First and Only Breath-Actuated Aerosol Inhaled Corticosteroid in the
United States Designed to Help Eliminate the Need for Hand-Breath
JERUSALEM--(BUSINESS WIRE)--Feb. 16, 2018--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) announced
today that QVAR® RediHaler™ (beclomethasone
dipropionate HFA) Inhalation Aerosol is now commercially available to
patients in both 40 mcg and 80 mcg strengths by prescription in the U.S.
QVAR® RediHaler™ is the first and only
breath-actuated aerosol inhaled corticosteroid for the maintenance
treatment of asthma as a prophylactic therapy in patients 4 years of age
and older. It is not indicated for the relief of acute bronchospasm.
This press release features multimedia. View the full release here:
QVAR® RediHaler™ product image (Photo: Business Wire)
“When it comes to the treatment of asthma, proper inhaler technique
remains a critical issue for patients. In fact, nearly 68 percent of
patients do not use their metered dose inhalers (MDIs) well enough to
benefit from the prescribed medication1, leading to
potentially uncontrolled asthma symptoms2,” said Dr. Warner
W. Carr, MD, Associate Medical Director of Southern California Research
at Allergy and Asthma Associates of Southern California Medical Group.
“As a physician, it’s often a challenge to know if my patients are using
their inhalers correctly once they leave the office. It’s reassuring to
see new device technologies come to market, such as the QVAR®
RediHaler™ device, which is designed specifically to
eliminate the need for hand-breath coordination.”
QVAR® RediHaler™ differs from conventional
metered-dose inhalers (MDIs) as it delivers medication via a
breath-actuated inhaler, eliminating the need for hand-breath
coordination during inhalation. QVAR® RediHaler™
administers the same active ingredient found in the previously available
QVAR® (beclomethasone dipropionate HFA) Inhalation Aerosol,
but utilizes innovative breath-actuated inhaler technology. QVAR® RediHaler™
was also designed to be ready for use, with no shaking or priming
needed. Because the medication delivery is breath actuated, it should
not be used with a spacer or volume holding chamber.
“QVAR® has been an available asthma treatment option for well
over a decade, so we are excited by the new technology of QVAR®
RediHaler™ that directly addresses an unmet need in the field
of asthma management,” said Brendan O’Grady, Executive Vice President,
North America Commercial at Teva. “By merging our breath-actuated
inhaler technology with asthma medication, we hope to better serve the
needs of the respiratory community and look forward to seeing the
adoption of QVAR® RediHaler™ in the coming months.”
With the launch of QVAR® RediHaler™, Teva is discontinuing
sales of the previously available QVAR®. Patients currently
prescribed QVAR® and/or their caregivers are encouraged to
speak with a healthcare professional about how this new treatment option
may impact their treatment plan and how to obtain and use QVAR®
RediHaler™, if desired. QVAR® RediHaler™
will be priced at parity to QVAR®.
QVAR® RediHaler™ (beclomethasone dipropionate HFA) Inhalation
Aerosol is a breath-actuated inhaled prescription medicine used as a
maintenance treatment for the prevention and control of asthma in people
4 years of age and older.
QVAR® RediHaler™ Inhalation Aerosol is not used to
relieve sudden breathing problems and won’t replace a rescue inhaler.
Important Safety Information
Do not use QVAR® RediHaler™ to treat sudden
severe symptoms of asthma. Always have a rescue inhaler with you to
treat sudden symptoms.
Do not use QVAR® RediHaler™ if you are allergic
to beclomethasone dipropionate or any of the ingredients in QVAR®
Do not use QVAR® RediHaler™ more
often than prescribed.
Tell your healthcare provider about all the medicines you take and
about all of your health conditions.
may cause serious side effects, including:
Fungal infections (thrush) in your mouth and
throat. Rinse your mouth with water without swallowing
after using QVAR® RediHaler™ to help
prevent an infection in your mouth or throat.
