TEL AVIV, Israel & PARSIPPANY, N.J. & SAN ANTONIO--(BUSINESS WIRE)--Teva Respiratory, LLC, an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced today that the company is collaborating with Amazon Web Services, Inc. (AWS) and Onica, a Rackspace Technology company, to build and host its Digital Health Platform.
Teva’s Digital Health Platform is a cloud-based backend data system that currently supports the company’s FDA-approved Digihaler® portfolio, the first-ever family of breath-actuated digital inhalers that contain built-in sensors and Bluetooth® Wireless Technology, which connects to a companion mobile app that tracks inhaler events and measures inspiratory flow when a patient inhales.
Technology, like the Digihaler® family of inhalers, provides objective inhaler event data which may help foster patient and healthcare provider (HCP) dialogue and help inform treatment decisions. The Digihaler® device automatically detects, records and stores inhaler event data and measures inspiratory flow rates.
“Onica leads some of the most complex technology projects in the world,” said Tolga Tarhan, CTO, Rackspace Technology. “We are positioned at the intersection of healthcare and technology. Through our partnership with Teva, we stand to revolutionize the way patients access their data. Accessibility and security are at the forefront of our services and we are proud to be working on Teva’s Digital Health Platform.”
Onica's development team supported the serverless build of Teva’s Digital Health Platform, allowing the system to fully leverage the best-in-breed cloud capabilities of AWS. Hosting Teva’s Digital Health Platform on AWS will allow for extreme scalability, resiliency and cost-effectiveness.
“We’re pleased to bring together AWS’s unmatched portfolio of services with Teva’s long-standing respiratory reputation and expertise to now provide objective inhaler use data which may help inform physicians in the care and treatment of patients,” said Shez Partovi, MD, Director of Worldwide Business Development for Healthcare, Life Sciences, and Genomics at AWS. “Teva’s approach to providing patients with access to and control of sharing their inhaler event data with their healthcare provider has the potential to impact and inform how patient care is delivered, and specifically, within the asthma and chronic obstructive pulmonary disease (COPD) disease states.”
With this cloud system in place, users will be able to view stored information on their Digihaler® events via the companion mobile app, which can be linked to multiple inhaler devices. Patients can review their data over time, receive event notifications, including if their inhalation technique may need improvement. If desired, this information can be shared with their healthcare providers to have more informed discussions about their condition and treatment.
“With our Digihaler® products now being commercially available to patients, ensuring data security is paramount,” said Sven Dethlefs, Executive Vice President, Global Marketing & Portfolio at Teva Pharmaceuticals. “With digital health and remote monitoring emerging as vital elements of patient care, we are excited to be working with AWS and Onica who are experienced in ensuring patients’ information is secure while easily accessible to them.”
The Digihaler® portfolio currently includes 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, in addition to AirDuo® Digihaler® (fluticasone propionate and salmeterol) Inhalation Powder and ArmonAir® Digihaler® (fluticasone propionate) Inhalation Powder, both indicated for the maintenance treatment of asthma in patients 12 years of age and older. All three products are approved by the U.S. Food and Drug Administration (FDA) and are commercially available to patients by prescription. Please view the complete indications and Important Safety Information for these products below.
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
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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
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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
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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
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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)
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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.
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.
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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.
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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.
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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
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AIRDUO DIGIHALER can also cause additional serious side effects, including:
-
Effects on the heart
- increased blood pressure
- a fast or irregular heartbeat
- chest pain
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Effects on the nervous system
- Tremor
- nervousness
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Effects on the heart
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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.
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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
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Additionally, AIRDUO DIGIHALER has common side effects of:
- back pain
- infection of nose and throat (nasopharyngitis)
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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.
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
This Press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Teva’s digital health platform supporting our Digihaler® portfolio 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 achieve the expected benefits from our digital health platform;
- 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.
About Onica, a Rackspace Technology Company
Onica is a global cloud native services provider at the forefront of cloud computing. As an Amazon Web Services (AWS) APN Premier Consulting Partner and audited Managed Services Provider, we help our customers solve the most complex and transformative cloud projects in the world to build new revenue streams, increase efficiency, and deliver incredible experiences.
As a Rackspace Technology Company, we are backed by a global network of experts delivering proven solutions across the full spectrum of cloud technology. Everything we do is wrapped in our obsession with our customers’ success – our Fanatical Experience™ – so they can work faster, smarter, and stay ahead of what’s next.
