טבע תציג נתונים אודות דיסקינזיה מאוחרת והנטינגטון בכנס הבינלאומי למחלת פרקינסון והפרעות תנועה

המצגות כוללות נתונים עבור deutetrabenazine ו- pridopidine

ירושלים, 1 ביוני 2017– טבע תעשיות פרמצבטיות בע"מ (NYSE ו-TASE: TEVA) הודיעה היום כי נתונים בנוגע לטבליות deutetrabenazine לטיפול בדיסקינזיה מאוחרת וכוריאה (מחולית) הקשורה למחלת הנטינגטון, ו-pridopidine לטיפול במחלת הנטינגטון יוצגו ב-18 מצגות פוסטר בכנס הבינלאומי ה-21 למחלת פרקינסון והפרעות תנועה שיתקיים בוונקובר, קנדה, בין 4-8 ביוני.

"תחום מערכת העצבים המרכזית ומחלות ניווניות בטבע הינו נרחב ואנו שמחים לחלוק את הנתונים החשובים הללו בנוגע לדיסקינזיה מאוחרת ומחלת הנטינגטון עם מומחים עולמיים בהפרעות תנועה. אנו מצפים להיות חלק מהתקדמות המחקר בתחום זה," אמר ד"ר מייקל היידן, נשיא מו"פ גלובלי והמדען הראשי של טבע. "מגוון הנתונים הרחב אשר יוצגו בכנס זה מציג את מחויבותנו לפתח אפשרויות טיפול משמעותיות עבור המטופלים."

הנתונים שיוצגו מתוך המחקרים שערכה טבע כוללים:

Deutetrabenazine in Tardive Dyskinesia

  • [ABSTRACT 414] Addressing Involuntary Movements in Tardive Dyskinesia (AIM-TD): Efficacy, Safety and Tolerability of Fixed-Dose Deutetrabenazine for the Treatment of Tardive Dyskinesia (Poster Session June 6; 1:45pm-3:15pm) K.E. Anderson, M.D., D. Stamler M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi M.D., Ph.D., J. Jimenez-Shahed M.D., W.G. Ondo, M.D., H.H. Fernandez, M.D.
  • [ABSTRACT 410] Addressing Involuntary Movements in Tardive Dyskinesia (AIM-TD): Improvements in Clinical Global Impression of Change (CGIC) with Deutetrabenazine Treatment in Tardive Dyskinesia (TD) (Poster Session June 6; 1:45pm-3:15pm) J. Jimenez-Shahed, M.D., H.H. Fernandez, M.D., R.A. Hauser, M.D., MBA, M.D. Davis, Ph.D., S.A. Factor, DO, J. Isojarvi, M.D., Ph.D., W.G. Ondo, M.D., D. Stamler, M.D., K.E. Anderson, M.D.
  • [ABSTRACT 409] Deutetrabenazine is Associated with an Improvement in Involuntary Movements in Patients With Tardive Dyskinesia as Seen by the High Proportion of Responders to Deutetrabenazine Treatment in the AIM-TD Study (Poster Session June 6; 1:45pm-3:15pm) J. Jimenez-Shahed, M.D., H.H. Fernandez, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
  • [ABSTRACT 406] Deutetrabenazine Treatment Response by Concomitant Dopamine-Receptor Antagonists in the Phase III, Randomized, Double-Blind, Placebo-Controlled AIM-TD Trial in Tardive Dyskinesia (Poster Session June 6; 1:45pm-3:15pm) J. Jimenez-Shahed, M.D., H.H. Fernandez, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
  • [ABSTRACT 397] Effect of Deutetrabenazine on QTcF Interval in the AIM-TD Study: a 12-Week, Phase III, Randomized, Double-Blind, Placebo-Controlled Study (Poster Session June 6; 1:45pm-3:15pm) K.E. Anderson, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A., Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D., J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D., Ph.D., W.G. Ondo, M.D., H.H. Fernandez, M.D.
  • [ABSTRACT 403] Effect of Deutetrabenazine on Quality of Life in Patients With Tardive Dyskinesia in AIM-TD, a 12-Week Double-Blind, Placebo-Controlled Study (Poster Session June 6; 1:45pm-3:15pm) S.A., Factor, DO, K.E. Anderson, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D., J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D., Ph.D., W.G. Ondo, M.D., H.H. Fernandez, M.D.
  • [ABSTRACT 404] Improvements in Clinical Global Impression of Change With Deutetrabenazine Treatment in Tardive Dyskinesia From the ARM-TD and AIM-TD Studies (Poster Session June 6; 1:45pm-3:15pm) H.H. Fernandez, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D., J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D., Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
  • [ABSTRACT 407] Evaluation of Patient-Reported Outcomes in Tardive Dyskinesia Patients with Underlying Psychotic and Mood Disorders in the ARM-TD and AIM-TD Trials (Poster Session June 6; 1:45pm-3:15pm) H.H. Fernandez, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D., J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D., Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
  • [ABSTRACT 412] The Effect of Deutetrabenazine by Body Region Score of the Abnormal Involuntary Movement Scale in Tardive Dyskinesia: ARM-TD and AIM-TD Studies (Poster Session June 6; 1:45pm-3:15pm) H.H. Fernandez, M.D., D. Stamler, M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi, M.D., Ph.D., L.F. Jarskog, M.D., J. Jimenez-Shahed, M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D., Ph.D., W.G. Ondo, M.D., K.E. Anderson, M.D.
  • [ABSTRACT 402] Long-Term Safety of Deutetrabenazine for the Treatment of Tardive Dyskinesia: Results From an Open-Label, Long-Term Study (Poster Session June 6; 1:45pm-3:15pm) K.E. Anderson, M.D., D. Stamler M.D., M.D. Davis, Ph.D., S.A. Factor, DO, R.A. Hauser, M.D., MBA, J. Isojarvi M.D., Ph.D., J. Jimenez-Shahed M.D., R. Kumar, M.D., FRCPC, S. Ochudlo, M.D., Ph.D., W.G. Ondo, M.D., H.H. Fernandez, M.D.

