ELlGN-GI will create a huge impact on preterm infants’ care and improve their outcomes, as well as reduce complications and hospitalization – thus costs and staff burden. Elgan performed a market research study, incorporating data collected in the previous phase III clinical trial. The report included identifying and analysing the main value drivers of ELGN-GI from the payers' perspective in several key markets, considering the specificities in each of them- a tailored market access approach was developed. Potential Reimbursement schemes, purchasing methods and funding mechanisms for inpatient medications were discussed, as well as potential competitors.
Scientific findings identified microbiome changes following administration of the ELGN-GI drug, potentially explaining the underlying mechanism for the efficacy observed and reduction in the rate of necrotizing enterocolitis. These results are under review and publishing by the investigators. They might support pharmaco-economic and clinical benefits of the drug, promoting the adoption and sales post- launch.
Elgan is routinely attending and sponsoring local and international medical conferences. Several scientific presentations of Elgan's data were delivered during these meetings, with great interest from the participants. The European neonatology community is familiar and supportive of Elgan's clinical program. Elgan continues to collaborate with nonprofit patient parent organizations, that are also supportive of the project. This wide support from the relevant stakeholders will facilitate the adoption of the product once approved, towards becoming a worldwide standard of care.
Elgan's intellectual property is extensive, with many patents allowed over the last two years, substantiating the exclusivity of the drug in the market. Being an orphan drug as well as paediatric, it is also eligible for additional regulatory exclusivities.
