Teva Launches Two Digital Inhalers in the U.S., AirDuo® Digihaler® (fluticasone propionate and salmeterol) Inhalation Powder and ArmonAir® Digihaler® (fluticasone propionate) Inhalation Powder

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200921005170/en/

(Photo: Business Wire)

“Being able to now offer AirDuo^® Digihaler^® and ArmonAir^® Digihaler^® to patients is an exciting step forward for Teva, and one that we are extremely proud of,” said Brendan O’Grady, Executive Vice President, North America Commercial at Teva Pharmaceuticals. “With the launch of these two maintenance products, we’re now able to offer the full Digihaler^® portfolio to patients, potentially allowing them to gain an even deeper understanding of their overall asthma treatment regimen due in part to the data collection capabilities of the Digihaler^® portfolio of products.”

Both products contain built-in Bluetooth^® Wireless Technology, which connect to a companion mobile app and provide data on inhaler use, which is recorded as an event when the cap is opened or a patient inhales. AirDuo^® Digihaler^® and ArmonAir^® Digihaler^® are part of Teva’s Digihaler^® portfolio, which also includes ProAir^® Digihaler^®, the first and only digital rescue inhaler indicated in patients four years or older for the treatment or prevention of bronchospasm who have reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB). All three products are now commercially available to patients by prescription. Please view the Important Safety Information for these products below.

“The launch of AirDuo^® Digihaler^® and ArmonAir^® Digihaler^® completes our portfolio of digitally connected inhalers and allows Teva to provide maintenance and rescue digital inhaler options to the U.S. respiratory community, especially in a time when digital health tools are more important than ever,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio at Teva Pharmaceuticals. “The full Digihaler^® family is a major step forward for digital health technologies in helping to transform patient care, and we hope it will enable patients and their healthcare providers to better inform treatment decisions. For Teva, the Digihaler^® launch is the starting point for new software-based innovations in respiratory, moving treatment options beyond new therapeutic entities.”

The AirDuo^® Digihaler^® and ArmonAir^® Digihaler^® inhalers automatically detect, record and store objective inhaler use data, including peak inspiratory flow. Both products have the ability to remind the patient how often the devices have been used, measure inspiratory flow rates and determine if inhalation technique may need improvement. This usage and inspiratory flow data are then directly sent to the Digihaler^® app via Bluetooth^® technology, giving patients the ability to share their data with healthcare providers (HCPs) if they choose to. Access to this data may allow HCPs to make more informed treatment decisions.

AirDuo^® Digihaler^® was approved by the U.S. Food and Drug Administration (FDA) in July 2019 in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. ArmonAir^® Digihaler^® was approved by the FDA in February 2020 in a low, medium and high dose: 55 mcg, 113 mcg and 232 mcg administered as one inhalation twice daily.

“Until now, I have had to rely on my patients’ memory to share the details of their inhaler use habits with me – which, despite their best efforts, can be difficult and confusing. Being able to see my patients’ rescue and maintenance inhaler use data can help me assess if they are using their inhalers as prescribed,” said Dr. J. Allen Meadows, MD, FACAAI, Clinical Faculty, Alabama College of Osteopathic Medicine. “In addition, getting access into their inspiratory flow rates may also help me identify patients who might need coaching in inhaler technique improvement.”

The Wholesale Acquisition Cost (WAC or “list price”) for AirDuo^® Digihaler^® in the doses 55/14 mcg and 113/14 mcg is $399 and the WAC price for the 232/14 mcg dose is $449. The WAC price of ArmonAir^® Digihaler^® in the doses 55 mcg and 113 mcg is $239 and the WAC price for the 232 mcg dose is $299. Actual costs to individual patients and providers for both products are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance program.

