Replies to post #391466 on Innovation Pharmaceuticals Inc (IPIX)

[threebabiesbusy]

Coverage Perspectives:

Developing Brilacidin as a New Drug Application (NDA), via the 505(b)(1) pathway, significantly improves Brilacidin’s commercialization prospects in the OM therapeutic area. OM products, such as MuGard, GelClair, Episil, and Caphosol, which were developed as devices and not drugs, have struggled to show clinical benefit, as they are primarily palliative in nature, and from a government payer perspective are not covered under Medicare Part D. Reimbursement Landscape: At least 2 approved drugs in all therapeutic drug classes must be made available under Medicare Part D, per USP Medicare Model Guidelines. The guidelines establish the framework (the rules) that drive payer formularies.

*Given there are no approved drugs for OM in HNC, should Brilacidin be approved, it is highly likely it would be included in payer formularies as a pharmacy benefit.

[threebabiesbusy]

Commercial Opportunity:

Annually, in the U.S., Brilacidin has the potential to address 52,000 OM patients in HNC, with potential future extension to 20,000 OM patients in Hematopoietic Stem Cell Transplantation (HSCT), and 160,000 OM patients in all chemotherapy categories. Based on physician estimates of Brilacidin adoption and other pricing-based assumptions, forecasts of U.S. annual sales are $188 million for OM in HNC patients in 2030, with a potential additional upside of $106 million for OM in HSCT and $598 million for OM in all chemotherapy categories. "This analysis reinforces Brilacidin's potential to become a breakthrough OM treatment and commercialization success