<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 </SEC-HEADER> <DOCUMENT> <TYPE>6-K <SEQUENCE>1 <FILENAME>htm_9423.htm <DESCRIPTION>LIVE FILING <TEXT> <!-- HTML Header Page --> <HTML> <HEAD> <TITLE> Teva Pharmaceutical Industries Ltd. - Form 6-K </TITLE> </HEAD> <!-- End HTML Header Page --><!-- Cover Page Header --> <BODY bgcolor=white text=black> <HR NOSHADE> <A NAME="DOCUMENT_TOP"> </A> <P align="center"> <FONT size="+1"><B> UNITED STATES<BR> SECURITIES AND EXCHANGE COMMISSION<BR> Washington, D.C. 20549</B> </P> <P> <CENTER> <FONT SIZE="+2" FACE="Arial"><B>FORM 6-K</B></FONT><BR> </CENTER> </P> <P> <CENTER> <FONT size="+1"> REPORT OF FOREIGN PRIVATE ISSUER<BR>PURSUANT TO RULE 13a-16 OR 15d-16<BR>UNDER THE SECURITIES EXCHANGE ACT OF 1934 </FONT> </CENTER> </P> <P> <CENTER> For the month of April, 2015 </CENTER> </P> <P> <CENTER> Commission File Number: 001-16174 </CENTER> </P> <!-- End Cover Page Header --> <!-- Cover Page Registrant --> <TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%"> <TR> <TD VALIGN="BOTTOM" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"> <FONT SIZE="+2"><B>Teva Pharmaceutical Industries Ltd. </B></FONT><BR> <FONT SIZE="-7">———————————————————————————————————</FONT> </TD> </TR> <TR> <TD VALIGN="CENTER" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"> <FONT SIZE="-1">(Translation of registrant’s name into English)</FONT> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"> </TD> </TR> <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> <TR> <TD VALIGN="BOTTOM" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"> <FONT FACE="Courier" SIZE="+0">5 Basel Street, P.O. Box 3190 <br>Petach Tikva 4951033 Israel<br> <br></FONT> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"> <FONT SIZE="-7">———————————————————————————————————</FONT><BR> <FONT SIZE="-1">(Address of principal executive office)</FONT> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="CENTER" WIDTH="100%" COLSPAN="5"> </TD> </TR> </TABLE> <!-- End Cover Page Registrant --> <!-- Checkboxes Page --> <TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%"> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="100%" COLSPAN="5"> 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 </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" COLSPAN="5" WIDTH="100%"> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" COLSPAN="5" WIDTH="100%"> 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>] </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" COLSPAN="5" WIDTH="100%"> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" COLSPAN="5" WIDTH="100%"> 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>] </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" COLSPAN="5" WIDTH="100%"> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" COLSPAN="5" WIDTH="100%"> 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 </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" COLSPAN="5" WIDTH="100%"> </TD> </TR> </TABLE> <TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%"> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="100%"> 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> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="100%"> </TD> </TR> </TABLE> <!-- End Checkboxes Page --> <!-- HR Page Break --> <HR NOSHADE> <DIV ALIGN="LEFT" STYLE="PAGE-BREAK-BEFORE:ALWAYS"> <!-- End HR Page Break --><!-- Report Page --> <FONT SIZE="3"> <PRE> </PRE> </FONT> <!-- End Report Page --> <!-- Page Break --> <HR NOSHADE> <DIV ALIGN="LEFT" STYLE="PAGE-BREAK-BEFORE:ALWAYS"> <!-- Page Break --> <DIV ALIGN="LEFT" STYLE="PAGE-BREAK-BEFORE:ALWAYS"> <!-- End Page Break --> <!