Teva Announces FDA Approval of AirDuo® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder

JERUSALEM & PARSIPPANY, N.J.--(BUSINESS WIRE)-- Teva Pharmaceuticals Industries Ltd. (NYSE and TASE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved AirDuo^® Digihaler™ (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, a combination therapy digital inhaler with built-in sensors that connects to a companion mobile application to provide information on inhaler use to people with asthma. AirDuo^® Digihaler™ is indicated for the treatment of asthma in patients aged 12 years and older. AirDuo^® Digihaler^™ is not used to relieve sudden breathing problems and won’t replace a rescue inhaler.

“We are thrilled to be able to expand our Digihaler™ portfolio to now include a maintenance treatment,” said Tushar Shah, M.D., Global Head of Specialty Clinical Development at Teva Pharmaceuticals. “With this approval, patients can now track how frequently they are using their inhalers. Granting patients the ability to track their maintenance inhaler use may help inform conversations with their doctors about treatment adherence and proper technique.”

Like ProAir^® Digihaler™ (albuterol sulfate 117 mcg) inhalation powder, indicated for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease, and for prevention of exercise-induced bronchospasm (EIB) in patients four years and older, AirDuo^® Digihaler™ contains built-in sensors that detect when the inhaler is used and measure inspiratory flow rates. This data is 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. Patients can also schedule reminders on their smartphone to take their AirDuo^® Digihaler™ as prescribed.

“Even the most diligent asthma patients may not realize they are not following their treatment regimen, despite their best efforts,” said Dr. Nabeel Farooqui, MD, FAAAAI, FACAAI, Assistant Professor, Department of Medicine, Indiana University School of Medicine. “The ability to now measure their inspiratory flow rates and track their maintenance medication use, as well as the frequency with which they use their inhaler, may provide important data and insights to help inform treatment discussions with physicians. As a doctor, it’s exciting that my patients are able to share this type of information with me.”

The approval of AirDuo^® Digihaler™ is based on the review of the supplemental new drug application (sNDA) submitted by Teva to the FDA. AirDuo^® Digihaler™ combines a breath-actuated, multi-dose dry powder inhaler with fluticasone propionate, an inhaled corticosteroid (ICS) medicine that may help to decrease inflammation in the lungs, which can lead to breathing problems, and salmeterol, a long acting beta₂ adrenergic agonist (LABA), which helps the muscles around the airways in the lungs stay relaxed in order to prevent symptoms. AirDuo^® Digihaler^™ contains salmeterol. LABA medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo^® Digihaler^™ contains an 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.

AirDuo^® Digihaler^™ was approved in a low, medium and high dose: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. As a fixed dose combination asthma therapy containing an ICS and a LABA, AirDuo^® Digihaler^™ contains the same active ingredients as Advair Diskus^®, which is also approved in low, medium and high doses: 100/50 mcg, 250/50 mcg and 500/50 mcg.

“For the 25 million Americans living with asthma¹, advancements like this one are important and could help patients track their inhaler use and frequency,” said Tonya Winders, President & CEO of the Allergy & Asthma Network. “Allowing patients access to both their rescue and maintenance inhaler use information on their smartphones is a promising step towards potentially fostering greater discussions about asthma management.”

“The approval of AirDuo^® Digihaler^™ is an important step for Teva and the respiratory community to create a technology platform for use in asthma management along with the previously-approved ProAir^® Digihaler^™,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio. “This technology aims at delivering innovations through cloud-based services with the target to provide new insights to guide treatment choices for caregivers to help them improve outcomes for asthma patients.”

AirDuo^® Digihaler™ is expected to become commercially available to patients by prescription in 2020. For more information, visit www.AirDuoDigihaler.com.

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 different 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, 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 uncertainty of commercial success of AirDuo® Digihaler;
• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY® and AUSTEDO®; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; 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; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; 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: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; 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 in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets ;
• compliance, regulatory and litigation matters, including: 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 selling and marketing 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, 2018, including the sections thereof 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.

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.

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

View source version on businesswire.com: https://www.businesswire.com/news/home/20190715005280/en/