FDA Approves TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) Supplemental New Drug Application (sNDA) to include data for the Reduction of COPD Exacerbations and Hospitalizations

MORRISVILLE, N.C.--(BUSINESS WIRE)-- Circassia Pharmaceuticals Inc. (“Circassia” or “the Company”), announced today that the US Food and Drug Administration (FDA) added new data to the TUDORZA^® PRESSAIR^® (aclidinium bromide inhalation powder) Prescribing Information that includes data from the ASCENT trial showing that TUDORZA PRESSAIR reduces exacerbations in chronic obstructive pulmonary disease (COPD) and does not increase major adverse cardiovascular events (MACE) in COPD patients with cardiovascular disease and/or significant cardiovascular risk factors.¹ TUDORZA PRESSAIR is indicated for the maintenance treatment of patients with COPD.²

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TUDORZA® PRESSAIR® (aclidinium bromide inhalation powder) (Photo: Business Wire)

According to Kenneth Chapman, MD, Clinical Researcher, Krembil Research Institute, University Health Network, University of Toronto, and investigator on the ASCENT trial: “Most people who have COPD are also at a higher risk for cardiovascular disease because the most common cause of COPD is long-term smoking. The ASCENT trial was important because it looked at people who are in this high-risk cardiovascular category. For a very long time, patients with a high cardiovascular risk were excluded from long-acting muscarinic antagonist (LAMA) trials, so we were unclear about the effect of LAMAs on cardiovascular disease; confidence has been low and questions about its safety have lingered. ASCENT showed that TUDORZA PRESSAIR use led to clear and consistent reduction in exacerbations and reductions in flare-ups. This leads to lower emergency room visits and lower hospital admissions.”

COPD exacerbations, or “flare-ups,” include a sudden worsening of symptoms such as shortness of breath, worsened cough, headaches.³ Frequent exacerbations accelerate disease progression and death.⁴ Exacerbations also lead to increased unscheduled physician and emergency room visits, which can add to the financial burden of COPD on individuals and the healthcare system.⁵

“It was essential to answer the question about major adverse cardiovascular events and safety in COPD patients with cardiovascular co-morbidity. The inclusion of the ASCENT safety information in the updated TUDORZA PRESSAIR label addresses that question,” said Michael Asmus, Vice President, US Medical Affairs, Circassia. “Exacerbations are also serious, and sometimes life-threatening events, and it’s gratifying to make a difference in helping to improve the lives of people who live with COPD.”

“The expanded label for TUDORZA PRESSAIR is welcome news for the COPD community and providers who care for COPD patients,” said David Acheson, Senior Vice President, US Commercial, Circassia. “Circassia is proud to be a leader in the respiratory health space, and today’s news further demonstrates our commitment to respiratory health.”

ASCENT was a randomized, double-blind, placebo-controlled of up to 36-months study that evaluated the effect of TUDORZA PRESSAIR on MACE and exacerbations in 3,630 patients with moderate-to-very-severe COPD.⁶ All patients had a history of cardiovascular or cerebrovascular disease and/or significant cardiovascular risk factors.⁶ This phase IV trial found that, compared to placebo, TUDORZA PRESSAIR does not increase MACE and reduced exacerbations in the first year in COPD patients with high cardiovascular risk.¹ TUDORZA PRESSAIR is not a rescue medicine and should not be used for treating sudden breathing problems.² In this study, adverse reactions occurring at a rate of ≥2% and more common than placebo were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease.²

Please see complete Important Safety Information below and full prescribing information here.²

About COPD in the US

COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which makes it hard to breathe and results in breathlessness.⁷ According to the American Lung Association, COPD is the third leading cause of death in the United States.⁸ More than 11 million people have been diagnosed with COPD, but millions more may have the disease without knowing it.⁸ COPD causes serious long-term disability and early death, and the number of people dying from COPD is growing.⁸

According to the World Health Organization, the most common symptoms of COPD are breathlessness (or a “need for air”), chronic cough, and sputum (mucous) production.⁷ Sufferers also frequently experience exacerbations, that is, serious episodes of increased breathlessness, cough and sputum production that last from several days to a few weeks.⁷ These episodes can be seriously disabling and result in need for urgent medical care (including hospitalization) and sometimes death.⁷

About TUDORZA PRESSAIR

TUDORZA^® PRESSAIR^® (aclidinium bromide inhalation powder) is a prescription medicine used two times a day for the maintenance treatment of COPD.² It is not a rescue medicine and should not be used for treating sudden breathing problems.² Full Prescribing Information for TUDORZA PRESSAIR can be found here.²

About Circassia Pharmaceuticals Inc.

