JERUSALEM--(BUSINESS WIRE)--Apr. 28, 2015--
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced the
launch of the generic equivalent to Abilify® (aripiprazole)
Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, in the United
States. Aripiprazole tablets, an atypical antipsychotic medication, are
approved for the treatment of schizophrenia and for the acute treatment
of manic and mixed episodes associated with bipolar I disorder.
“Our commitment at Teva is to make affordable, high-quality generic
medicines available to millions of patients every day. We are pleased to
launch generic Aripiprazole tablets and offer a generic treatment for
patients suffering from schizophrenia and bipolar I disorder,” said
Siggi Olafsson, President and CEO, Global Generic Medicines for Teva.
Teva remains involved in a patent litigation in the U.S. District Court
for the District of New Jersey in which Otsuka Pharmaceutical Co., Ltd.
has asserted three patents, and recently requested a temporary
restraining order (TRO) based solely on one of those patents, a
combination patent, to block generic competition beyond the April 20,
2015 expiration of pediatric exclusivity on Otsuka’s compound patent. On
April 16, 2015, the District Court denied Otsuka’s request for a TRO
based on the combination patent, finding that Otsuka’s likelihood of
success on the merits is low.
Schizophrenia is a complex, long-term medical illness that affects a
person’s ability to think clearly, manage emotions, make decisions and
relate to others. Approximately one percent of adult Americans live with
schizophrenia. Schizophrenia is a chronic and disabling brain disorder
that affects men and women equally, where people interpret reality
abnormally. Symptoms of schizophrenia may include hallucinations,
delusions, trouble with thinking and concentration, and lack of
motivation.
There are several types of bipolar disorder. Bipolar I disorder is a
specific type of bipolar disorder characterized by manic or mixed
episodes of feelings of extreme irritability or euphoria. Bipolar I
disorder is the most severe form of the illness marked by extreme manic
episodes.
Abilify® (aripiprazole) Tablets, marketed by Otsuka
Pharmaceutical, had annual sales of approximately $7.8 billion in the
United States, according to IMS data as of December 2014.
About Aripiprazole Tablets
Aripiprazole tablets are indicated for:
-
Treatment of schizophrenia in adults and adolescents (13 to 17 years
of age).
-
Acute treatment of manic and mixed episodes associated with bipolar I
disorder as monotherapy and as adjunctive therapy to lithium or
valproate in adults and pediatrics (10 to 17 years of age).
Important Safety Information
Elderly patients with dementia-related psychosis treated with
antipsychotic drugs are at an increased risk of death. Aripiprazole is
not approved for the treatment of patients with dementia-related
psychosis. Antidepressants increased the risk of suicidal thoughts and
behavior in children, adolescents, and young adults in short-term
studies. In patients of all ages who are started on antidepressant
therapy, monitor closely for worsening, and for emergence of suicidal
thoughts and behaviors. Advise families and caregivers of the need for
close observation and communication with the prescriber.
Aripiprazole is contraindicated in patients with a history of a
hypersensitivity reaction to aripiprazole. Reactions have ranged from
pruritus/urticaria to anaphylaxis.
In clinical studies of dementia-related psychosis, there was an
increased incidence of cerebrovascular adverse events, including
fatalities, in aripiprazole-treated elderly patients.
A potentially fatal symptom complex sometimes referred to as Neuroleptic
Malignant Syndrome (NMS) may occur with administration of antipsychotic
drugs, including aripiprazole. Management of NMS should include
immediate discontinuation of antipsychotic drugs and other drugs not
essential to concurrent therapy, intensive symptomatic treatment, and
medical monitoring.
A syndrome of potentially irreversible, involuntary, dyskinetic
movements may develop in patients treated with antipsychotic drugs. If
signs and symptoms of tardive dyskinesia appear in a patient on
aripiprazole, drug discontinuation should be considered if clinically
appropriate.
Atypical antipsychotic drugs have been associated with metabolic changes
that include hyperglycemia/diabetes mellitus, dyslipidemia, and body
weight gain. Monitor glucose regularly in patients with and at risk for
diabetes. Clinical monitoring of weight is recommended.
Aripiprazole may cause orthostatic hypotension. Aripiprazole should be
used with caution in patients with known cardiovascular disease,
cerebrovascular disease, or conditions which would predispose patients
to hypotension.
Leukopenia, neutropenia, and agranulocytosis have been reported with
antipsychotic agents, including aripiprazole. Patients with a
history of a clinically significant low WBC/ANC or drug-induced
leukopenia/neutropenia should have their complete blood count monitored
frequently during the first few months of therapy. Discontinuation of
aripiprazole should be considered at the first sign of a clinically
significant decline in WBC in the absence of other causative factors.
Aripiprazole should be used cautiously in patients with a history of
seizures or with conditions that lower the seizure threshold. Conditions
that lower the seizure threshold may be more prevalent in a population
of 65 years or older.
Aripiprazole, like other antipsychotics, may have the potential to
impair judgment, thinking, or motor skills. Patients should be cautioned
about operating hazardous machinery, including automobiles, until they
are reasonably certain that therapy with aripiprazole does not affect
them adversely.
Disruption of the body’s ability to reduce core body temperature has
been attributed to antipsychotic agents. Appropriate care is advised
when prescribing aripiprazole for patients who will be experiencing
conditions which may contribute to an elevation in core body temperature.
The possibility of a suicide attempt is inherent in schizophrenia and
bipolar disorder, and close supervision of high-risk patients should
accompany drug therapy. Prescriptions for aripiprazole should be written
for the smallest quantity consistent with good patient management in
order to reduce the risk of overdose.
Esophageal dysmotility and aspiration have been associated with
antipsychotic drug use, including aripiprazole. Aripiprazole and other
antipsychotic drugs should be used cautiously in patients at risk for
aspiration pneumonia.
In clinical trials, commonly observed adverse reactions (incidence ≥ 5%
and at least twice that for placebo) were:
-
Adult patients with schizophrenia: akathisia
-
Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal
disorder, somnolence, and tremor
-
Adult patients (monotherapy) with bipolar mania: akathisia, sedation,
restlessness, tremor, and extrapyramidal disorder
-
Adult patients (adjunctive therapy with lithium or valproate) with
bipolar mania: akathisia, insomnia, and extrapyramidal disorder
-
Pediatric patients (10 to 17 years) with bipolar mania: somnolence,
extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision,
salivary hypersecretion, and dizziness.
Please see accompanying Full
Prescribing Information, including Boxed Warning.
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 innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; 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;
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. 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:
United States
Kevin
C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR:
Israel
Iris
Beck Codner, 972 (3) 926-7687
or
United States
Denise
Bradley, 215-591-8974