Teva Announces Top-Line Results from Phase III Studies of Subcutaneously Administered Reslizumab in Patients with Severe Eosi...
January 22 2018 - 8:00AM
Business Wire
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced that a Phase III registration study evaluating
subcutaneously administered reslizumab (110 mg) in a pre-filled
syringe did not meet its primary endpoint of significantly reducing
the frequency of clinical asthma exacerbations (CAEs) in patients
with uncontrolled asthma and elevated blood eosinophils
>300/mcL. A Phase III claim-support study evaluating
subcutaneously administered reslizumab in patients with oral
corticosteroid (OCS)-dependent asthma did not meet its primary
endpoint of reduction in daily OCS dose.
“We are disappointed that these trials of the reslizumab
formulation administered subcutaneously at a fixed-dose of 110 mg
did not meet their primary endpoints. However, these results
reinforce the role of eosinophils in severe asthma disease biology
and the importance of defining the right blood eosinophil cutoff
point for patient selection. We continue to see the positive impact
of the intravenous formulation as a clinically effective 3mg/kg
weight-based dosing option in patients with asthma and elevated
blood eosinophils who are inadequately controlled on
standard-of-care therapy,” said Tushar Shah, MD, Senior Vice
President, Specialty Clinical Development and Medical Affairs at
Teva.
In the registration study, a pre-specified a priori-powered
subgroup analysis of 80% of the total randomized severe asthma
patient population with baseline blood eosinophil count of ≥
400/mcL showed significant reduction in CAE risk (p <0.025).
This patient population is similar to those studied in the Phase
III clinical trials for CINQAIR®/CINQAERO® (reslizumab) injection,
the currently approved intravenous formulation, which also used a
blood eosinophil count of ≥ 400/mcL.
Teva will review the full data to determine next steps.
No new safety concerns to the known safety profile of reslizumab
were identified in review of the data from these studies and no
cases of anaphylaxis related to reslizumab were reported.
About the Studies
Study NCT02452190 was a registration Phase III, 52-week,
double-blind, placebo-controlled study designed to evaluate the
efficacy and safety of reslizumab administered subcutaneously in
468 patients with uncontrolled asthma and elevated blood
eosinophils. Its primary objective was to demonstrate the efficacy
of reslizumab (110 mg) fixed, subcutaneous dosing every 4 weeks, as
assessed by the reduction in frequency of clinical asthma
exacerbations (CAEs). For further details on the study, please
visit:
https://clinicaltrials.gov/ct2/show/NCT02452190?term=NCT02452190&cntry1=NA%3AUS&rank=1
Study NCT02501629 was a claim-support Phase III, 24-week,
double-blind, placebo-controlled, parallel-group study to evaluate
the efficacy and safety of reslizumab administered subcutaneously
in 177 patients with oral corticosteroid (OCS) dependent asthma and
elevated blood eosinophils. Its primary objective was to
demonstrate the efficacy of reslizumab (110 mg) fixed, subcutaneous
dosing every 4 weeks, as assessed by reduction in daily OCS dose
compared with baseline. For further details on the study, please
visit:
https://clinicaltrials.gov/ct2/show/NCT02501629?term=reslizumab&cntry1=NA%3AUS&draw=2&rank=10
About CINQAIR®/CINQAERO®
(reslizumab) injection for intravenous use
CINQAIR (reslizumab) Injection is an interleukin-5 antagonist
monoclonal antibody (IgG4 kappa) indicated for add-on maintenance
treatment of patients with severe asthma aged 18 years and older,
and with an eosinophilic phenotype.
Limitations of Use: CINQAIR is
not indicated for:
- treatment of other eosinophilic
conditions
- relief of acute bronchospasm or status
asthmaticus
IMPORTANT SAFETY INFORMATION
WARNING: ANAPHYLAXIS
- Anaphylaxis has been observed with
CINQAIR infusion in 0.3% of patients in placebo-controlled clinical
studies. Anaphylaxis was reported as early as the second dose of
CINQAIR.
- Anaphylaxis can be life-threatening.
Patients should be observed for an appropriate period of time after
CINQAIR administration by a healthcare professional prepared to
manage anaphylaxis. Discontinue CINQAIR immediately if the patient
experiences signs or symptoms of anaphylaxis.
CONTRAINDICATIONS
- CINQAIR is contraindicated in patients
who have known hypersensitivity to reslizumab or any of its
excipients.
WARNINGS AND PRECAUTIONS
- Acute Asthma Symptoms or
Deteriorating Disease: CINQAIR should not be used to treat
acute asthma symptoms or acute exacerbations. Do not use CINQAIR to
treat acute bronchospasm or status asthmaticus. Patients should
seek medical advice if their asthma remains uncontrolled or worsens
after initiation of treatment with CINQAIR.
