Commercial opportunity

Circassia’s portfolio of products target use in 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.

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, where it has the commercial rights to the product. Tudorza® is part of the long-acting muscarinic antagonist (LAMA) market, which totalled approximately $2 billion in revenues in the US in 2018 with Tudorza® accounting for approximately 2.6% of prescriptions. As a result, Tudorza® has significant potential, with a modest improvement in market share and / or a move to higher value channels representing a growth opportunity.

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 from an estimated $1 billion in 2019 to over $1.5 billion in the coming five years.

LungFit PH 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 2018.

LungFit PH* 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.

*LungFit PH 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.