-- Signatures Page Header --> <FONT SIZE="+1"> <CENTER> <B>SIGNATURES</B> </CENTER> </FONT> <TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%"> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="100%"> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="100%"> 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. </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="100%"> </TD> </TR> </TABLE> <!-- End Signatures Page Header --> <!-- Signatures Page Details --> <TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="100%"> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="40%"> </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="4%%"> </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="56%"> Teva Pharmaceutical Industries Ltd. </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="40%"> </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="4%%"> </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="56%"> </TD> </TR> <TR> <TD VALIGN="TOP" ALIGN="LEFT" WIDTH="40%"> Date: 04/28/2015 </TD> <TD VALIGN="TOP" ALIGN="LEFT" WIDTH="4%%"> By: </TD> <TD VALIGN="TOP" ALIGN="LEFT" WIDTH="56%"> Eyal Desheh<BR><HR WIDTH="30%" NOSHADE> </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="40%"> </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="4%%"> Name: </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="56%"> Eyal Desheh </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="40%"> </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="4%%"> Title: </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="56%"> Group EVP & CFO </TD> </TR> <TR> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="40%"> </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="4%%"> </TD> <TD VALIGN="BOTTOM" ALIGN="LEFT" WIDTH="56%"> </TD> </TR> </TABLE> <!-- End Signatures Page Details --> <!-- HR Page Break --> <HR NOSHADE> <DIV ALIGN="LEFT" STYLE="PAGE-BREAK-BEFORE:ALWAYS"> <!-- End HR Page Break --><!-- Exhibit Index Header Page --> <CENTER> <FONT SIZE="+1"><B> EXHIBIT INDEX </B></FONT> </CENTER> <BR> <CENTER> <TABLE CELLSPACING="0" BORDER="0" CELLPADDING="0" WIDTH="60%"> <TR VALIGN="BOTTOM"> <TD NOWRAP ALIGN="LEFT" WIDTH="8%"> <FONT SIZE="-1"><B>Exhibit No.</B></FONT> </TD> <TD WIDTH="15%"> </TD> <TD NOWRAP ALIGN="LEFT" WIDTH="77%"> <FONT SIZE="-1"><B>Description</B></FONT> </TD> </TR> <TR VALIGN="BOTTOM"> <TD NOWRAP ALIGN="CENTER" WIDTH="8%"> <HR SIZE="1" NOSHADE> </TD> <TD WIDTH="15%"> </TD> <TD NOWRAP ALIGN="CENTER" WIDTH="77%"> <HR ALIGN="LEFT" SIZE="1" WIDTH="88%" NOSHADE> </TD> </TR> <!-- Exhibit Index Header Page --> <!-- Exhibit Index Item --> <TR VALIGN="BOTTOM"> <TD VALIGN="TOP" WIDTH="8%" nowrap> <FONT SIZE="-1">99.1<FONT> </TD> <TD WIDTH="15%"> </TD> <TD ALIGN="LEFT" VALIGN="TOP" WIDTH="77%"> <FONT SIZE="2">TEVA LAUNCHES GENERIC ABILIFY® TABLETS IN THE UNITED STATES</FONT> </TD> </TR> <!-- End Exhibit Index Item --> <!-- ExhibitIndexFooter --> <TR VALIGN="BOTTOM"> <TD VALIGN="TOP" WIDTH="8%" nowrap> </TD> <TD WIDTH="15%"> </TD> <TD ALIGN="LEFT" VALIGN="TOP" WIDTH="77%"> </TD> </TR> </TABLE> <!-- End ExhibitIndexFooter --> <!-- HR Page Break --> <HR NOSHADE> <DIV ALIGN="LEFT" STYLE="PAGE-BREAK-BEFORE:ALWAYS"> <!-- End HR Page Break --><!-- HTML Footer Page --> </BODY> </HTML> <!-- End HTML Footer Page --> </TEXT> </DOCUMENT> <DOCUMENT> <TYPE>EX-99.1 <SEQUENCE>2 <FILENAME>exhibit1.htm <DESCRIPTION>EX-99.1 <TEXT> <!-- ExhibitContentHeader Page --> <HTML> <HEAD> <TITLE> Exhibit EX-99.1 </TITLE> </HEAD> <!-- End HTML Header Page --> <!-- ExhibitContentPage --> <BODY style="font-family: 'Times New Roman',Times,serif"> <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> <P align="center" style="font-size: 10pt"># # # <P align="center" style="font-size: 10pt; display: none"> <!-- v.121908 --> </BODY> <!-- End ExhibitContentPage --> <!-- ExhibitContentFooter Page --> </HTML> <!-- ExhibitContentFooter Page --> </TEXT> </DOCUMENT> </SEC-DOCUMENT>