial synergies, pipeline supported by continuous screening, focus on COGs and therapeutic rationale, value capture in the market.
Steps: CDA, TPP and market assumptions exchange, technical-commercial workshop, feasibility and project plan, term sheet with milestones, budget and distribution scheme, joint team kickoff.
Development under Contract
With development under contract, Amarin transforms defined TPPs into robust, audit-ready products.
We manage every phase—QbD, formulation, analytical methods, stability, scale-up, and dossier preparation—with technical rigor and cost visibility.
Our GMP-certified facility ensures reproducible, scalable manufacturing, with tech transfer available when required.
This model provides predictability, compliance, and long-term value, aligning partner goals with Amarin’s proven expertise in transdermal and topical systems.
Reliable developments designed to scale
We develop under contract when clients define the Target Product Profile and require technical precision, cost visibility, and disciplined project execution. We work in phases with closed deliverables: pre-formulation and QbD, formula and process development, analytical methods, stability, scale-up, and dossier preparation.
We design the appropriate study for each objective, prioritizing robustness and total cost. Decisions are simple, based on metrics, critical tolerances, and mitigation routes. Our focus is not only technical but also industrial: creating a solid, reproducible product that withstands audits. From day one, we control COGs, select materials and processes with supply and auditability in mind, and plan manufacturing in our flexible plant, with campaign capacity, variable scales, PPQ, and documentation ready. If required, we prepare technology transfer packages to manufacture at partner sites.
Intellectual property is framed from the term sheet, with background ownership preserved and clear agreements on results, licenses, protection, and freedom-to-operate strategies.
Our track record in transdermals and topicals translates into predictability, compliance, and a technical foundation that sustains margins over time.
Benefits: TPP control, milestone-based traceability, COGs under control, technical package ready for audits, in-house manufacturing with transfer option, and clear IP ownership reducing friction in registration and commercialization.
Steps: CDA, scope and success criteria, phased proposal with timeline and costs, communication plan and decision structure, first decision gate after feasibility.