APPROVED USES AND IMPORTANT SAFETY INFORMATION FOR AIRDUO^® DIGIHALER^® AND ARMONAIR^® DIGIHALER^®

APPROVED USES

• AIRDUO^® DIGIHALER^® (fluticasone propionate and salmeterol) inhalation powder is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.
• ARMONAIR^® DIGIHALER^® (fluticasone propionate) inhalation powder is a prescription medicine for the long-term treatment of asthma in patients 12 years and older.
• AIRDUO DIGIHALER and ARMONAIR DIGIHALER are not used to relieve sudden breathing problems from asthma and won’t replace a rescue inhaler.

AIRDUO DIGIHALER and ARMONAIR DIGIHALER each contain a built-in electronic module that records and stores information about inhaler events. AIRDUO DIGIHALER and ARMONAIR DIGIHALER may be used with, and transmit information to, a mobile App.

AIRDUO DIGIHALER and ARMONAIR DIGIHALER do not need to be connected to the app in order for you to take your medicine.

IMPORTANT SAFETY INFORMATION

• AIRDUO DIGIHALER contains salmeterol. Long-acting beta2-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AIRDUO DIGIHALER contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
• Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
• Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure.
• Do not use AIRDUO DIGIHALER or ARMONAIR DIGIHALER more often than prescribed.
• Do not take AIRDUO DIGIHALER with other medicines that contain a LABA for any reason.
• Tell your healthcare provider about all the medicines you take and about all of your health conditions.
• Do not stop using ARMONAIR DIGIHALER, even if you are feeling better, unless your healthcare provider tells you to. If you miss a dose of ARMONAIR DIGIHALER, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
• AIRDUO DIGIHALER and ARMONAIR DIGIHALER can cause serious side effects, including:
  • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AIRDUO DIGIHALER or ARMONAIR DIGIHALER to help reduce your chance of getting thrush.
  • Weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
  • Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an ICS (such as AIRDUO DIGIHALER or ARMONAIR DIGIHALER). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
    • feeling tired
    • lack of energy
    • Weakness
    • nausea and vomiting
    • low blood pressure
• For AIRDUO DIGIHALER, there may be sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AIRDUO DIGIHALER and call your healthcare provider right away.
• Serious allergic reactions. Stop using AIRDUO DIGIHALER or ARMONAIR DIGIHALER and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of your face, mouth, and tongue
  • breathing problems
• AIRDUO DIGIHALER can also cause additional serious side effects, including:
  • Effects on the heart
    • increased blood pressure
    • a fast or irregular heartbeat
    • chest pain
  • Effects on the nervous system
    • Tremor
    • nervousness
• AIRDUO DIGIHALER and ARMONAIR DIGIHALER can cause:
  • Bone thinning or weakness (osteoporosis)
  • Slowed growth in children. A child’s growth should be checked often.
  • Eye problems including glaucoma and cataracts. You should have regular eye exams while using AIRDUO DIGIHALER or ARMONAIR DIGIHALER.
• For AIRDUO DIGIHALER, changes may occur in laboratory blood values (sugar, potassium, certain types of white blood cells)
• For ARMONAIR DIGIHALER increased wheezing (bronchospasm) may occur. Increased wheezing can happen right away after using ARMONAIR DIGIHALER. If this occurs, stop using ARMONAIR DIGIHALER and call your healthcare provider. Always have a rescue inhaler with you to treat sudden wheezing.
• Common side effects of AIRDUO DIGIHALER and ARMONAIR DIGIHALER include:
  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • Headache
  • cough
• Additionally, AIRDUO DIGIHALER has common side effects of:
  • back pain
  • infection of nose and throat (nasopharyngitis)
• ARMONAIR DIGIHALER has common side effects of:
  • upper respiratory tract infection
  • infection or inflammation of nose and throat (nasopharyngitis)
• These are not all the possible side effects of AIRDUO DIGIHALER and ARMONAIR DIGIHALER. Call your healthcare provider for medical advice about side effects.
• You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information for AIRDUO DIGIHALER and ARMONAIR DIGIHALER.

