New Phase III data presented at European Respiratory Society Congress
(ERS) builds on recent exacerbation reduction data, creating a special
efficacy profile for reslizumab
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Reslizumab shown to significantly improve lung function and asthma
control
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Findings support reslizumab benefits specifically for moderate to
severe asthma patients with elevated level of blood eosinophils
JERUSALEM--(BUSINESS WIRE)--Sep. 8, 2014--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) today announced positive
new data from Phase III studies of the company’s anti-IL5 monoclonal
antibody, reslizumab, in patients with uncontrolled moderate to severe
asthma with elevated eosinophils, treated with standard of care
therapies. The data demonstrated that reslizumab treatment resulted in
significant improvement in lung function and asthma control measures and
showed a safety profile comparable to placebo.
Reslizumab treatment (3.0 mg/kg and 0.3 mg/kg IV injection every four
weeks) resulted in significant improvements in lung function versus
placebo when administered to patients, with moderate to severe asthma
with elevated eosinophils. Improvement was measured by overall change in
Forced Expiratory Volume in 1 second (FEV1), a standard
measure of the degree of airway obstruction in asthma. Improvements were
noted as early as four weeks after initial dose administration and were
maintained at the end of the 16 week treatment period. Furthermore,
reslizumab produced significant improvements in patient reported asthma
control, assessed by using the Asthma Control Questionnaire (ACQ), which
includes questions on symptoms, activity limitation, and the use of
non-steroidal rescue medication. Improvements in FEV1 and ACQ
for the 0.3 mg/kg dose were numerically smaller than for the 3 mg/kgdose.
The majority of reported adverse events (AEs) were mild to moderate and
comparable across the treatment groups. The most common AEs in any
treatment group were asthma, headache, nasopharyngitis, and upper
respiratory tract infection.
"Uncontrolled asthma with eosinophilia is in desperate need of novel
targeted therapies. The key aspects to the success of a treatment for
these patients is the confidence and reduced impact on quality of life
that comes from reduced exacerbations and the sense of normality that
comes with better disease control. Reslizumab fulfills an important
unmet need and has the potential to deliver on both counts," said Dr.
Leif Bjermer, principal investigator of the study and professor of
respiratory medicine and allergology at Skane University Hospital in
Lund, Sweden.
Results from a second study, utilizing only the 3 mg/kg dose of
reslizumab, in an asthma population that was not selected for elevated
blood eosinophils, demonstrated minimal improvements in asthma control,
and provides support for the eosinophil threshold of ≥400/µL set for the
reslizumab phase III program.
"Teva has conducted an extensive and robust phase III clinical trial
program that has clearly demonstrated the potential utility of
reslizumab for patients who face a very challenging asthmatic condition.
Reduced exacerbation, improved lung function and better asthma control
positions reslizumab as a potential new targeted therapy for patients
with uncontrolled asthma associated with elevated eosinophils,” said Dr.
Michael Hayden, President of Global R&D and Chief Scientific Officer at
Teva Pharmaceutical Industries Ltd."
Teva-Sponsored Data Highlights Include:
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A randomized phase III study of the efficacy and safety of
reslizumab in subjects with asthma with elevated eosinophils (Poster
Presentation on Sunday, Sept 7, 2014. 8:30 – 10:30am. Session 57) Leif
Bjermer, Catherine Lemiere, Jorge Maspero, Monika Ciesielska,
Christopher O'Brien, James Zangrilli.
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A randomized phase III study of reslizumab efficacy in relation to
blood eosinophil levels in patients with moderate to severe asthma
(Oral Presentation: Wednesday, Sept 10, 2014. 10:15am. Session
488) Jonathan Corren, Steven Weinstein, Lindsay Janka, Christopher
O'Brien, James Zangrilli
The full abstracts can be found at: https://www.ersnetsecure.org/public/prg_congres.entree?ww_i_congres=149
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. Recently announced results from two pivotal Phase III studies
demonstrated that reslizumab treatment (3.0 mg/kg IV injection every
four weeks) resulted in statistically significant reductions in the
frequency of clinical asthma exarcebations compared to placebo (50% and
60% respectively, P<0.0001 for both) with an adverse event profile
comparable to placebo.
About the Studies
Study NCT01270464 was a 16-week, randomized, double-blind,
placebo-controlled, parallel-group study to evaluate the efficacy and
safety of reslizumab (0.3 or 3.0 mg/kg) as treatment for patients (12-75
years of age, n=311) with eosinophilic asthma.
The primary objective was is to determine whether reslizumab
administered once every 4 weeks for a total of 4 doses, is more
effective than placebo in improving lung function in patients with
eosinophilic asthma.
Study NCT01508936 was a 16-week, randomized, double-blind,
placebo-controlled study to evaluate the efficacy and safety of
reslizumab (3.0 mg/kg IV injection every four weeks) treatment in
patients (18-65 years of age, n= 492) with moderate to severe asthma.
The primary objective of the study was to assess reslizumab effect on FEV1
in relation to baseline blood eosinophils in subjects with moderate to
severe asthma.
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;
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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
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Forward-looking statements speak only as of the date on which they are
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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
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