Presentations Highlight New Results for Two
Asthma Therapies – CINQAIR® (reslizumab) Injection and ProAir
RespiClick® (albuterol sulfate) Inhalation Powder
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced that seven company-sponsored abstracts will be presented
at the 2016 American Thoracic Society (ATS) International
Conference in San Francisco, California on May 13-18, 2016.
Data to be presented include two late-breaking abstracts for
CINQAIR® (reslizumab) Injection, an interleukin 5 antagonist
monoclonal antibody (IgG4 kappa) recently approved by the U.S. Food
and Drug Administration (FDA) for add-on maintenance treatment of
patients with severe asthma aged 18 years and older, and with an
eosinophilic phenotype. CINQAIR® is not indicated for the treatment
of other eosinophilic conditions or the relief of acute
bronchospasm or status asthmaticus.
Two CINQAIR® abstracts are based on efficacy data pooled from
two 52-week placebo-controlled trials. The first abstract describes
the association between early improvements in lung function and
asthma symptoms, and the frequency of asthma exacerbations. The
second abstract evaluated the effect of CINQAIR® on the need for
rescue systemic corticosteroid use. Both abstracts will be
presented during a thematic poster session focused on eosinophilic
airway disease. A third CINQAIR® abstract focused on the
steady-state pharmacokinetic profile across a range of patient body
weight categories in support of weight-based dosing for intravenous
CINQAIR®.
Teva will also present data for ProAir RespiClick® (albuterol
sulfate) Inhalation Powder which was recently FDA approved for
expanded use in pediatric patients (aged 4 and above). Data slated
for poster presentation will include an analysis of the time to and
duration of response to ProAir RespiClick® and ProAir (HFA)
Inhalation Aerosol in children (aged 4–11 years) relative to
placebo.
Finally, two abstracts from Teva Health Economics and Outcomes
Research will be presented. These abstracts focus on the clinical
and economic burden of uncontrolled asthma and elevated eosinophil
levels and adherence to guideline-recommended asthma medication in
inadequately controlled asthma patients.
“We are pleased to present new results at ATS for two important
therapies for specific subgroups of the asthma patient population –
children ages 4-11 and adults living with a severe form of the
condition,” said Tushar Shah, MD, Senior Vice President, Teva
Global Respiratory Research and Development. “This international
platform allows us to broadly showcase the meaningful work that
Teva continues to do in the respiratory space. It is our hope that
through the research and development of innovative medications we
can better serve the needs of those living with asthma.”
The following Teva-sponsored data will be presented at the 2016
ATS International Conference:
CINQAIR® (reslizumab) Injection
- #P732: Association between Early
Improvements In Lung Function and Asthma Control with Reslizumab
and the Annual Rate of Asthma Exacerbations
- This abstract will be presented via
thematic poster discussion on Sunday, May 15, 2016 during the A39:
Eosinophilic Airway Disease session from 9:00 AM – 12:45 PM.
- #P733: Effect of reslizumab
treatment on rescue systemic corticosteroid use in patients with
asthma and elevated blood eosinophils: results from a pooled
analysis of two phase 3, placebo-controlled trials
- This abstract will be presented via
thematic poster discussion on Sunday, May 15, 2016 during the A39:
Eosinophilic Airway Disease session from 9:00 AM – 12:45 PM.
- #P55: The steady-state
pharmacokinetic (PK) profile across a range of patient body weight
categories supports weight-based dosing for intravenous (IV)
reslizumab
- This abstract will be presented via
thematic poster discussion on Sunday, May 15, 2016 during the A36:
Clinical Problems with Asthma and Allergy session from 9:00 AM –
12:45 PM.
ProAir RespiClick® (albuterol sulfate)
Inhalation Powder
- #P631: Duration of Response and
Time to Response of Albuterol Multidose Dry Powder Inhaler vs
Albuterol Hydrofluoroalkane and Placebo in Children With Asthma
- This abstract (A3809) will be presented
via poster at B51: the Pediatric Asthma: Evaluation and Treatment
session on Monday, May 16, 2016 from 9:00 AM – 4:15 PM.
- #P637: No Tachyphylaxis
Following Chronic Use of Albuterol Multidose Dry Powder Inhaler in
Children With Asthma Over 3 Weeks
- This abstract (A3810) will be presented
via poster at the B51: Pediatric Asthma: Evaluation and Treatment
session on Monday, May 16, 2016 from 9:00 AM – 4:15 PM.
Health Economics & Outcomes Research
- #8733: Clinical and Economic
Burden of Uncontrolled Asthma and Elevated Eosinophil Levels
- This oral presentation will occur
during the A16: Epidemiology and Health Care Costs of Pediatric and
Adult Asthma mini symposium on Sunday, May 15, 2016 from 9:00 AM –
11:00 AM.
