Commercial opportunity

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.

Asthma therapies

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 treatments

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.

Tudorza®

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.

Duaklir®

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.

Spiriva® substitute

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

Disclaimer

This website contains forward-looking statements within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as “may,” “anticipates,” “estimates,” “expects,” “intends,” “plans,” “believes,” and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) our ability to develop and bring to market new products, (2) our ability to successfully complete any necessary or required clinical studies with our products, (3) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (4) our success in implementing our sales, marketing and manufacturing plans, (5) the level of adoption of our products by medical practitioners, (6) the emergence of other products that may make our products obsolete, (7) protection and validity of patents and other intellectual property rights, (8) the impact of currency exchange rates, (9) the effect of competition by other companies, (10) the outcome of significant litigation, (11) our ability to obtain reimbursement for our product from government and commercial payors, (12) the impact of global economic conditions, (13) our ability to successfully integrate acquired businesses, (14) changes and reforms in applicable healthcare laws and regulations, (15) quality issues and adverse events related to our products, and (16) other risks and factors identified under such headings as “Risk Factors,” “Cautionary Language Regarding Forward-Looking Statements” and “Operating Results and Financial Review and Prospects” in the Company’s Annual Report.