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Classified in: Health, Science and technology
Subjects: Conference, Product/Service, Trade Show, Annual Meeting

Teva to Present New Data from CONNECT2 Study on its Digihaler® System at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2023 Annual Meeting

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that new data on its Digihaler System will be presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2023 Annual Meeting, being held February 24-27 in San Antonio, Texas. The data includes findings from the CONNECT2 clinical trial program as well as information on patients and healthcare professionals' real-world use of the smart inhaler system. The Digihaler System is the first and only smart inhaler system with built-in sensors that provide objective inhaler event data to help patients and their doctors support asthma management and develop personalized treatment plans.

The data will be featured in five posters, which will highlight:

"The data we are presenting at AAAAI share meaningful insights for doctors and asthma patients about asthma management based on information provided by the Digihaler System," said Tanisha Hill, Senior Medical Director, Respiratory and Digital Health Medical Lead at Teva. "Understanding trends around adherence and predictors of success in disease management are important to informing more personalized treatment."

Digihaler is a digital health system comprised of an electronic multi-dose dry powder smart inhaler, connected app, Digital Health Platform cloud solution and dashboard. Digihaler inhalers have built-in flow sensors that detect, record and store objective data showing how often and how well patients use their inhalers, as measured by inspiratory flow. Patients are able to view their data on the Digihaler app, including inhaler use patterns over time, and can share it with a healthcare provider to facilitate dialogue and personalize treatment discussions. Healthcare providers can also monitor the data on a dashboard with patient permission.

As per the U.S. Food and Drug Administration (FDA) approved label, there is no evidence that the use of the app leads to improved clinical outcomes, including safety and efficacy.


The CONNECT clinical program evaluated the potential impact of Digihaler System on patient-provider interactions, adherence over time, inhaler technique and frequency of short-acting beta agonist (SABA) use. The CONNECT2 trial was conducted to assess the role of both the ProAir® Digihaler (albuterol sulfate) inhalation powder and AirDuo® Digihaler (fluticasone propionate and salmeterol) inhalation powder in the treatment of asthma as part of the Digihaler System.

CONNECT2 was a 24-week open-label, multicenter, randomized, parallel group study that evaluated the impact of this Digihaler System on asthma management compared to standard of care (SoC) in 427 patients with asthma. Participants in the SoC group continued treatment with their current SoC asthma maintenance and reliever medications.

Digihaler integrated inhalers transmit data wirelessly to a smartphone application (App), which allows for inhaler event tracking. The App includes a voluntary, non-respiratory-specific DSA. The DSA includes questions asking how a patient is feeling on a three-point scale ranging from sad to neutral to happy.

The two CONNECT2 analyses that will be presented at AAAAI explore:

Real-World Digital Health Platform Analysis

The Digihaler Digital Health Platform allows patients to track their inhaler events, and inhaler use, which is recorded as an event when the cap is opened or a patient inhales. The objective data is collected in the App and can be shared with physicians to help them make more informed treatment decisions.

The poster that will be presented at AAAAI explores:

Implementation Study

The study was comprised of telephone interviews and web surveys with specialists who prescribed the digital inhaler to at least one of their patients with asthma or chronic obstructive pulmonary disease (COPD). The surveys and semi-structured interviews were used to evaluate barriers and facilitators to implementation from participants. Investigators utilized the consolidated framework for implementation research (CFIR) theoretical framework to better understand how the Digihaler System was used in clinical practice and report recommendations from early adopters of the technology.

The two implementation research posters that will be presented at AAAAI explore:

These poster presentations can be accessed by registering for the meeting.

Teva-sponsored data to be presented includes:

#P37 Real-World Inhaler Usage Patterns Obtained from a Digital Health Platform
Session: Poster Presentations and Case Study Posters
Date/Time: Friday, February 24th, 3:15 PM ? 4:15 PM

#P487 Relationship Between SABA Use and Self-Assessment Responses in Patients with Asthma
Session: Poster Presentations and Case Study Posters
Date/Time: Sunday, February 26th, 9:45 AM ? 10:45 AM

#P488 Relationship Between Medication Adherence and Self-Assessment Responses in Patients with Asthma
Session: Poster Presentations and Case Study Posters
Date/Time: Sunday, February 26th, 9:45 AM ? 10:45 AM

#P504 Use of Theory-Based Implementation Research to Evaluate Barriers and Facilitators to Implementation of a Novel Digital Inhaler Technology in Clinical Practice
Session: Poster Presentations and Case Study Posters
Date/Time: Sunday, February 26th, 9:45 AM ? 10:45 AM

#P511 Implementation of a Novel Digital Inhaler Technology in Real-World Clinical Practice: Experiences and Recommendations from Early Adopters
Session: Poster Presentations and Case Study Posters
Date/Time: Sunday, February 26th, 9:45 AM ? 10:45 AM

ProAir Digihaler Indications and Usage

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.

Important Safety Information About ProAir Digihaler

Please read the full Prescribing Information.

AirDuo Digihaler Indications and Usage

AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, a mobile App.

AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine.

Important Safety Information About AirDuo Digihaler

Please see full Prescribing Information for AirDuo Digihaler.

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 and innovative 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 innovative 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 digihaler products family, including ProAir Digihaler and AirDuo Digihaler; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our innovative medicines, 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, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; 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 Annual Report on Form 10-K for the year ended December 31, 2022, 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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