Teva Announces New Findings Highlighting Potential of ProAir® Digihaler® (albuterol sulfate) Inhalation Powder to Address Asthma Treatment Challenges

Results were presented in a late-breaking oral session at the ATS 2022 annual meeting

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced new study findings based on newly established clinical thresholds on short-acting beta agonist (SABA) use that highlight real-world SABA usage among patients with asthma in the U.S. and the potential for ProAir^® Digihaler^® (albuterol sulfate) inhalation powder, a digital inhaler, to help inform treatment discussions and decisions. The findings were presented in a late-breaking oral session at the American Thoracic Society (ATS) 2022 Annual Meeting.

Among the study findings, nearly one-third of asthma patients made 138 or more inhalations during the 12-week study period, which was equivalent to 600 or more inhalations, or three or more canisters, per year. In this study analysis, valid inhalations are defined as events when the patient inhales at a peak inspiratory flow (PIF) rate between >18 to <120 liters/minute with no errors in use. The findings are the first application of evidence-based clinical statements from an independent U.S. expert consensus that identify risk of asthma exacerbation, including potential for a life-threatening event, based on patients’ SABA overuse. These results suggest digital inhalers may help healthcare professionals identify and address SABA reliever overuse and help inform clinical decision-making based on individual insights from objective patient SABA reliever usage data downloaded directly from their ProAir Digihaler.

“These findings shed important light on patients’ real-world use of SABA and the potential of objective data from digital health tools like ProAir Digihaler to help inform treatment decisions,” said Tanisha Hill, Senior Medical Director, Respiratory and Digital Health Medical Lead at Teva. “The findings suggest that, with ProAir Digihaler, accurate and objective data on reliever inhaler use can help facilitate treatment discussions between providers and patients.”

“Many patients with poorly controlled asthma rely on SABA when they have an asthma exacerbation,” said Njira Lugogo, MD, Clinical Associate Professor, University of Michigan, and lead study author. “Our research shows that there is a gap between clinical recommendations and real-world management of asthma, and shows how digital tools, such as ProAir Digihaler, may help address some of these challenges.”

Data on SABA usage among 359 patients downloaded from ProAir Digihaler devices were used to apply and validate clinical action thresholds for risk associated with SABA reliever overuse established by independent expert consensus. Patients made one or more valid inhalations (PIF >18 to <120 with no errors in use) from a ProAir Digihaler device over a 12-week period. Elevated SABA use among sub-optimally controlled asthma patients was found to be more common than previously understood.¹ Detailed results include:

• 89% (319/359) of patients met the consensus threshold of SABA reliever medication use that is ≥100% over baseline during one or more study weeks, and 72% (260/359) met the threshold of SABA reliever medication use ≥200% above baseline. These thresholds were determined by independent consensus to likely indicate impending or ongoing exacerbation.¹
• 17% (62/359) of patients made 25 or more valid inhalations in a week, a level associated with unanimous consensus of likely impending or ongoing exacerbation.¹ This included 14% (40/295) of patients who did not have a confirmed exacerbation.¹
• Nearly one-third of patients (29%, 104/359) exhibited a rate of SABA reliever use over 12 weeks equivalent to three or more canisters per year, which was determined by consensus to be associated with increased risk of asthma exacerbation and death.¹ This included 52% (33/64) of patients who had asthma exacerbations during the study period, and 24% (71/295) who did not have confirmed exacerbations.¹

About ProAir Digihaler

ProAir Digihaler (albuterol sulfate) Inhalation Powder is a prescription medicine used in people ≥4 years of age for the treatment or prevention of bronchospasm in people who have reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

The Digihaler Inhalers are the first family of smart inhalers with built-in sensors that capture personal inhaler data and allow patients to track and share their data. ProAir Digihaler (albuterol sulfate) Inhalation Powder is the first and only breath-actuated, digital short-acting beta agonist (SABA) inhaler with built-in flow sensors that detect, record and store objective data showing how often and how well patients use their rescue inhaler, as measured by inspiratory flow. Patients are able to view their personalized data on the Digihaler app and can share it with a healthcare provider to inform their asthma treatment plan, facilitate dialogue and guide decisions around treatment adjustments. This personal inhaler data can record how well a patient uses their inhaler by measuring the strength of inhalations, indicating when inhaler technique may need improvement. In addition, the data can capture rescue inhaler user patterns over time and show trends indicating when increasing SABA use might be associated with disease worsening.

Important Safety Information About ProAir Digihaler

• Contraindications: ProAir Digihaler (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
• Paradoxical Bronchospasm: ProAir Digihaler can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir Digihaler and institute alternative therapy if paradoxical bronchospasm occurs.
• Deterioration of Asthma: Need for more doses of ProAir Digihaler than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment, such as possible need for anti-inflammatory treatment, e.g., corticosteroids
• Use of Anti-Inflammatory Agents: ProAir Digihaler alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
• Cardiovascular Effects: ProAir Digihaler, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued. ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
• Do Not Exceed Recommended Dose: Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma
• Hypersensitivity Reactions including Anaphylaxis: Immediate hypersensitivity reactions may occur after administration of albuterol sulfate, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of therapies containing lactose, an inactive ingredient in ProAir Digihaler
• Coexisting Conditions: ProAir Digihaler, like all sympathomimetic amines, should be used with caution in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines
• Hypokalemia: As with other beta-agonists, ProAir Digihaler may produce significant hypokalemia in some patients. The decrease is usually transient, not requiring supplementation
• Most common adverse reactions (≥1% and >placebo) are back pain, pain, gastroenteritis viral, sinus headache, urinary tract infection, nasopharyngitis, oropharyngeal pain and vomiting
• Drug Interactions: Other short-acting sympathomimetic bronchodilators should not be used concomitantly with ProAir Digihaler
  • Beta-Blockers: Beta-adrenergic-receptor blocking agents not only block the pulmonary effect of beta-agonists, such as ProAir Digihaler, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers
  • Diuretics: Caution is advised in the coadministration of beta-agonists with non-potassium sparing diuretics (such as loop or thiazide diuretics). Consider monitoring potassium levels
  • Digoxin: Carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and ProAir Digihaler
  • Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: ProAir Digihaler should be administered with extreme caution to patients being treated with these agents, or within 2 weeks of discontinuation of these agents, because the action of albuterol on the cardiovascular system may be potentiated. Consider alternative therapy

Please read the full Prescribing Information.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve people’s lives for more than a century. We are a global leader in generic, biosimilar and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at www.tevapharm.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of our digital inhalers portfolio, including ProAir Digihaler; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO^®, AJOVY^® and COPAXONE^®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

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¹ Lugogo N, Oppenheimer J, Merchant R, et al. Application of Modified Delphi Expert Consensus Thresholds on SABA Reliever Use in Asthma to Date Obtained From a 12-week Study of a Digital Inhaler in Suboptimally Controlled Asthma Patients. Abstract presented at 2022 American Thoracic Society Annual Meeting, May 13-18, San Francisco, CA.

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