APPROVED USES FOR PROAIR^® DIGIHALER^®

ProAir^® Digihaler^® (albuterol sulfate) Inhalation Powder is a prescription medicine used in people 4 years of age and older to:

• treat or prevent bronchospasm in people who have reversible obstructive airway disease
• prevent exercise-induced bronchospasm

ProAir Digihaler contains a built-in electronic module that detects, records and stores inhaler event information. ProAir Digihaler may be used with, and transmits information to, a mobile app. ProAir Digihaler does not need to be connected to the mobile app in order for patients to take their medicine.

IMPORTANT SAFETY INFORMATION FOR PROAIR^® DIGIHALER^®

• Do not use ProAir Digihaler (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, milk proteins, or any of the ingredients in ProAir Digihaler. Ask your healthcare provider if you have any questions or are not sure
• Before using ProAir Digihaler, tell your healthcare provider about all of your medical conditions, including if you:
  • have heart problems
  • have high blood pressure (hypertension)
  • have convulsions (seizures)
  • have thyroid problems
  • have diabetes
  • have low potassium levels in your blood
  • are pregnant or planning to become pregnant
  • are breastfeeding or planning to breastfeed
• Tell your healthcare provider about all the medicines you take, especially:
  • other inhaled medicines or asthma medicines
  • beta blocker medicines
  • diuretics
  • digoxin
  • monoamine oxidase inhibitors
  • tricyclic antidepressants
• Do not increase your dose or take extra doses of ProAir Digihaler without first talking to your healthcare provider
• Get medical help right away if ProAir Digihaler no longer helps your symptoms, your symptoms get worse or you need to use your inhaler more often
• While you are using ProAir Digihaler, do not use other inhaled rescue medicines and asthma medicines unless your healthcare provider tells you to do so
• ProAir Digihaler may cause serious side effects, including:
  • worsening trouble breathing, coughing and wheezing (paradoxical bronchospasm). If this happens, stop using ProAir Digihaler and call your healthcare provider or get emergency help right away. This is more likely to happen with your first use of a new asthma inhalation medicine
  • heart problems, including faster heart rate and higher blood pressure
  • possible death in people with asthma who use too much ProAir Digihaler
  • allergic reactions. Call your healthcare provider right away if you have the following symptoms of an allergic reaction:
    • itchy skin
    • swelling beneath your skin or in your throat
    • rash
    • worsening trouble breathing
  • changes in laboratory blood values (sugar, potassium)
• The most common side effects of ProAir Digihaler include:
  • back pain
  • body aches and pain
  • upset stomach
  • sinus headache
  • urinary tract infection
  • your heart feels like it is pounding or racing (palpitations)
  • chest pain
  • fast heart rate
  • shakiness
  • nervousness
  • headache
  • dizziness
  • sore throat
  • runny nose
• These are not all of the possible side effects of ProAir Digihaler. For more information, ask your healthcare provider or pharmacist
• You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

Please read the full Prescribing Information for ProAir 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 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 regarding AirDuo^® Digihaler^® and ArmonAir^® Digihaler^®, 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. Important factors that could cause or contribute to such differences include risks relating to:

• The commercial success of our Digihaler family of inhalers;
• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE^®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY^® or AUSTEDO^®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
• our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
• our business and operations in general, including: uncertainty regarding the magnitude, duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; 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; effectiveness of our restructuring plan announced in December 2017; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our suppliers; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets; and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
• compliance, regulatory and litigation matters, including: our ability to successfully defend against the DOJ criminal charges of a Sherman Act violations; increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time due to modified government operations due to the COVID-19 pandemic, including effects on product and patent approvals due to the COVID-19 pandemic; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in our Quarterly Reports on Form 10-Q for the first and second quarters of 2020 and in our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned “Risk Factors” and “Forward Looking Statements.” 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.

The Bluetooth^® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Teva Pharmaceutical Industries Ltd. is under license. Other trademarks and trade names are those of their respective owners.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200921005170/en/