EirGenix Inc. (TPE: 6589) announced a second, worldwide exclusive licensing agreement with Sandoz AG (SWX: SDZ) to commercialize its independently developed pertuzumab biosimilar, EG1206A—Roche’s Perjeta counterpart—across all territories outside of Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, Japan, and the entire ASEAN‑EMEA region.
Deal Highlights
- Financial Terms
- Up to USD 152 million in upfront and milestone payments.
- Profit‑share mechanics post‑launch, plus sales‑incentive tiers tied to market performance.
- Scope and Responsibilities
- EirGenix leads product development, manufacturing, and supply chain management.
- Sandoz provides marketing, distribution, and commercial expertise in the licensed territories.
- Territorial Cadence
- All countries except Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, and Japan.
Scientific & Regulatory Context
- Clinical Milestone
- EG1206A has completed its pharmacokinetic (PK) study and received positive feedback from the U.S. FDA and EMA.
- The regulatory outcome confirms eligibility for an abbreviated development pathway, enabling waiver of Phase 3 comparative efficacy trials.
- Strategic Positioning
- EG1206A represents the third biosimilar in EirGenix’s portfolio, following the prior AGX licensing of EG12014 (trastuzumab).
- The deal positions EirGenix as a growing player within the lucrative breast‑cancer biosimilar market.
Investor Impact
- Cash‑Flow Advantage – Immediate up‑front and milestone income potentially boosting the 2025 earnings guide.
- Revenue‑Sharing Structure – Long‑term upside as EG1206A captures market share across > 50 high‑growth markets.
- Operational Focus – By handling R&D and manufacturing, EirGenix retains control over supply‑chain efficiencies.
Forward‑Looking Statements
The comments made herein are forward‑looking and are subject to risks and uncertainties. Material adverse changes may cause actual results to differ materially.-Fineline Info & Tech