Circassia Pharmaceuticals Inc. is part of the Circassia Pharmaceuticals plc group. Circassia is a world-class specialty pharmaceutical business focused on respiratory disease. Circassia sells its novel, market-leading NIOX^® asthma management products directly to specialists in the United States, United Kingdom, China and Germany, and in a wide range of other countries through its network of partners. In the United States, Circassia has a commercial collaboration with AstraZeneca in which it has the commercial rights to chronic obstructive pulmonary disease (COPD) treatments TUDORZA PRESSAIR and DUAKLIR^® PRESSAIR^®. Circassia also has the commercial rights to the late-state ventilator-compatible nitric oxide product AirNOvent in the United States and China. For more information please visit www.circassia.com, or follow us on Twitter [@CircassiaUSA] and LinkedIn [CircassiaUSA].

Important Safety Information for TUDORZA PRESSAIR

• TUDORZA PRESSAIR is contraindicated in patients with severe hypersensitivity to milk proteins or who have hypersensitivity to aclidinium bromide or any of the excipients
• TUDORZA PRESSAIR is not indicated for the initial treatment of acute episodes of bronchospasm (ie, rescue therapy)

• Immediate hypersensitivity reactions, including anaphylaxis, angioedema (swelling of lips, tongue, or throat), urticaria, rash, bronchospasm, or itching have occurred after administration of TUDORZA PRESSAIR. Additionally, inhaled medicines, including TUDORZA PRESSAIR, may cause paradoxical bronchospasm. If any of these occurs, treatment with TUDORZA PRESSAIR should be stopped and other treatments considered
• TUDORZA PRESSAIR should be used with caution in patients with narrow-angle glaucoma or urinary retention. Instruct patients to consult a physician immediately should any signs or symptoms of acute narrow-angle glaucoma or prostatic hyperplasia or bladder-neck obstruction develop
• The most common adverse reactions (≥3 % incidence and greater than placebo) were headache (6.6% vs 5.0%), nasopharyngitis (5.5% vs 3.9%), and cough (3.0% vs 2.2%), for TUDORZA PRESSAIR vs placebo, respectively. In a long-term 3-year trial, adverse reactions (occurring at a rate of ≥2 % and more common than placebo) were nausea, back pain, cough, hypertension, sinusitis, constipation, arthralgia, anemia, muscle spasms, cardiac failure congestive, cellulitis, and gastroesophageal reflux disease

Indication for TUDORZA PRESSAIR

TUDORZA^® PRESSAIR^® (aclidinium bromide inhalation powder) is an anticholinergic indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).²

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Forward-looking statements

This press release contains certain projections and other forward-looking statements with respect to the financial condition, results of operations, businesses and prospects of Circassia. The use of terms such as “may”, “will”, “should”, “expect”, “anticipate”, “project”, “estimate”, “intend”, “continue”, “target” or “believe” and similar expressions (or the negatives thereof) are generally intended to identify forward-looking statements. These statements are based on current expectations and involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. Any of the assumptions underlying these forward-looking statements could prove inaccurate or incorrect and therefore any results contemplated in the forward-looking statements may not actually be achieved. Nothing contained in this press release should be construed as a profit forecast or profit estimate. Investors or other recipients are cautioned not to place undue reliance on any forward-looking statements contained herein. Circassia undertakes no obligation to update or revise (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events or other circumstances.

Aclidinium is marketed under a number of brand names around the world, including TUDORZA^®, Eklira^® and Bretaris^®

US-27779 Last Updated 3/19

References:

1. Wise RA, et al. Effects of aclidinium bromide on major adverse cardiovascular events and COPD exacerbations in patients with COPD and cardiovascular risk factors. Am J Respir Crit Care Med 2018;197:A7711.

2. TUDORZA^® PRESSAIR^® (aclidinium bromide inhalation powder) [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2019.

3. COPD Foundation. “Avoiding COPD Exacerbations.” https://www.copdfoundation.org/Learn-More/I-am-a-Person-with-COPD/Avoiding-Exacerbations-and-Pneumonia.aspx Accessed March 14, 2019.

4. Halpin DMG, et al. Exacerbation frequency and course of COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:653-661.

5. Dhamane AD, et al. COPD exacerbation frequency and its association with health care resource utilization and costs. Int J Chron Obstruct Pulmon Dis. 2015;10:2609-2618.

6. Wise RA, et al. Long-term evaluation of the effects of aclidinium bromide on major adverse cardiovascular events and COPD exacerbations in patients with moderate to very severe COPD: rationale and design of the ASCENT COPD study. Chronic Obstr Pulm Dis. 2018;5(1):5-15.

7. World Health Organization. Chronic Obstructive Pulmonary Disease (COPD) Fact Sheet. December 1, 2017. https://www.who.int/news-room/fact-sheets/detail/chronic-obstructive-pulmonary-disease-(copd) Accessed March 15, 2019.

8. American Lung Association. https://www.lung.org/lung-health-and-diseases/lung-disease-lookup/copd/learn-about-copd/how-serious-is-copd.html Accessed March 15, 2019.

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