- Malignancy: In
placebo-controlled clinical studies, 6/1028 (0.6%) patients
receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm
reported compared to 2/730 (0.3%) patients in the placebo group.
The observed malignancies in CINQAIR-treated patients were diverse
in nature and without clustering of any particular tissue type. The
majority of malignancies were diagnosed within less than six months
of exposure to CINQAIR.
- Reduction of Corticosteroid
Dosage: No clinical studies have been conducted to assess
reduction of maintenance corticosteroid dosages following
administration of CINQAIR. Do not discontinue systemic or inhaled
corticosteroids abruptly upon initiation of therapy with CINQAIR.
Reductions in corticosteroid dose, if appropriate, should be
gradual and performed under the supervision of a physician.
Reduction in corticosteroid dose may be associated with systemic
withdrawal symptoms and/or unmask conditions previously suppressed
by systemic corticosteroid therapy.
- Parasitic (Helminth) Infection:
Eosinophils may be involved in the immunological response to some
helminth infections. Treat patients with pre-existing helminth
infections before initiating CINQAIR. If patients become infected
while receiving treatment with CINQAIR and do not respond to
anti-helminth treatment, discontinue treatment with CINQAIR until
infection resolves.
ADVERSE REACTIONS
- Adverse reactions that occurred at ≥2%
incidence and more commonly than in the placebo group included 1
event: oropharyngeal pain (2.6% vs. 2.2%).
- Elevated baseline creatine
phosphokinase (CPK) was more frequent in patients randomized to
CINQAIR (14%) versus placebo (9%). Transient CPK elevations in
patients with normal baseline CPK values were observed more
frequently with CINQAIR (20%) versus placebo (18%) during routine
laboratory assessments.
- Myalgia was reported in 1% (10/1028) of
patients in the CINQAIR 3 mg/kg group compared to 0.5% (4/730) of
patients in the placebo group.
- Immunogenicity: In placebo-controlled
studies, a treatment-emergent anti-reslizumab antibody response
developed in 53/983 (5.4%) of CINQAIR-treated patients (3 mg/kg).
The antibody responses were of low titer and often transient. There
was no detectable impact of the antibodies on the clinical
pharmacokinetics, pharmacodynamics, clinical efficacy, and safety
of CINQAIR.
Please click here for Full Prescribing Information
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in over 60 markets every day. Headquartered in
Israel, Teva is the world’s largest generic medicines producer,
leveraging its portfolio of more than 1,800 molecules to produce a
wide range of generic products in nearly every therapeutic area. In
specialty medicines, Teva has the world-leading innovative
treatment for multiple sclerosis as well as late-stage development
programs for other disorders of the central nervous system,
including movement disorders, migraine, pain and neurodegenerative
conditions, as well as a broad portfolio of respiratory products.
Teva is leveraging its generics and specialty capabilities in order
to seek new ways of addressing unmet patient needs by combining
drug development with devices, services and technologies. Teva's
net revenues in 2016 were $21.9 billion. For more information,
visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding Subcutaneously Administered Reslizumab, which are based
on management’s current beliefs and expectations and are subject to
substantial risks and uncertainties, both known and unknown, that
could cause our future results, performance or achievements to
differ significantly from that expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to:
- the uncertainty of commercial success
of reslizumab;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: uncertainties relating to the potential success and our
ability to effectively execute a restructuring plan; uncertainties
relating to the potential benefits and success of our new
organizational structure and recent senior management changes; our
ability to develop and commercialize additional pharmaceutical
products; manufacturing or quality control problems, which may
damage our reputation for quality production and require costly
remediation; interruptions in our supply chain; disruptions of our
or third party information technology systems or breaches of our
data security; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products; our ability to consummate dispositions on terms
acceptable to us; adverse effects of political or economic
instability, major hostilities or terrorism on our significant
worldwide operations; and our ability to successfully bid for
suitable acquisition targets or licensing opportunities, or to
consummate and integrate acquisitions;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks; and other factors discussed
in our Annual Report on Form 20-F for the year ended December
31, 2016 (“Annual Report”), including in the section captioned
“Risk Factors,” and in our other filings with the U.S.
Securities and Exchange Commission, which are available at
www.sec.gov and www.tevapharm.com. 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 contained herein, whether as a result of new
information, future events or otherwise. You are cautioned not to
put undue reliance on these forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20180122005789/en/
Teva Pharmaceutical Industries Ltd.IR
Contacts:United StatesKevin C. Mannix,
215-591-8912Ran Meir, 215-591-3033orIsraelTomer
Amitai, 972 (3) 926-7656orPR
Contacts:IsraelYonatan Beker, 972 (54)
888-5898orUnited StatesKaelan Hollon,
202-412-7076Michelle Larkin, 610-786-7335
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