Brilacidin – Competitive Positioning, Market Opportunity for Oral Mucositis

Competitive Positioning

Based on our preliminary estimates, the total Brilacidin oral mucositis market opportunity in Head and Neck Cancer annually in the U.S. and Europe would be approximately $600 million to $1.2 billion.

In follow-up to today’s Press Release, the Company wanted to provide shareholders with additional perspectives on the competitive positioning and market opportunity of Brilacidin oral rinse for use in Head and Neck Cancer (HNC) patients undergoing chemoradiation. Compared to other oral mucositis (OM) drug candidates being evaluated in clinical testing, Innovation Pharmaceuticals believes its drug candidate, Brilacidin oral rinse, occupies a leadership position as preparations move forward for its planned Phase 3 program. Most potential competitor drug candidates target minimizing symptoms and not prevention, and/or are disadvantaged by not having as patient-friendly modes of delivery (IV) in comparison to our easily-administered oral rinse. For detailed comparative analysis, please see our Company blog post on the topic, linked below:

Market Opportunity (HNC-Only, US and Europe)

According to published statistics, and based on other data sources, oral mucositis accompanies chemoradiation treatment in almost all Head and Neck Cancer patients undergoing treatment. The annual incidence of HNC in the US and Europe is approximately 150,000 (worldwide approximately 750,000 cases). Approximately 60 to 70% of these patients will develop Severe Oral Mucositis (SOM) (WHO Grade > 3) (confirmed in our own clinical study). Because it cannot be predicted which patients will get SOM, all patients would begin Brilacidin as soon as starting chemoradiation and continue until completion (typically a seven-week course). Given that Brilacidin is administered as a convenient and patient-friendly oral rinse (swish and spit, 3x daily), we believe that our market penetration could realistically approach 80 percent within the first three years following market introduction. This would translate into a targeted 120,000 treated HNC patients in the U.S. and Europe per year according to the anticipated label indication. Moreover, following  regulatory approval in HNC, we would anticipate the potential to expand the label to capture a broadened market—patients experiencing OM across various cancer indications, estimated to include as many as 650,000 people annually (25% to 60% of all cancer patients receiving chemotherapy experience OM).

We believe most other competitor products in development, with less patient-friendly modes of delivery (e.g., IV), would be less able to reach this broader OM market. An additional factor that should help to expedite market adoption of Brilacidin oral rinse includes the potential to avoid incremental inpatient costs incurred in those SOM patients requiring hospitalization, estimated to be between $18,000 and $25,000 per incident. Private and government payers would thus be incentivized to adopt preventative treatment due to large potential cost-savings. We anticipate being able to price Brilacidin at $5,000 to $10,000 per full course of treatment based on the large unmet need as well based on initial pricing for the only other OM drug ever approved (Palifermin, hematopoietic stem cell transplantation, HSCT). Based on our preliminary estimates, the total Brilacidin oral rinse market opportunity annually in the U.S. and Europe would be approximately $600 million to $1.2 billion.

For additional insight into the Brilacidin market opportunity for oral mucositis, refer to additional Company blog posts, linked below:

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