מידע חדש מתכנית הפיתוח של טבע למיגרנה

נתונים ממחקרי שלב 2b של טבע עבור TEV-48125 מפורסם במאמרים עוקבים במגזין Lancet Neurology היוקרתי

29 ספט 2015 | זמן קריאה ממוצע: 7 דקות

ירושלים, 29 במאי2019 – טבע תעשיות פרמצבטיות בע"מ  (NYSE and TASE: TEVA)  הודיעה היום כי נתוני מחקר IIIb FOCUS, אשר העריכו את היעילות והבטיחות של fremanezumabלצורך טיפול מונע במיגרנה בקרב מטופלים בוגרים, שחוו בעבר תגובה בלתי מספקת לשניים עד ארבעה סוגים של טיפולים מונעי מיגרנה, ייוצג בקונגרס ה -13 של האיחוד האירופי לכאבי ראש (EHF). קונגרס אירופי זה מיועד עבור אנשי מקצוע בתחום הבריאות ושואף לשפר את חייהם של חולים שנפגעו על ידי מיגרנה על ידי הצגת עדויות מדעיות חדשות על מניעת מיגרנה, מחלות נלוות, ופתוגנזה של מיגרנה. EHF מתקיים במרכז הכנסים הבינלאומי "מגהרון" (MAICC) באתונה, יוון ב -30 במאי - 1 ביוני 2019.

 

מחקר FOCUS הוא המחקר הגדול ביותר עד כה בחולים שלא הגיבו כראוי למספר סוגים של טיפולים למניעת מיגרנה. זהו המחקר הראשון מסוגו המתבצע בחולים עם מיגרנה כרונית כמו גם ארעית.

 

ד"ר ג'ושוע מ' כהן, MD, MPH, FAHS, מנהל רפואי מוביל למיגרנה וכאבי ראש בטבע, אמר כי "לחולים עם תגובה לא מספקת לטיפולים מונעי מיגרנה מרובים יש צורך משמעותי בניהול המיגרנה שלהם. תוצאות המחקר של FOCUS מדגימות את התועלת של fremanezumab בהתייחסות לנטל המחלה באוכלוסיית מטופלים הקשה לטיפול זו. טבע מחויבת לענות על הצרכים של חולי מיגרנה ומשפחותיהם ואנו נבדוק אפשרויות לקיום מחקר בשלב IV עם fremanezumab כדי להגדיל את ההבנה שלנו של המחלה".

 

פרופ' לנוירולוגיה ויו"ר מרכז ליידן ליישום מדעי המוח במרכז הרפואי של אוניברסיטת ליידן, מישל ד. פרארי, MD PhD, FANA, FRCP אמר: "נתוני המחקר של FOCUS מראים באופן משכנע שחולים עם קושי לטפל במיגרנה, שלא הגיבו לעד ארבעה טיפולים מונעי מיגרנה, עשויים להפיק תועלת משמעותית מן הטיפול עם fremanezumab. אני שמח שהנתונים הללו יוצגו לראשונה בקונגרס EHF באתונה".

 

במחקר FOCUS, מטופלים שטופלו ב- fremanezumab חוו ירידה משמעותית במספר חודשי המיגרנה הממוצע בהשוואה לפלסבו במהלך תקופת הטיפול של 12 שבועות, הן במשטרי מינון חודשיים והן רבעוניים. בנוסף, מטופלים שטופלו ב- fremanezumab חוו שיפור משמעותי בהשוואה לפלצבו בכל נקודות הסיום המשניות עבור משטרי המינון הרבעוניים והחודשיים. טבע גם תארח ביום שישי סימפוזיון כלווין לכנס הראשי.

 

הנתונים המלאים אשר מומנו על ידי טבע ואשר יוצגו בכנס כוללים:

 

Oral presentations:

 

30th May 2019

12.00pm – 12.15pm

Presenter: Prof. Messoud Ashina

 

Efficacy and safety of fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study.

 

31st May 2019

14.45pm – 15.00pm

Presenter: Prof. Richard Lipton

 

Long-term efficacy of fremanezumab in patients who reverted from a chronic to an episodic migraine classification.

 

31st May 2019

15.00pm – 15.15pm

Presenter: Joshua M. Cohen

 

Efficacy, clinically meaningful responses, and impact on acute headache medication use with fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study.

 

 

e-Poster presentations

 

FOCUS Study:

The FOCUS Study provides data in migraine patients who responded inadequately to two to four classes of prior migraine preventive medications.

Titles of the presentations include:

 

  • Efficacy of fremanezumab in patients with migraine and documented inadequate response to 2, 3, or 4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study
  • Early onset of response to fremanezumab in patients with migraine and a documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study
  • Impact of age and sex on efficacy offremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study

 

Long-Term Study:

The following presentations will be presented: -

 

Efficacy

  • