By Fineline Cube 
GlaxoSmithKline plc (GSK, NYSE: GSK) and Empirico Ltd. today announced a global exclusive licence agreement for Empirico’s investigational product EMP‑012. The deal grants GSK full worldwide development, regulatory, and commercial rights, while Empirico retains responsibility for Phase I clinical development until completion.
Deal Structure
- Upfront Payment – GSK pays USD 85 million at signing.
- Milestone Potential – Up to USD 660 million in development, regulatory, and commercial milestone payments, plus tiered royalties on worldwide net sales.
- Development Path – Empirico will lead the ongoing Phase I trial; upon success, GSK will take over global development, regulatory filings, and commercialization.
EMP‑012 – A First‑in‑Class siRNA for COPD
- Mechanism – EMP‑012 is a highly selective, small‑interfering‑RNA (siRNA) that targets a novel inflammatory pathway implicated in chronic obstructive pulmonary disease (COPD).
- Clinical Status – Currently in Phase I to evaluate safety, tolerability, and pharmacokinetics.
- Expansion Potential – The therapeutic platform could extend to other inflammatory respiratory diseases such as asthma and bronchiectasis.
Strategic Rationale
- GSK’s Portfolio – The partnership aligns with GSK’s focus on respiratory and inflammatory indications and expands its pipeline with a novel mechanism of action.
- Empirico’s Expertise – Empirico retains clinical control, enabling it to secure future collaborations while leveraging GSK’s global reach for eventual commercialization.
Forward‑Looking Statements
This release contains forward‑looking statements that involve risks and uncertainties. Actual results may differ materially.-Fineline Info & Tech