Worsening asthma or sudden asthma attacks. After using your
rescue inhaler, contact your healthcare provider right away if you
do not get relief from your sudden asthma attacks
Reduced adrenal function (adrenal insufficiency). This
potentially life-threatening condition can happen when you stop
taking oral corticosteroid medicines and start using inhaled
corticosteroid medicines (such as QVAR® RediHaler™).
Tell your healthcare provider right away about any signs and
symptoms of adrenal insufficiency such as: feeling tired or
exhausted (fatigue); lack of energy; low blood pressure
(hypotension); dizziness or feeling faint; nausea and vomiting; or
Immune system effects and a higher chance for infections. Tell
your healthcare provider about any signs or symptoms of infection
such as: fever, chills, pain, feeling tired, body aches, nausea,
Increased wheezing (bronchospasm) right after using QVAR®
RediHaler™. Always have a rescue
inhaler with you to treat sudden wheezing.
Serious allergic reactions. Stop using QVAR®
RediHaler™ and call your healthcare provider or
get emergency medical help right away if you get any of the
following: hives; swelling of your lips, tongue, or face; rash; or
Slowed growth in children. Children should have their
growth checked regularly while using QVAR® RediHaler™.
Lower bone density. This may be a problem for people who
already have a higher chance for low bone density (osteoporosis).
Eye problems. If you have had glaucoma, cataracts or
blurred vision in the past, you should have regular eye exams
while using QVAR® RediHaler™.
Common side effects of QVAR® RediHaler™
include: yeast infection in the mouth (oral candidiasis); cold
symptoms (upper respiratory tract infection); pain in the throat
(oropharyngeal pain); pain or swelling in your nose and throat
(nasopharyngitis); sinus irritation (sinusitis); and hay fever
These are not all the possible side effects of QVAR®
RediHaler™. Call your doctor for medical advice about side
effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information at http://www.qvarredihaler.com/Pdf/PI.pdf
A copy may be requested from the US Medical Information Contact Center
for Teva Specialty Medicines at 888-4-TEVA-RX (888-483-8279) and USMedInfo@tevapharm.com
or Teva’s Public Relations or Investor Relations contacts.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic
medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net
revenues in 2017 were $22.4 billion. For more information, visit 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 the U.S. launch of QVAR® RediHaler™,
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 potential benefits and uncertainty of commercial success of
our specialty medicines business, including: competition for our
specialty products, especially Copaxone®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives;
challenges inherent in product research and development, uncertainty
of clinical success and obtaining regulatory approvals as well as our
ability to achieve expected results from investments in our product
pipeline; competition from companies with greater resources and
capabilities; and the effectiveness of our patents and other measures
to protect our intellectual property rights;
our business and operations in general, including: failure to
effectively execute the recently announced restructuring plan;
uncertainties relating to the potential benefits and success of our
new organizational structure and recent senior management changes; our
ability to develop and commercialize additional pharmaceutical
products; 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
restructuring of our manufacturing network, including potential
related labor unrest; the impact of continuing consolidation of our
distributors and customers; and variations in patent laws that may
adversely affect our ability to manufacture our products;
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;
potential additional adverse consequences following our resolution
with the U.S. government of our FCPA investigation; governmental
investigations into sales and marketing practices; potential liability
for sales of generic products prior to a final resolution of
outstanding patent litigation; 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; and other factors
discussed in our Annual Report on Form 20-F for the year
ended December 31, 2016 (“Annual Report”), 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
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
1. Fink JB, Rubin BK. Problems with inhaler use: a call for improved
clinician and patient education. Respir Care. 2005;50(10):1360-1374.
D. Price, S. Bosnic-Anticevich, A. Briggs, H. Chrystyn, C. Rand, G.
Scheuch, J. Bousquet. Inhaler competence in asthma:Common errors,
barriers to use and recommended solutions. Respiratory Medicine. 2013;
View source version on businesswire.com: http://www.businesswire.com/news/home/20180212005322/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
C. Mannix, 215- 591-8912
Ran Meir, 215-591-3033
Amitai, 972 (3) 926-7656
Beker, 972 (54) 888-5898
Michelle Larkin, 610-786-7335