Studies demonstrate greater efficacy with lower doses delivered via
multidose dry-powder inhaler (MDPI) compared to placebo
Results showcase Teva’s expanding respiratory R&D capabilities and
support advancement of core, breath-actuated MDPI platform
JERUSALEM--(BUSINESS WIRE)--Nov. 19, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced positive top-line results from three Phase III clinical
studies designed to evaluate the efficacy and safety of fluticasone
propionate/salmeterol, a combination inhaled corticosteroid (ICS) and
long-acting beta agonist (LABA) delivered via a multidose dry powder
inhaler (MDPI) and fluticasone propionate, an ICS monotherapy delivered
via a MDPI in adolescent and adult patients with asthma. Top-line data
showed that the studies met their primary endpoints. Importantly, the
studies also showed similar overall safety profiles as compared to
therapies in the corresponding drug classes.
“These data support Teva’s commitment to further optimize the treatment
of respiratory disease through the development of devices and therapies
that help address the needs of patients and physicians,” said Tushar
Shah, MD, Senior Vice President, Teva Global Respiratory Research and
Development. “With this dual development program we have demonstrated
clinically significant levels of effectiveness, by delivering
combination and monotherapy at lower doses utilizing our core,
breath-actuated, MDPI platform.”
Fluticasone propionate/salmeterol MDPI demonstrated, in the double-blind
studies, clinically relevant and greater benefit at all doses (50/12.5,
100/12.5, and 200/12.5 mcg BID nominal delivered doses) versus placebo
and versus respective monotherapy (fluticasone propionate) in the
improvement of lung function as measured by the change from baseline in
trough Forced Expiratory Volume in one second (FEV1) at the
12-week trial period and standardized baseline-adjusted area under the
effect curve FEV1 from time 0 to 12 hours post dose at Week
12. This initial set of results shows the adverse event profile of
fluticasone propionate/salmeterol MDPI was comparable to fluticasone
propionate monotherapy and placebo.
Fluticasone propionate MDPI also demonstrated clinically relevant and
greater benefit at all doses (50, 100, and 200 mcg BID nominal delivered
doses) versus placebo in the improvement of lung function, in the
double-blind studies. The initial set of results shows the adverse event
profile of fluticasone propionate MDPI was comparable to placebo.
The majority of adverse events were mild to moderate in severity. There
were no drug-related deaths across any of the trials. Further analyses
of additional efficacy and safety data are ongoing. Full results will be
submitted for presentation at future scientific meetings and for
publication in peer reviewed journals.
“We have made significant progress in furthering our respiratory
pipeline with a focus on a complete asthma management system utilizing
our breath-actuated MDPI platform,” said Michael Hayden, M.D., Ph.D.,
President of Global R&D and Chief Scientific Officer at Teva. “We have
successfully developed and launched products that utilize our
breath-actuated MDPI platform in select markets around the world. These
data support the broadening of our portfolio in using this technology to
develop and deliver additional respiratory therapeutic options.”
Regulatory submissions for both fluticasone propionate/salmeterol MDPI
and fluticasone propionate MDPI in the U.S. are planned for 2016.
About The Studies
Study FSS-AS-301 was a Phase III, 12-week, global, multicenter,
randomized, double-blind, placebo-controlled, efficacy and safety study
of fluticasone propionate multidose dry powder inhaler (MDPI) compared
with fluticasone propionate/salmeterol multidose dry powder inhaler
(MDPI) in 1363 adolescent and adult patients with persistent asthma
symptomatic despite low-dose or mid-dose inhaled corticosteroid therapy.
Its primary objective was to evaluate the efficacy of fluticasone
propionate MDPI (at two doses: 50 mcg BID or 100 mcg BID) and
fluticasone propionate/salmeterol MDPI (at two doses: 50/12.5 mcg BID or
100/12.5 mcg BID) when administered over a 12-week period in patients 12
years of age and older with persistent asthma. For further details on
the study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT02139644
Study FSS-AS-30017 was a Phase III, 12-week, global, multicenter,
randomized, double-blind, placebo-controlled, efficacy and safety study
of fluticasone propionate multidose dry powder inhaler (MDPI) compared
with fluticasone propionate/salmeterol multidose dry powder inhaler
(MDPI) in 1661 adolescent and adult patients with persistent asthma
symptomatic despite inhaled corticosteroid therapy. Its primary
objective was to evaluate the efficacy of fluticasone propionate MDPI
(at two doses: 100 mcg BID or 200 mcg BID) and fluticasone propionate
salmeterol MDPI (at two doses: 100/12.5 mcg BID or 200/12.5 mcg BID)
when administered over a 12-week period in patients 12 years of age and
older with persistent asthma. For further details on the study, please
visit: https://www.clinicaltrials.gov/ct2/show/NCT02141854
Study FSS-AS-305 was a Phase III, 26-week, multicenter, open-label study
to assess the long-term safety of fluticasone propionate multidose dry
powder inhaler (MDPI) and fluticasone salmeterol/propionate multidose
dry powder inhaler (MDPI) in 1087 adolescent and adult patients with
persistent asthma. Its primary objective was to evaluate the long-term
safety of fluticasone propionate inhalation powder (at two doses: 100
mcg BID or 200 mcg BID) and fluticasone propionate/salmeterol inhalation
powder (at two doses: 100/12.5 mcg BID or 200/12.5 mcg BID) when
administered with the Teva multidose dry powder inhaler (MDPI) device as
compared to corresponding reference products over a 26-week period in
patients 12 years of age and older with persistent asthma. For further
details on the study, please visit: https://www.clinicaltrials.gov/ct2/show/NCT02175771
About Teva Respiratory
Teva 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 inadequately controlled 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 Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to 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 2014 amounted to $20.3
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®
(including competition from orally-administered alternatives, as well as
from generic equivalents such as the recently launched Sandoz product)
and our ability to continue to migrate users to our 40 mg/mL version and
maintain patients on that version; our ability to identify and
successfully bid for suitable acquisition targets or licensing
opportunities (such as our pending acquisitions of Allergan’s generic
business and Rimsa), or to consummate and integrate acquisitions; 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;
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; 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 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; 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, 2014 and in our other filings with the U.S. Securities and Exchange
Commission.
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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