Teva Announces FDA Approval of ArmonAir® Digihaler™ (fluticasone propionate) Inhalation Powder

Teva’s Digital Inhaler Portfolio Now Includes Products from Three of the Most Commonly Prescribed Classes of Asthma Treatments

TEL AVIV & PARSIPPANY, N.J.–(BUSINESS WIRE)–Teva Respiratory, LLC, an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved ArmonAir^® Digihaler™ (fluticasone propionate) Inhalation Powder, an inhaled corticosteroid (ICS) delivered via Teva’s Digihaler™ device, which contains built-in sensors and connects to a companion mobile application that provides information on inhaler use to people with asthma. ArmonAir^® Digihaler™ is indicated for the maintenance treatment of asthma in patients 12 years and older. ArmonAir^® Digihaler^™ is not indicated for the relief of acute bronchospasm.

ArmonAir^® Digihaler™ joins the approved Digihaler™ portfolio of products, including ProAir^® Digihaler™ (albuterol sulfate 117 mcg) Inhalation Powder, which is indicated for use in patients 4 years of age and older to treat or prevent bronchospasm in those who have reversible obstructive airway disease and to prevent exercise-induced bronchospasm, and AirDuo^® Digihaler™ (fluticasone propionate and salmeterol) Inhalation Powder, which is indicated for the maintenance treatment of asthma in patients 12 years of age and older. The Digihaler™ device detects when the inhaler is used and measures inspiratory flow rates. These data are then sent to a companion mobile app using Bluetooth^® Wireless Technology so that patients can review their data over time, and if desired, share it with their healthcare providers to have more informed discussions about their condition and treatment. Patients also can schedule reminders on their smartphone to take either their ArmonAir^® Digihaler™ or AirDuo^® Digihaler™ as prescribed. Please view the Important Safety Information for these products below.

“My patients often struggle to remember to take their medicine and track their maintenance and rescue medication usage which can play a significant role in asthma management,” said Dr. Nabeel Farooqui, MD, FAAAAI, FACAAI, Assistant Professor, Department of Medicine, Indiana University School of Medicine. “Enabling patients to track their inhaler use data, including frequency and inspiratory flow rates, each time they use their inhaler, can play a significant role in helping me have open, informed conversations with them about how best to manage their condition.”

“The approval of a third product in the Digihaler™ portfolio is an incredibly exciting milestone for us,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. “Our portfolio now includes a rescue treatment, a maintenance combination therapy, and now a maintenance monotherapy. All three of these digital inhalers with built-in sensors pair with companion mobile apps, allowing patients to track their inhaler use across multiple digital devices and have a better understanding of their condition. Patients may also choose to share this data with their healthcare providers.”

The approval of ArmonAir^® Digihaler™ is based on the review of the supplemental new drug application (sNDA) submitted by Teva to the FDA. ArmonAir^® Digihaler^™ was approved in a low, medium and high dose: 55 mcg, 113 mcg and 232 mcg administered as one inhalation twice daily.

“Twenty-five million Americans are living with asthma¹, and it’s important that they track their medication use and frequency to ensure they are managing the disease appropriately,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “Thanks to technological advancements like these, the ability to monitor this type of data for different types of asthma medications can help patients foster open conversations with their healthcare providers, in an effort to ensure their asthma is well-managed.”

The complete Digihaler™ portfolio is expected to become commercially available to patients later this year.

ARMONAIR^® DIGIHALER^™ APPROVED USES

ArmonAir^® Digihaler™ (fluticasone propionate) inhalation powder is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in patients 12 years and older.

ArmonAir Digihaler is not used to relieve sudden breathing problems from asthma and won’t replace a rescue inhaler.

ArmonAir Digihaler contains a built-in electronic module that records and stores information about inhaler events. ArmonAir Digihaler may be used with, and transmits information to a mobile App. ArmonAir Digihaler does not need to be connected to the app in order for you to take your medicine.

ARMONAIR^® DIGIHALER^™ IMPORTANT SAFETY INFORMATION

• Do not use ArmonAir Digihaler to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
• Do not use 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.
• Tell your healthcare provider about all the medicines you take and about all of your health conditions.
• Do not use ArmonAir Digihaler more often than prescribed.
• 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.
• 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 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 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
• serious allergic reactions. Stop using 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
• 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 ArmonAir Digihaler.

• increased wheezing (bronchospasm). 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 ArmonAir Digihaler include:

• infection or inflammation of nose and throat (nasopharyngitis)
• upper respiratory tract infection
• thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
• headache
• cough
• These are not all the possible side effects of 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 ArmonAir Digihaler.

AIRDUO^® DIGIHALER^™ APPROVED USES

• AirDuo Digihaler 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.
• AirDuo Digihaler is not used to relieve sudden breathing problems from asthma and won’t replace a rescue inhaler.

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.

AIRDUO^® DIGIHALER^™ 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 to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
• Do not use AirDuo 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 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.
• AirDuo 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 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 inhaled corticosteroid (such as AirDuo 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
• 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 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
• Effects on heart
  • increased blood pressure
  • a fast or irregular heartbeat
  • chest pain
• Effects on nervous system
  • tremor
  • nervousness
• 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.
• Changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
• Common side effects of AirDuo Digihaler include:
  • Infection of nose and throat (nasopharyngitis)
  • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
  • back pain
  • headache
  • cough
• These are not all the possible side effects of AirDuo 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.

PROAIR^® DIGIHALER^™ APPROVED USES

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 you to take your medicine.

PROAIR^® DIGIHALER^™ IMPORTANT SAFETY INFORMATION

• 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.

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 FDA approval of 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 ArmonAir Digihaler;
• 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 oyrally-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: implementation 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; 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 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: 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; 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 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.

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1. National Center for Health Statistics. Centers for Disease Control. Asthma. 2017. http://www.cdc.gov/nchs/fastats/asthma.htm.

 

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