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Teva Pharmaceutical Industries Ltd. — Earnings Release 2015
Jul 6, 2016
7082_rns_2016-07-06_960f7d64-f987-4cbb-adf6-a3221cb55ea6.pdf
Earnings Release
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Teva and the Huntington Study Group Announce Publication of Pivotal Phase III Data on Deutetrabenazine (SD-809) in Huntington Disease from First-HD Trial in JAMA
Jerusalem, July 5, 2016 – Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) and the Huntington Study Group (HSG) today announced the publication of data from the Phase III, placebocontrolled and randomized First-HD (First Time Use of SD-809 in Huntington Disease) study evaluating the efficacy and safety of SD-809 (deutetrabenazine) tablets for the treatment of chorea associated with Huntington disease (HD). These pivotal data were published today by The Journal of the American Medical Association (JAMA).
"We are proud to have the First-HD results published in JAMA," said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. "This study highlights the meaningful clinical impact deutetrabenazine can have on chorea associated with HD. We will continue to work to bring this treatment option to patients living with HD."
"As a physician who cares for people with HD, it's gratifying to see positive results from a well-designed, fully enrolled trial. Until we find a cure, we aim to bring our patients more treatment options to relieve symptoms," said Dr. Samuel Frank, M.D., Principal Investigator of the First-HD trial, Huntington Study Group Executive Committee member, and Director of the HDSA Center of Excellence at Beth Israel Deaconess Medical Center in Boston, MA. "We are grateful to the people who participated in this trial and their families and support systems that made their participation possible. Research in the HD community depends on volunteers enrolling in trials."
For more information regarding this JAMA publication, visit http://jama.jamanetwork.com/issue.aspx.
About SD-809 (deutetrabenazine) Tablets
SD-809 (deutetrabenazine) is an investigational, oral, small-molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is being developed for the treatment of chorea associated with Huntington disease (HD). Deutetrabenazine has been granted Orphan Drug Designation for the treatment of HD by the U.S. Food and Drug Administration (FDA). Teva is also investigating the potential of deutetrabenazine for treating tardive dyskinesia, for which the FDA has granted a breakthrough therapy designation, and for tics associated with Tourette syndrome, for which the FDA has granted orphan status for pediatric use. Deutetrabenazine uses Teva's deuterium technology.
About Huntington Disease
Huntington disease (HD) is a fatal neurodegenerative disease characterized by uncoordinated and uncontrollable movements, cognitive deterioration and behavioral and/or psychological problems. Onset of HD symptoms typically occurs in middle age, but the disease also manifests in children and the elderly. HD is the most common genetic cause of abnormal involuntary writhing movements called chorea.
| IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 |
About the Huntington Study Group (HSG)

The Huntington Study Group is an independent, not-for-profit network of 400 researchers, coordinators, and other clinicians at more than 100 academic medical centers in the United States, Canada, Australia, New Zealand, South America, and Europe, that work together to seek treatments that make a difference for people affected by Huntington disease. It has facilitated more than 30 clinical trials and studies in HD with more than 10,000 at-risk, prodromal and manifest HD participants.
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
| IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 |
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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| IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 | |
|---|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | ||
| Tomer Amitai | Israel | 972 (3) 926-7656 | ||
| PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 | |
| Denise Bradley | United States | (215) 591-8974 | ||
| Nancy Leone | United States | (215) 284-0213 | ||
טבע וקבוצת המחקר של מחלת הנטינגטון מודיעות על פרסום נתונים בכתב העת JAMA ממחקר מרכזי בשלב ,3 HD-First, בעניין Deutetrabenazine( -809SD )לטיפול במחלת הנטינגטון
ירושלים, 5 ביולי 2016 – טבע תעשיות פרמצבטיות בע"מ )NYSE ו-TASE: TEVA )וקבוצת המחקר של מחלת הנטינגטון )HSG – Group Study Huntington )הודיעו היום על פרסום נתונים ממחקר שלב 3 האקראי ומבוקר הפלצבו HD-First( שימוש ראשון ב-809-SD לטיפול במחלת הנטינגטון, ראשי התיבות of Use Time First Disease Huntington in -809SD), שנועד להעריך את היעילות והבטיחות של טבליות -809SD )deutetrabenazine )לטיפול בכוריאה )מחולית( הנלווית למחלת הנטינגטון )HD). הנתונים המרכזיים מהמחקר התפרסמו היום על ידי כתב העת של איגוד הרפואה האמריקאי ) Medical American the of Journal .)Association – JAMA
"אנו גאים לפרסם את התוצאות ממחקר HD-First ב-JAMA", אמר ד"ר מייקל היידן, נשיא המו"פ הגלובלי והמדען הראשי של טבע. "המחקר ממחיש את ההשפעה הקלינית המשמעותית אשר deutetrabenazine עשויה להביא בטיפול בכוריאה הנלווית למחלת הנטינגטון. אנו נמשיך לעשות מאמצים כדי להביא את אפשרות טיפול זו לאנשים החיים עם המחלה".
