<SEC-DOCUMENT>0001309014-15-000311.txt : 20150428
<SEC-HEADER>0001309014-15-000311.hdr.sgml : 20150428
<ACCEPTANCE-DATETIME>20150428154944
ACCESSION NUMBER: 0001309014-15-000311
CONFORMED SUBMISSION TYPE: 6-K
PUBLIC DOCUMENT COUNT: 2
CONFORMED PERIOD OF REPORT: 20150428
FILED AS OF DATE: 20150428
DATE AS OF CHANGE: 20150428
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: TEVA PHARMACEUTICAL INDUSTRIES LTD
CENTRAL INDEX KEY: 0000818686
STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834]
IRS NUMBER: 000000000
STATE OF INCORPORATION: L3
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 6-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 001-16174
FILM NUMBER: 15798453
BUSINESS ADDRESS:
STREET 1: 5 BAZEL ST
STREET 2: P O B 3190
CITY: PETACH TIKVA
STATE: L3
ZIP: 49131
MAIL ADDRESS:
STREET 1: TEVA PHARMACEUTICAL INDUSTRIES LIMITED
STREET 2: 5 BAZEL ST PO B 3190
CITY: PETACH TIKVA
STATE: L3
ZIP: 49131
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<TYPE>6-K
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<FILENAME>htm_9423.htm
<DESCRIPTION>LIVE FILING
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Teva Pharmaceutical Industries Ltd. - Form 6-K
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UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION<BR>
Washington, D.C. 20549</B>
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<FONT SIZE="+2" FACE="Arial"><B>FORM 6-K</B></FONT><BR>
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REPORT OF FOREIGN PRIVATE ISSUER<BR>PURSUANT TO RULE 13a-16 OR 15d-16<BR>UNDER THE SECURITIES EXCHANGE ACT OF 1934
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For the month of April, 2015
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Commission File Number: 001-16174
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<FONT SIZE="+2"><B>Teva Pharmaceutical Industries Ltd. </B></FONT><BR>
<FONT SIZE="-7">———————————————————————————————————</FONT>
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<FONT SIZE="-1">(Translation of registrant’s name into English)</FONT>
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<TR><TD VALIGN="BOTTOM" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"><FONT FACE="Courier" SIZE="+0">Israel</FONT><BR><FONT SIZE="-7">———————————————————————————————————</FONT></TD></TR><TR><TD VALIGN="CENTER" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"><FONT SIZE="-1">(Jurisdiction of incorporation or organization)</FONT></TD></TR><TR><TD VALIGN="BOTTOM" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"> </TD></TR>
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<FONT FACE="Courier" SIZE="+0">5 Basel Street, P.O. Box 3190 <br>Petach Tikva 4951033 Israel<br> <br></FONT>
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<FONT SIZE="-7">———————————————————————————————————</FONT><BR>
<FONT SIZE="-1">(Address of principal executive office)</FONT>
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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: [<FONT FACE="Courier">x</FONT>] Form 20-F [<FONT FACE="Courier"> </FONT>] Form 40-F
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): [<FONT FACE="Courier"> </FONT>]
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Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): [<FONT FACE="Courier"> </FONT>]
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Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934: [<FONT FACE="Courier"> </FONT>] Yes [<FONT FACE="Courier">x</FONT>] No
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If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): <FONT FACE="Courier"><U> n/a </U></FONT>
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<B>SIGNATURES</B>
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Teva Pharmaceutical Industries Ltd.
