Teva’s Digital Inhaler Portfolio Now Powered by
AWS
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.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20201021005045/en/
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
- 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.
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
- 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.
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20201021005045/en/
IR Contacts: Kevin C. Mannix United States (215) 591-8912
Yael Ashman Israel 972 (3) 914-8262 PR Contacts: Yonatan
Beker Israel 972 (54) 888-5898 Doris Li United States
(973) 295-7563
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