[November 07, 2014] |
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Teva Presents Data for Investigational Short-Acting Beta-Agonist Inhaler (Albuterol MDPI) at 2014 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology
JERUSALEM --(Business Wire)--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that
four company-sponsored abstracts evaluating the safety and efficacy of
albuterol multi-dose dry-powder inhaler (MDPI), an investigational
breath-actuated, dry-powder, short-acting beta-agonist (SABA), will be
presented at the 2014 Annual Scientific Meeting of the American College
of Allergy, Asthma & Immunology (ACAAI) in Atlanta, Georgia on November
6-10, 2014.
"We are extremely pleased by the albuterol MDPI data that is being
presented at ACAAI this year," said Tushar Shah, MD, Senior Vice
President, Teva Global Respiratory Research and Development. "It is our
hope that, if approved, albuterol MDPI will fill an unmet need in the
asthma and reversible bronchospasm marketspace by providing patients
with an inhalation-driven, multi-dose dry-powder inhaler that helps
eliminate the need to coordinate inhalation with actuation."
The following albuterol MDPI data will be presented during poster
sessions on Saturday, November 8 from 3:30-4:30 p.m. and Sunday,
November 9 from 7:30-8:30 a.m. in Hall A-1 of the Georgia World
Conference Center at the 2014 ACAAI Annual Scientific Meeting:
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P76: Cumulative Dose Comparison of the Efficacy and Safety of
Albuterol-Multidose Dry-Powder Inhaler and Albuterol-Hydrofluoroalkane
Metered-Dose Inhaler in Adults with Asthma
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P56: A Novel Albuterol-Multidose Dry-Powder Inhaler in Adult
and Adolescent Patients with Exercise-Induced Bronchoconstriction: A
Single-Dose Study
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P74: Efficacy of Albuterol-Multidose Dry-Powder Inhaler Versus
Placebo in Subjects 12 Years of Age and Older with Persistent Asthma
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P73: Albuterol-Multidose Dry-Powder Inhaler in Patients 12
Years and Older with Persistent Asthma: 12 and 52 Week Safety
All abstracts will be published in a supplement to the November issue of Annals
of Allergy, Asthma & Immunology, ACAAI's scientific journal.
In July 2014, the U.S. Food and Drug Administration accepted for review
the new drug application submitted by Teva for albuterol MDPI with FDA
Regulatory Action expected in March 2015. The submission was based on
data from eight clinical studies that evaluated the safety and efficacy
of albuterol MDPI in adults and adolescents (12 years of age and older)
with asthma and EIB. If approved, albuterol MDPI would become the first
breath-actuated, dry-powder, symptomatic, and rescue inhaler available
to asthma patients in the US.
The studies to be presented compare the safety and efficacy of albuterol
MDPI to albuterol hydrofluoroalkane (HFA) metered-dose inhaler and to
placebo. The safety profile of albuterol MDPI in these studies was
comparable to both the placebo and albuterol HFA and consistent with
that of the well-characterized profile of albuterol in subjects with
asthma. Additional data regarding the use of albutrol MDPI for
exercise-induced bronchoconstriction (EIB) in adolescents and adults
with a history of the condition will also be presented.
About Asthma
Asthma is a chronic (long-term) disease of inflammation of both the
large and small airways of the lung, characterized by symptoms of
wheezing and coughing. Asthma causes recurring periods of wheezing (a
whistling sound when you breathe), chest tightness, shortness of breath
and coughing that often occurs at night or early in the morning. Without
appropriate treatment, asthma symptoms may become more severe and result
in an asthma attack, which can lead to hospitalization and even death.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) 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 Specialty Medicines businesses focus on CNS, respiratory,
oncology, pain, 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.
Safe Harbor Statement under the U.S. Private Securities Litigation
Reform Act of 1995:
This release contains forward-looking statements, which are based on
management's current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
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
licensing opportunities, or to consummate and integrate acquisitions;
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
by insurance; increased government scrutiny in both the U.S. and Europe
of our patent settlement agreements; our exposure to currency
fluctuations and restrictions as well as credit risks; the effectiveness
of our patents, confidentiality agreements and other measures to protect
the intellectual property rights of our specialty medicines; the
effects of reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
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
the capital markets; any failure to recruit or retain key personnel, or
to attract additional executive and managerial talent; adverse effects
of political or economical instability, major hostilities or acts of
terrorism on our significant worldwide operations; interruptions in our
supply chain or problems with internal or third-party information
technology systems that adversely affect our complex manufacturing
processes; significant disruptions of our information technology systems
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
capabilities; decreased opportunities to obtain U.S. market exclusivity
for significant new generic products; potential liability in the U.S.,
Europe and other markets for sales of generic products prior to a final
resolution of outstanding patent litigation; any failures to comply with
complex Medicare and Medicaid reporting and payment obligations; the
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
statement, whether as a result of new information, future events or
otherwise.
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