JERUSALEM--(BUSINESS WIRE)--Apr. 29, 2014--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that
the European Commission has granted marketing authorization for DuoResp
Spiromax® for the treatment of patients with asthma and
chronic obstructive pulmonary disease (COPD) where the use of a
combination of an inhaled corticosteroid and long-acting beta2-adrenoceptor
agonist is appropriate.
DuoResp Spiromax® is a new, multi-dose dry-powder inhaler
containing a Fixed Dose Combination (FDC) of budesonide, an inhaled
corticosteroid to treat the underlying inflammation in asthma and COPD,
and formoterol fumarate dihydrate, a rapid-acting and long-lasting beta2
agonist for the relief of bronchoconstriction in asthma and COPD.
“We are delighted to receive approval for DuoResp Spiromax®,”
said Rob Koremans, M.D., President and CEO, Teva Global Specialty
Medicines. “This is a major advance in inhalers – the need for more
intuitive devices is critical and has been highlighted by healthcare
professionals and patient groups. It is widely accepted that poor or
inadequate inhaler technique not only negatively impacts treatment
adherence, but means that patients do not obtain the full benefit from
their medication.”
Koremans added, “We are extremely proud of Spiromax. Our innovative
approach to the development of the product means that it offers the key
features required for an ideal inhaler. DuoResp Spiromax®
provides a valuable addition to currently available inhalation devices
for the treatment of asthma and COPD. It is the first and important
milestone in the rollout of our Respiratory portfolio in Europe.”
DuoResp Spiromax® has been demonstrated to be therapeutically
equivalent to the well-established budesonide/formoterol combination.
The Spiromax inhaler uses a unique technology to deliver a
consistent, effective and accurate dose.
Inhaled therapy with fixed dose combinations of inhaled corticosteroids
and long-acting beta-agonists is an important step in achieving good
asthma and COPD control. However a substantial percentage of users of
inhalers worldwide have inadequate inhaler technique and increased
inhalation errors.
The Spiromax inhaler has been designed by looking at patient inhalation
challenges not in terms of human error, but as a design problem to be
solved. The result is an inhaler designed to improve ease of use and
consistent delivery from the first to the last dose with
three simple steps: open, breathe and close. Furthermore, it confirms to
patients that a dose has been taken through a taste of lactose and a
clear dose indicator.
Two Phase III trials in patients with persistent asthma are ongoing in
Europe to compare the benefits of DuoResp Spiromax and a
budesonide/formoterol multi-dose dry powder inhaler. Both studies are
expected to report out in 2014.
About Asthma and COPD
30 million people in Europe are living with asthma, with an estimated
82,000 hospital admissions each year costing some €33.9 billion. COPD
affects 23 million people in Europe, resulting in 1.1 million hospital
admissions annually and estimated indirect and direct costs of €48.4
billion.
About Teva
Teva Pharmaceutical Industries Ltd. is a leading global pharmaceutical
company, committed to increasing access to high-quality healthcare by
developing, producing and marketing affordable generic drugs as well as
innovative and specialty pharmaceuticals and active pharmaceutical
ingredients. Headquartered in Israel, Teva is the world's leading
generic drug maker, with a global product portfolio of more than 1,000
molecules and a direct presence in approximately 60 countries. Teva's
branded businesses focus on CNS, oncology, pain, respiratory and women's
health therapeutic areas as well as biologics. Teva currently employs
approximately 45,000 people around the world and reached $20.3 billion
in net revenues in 2013.
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Reform Act of 1995:
This release contains forward-looking statements, which are based on
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contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially COPAXONE®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents); the possibility of
material fines, penalties and other sanctions and other adverse
consequences arising out of our ongoing FCPA investigations and related
matters; our ability to achieve expected results from the research and
development efforts invested in our pipeline of specialty and other
products; our ability to reduce operating expenses to the extent and
during the timeframe intended by our cost reduction program; our ability
to identify and successfully bid for suitable acquisition targets or
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the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
our potential exposure to product liability claims that are not covered
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of our patent settlement agreements; our exposure to currency
fluctuations and restrictions as well as credit risks; the effectiveness
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the intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical pricing,
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marketing practices, particularly for our specialty pharmaceutical
products; uncertainties related to our recent management changes; the
effects of increased leverage and our resulting reliance on access to
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supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
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or breaches of our data security; competition for our generic
products, both from other pharmaceutical companies and as a result of
increased governmental pricing pressures; competition for our specialty
pharmaceutical businesses from companies with greater resources and
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for significant new generic products; potential liability in the U.S.,
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resolution of outstanding patent litigation; any failures to comply with
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impact of continuing consolidation of our distributors and customers;
significant impairment charges relating to intangible assets and
goodwill; potentially significant increases in tax liabilities; 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; variations in patent laws that may adversely affect our
ability to manufacture our products in the most efficient manner;
environmental risks; and other factors that are discussed in our Annual
Report on Form 20-F for the year ended December 31, 2013 and in our
other filings with the U.S. Securities and Exchange Commission.
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
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Source: Teva Pharmaceutical Industries Ltd.
Teva
IR:
United States
Kevin C. Mannix, 215-591-8912
or
Ran
Meir, 215-591-3033
or
Israel
Tomer Amitai, 972
(3) 926-7656
or
PR:
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Iris Beck Codner, 972
(3) 926-7687
or
United States
Denise Bradley, 215-591-8974
or
Nancy
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