Deutetrabenazine in Chorea Associated with Huntington Disease

  • [ABSTRACT 468] The Long-Term Safety of Deutetrabenazine for Chorea in Huntington Disease: Updated Safety Results from the ARC-HD Trial (Poster Session June 6; 1:45pm-3:15pm) S. Frank, M.D., C. Vaughan, M.D., M.H.S., D. Stamler, M.D., D. Oakes, Ph.D., M. Davis, Ph.D., S. Eberly, M.S., E. Kayson, M.S., R.N.C., J. Whaley, J. Goldstein, B.S., C. Testa, M.D., Ph.D.

Health Economics and Outcomes Research (HEOR)

  • [ABSTRACT 413] Healthcare Utilization and Costs for Patients With Tardive Dyskinesia (Poster Session June 6; 1:45pm-3:15pm) B. Carroll, PharmD, T. Park, PharmD, D. Irwin, Ph.D., MSPH, S. Gandhi, Ph.D.
  • [ABSTRACT 411] Estimation of Tardive Dyskinesia Incidence and Prevalence in the United States (Poster Session June 6; 1:45pm-3:15pm) A. Dhir, T. Schilling, M.D., V. Abler, DO, R. Potluri, B. Carroll, PharmD
  • [ABSTRACT 488] Demographic and Clinical Characteristics and Tetrabenazine (TBZ) Persistence in Patients With Huntington Disease (HD)-Associated Chorea (Poster Session June 6; 1:45pm-3:15pm) V.W. Sung, M.D., R. Iyer, Ph.D., MBA, S. Gandhi, Ph.D., V. Abler, DO, B. Davis, D.E. Irwin, Ph.D., MSPH, K.E. Anderson, M.D.
  • [ABSTRACT 486] A Descriptive Analysis of a Real-World Population With Huntington Disease-Associated Chorea (HDAC) Treated With Tetrabenazine: Findings From An Electronic Medical Records (EMR) Database (Poster Session June 6; 1:45pm-3:15pm) R. Iyer, Ph.D., MBA, D. Aleyras, Ph.D., S. Gandhi, Ph.D., T. Schilling, M.D., V. Abler, DO, F. Cao, K.L. Johnson, K.E. Anderson, M.D.

