Bluetooth
®
Wireless Technology,
Flow
Sensors and Companion Mobile Application Track Inhaler Use in
People with Asthma & COPD
JERUSALEM--(BUSINESS WIRE)--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced
today that the U.S. Food and Drug Administration (FDA) has approved
ProAir® Digihaler™ (albuterol sulfate 117 mcg) inhalation
powder, the first and only digital inhaler with built-in sensors which
connects to a companion mobile application and provides inhaler use
information to people with asthma and COPD. ProAir®
Digihaler™ is 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 aged four years and older.
“This approval marks a significant milestone not only for Teva, but for
the respiratory community as it allows patients and their caregivers to
better understand inhaler usage through digital technology,” said Sven
Dethlefs, Executive Vice President, Global Marketing & Portfolio. “Teva
recognizes the importance of integrating technology into patient care,
and we are very proud to lead the way with the approval of ProAir®
Digihaler™. The digital technology built into ProAir®
Digihaler™ provides patients with data on their inhaler use, which may
help them to have a more informed dialogue with their healthcare
provider regarding their asthma or COPD management.”
ProAir® Digihaler™ contains built-in sensors that detect when
the inhaler is used and measure inspiratory flow. This inhaler-use data
is then sent to the companion mobile app using Bluetooth® Wireless
Technology so patients can review their data over time, and if desired,
share it with their healthcare professionals.
“There are 25 million Americans living with asthma1, many of
whom use inhalers as part of their treatment regimen. Despite
advancements in care over the years, we know that many are using their
rescue medications incorrectly2 or too often3,”
said Tonya Winders, President & CEO of the Allergy & Asthma Network.
“The FDA approval of ProAir® Digihaler™ is
significant because it may help patients track their inhaler usage and
provide data that can be used to work more closely with their HCPs on
their asthma management. This approval is a major step forward and is
indicative of how medications are evolving through technological
innovations.”
The approval of ProAir® Digihaler™ is based on the review of
a supplemental new drug application (sNDA) submitted by Teva to the FDA.
ProAir® Digihaler™ combines a breath-activated, multi-dose
dry powder inhaler with albuterol, the most widely used asthma rescue
medication, with a built-in electronic module and a companion mobile app.
“One of the challenges physicians are faced with in caring for their
asthma and COPD patients is knowing if their patients are using their
inhaled medication as they should. That’s what makes a product like this
so important to doctor-patient discussions,” said Tushar Shah, M.D.,
Global Head of Specialty Clinical Development & Medical Affairs at Teva
Pharmaceuticals. “Offering a tool that enables doctors to see data on
their patients’ inhaler usage will allow them to have more productive
conversations about identifying issues and how to manage their illness.”
ProAir® Digihaler™ will be available in 2019 through a small
number of “Early Experience” Programs, which will be conducted in
partnership with healthcare systems and in limited geographies, in order
to gather real-world experience. A national launch is planned for 2020.
For more information, visit www.ProAirDigihaler.com.
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.
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. is a global leader in generic
medicines, with innovative treatments in select areas, including CNS,
pain and respiratory. We deliver high-quality generic products and
medicines in nearly every therapeutic area to address unmet patient
needs. We have an established presence in generics, specialty, OTC and
API, building on more than a century-old legacy, with a fully integrated
R&D function, strong operational base and global infrastructure and
scale. We strive to act in a socially and environmentally responsible
way. Headquartered in Israel, with production and research facilities
around the globe, we employ 45,000 professionals, committed to improving
the lives of millions of patients. Learn more at www.tevapharm.com.
Teva 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 ProAir
®
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 ProAir
®
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; 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 substantially increased indebtedness and significantly
decreased cash on hand, 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 sales 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, 2017, including in the section captioned “Risk Factors,”
and in our other filings with the U.S. Securities and Exchange
Commission, which are available at
www.sec.gov
and
www.tevapharm.com
.
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/20181221005554/en/
IR Contacts:
Kevin C. Mannix
United States
(215) 591-8912
Ran Meir
United States
972 (3) 926-7516
PR Contacts:
Yonatan Beker
Israel
972 (54) 888-5898
Doris Saltkill
United States
(913) 777-3343
Source: Teva Pharmaceutical Industries Ltd.