- #P224: Adherence to
Guideline-Recommended Asthma Medication has no impact on Healthcare
Resource Utilization and Costs in inadequately controlled asthma
patients
- This abstract will be presented during
a thematic poster at the B48: Asthma: Insights from the Bench,
Genetics and Epidemiology session on Monday, May 16, 2016 from 9:00
AM – 4:15 PM.
About CINQAIR® (reslizumab) Injection
CINQAIR® is a humanized interleukin-5 (IL-5) antagonist
monoclonal antibody (IgG4 kappa), approved by the U.S. Food and
Drug Administration (FDA) for add-on maintenance treatment of
patients with severe asthma in aged 18 years and older, and with an
eosinophilic phenotype. IL-5 is the most selective eosinophil
cytokine known and plays a major role in the maturation, activation
and survival of eosinophils. In asthma patients, the eosinophilic
phenotype is associated with compromised lung function, more
frequent symptoms, and increased risk of exacerbations. It has been
proposed that reslizumab binds to human IL-5 and prevents it from
binding to the IL-5 receptor, thereby reducing eosinophilic
inflammation, however, the mechanism of reslizumab action in asthma
has not been definitively established.
Important Safety InformationWARNING:
ANAPHYLAXISAnaphylaxis 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.CINQAIR is
contraindicated in patients who have known hypersensitivity to
reslizumab or any of its excipients.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.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.Eosinophils may be involved in
the immunological response to some parasitic (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 that occurred at greater than or equal
to 2% incidence and more commonly than in the placebo group
included 1 event: oropharyngeal pain (2.6% vs. 2.2%).Please
click here for full Prescribing Information, including Boxed
Warning:http://www.cinqair.com/pdf/PrescribingInformation.pdf
About ProAir RespiClick® (albuterol sulfate)
Inhalation Powder
ProAir RespiClick® (albuterol sulfate) Inhalation Powder is
indicated in patients 4 years of age and older for the treatment or
prevention of bronchospasm with reversible obstructive airway
disease and for the prevention of exercise-induced
bronchospasm.
Important Safety Information
- ProAir RespiClick® (albuterol sulfate)
Inhalation Powder is contraindicated in patients with
hypersensitivity to albuterol or patients with a severe
hypersensitivity to milk proteins. Rare cases of hypersensitivity
reactions, including urticaria, angioedema, and rash have been
reported after the use of albuterol sulfate. There have been
reports of anaphylactic reactions in patients using inhalation
therapies containing lactose
- ProAir RespiClick® can produce
paradoxical bronchospasm that may be life-threatening. Discontinue
ProAir RespiClick® and institute alternative therapy if paradoxical
bronchospasm occurs
- Need for more doses of ProAir
RespiClick® than usual may be a marker of acute or chronic
deterioration of asthma and requires reevaluation of treatment
- ProAir RespiClick® alone may not be
adequate to control asthma in many patients. Early consideration
should be given to adding anti-inflammatory agents, e.g.,
corticosteroids
- ProAir RespiClick®, like other
beta-adrenergic agonists, can produce clinically significant
cardiovascular effects in some patients, as measured by heart rate,
blood pressure, and/or symptoms. If such effects occur, the drug
may need to be discontinued
- ProAir RespiClick®, as with all
sympathomimetic amines, should be used with caution in patients
with cardiovascular disorders (especially coronary insufficiency,
cardiac arrhythmias, and hypertension), convulsive disorders,
hyperthyroidism, and diabetes
- Fatalities have been reported in
association with excessive use of inhaled sympathomimetic drugs in
patients with asthma. Do not exceed the recommended dose
- Immediate hypersensitivity reactions
may occur. Discontinue ProAir RespiClick® immediately
- ProAir RespiClick® may produce
significant hypokalemia in some patients, which has the potential
to produce adverse cardiovascular effects. The decrease is usually
transient, not requiring supplementation
- Potential drug interactions can occur
with beta-blockers, diuretics, digoxin, or monoamine oxidase
inhibitors, and tricyclic antidepressants
- In controlled studies of ProAir
RespiClick® in patients 12 years of age and older, adverse events
that occurred at an incidence rate of at least 1% and greater than
placebo included back pain (2% vs 1%), pain (2% vs <1%),
gastroenteritis viral (1% vs <1%), sinus headache (1% vs
<1%), and urinary tract infection (1% vs <1%)
- In controlled studies of ProAir
RespiClick® in patients 4 to 11 years of age, adverse events that
occurred at an incidence rate of at least 2% and greater than
placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2%
vs 1%), and vomiting (3% vs 1%)
Please click here for Full Prescribing Information:
http://www.myproair.com/respiclick/library/docs/PINew.pdf
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 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 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 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 Contacts:United
StatesKevin C. Mannix, 215-591-8912orUnited StatesRan
Meir, 215-591-3033orIsraelTomer Amitai, 972 (3)
926-7656orPR Contacts:IsraelIris Beck Codner, 972 (3)
926-7687orUnited StatesDenise Bradley, 215-591-8974orUnited
StatesNancy Leone, 215-284-0213
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