Bellus Health (TSX:BLU)(NASDAQ:BLU) is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hyper-sensitization disorders. The company is developing BLU-5937 for the treatment of chronic cough.
Hyper-sensitization-related disorders represent areas of significant unmet medical need and potentially large market opportunities. BLU-5937’s characteristics observed in the company’s pre-clinical studies and Phase 1 and 2 clinical trials position it for development as a potential competitive treatment option.
Potential market opportunity
Chronic cough is a cough lasting more than eight weeks and may have a significant adverse impact on patients’ quality of life. The company estimates that 10% of the adult population in developed countries suffer from chronic cough including the United States, nations in the European Union, the United Kingdom and Japan. This represents approximately 26 million patients with chronic cough in the United States alone. Many patients report that chronic cough has a marked effect on an individual’s quality of life including sleep disruption, tiredness, incontinence, and disrupting social interactions.
These patients continue to cough despite treatment for potential underlying causes that trigger the cough. The company estimates that approximately one-third, or three million patients in the U.S. have been coughing for over a year, a key inclusion criteria in current trials.
When segmented by severity, about 45% of patients have moderate to severe disease and 55% have mild disease. Severely affected patients have a debilitating disease, mildly affected patients have fewer but still relevant impact from the disease. The company estimates that approximately 30% of chronic cough patients, or approximately nine million patients in the U.S., have severe cough which is the expected addressable patient population for BLU-5937.
Robust business strategy
Bellus is focused on the development and commercialization of BLU-5937 as a potential differentiated treatment option for patients, as well as for the treatment of chronic pruritus associated with other hyper-sensitization-related disorders. The key elements of the company’s strategy is to advance the development of BLU-5937 in the treatment of chronic cough. The company is focused on efficiently developing BLU-5937 to treat patients with chronic cough.
The company is also focused on advancing the development of BLU-5937 in the treatment of chronic pruritus. Bellus is conducting a Phase 2 clinical trial to evaluate the efficacy and safety of BLU-5937 in patients with chronic pruritus associated with hyper-sensitization-related disorders. Bellus is looking to maximize the value of BLU-5937 by maintaining flexibility to develop and commercialize the company’s product independently or through collaborations.
Valuable intellectual property
In March 2020, the company acquired all of the remaining BLU-5937 intellectual property rights and now owns 100% of the BLU-5937 assets. Bellus has indicated that it may choose to pursue the development and commercialization of BLU-5937 independently or through collaborations with third parties. The company is also focused on leveraging proprietary technology platforms to pursue other hyper sensitization-related conditions.
As for potential pricing considerations for BLU-5937, comparable analogue drugs on the U.S. market have a monthly wholesale acquisition cost that ranges from $300 to $600. Bellus believes that it can produce BLU-5937 at a much lower cost, which could add significant shareholder value.