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Date: 04/28/2015
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By:
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Eyal Desheh<BR><HR WIDTH="30%" NOSHADE>
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Name:
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Eyal Desheh
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Title:
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Group EVP & CFO
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EXHIBIT INDEX
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<FONT SIZE="-1"><B>Description</B></FONT>
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<FONT SIZE="-1">99.1<FONT>
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<FONT SIZE="2">TEVA LAUNCHES GENERIC ABILIFY® TABLETS IN THE UNITED STATES</FONT>
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<FILENAME>exhibit1.htm
<DESCRIPTION>EX-99.1
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Exhibit EX-99.1
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<P align="center" style="font-size: 10pt"><FONT style="font-size: 10pt"><B>TEVA LAUNCHES GENERIC ABILIFY</B><sup><B>®</sup> TABLETS<BR>
IN THE UNITED STATES</B></FONT>
<P align="left" style="font-size: 10pt"><B>Jerusalem, April 28, 2015 – </B>Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced
<BR>
the launch of the generic equivalent to Abilify<sup>®</sup> (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.
<P align="left" style="font-size: 10pt">“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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">Abilify<sup>®</sup> (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.
<P align="left" style="font-size: 10pt"><U><B>About Aripiprazole Tablets</B></U>
<P align="left" style="font-size: 10pt">Aripiprazole tablets are indicated for:
<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
<TD width="1%" nowrap align="right">•</TD>
<TD width="1%"> </TD>
<TD>Treatment of schizophrenia in adults and adolescents (13 to 17 years of age).</TD>
</TR>
</TABLE>
<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
<TD width="1%" nowrap align="right">•</TD>
<TD width="1%"> </TD>
<TD>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).</TD>
</TR>
</TABLE>
<P align="left" style="font-size: 10pt"><U>Important Safety Information</U>
<P align="left" style="font-size: 10pt"><B>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.</B>
<P align="left" style="font-size: 10pt">Aripiprazole is contraindicated in patients with a history of a hypersensitivity reaction to
aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.
<P align="left" style="font-size: 10pt">In clinical studies of dementia-related psychosis, there was an increased incidence of
cerebrovascular adverse events, including fatalities, in aripiprazole-treated elderly patients.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">Leukopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents,
including aripiprazole<B>. </B>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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">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
<BR>
written for the smallest quantity consistent with good patient management in order to reduce the
risk of overdose.
<P align="left" style="font-size: 10pt">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.
<P align="left" style="font-size: 10pt">In clinical trials, commonly observed adverse reactions (incidence = 5% and at least twice that for
placebo) were:
<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
<TD width="1%" nowrap align="right">•</TD>
<TD width="1%"> </TD>
<TD>Adult patients with schizophrenia: akathisia</TD>
</TR>
</TABLE>
<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
<TD width="1%" nowrap align="right">•</TD>
<TD width="1%"> </TD>
<TD>Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder,
somnolence, and tremor</TD>
</TR>
</TABLE>
<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
<TD width="1%" nowrap align="right">•</TD>
<TD width="1%"> </TD>
<TD>Adult patients (monotherapy) with bipolar mania: akathisia, sedation, restlessness, tremor,
and extrapyramidal disorder</TD>
</TR>
</TABLE>
<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
<TD width="1%" nowrap align="right">•</TD>
<TD width="1%"> </TD>
<TD>Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania:
akathisia, insomnia, and extrapyramidal disorder</TD>
</TR>
</TABLE>
<P>
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">
<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
<TD width="1%" nowrap align="right">•</TD>
<TD width="1%"> </TD>
<TD>Pediatric patients (10 to 17 years) with bipolar mania: somnolence, extrapyramidal
disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness.</TD>
</TR>
</TABLE>
<P align="left" style="font-size: 10pt">Please see accompanying <U>Full Prescribing Information</U>, including Boxed Warning.
<P align="left" style="font-size: 10pt"><B>About Teva</B>
<P align="left" style="font-size: 10pt">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
<U>www.tevapharm.com</U>.
<P align="left" style="font-size: 10pt"><B>Teva’s Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:</B>
<P align="left" style="font-size: 10pt"><I>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</I><sup><I>®</I></sup><I> (including competition from orally-administered
alternatives, as well as from potential purported generic</I>
<P align="left" style="font-size: 10pt"><I>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 </I><I>Form 20-F</I><I> 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.</I>
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