On November 13, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company reported perspectives on the unmet patient need in OM and global commercial opportunity of Brilacidin, the Company’s defensin-mimetic drug candidate, for the prevention of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, NOV 13, 2019, View Source [SID1234551125]).
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"Quite simply, OM is a significant unmet patient need in supportive cancer care, with a sizable commercial opportunity attached to delivering novel OM therapies," said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "We believe that Brilacidin, as a result of our promising Phase 2 results showing a marked reduction in the incidence of SOM, further advantaged by a patient-friendly oral rinse formulation conveniently packaged in sachet form, leads the competitive field of OM drugs in development. Negotiations with potential pharmaceutical partners interested in licensing our Brilacidin for OM asset continue, with the Company remaining diligent as it works toward executing the next step in the drug candidate’s development."
Over 500,000 Annual Cases of SOM Globally by 2025 and No Drugs on Market Today
Millions of patients worldwide suffer from OM, a costly and debilitating side-effect of chemoradiation, with the majority of therapies currently in use consisting of medical devices that are palliative in nature and poorly reimbursed. OM is particularly common in HNC, affecting each year approximately 65,000, 150,000, and 300,000 patients respectively in the U.S., Europe and Asia. Worldwide, by 2025, annual new HNC cases are expected to approach 930,000. Almost all HNC patients will develop some form of OM, with ~70 percent developing SOM. Patients with SOM are more likely to experience treatment-limiting and even life-threatening interruptions in their chemoradiation regimens. Additional costs incurred due to SOM range from $18,000 to over $42,000 per case on average.
Rising Rates of Oral Cancer
While the incidence of many cancers is decreasing, oral cancer is on the rise. According to the Oral Cancer Foundation, about 657,000 cases of oral or oropharyngeal cancer (including the larynx) are reported annually worldwide. Common causes are the sexually transmitted HPV, smoking and alcohol consumption. The Centers for Disease Control and Prevention estimate that 7 out of every 10 oropharyngeal cancers are caused by HPV. About 43 percent of patients with oral cavity cancer die within five years.
Large Void, Up to $2.5 Billion Global Annual Market Opportunity
Various pharmaceutical companies are conducting clinical trials in an attempt to bring OM drugs to market. One company, Galera Therapeutics (Nasdaq: GRTX), an OM-focused pharma, raised $150 million in October 2018, and recently completed a $60 million IPO, to fund the development of its OM drug candidate. A safe and effective drug to prevent—or even reduce the duration of SOM—has the potential to fill a large void in supportive cancer care and capture a substantial new market, an annual global commercial opportunity estimated to range between $500 million and $2.5 billion.
Compelling Economics, Attractive Marketing Dynamic
The Company estimates relatively low Cost-of-Goods to produce Brilacidin oral rinse per course of treatment, thereby creating favorable economics to price the product competitively and still generate healthy margins. Palifermin (Kepivance), the only approved drug to treat OM (in Hematopoietic Stem Cell Transplantation), was priced at $8,250 upon product launch in 2005, and currently is priced at approximately $16,000. ProGrow Pharma Partners estimates the market price for novel OM drugs to be between $9,000 (Europe) and $18,000 (U.S.). By eliminating the considerable associated patient costs attributable to OM, surveys of payers in the U.S. have indicated a willingness to pay up to $20,000 for a preventative OM treatment.
Currently, about 2,500 facilities in the U.S. treat HNC patients undergoing chemoradiation regimens. As a subset, approximately 60 percent of all HNC patients are treated in just 500 of these facilities. A small salesforce could thus be deployed to detail physicians and other care professionals treating a majority of HNC patients. This marketing dynamic further lends to the attractive economics for the development of a drug in this category of medical need.
About Brilacidin Phase 2 Oral Mucositis Trial
The Company’s Brilacidin oral rinse for OM demonstrated a strong therapeutic benefit in HNC patients receiving the aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is in common use. In this patient population, incidence of SOM (WHO Grade ≥ 3) was reduced to 25.0 percent in the modified Intent-to-Treat (mITT) population, versus 71.4 percent in the placebo patient group. In the Per Protocol (PP) patient group, incidence of SOM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.
The completed Phase 2 study (see NCT02324335) met its primary endpoint, showing a reduction of SOM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of SOM and in delaying the onset of SOM. Furthermore, Brilacidin showed a favorable safety profile and was well-tolerated.
About Brilacidin and Severe Oral Mucositis
There currently are no FDA-approved drugs for the prevention of Severe OM (SOM) (WHO Grade ≥ 3) in HNC patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to over $42,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and worldwide, ~750,000 cases. Approximately 70 percent of HNC patients receiving chemoradiation typically will develop Severe OM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.