Pridopidine

  • [ABSTRACT 489] Efficacy, Safety, and Tolerability of Pridopidine in Huntington Disease (HD): Results From the Phase II Dose-Ranging Study, Pride-HD (Poster Session June 6; 1:45pm-3:15pm) R. Reilmann, M.D., Ph.D., A. McGarry, M.D., G. Bernhard Landwehrmeyer, M.D., F.R.C.P, K. Keiburtz, M.D., M.P.H., I. Grachev, M.D., Ph.D., E. Eyal, M.Sc., J. Savola, M.D., Ph.D., B. Borowsky, Ph.D., S. Papapetropoulos, M.D., Ph.D., M. Hayden, M.D.
  • [ABSTRACT 485] Implementation and Validation of a Biometric Solution for Remote Monitoring of Motor Symptoms in Patients with Huntington Disease in a Phase II Clinical Trial (Poster Session June 6; 1:45pm-3:15pm) S. Papapetropoulos, M.D., Ph.D., S. Fine, Ph.D., E. Cohen, B.Sc., C. Admati, B.Sc., Y. Dolan, B.Sc., I. Grachev, M.D., Ph.D., I.Grossman, Ph.D., M. Hayden, M.D.
  • [ABSTRACT 484] Effect of Pridopidine on Total Functional Capacity (TFC) in Huntington Disease (HD): Results of a Cohort Comparison of Open-HART and Historical Placebo Subjects (Poster Session June 6; 1:45pm-3:15pm) A. McGarry, M.D., V. Abler, D.O., P. Auinger, M.S., I. Grachev, M.D., Ph.D., S. Gandhi, Ph.D., S. Papapetropoulos, M.D., Ph.D.

אודות Deutetrabenazine

Deutetrabenazine, טיפול נסיוני לדיסקינזיה מאוחרת הוא חסם אוראלי של vesicular monoamine 2 transporter (VMAT2) המיועד לווסת את רמות הדופמין במוח. Deutetrabenazine מאושר בארה"ב לטיפול בכוריאה (מחולית) הנלווית למחלת הנטינגטון.

אודות Pridopidine

Pridopidine היא מולקולה המפותחת לטיפול במחלת הנטינגטון. Pridopidine נמשכת לקולטן Sigma-1, כפי שניתן להקיש ממכניזם הפעולה שלה

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה המשמשים כ-200 מיליוני מטופלים ב-100 שווקים מדי יום. טבע, שבסיסה בישראל, היא יצרנית התרופות הגנריות הגדולה בעולם, הממנפת את צבר מוצריה הכולל יותר מ-1,800 מולקולות לייצור מגוון רחב של מוצרים גנריים ברוב התחומים הטיפוליים. בתחום התרופות הייחודיות, לטבע יש את הטיפול החדשני המוביל בעולם לטיפול בטרשת נפוצה וכן תכניות מחקר מתקדמות למחלות אחרות של מערכת העצבים המרכזית, כולל הפרעות תנועה, מיגרנה, כאב ותופעות ניווניות, וכן פורטפוליו מוצרים רחב בתחום הנשימה. טבע ממנפת את יכולותיה בגנריקה ובתרופות הייחודיות במטרה לחפש דרכים חדשות לענות על צרכי המטופלים, וזאת על ידי שילוב פיתוח תרופות יחד עם פיתוח תכשירים, שירותים וטכנולוגיות. הכנסות טבע בשנת 2016 הסתכמו ב-21.9$ מיליארד. למידע נוסף על החברה, בקרו באתר www.tevapharm.com. 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

  • uncertainties relating to the potential benefits and success of our new structure and recent senior management changes as well as the potential success and our ability to effectively execute a restructuring plan;
  • our generics medicines business, including: that we are substantially more dependent on this business, with its significant attendant risks, following our acquisition of Allergan plc’s worldwide generic pharmaceuticals business (“Actavis Generics”); our ability to realize the anticipated benefits of the acquisition (and any delay in realizing those benefits) or difficulties in integrating Actavis Generics; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our generic products, both from competing products and as a result of increased governmental pricing pressures; and our ability to take advantage of high-value biosimilar opportunities;
  • our specialty medicines business, including: competition for our specialty products, especially Copaxone®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and may result in a downgrade of our credit ratings;
  • our business and operations in general, including: our ability to develop and commercialize additional pharmaceutical products; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel;the restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; variations in patent laws that may adversely affect our ability to manufacture our products; our ability to consummate dispositions on terms acceptable to us; adverse effects of political or economic instability, major hostilities or terrorism on our significant worldwide operations; and our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions;
  • compliance, regulatory and litigation matters, including: costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
  • other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; the significant increase in our intangible assets, which may result in additional substantial impairment charges; potentially significant increases in tax liabilities; and 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;


and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), including in the section captioned “Risk Factors,” and in our other filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov and www.tevapharm.com. 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 contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 

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