"כרופא המטפל בחולי הנטינגטון, זה מספק לראות תוצאות חיוביות מניסוי שתוכנן היטב ובוצע עם אוכלוסיית מחקר מלאה. עד שתימצא דרך לרפא את המחלה, המטרה שלנו היא לספק למטופלים שלנו יותר אפשרויות טיפול כדי להקל על תסמיני המחלה", אמר ד"ר סמואל פרנק, חוקר ראשי במחקר HD-First, חבר בוועד המנהלים של קבוצת המחקר של מחלת הנטינגטון ומנהל מרכז HDSA למצוינות במרכז הרפואי "בית ישראל" בבוסטון, מסצ'וסטס. "אנו אסירי תודה לאנשים שהשתתפו בניסוי, וכן למשפחות ולאנשים בסביבה התומכת שלהם שאפשרו את השתתפותם. המחקר בקהילת חולי הנטינגטון תלוי במתנדבים שימשיכו להירשם לניסויים".
מידע נוסף אודות הפרסום בכתב העת JAMA מופיע באתר aspx.issue/com.jamanetwork.jama://http.
אודות טבליות -809SD( deutetrabenazine)
-809SD( deutetrabenazine )הוא מולקולה קטנה ניסיונית הניתנת דרך הפה ומעכבת את ספיגת Vesicular Transporter 2 Monoamine, או 2VMAT. -809SD נמצאת בפיתוח לטיפול בכוריאה )מחולית( הנלווית למחלת הנטינגטון. התרופה בפיתוח קיבלה התוויה של תרופת יתום לטיפול במחלת ההנטינגטון מידי מנהל המזון והתרופות האמריקאי )FDA). טבע חוקרת גם את פוטנציאל השימוש בתרופה זו לטיפול בדיסקינזיה מאוחרת, שה-FDA העניק לו סיווג של "טיפול פורץ דרך", ולטיפול בעוויתות בלתי רצוניות )"טיקים"( הנלוות לתסמונת טורט, שה-FDA העניק לו מעמד של תרופת יתום לטיפול בילדים. -809SD מבוסס על טכנולוגיית הדאוטריום של טבע.
| IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 |
אודות מחלת הנטינגטון
מחלת הנטינגטון )HD )היא מחלה ניוונית חשוכת מרפא, שסימניה הם תנועות חסרות קואורדינציה או לא רצוניות, פגיעה בתפקוד הקוגניטיבי ובעיות התנהגותיות ו/או פסיכולוגיות. המחלה מתפרצת בדרך כלל בגיל העמידה, אך מופיעה גם בקרב ילדים וקשישים. מחלת הנטינגטון היא הגורם הגנטי הנפוץ ביותר לתנועות עוויתיות לא רצוניות הנקראות "כוריאה" )מחולית(.
אודות קבוצת המחקר של מחלת הנטינגטון )HSG)
קבוצת המחקר של מחלת הנטינגטון היא רשת עצמאית ללא כוונת רווח של 400 חוקרים, מתאמי מחקר ואנשי מדע אחרים הפועלים ביותר מ100- מרכזים רפואיים אקדמיים בארצות הברית, קנדה, אוסטרליה, ניו זילנד, דרום אמריקה ואירופה, העובדים בשיתוף פעולה כדי למצוא טיפולים שישפיעו לטובה על חייהם של אנשים המושפעים ממחלת הנטינגטון. הקבוצה השתתפה בעריכת יותר מ30- ניסויים ומחקרים קליניים בנושא מחלת הנטינגטון עם יותר מ10,000- משתתפים הנמצאים בסיכון לחלות, בשלבים מוקדמים של המחלה ולאחר התפרצות המחלה.
אודות טבע
טבע תעשיות פרמצבטיות בע"מ )TEVA :TASE & NYSE )היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה המשמשים מיליוני מטופלים מדי יום. טבע, שבסיסה בישראל, היא יצרנית התרופות הגנריות הגדולה בעולם, הממנפת את צבר מוצריה הכולל יותר מ1000- מולקולות לייצר מגוון רחב של מוצרים גנריים ברוב התחומים הטיפוליים. בתחום התרופות הייחודיות, טבע הינה חברה מובילה בטיפולים חדשניים למחלות מערכת העצבים המרכזית, כולל כאב, והיא מחזיקה גם צבר מוצרים חזק בתחום מחלות הנשימה. טבע משלבת את כישוריה בתחום התרופות הגנריות ובתחום התרופות הייחודיות בחטיבת המחקר והפיתוח הגלובלית שלה, במטרה ליצור דרכים חדשות לענות על צרכי המטופלים וזאת על ידי שילוב יכולות בתחום פיתוח תרופות יחד עם פיתוח תכשירים, שירותים וטכנולוגיות. הכנסות טבע בשנת 2015 הסתכמו ב\$19.7- מיליארד. למידע נוסף על החברה, בקרו באתר com.tevapharm.www.
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® (including competition from orally-administered alternatives, as well as from generic equivalents such as the recently launched Sandoz product) and our ability to continue to migrate users to our 40 mg/mL version and maintain patients on that version; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities (such as our pending acquisition of Allergan's generics business and Rimsa), or to consummate and integrate acquisitions; the possibility of material fines,
| IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 |

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; 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, 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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| IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 |