-
Reslizumab unequivocal in meeting primary end point in both studies
– cuts frequency of clinical asthma exacerbations by at least half
(50% and 60% respectively)
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Positive results pave the way for reslizumab regulatory submissions
planned for the first half of 2015 (initially US, followed by EU and
other regions), pending full analysis of the data
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Reslizumab’s combination of exacerbation reduction and lung
function improvement may constitute a significant differentiator in
this segment (data to be presented at European Respiratory Society
Congress, Sept 6-10)
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Over 10% of population suffer from asthma, a significant number are
inadequately controlled: A major challenge and a significant
opportunity for an effective, targeted, therapeutic option
JERUSALEM--(BUSINESS WIRE)--Sep. 2, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) announced today that
reslizumab, an investigational anti-IL-5 monoclonal antibody,
demonstrated clear levels of efficacy in achieving the primary endpoint
of reduction in the frequency of clinical asthma exacerbations (CAE)
compared to placebo in two pivotal Phase III studies in patients with
inadequately controlled moderate to severe asthma with elevated levels
of blood eosinophils.
In both trials, reslizumab treatment showed both clinically relevant and
statistically significant reductions in the frequency of CAE compared to
placebo (50% and 60% respectively, p <0.0001 for both). Reslizumab has
also demonstrated a positive effect on lung function and asthma control
in the Phase III program (data to be presented at the European
Respiratory Society Congress, Sept 6-10). The combination of an effect
on clinically important exacerbations and on improvements and
preservation of lung function suggest that reslizumab may be a uniquely
differentiated treatment for patients with moderate to severe asthma
with elevated levels of blood eosinophils.
“The consistent results from these duplicate Phase III trials
demonstrating substantial reductions in asthma exacerbations are
impressive,” said Professor Mario Castro, Washington University School
of Medicine, Division of Pulmonary and Critical Care Medicine and lead
investigator. “They support the potential of targeted anti-IL-5 therapy
with reslizumab in patients with moderate-severe persistent asthma and
elevated blood eosinophils who are at risk for asthma exacerbations and
are uncontrolled by standard asthma therapies.”
This initial set of results shows the adverse event profile of
reslizumab was comparable to placebo in both trials. The incidence of
common AEs (> 5%) was consistent with those seen in a moderate to severe
asthma population, the most frequent being upper respiratory tract
infections, asthma and headache. Further analyses of additional efficacy
and safety data are ongoing.
"These pivotal Phase III study results are striking. Asthma that is
inadequately controlled by current standard of care therapy continues to
present a serious problem for patients, physicians and healthcare
systems. The success of these studies gives us confidence that we may
have a valuable potential new treatment option for asthma patients, with
elevated levels of blood eosinophils, who are at risk of exacerbation,"
said Dr. Michael Hayden, President of Global R&D and Chief Scientific
Officer at Teva Pharmaceutical Industries Ltd. "We plan to submit
applications for approval in the US, Europe and other regions as soon as
possible.”
The results announced today provide a strong foundation for
investigation of additional indications, such as COPD with elevated
eosinophils. The ongoing development of a subcutaneous formulation will
further strengthen the franchise and is expected to be submitted for
approval in the second half of 2017.
These new data are from two global Phase III 12-month, randomized,
double-blind, placebo-controlled, parallel-group studies, evaluating the
efficacy and safety of intravenously administered reslizumab (3.0 mg/kg)
once every four weeks, compared to placebo in asthma patients (12-75
years of age with elevated blood eosinophils) that are inadequately
controlled by standard of care therapy.
The two pivotal Phase III studies involved 953 patients across 232
medical centers worldwide including the US, EU and the Far East. These
studies are part of the Phase III BREATH program that evaluated the
safety and efficacy of reslizumab treatment in four separate Phase III
trials involving more than 1700 adolescent and adult asthma patients
with elevated eosinophils, whose symptoms were inadequately controlled
with inhaled corticosteroids with or without another controller
medication.
Increased levels of blood eosinophils have been shown to correlate with
future risk and severity of asthma exacerbations. IL-5 is an important
element in the growth and activity of eosinophils and blocking its
activity has now been shown to reduce asthma exacerbation. Uncontrolled
asthma, associated with elevated eosinophils, impacts a large number of
patients. It is a major challenge for both clinicians and patients and
constitutes a significant burden on healthcare systems: It is estimated
that the market for severe asthma biotech drugs could exceed $7.5
billion a year in the United States and Europe alone.
Detailed analyses of the data are ongoing and full results will be
submitted for presentation to a future scientific meeting and for
publication in a peer reviewed journal.
About Reslizumab
Reslizumab is an investigational humanized monoclonal antibody (mAb)
against interleukin-5 (IL-5). IL-5 has been shown to play a crucial role
in the maturation, growth and chemotaxis (movement) of eosinophils,
inflammatory white blood cells implicated in a number of allergic
diseases.
About the Studies
Study NCT012870391
was a Phase III, 12-month, multicenter, randomized, double-blind,
placebo-controlled study designed to evaluate the efficacy, safety, and
immunogenicity of treatment with reslizumab in 489 patients with
eosinophilic asthma. Its primary objective was to demonstrate the
efficacy of reslizumab, at a dose of 3 mg/kg administered IV every 4
weeks, as assessed by the reduction in frequency of clinical asthma
exacerbations (CAEs). Principal investigator – Professor Mario
Castro, MD, Washington University School of Medicine, Division of
Pulmonary and Critical Care Medicine.
Study was conducted in 128 study centers including - USA, Australia,
Germany, France, New Zealand, Chile, Colombia, Israel, Sweden, Denmark,
Russia, Hungary, Czech Republic, Poland, South Africa, Thailand and more.
Study NCT01285323 was a Phase III, 12-month, double-blind,
placebo-controlled, parallel-group study to evaluate the efficacy and
safety of reslizumab treatment (3 mg/kg administered IV every 4 weeks)
in the reduction of clinical asthma exacerbations in 464 patients (12-75
years of age) with eosinophilic asthma whose symptoms are inadequately
controlled with inhaled corticosteroids. Principal investigator – Dr.
Stephanie Korn, Head of Clinical Research Pulmonology, Asthma and COPD
clinic, Mainz University Hospital in Germany.
Study was conducted in 104 study centers including - USA, Canada,
Argentina, Brazil, Mexico, Greece, Romania, Russia, Taiwan, Korea and
more.
About Asthma
Asthma is a common, chronic inflammatory condition that affects
approximately 12% of adults and 10% of children and adolescents; it is
estimated that 300 million people worldwide suffer from this condition.
Patients with inadequately controlled severe persistent asthma are at
risk of exacerbations, hospitalization and death, and often have
impaired quality of life.
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 reslizumab, as there can be no certainty as to
its application timing, approval, final product profile or market
penetration; 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, (215) 591-8912
or
United States
Ran Meir,
(215) 591-3033
or
Israel
Tomer Amitai, 972 (3)
926-7656
or
PR Contacts:
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or
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(215) 591-8974
or
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