Teva Announces FDA Acceptance of New Drug Applications for Fluticasone Propionate/Salmeterol & Fluticasone Propionate RespiCl...
28 Juin 2016 - 2:00PM
Business Wire
Therapies Utilize Core Multi-Dose Dry Powder
Inhaler Technology that Lowers Dosage and Eliminates Hand-Breath
Coordination During Inhalation
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA)
announced today that the U.S. Food and Drug Administration (FDA)
has accepted for review the company’s new drug applications (NDAs)
for two products for adolescent and adult patients with asthma. The
first, fluticasone propionate/salmeterol, is a fixed-dose
combination inhaled corticosteroid (ICS) and long-acting beta
agonist (LABA) delivered via Teva’s RespiClick® breath-actuated,
multi-dose dry powder inhaler (MDPI). The second, fluticasone
propionate, is an ICS monotherapy also delivered via the
RespiClick® device.
“The FDA acceptance of these two filings represents an exciting
time for Teva’s specialty respiratory medicines business as we
integrate both fixed dose combination and monotherapy into our
core, breath-actuated RespiClick device,” said Tushar Shah, MD,
Senior Vice President, Teva Global Respiratory Research and
Development. “By utilizing our RespiClick inhaler platform, we will
be able to deliver these established medications at a lower dosage
while eliminating the need for hand-breath coordination during
inhalation. We are pleased to proceed with the review of these
applications, aiming to ultimately provide a complete
breath-actuated asthma management system to help meet the needs of
patients with asthma.”
The NDAs for fluticasone propionate/salmeterol RespiClick and
fluticasone propionate RespiClick are supported by data from Teva’s
clinical development program, including data from three Phase III
trials which evaluated the efficacy and safety of the treatments in
adolescent and adult patients with asthma. In the double-blind
studies, both therapies showed clinically relevant and greater
benefit compared with placebo in the improvement of lung function
as measured by Forced Expiratory Volume in one second (FEV1).
Safety profiles for fluticasone propionate/salmeterol RespiClick
and fluticasone propionate RespiClick were found to be generally
comparable to placebo and the majority of adverse events were mild
to moderate in severity. In clinical trials for fluticasone
propionate/salmeterol RespiClick, the most common adverse reactions
(incidence ≥3%) were nasopharyngitis, headache, cough, oral
candidiasis and back pain. In fluticasone propionate RespiClick
clinical trials, the most common adverse reactions (incidence ≥3%)
were nasopharyngitis, headache, cough, oral candidiasis and upper
respiratory tract infection.
The NDAs for fluticasone propionate/salmeterol RespiClick and
fluticasone propionate RespiClick have been accepted by the FDA for
standard review with FDA Regulatory Action expected during the
first quarter of 2017.
About AsthmaAsthma is a chronic (long term) disease
usually characterized by airway inflammation and narrowing of the
airways, which can vary over time. Asthma may cause 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 RespiratoryTeva Respiratory develops and
delivers high-quality treatment options for respiratory conditions,
including asthma, COPD and allergic rhinitis. The Teva Respiratory
portfolio is centered on optimizing respiratory treatment for
patients and healthcare providers through the development of novel
delivery systems and therapies that help address unmet needs. The
company’s respiratory pipeline and clinical trial program are based
on drug molecules delivered in proprietary dry powder formulations
and breath-actuated device technologies, as well as a targeted
biologic treatment for severe asthma. Through research and clinical
development, Teva Respiratory continually works to expand,
strengthen and build upon its treatment portfolio to positively
impact the lives of the millions of patients living with
respiratory disease.
About TevaTeva 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 1,000 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 2015
amounted to $19.7 billion. For more information, visit
www.tevapharm.com.
Teva's 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 specialty products, especially
Copaxone® (which faces competition from orally-administered
alternatives and a generic version); our ability to consummate the
acquisition of Allergan plc’s worldwide generic pharmaceuticals
business (“Actavis Generics”) and to realize the anticipated
benefits of such acquisition (and the timing of realizing such
benefits); the fact that following the consummation of the Actavis
Generics acquisition, we will be dependent to a much larger extent
than previously on our generic pharmaceutical business; potential
restrictions on our ability to engage in additional transactions or
incur additional indebtedness as a result of the substantial amount
of debt we will incur to finance the Actavis Generics acquisition;
the fact that for a period of time following the consummation of
the Actavis Generics acquisition, we will have significantly less
cash on hand than previously, which could adversely affect our
ability to grow; 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 investments in our pipeline of
specialty and other products; 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; 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;
competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental
pricing pressures; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic 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 specialty pharmaceutical
businesses from companies with greater resources and capabilities;
the impact of continuing consolidation of our distributors and
customers; 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; our potential exposure to product liability claims that
are not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial
talent; any failures to comply with complex Medicare and Medicaid
reporting and payment obligations; significant impairment charges
relating to intangible assets, goodwill and property, plant and
equipment; the effects of increased leverage and our resulting
reliance on access to the capital markets; 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, 2015 and in our other filings with
the U.S. Securities and Exchange Commission (the "SEC").
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, whether as a
result of new information, future events or otherwise.
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Teva Pharmaceutical Industries Ltd.IR:United StatesKevin C.
Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley,
215-591-8974orNancy Leone, 215-284-0213
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