Circassia’s marketed and pipeline products target various respiratory indications, including asthma and chronic obstructive pulmonary disease (COPD), and offer significant commercial potential.
NIOX® asthma management
Asthma represents one of the largest healthcare burdens. In the US alone, there are 25 million asthmatics, with the economic cost of asthma estimated to account for over $80 billion per year. Worldwide, asthma affects 235 million people and is the most frequent chronic disease among children. As a result, our marketed NIOX® products used in asthma diagnosis and management have a major commercial opportunity.
Flixotide® / Flovent® substitute
Circassia’s product targets substitution of GSK’s Flixotide®/Flovent® pMDI, which generated global sales of $775 million in 2017 in pMDI and DPI formats. Due to the formulation challenges associated with inhaled respiratory medicines, and relatively limited competition in the pMDI market segment, our particle-engineered products have a significant potential commercial opportunity.
Seretide® substitute market
Our product contains fluticasone propionate and salmeterol xinafoate. These are the active components in GSK’s Seretide® combination therapy, which generated European sales of over $950 million in pMDI / DPI in 2017. The complexity of producing a directly substitutable version of Seretide® using traditional manufacturing technology, the rigorous standards required for approval and the limited competition in the pMDI market segment present a major potential opportunity for Circassia’s product.
COPD is a major health burden. The World Health Organization estimates that approximately 65 million people worldwide have moderate-to-severe COPD and it is predicted to become the third leading cause of death by 2030.
Circassia promotes the COPD treatment Tudorza® (aclidinium bromide) in the United States as part of its collaboration with AstraZeneca. The product is part of the long-acting muscarinic antagonist containing market, which totalled approximately $3.0 billion in revenues in 2018. Third-party estimates suggest that Tudorza® has the potential to achieve peak sales of over $90 million in the United States.
Circassia holds the US commercial rights to Duaklir®, a fixed dose combination of aclidinium bromide and formoterol fumarate. The product was approved in the US market in March 2019 and targets the US LAMA /LABA market, which is predicted to grow rapidly over the coming years. Third-party research suggests Duaklir® has a peak sales opportunity of over $180 million in the United States.
Circassia’s product contains tiotropium bromide, the active component in Boehringer Ingelheim’s dry powder treatment Spiriva® Handihaler®. Spiriva® is also available as an inhalation spray and is approved in a number of countries, including the US. The product accounted for total revenues of $3.2 billion in 2017.
Novel LABA / LAMA formulation & novel COPD therapy formulation
Circassia’s two novel formulations of currently approved drugs target an underserved segment of the specialist moderate-to-severe COPD market.
- The first contains a LABA / LAMA fixed dose combination. Third-party research suggests the product targets a patient population of up to 350,000 in the US and EU5 with a potential peak sales opportunity of up to $700 million.
- The second targets reductions in COPD exacerbations. The US / EU5 target patient population totals up to 200,000 and market research indicates the product has a potential peak sales opportunity of up to $250 million.
AirNOvent nitric oxide product
Inhaled nitric oxide is a pulmonary vasodilator, which is approved in the United States for use as part of a regimen in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn. The currently available product, INOMAX®, is used in neonatal intensive care units (NICUS) and its delivery system administers nitric oxide from pressurized cylinders in conjunction with ventilator systems. The product generated estimated US revenues of over $400 million in 2017.
AirNOvent* is a portable system that utilizes an electric voltage to produce precise quantities of nitric oxide from the nitrogen and oxygen in air. It offers a number of potential benefits over the existing competition. It is cylinder-free and is smaller, significantly lighter and more convenient and, unlike nitric oxide cylinder-based systems, does not require special storage and handling. As a result, it has the potential for use by NICUs, as well as smaller clinics without the facilities required to manage nitric oxide cylinders.
*AirNOvent is not an approved name for the product and may not be the final name submitted for approval
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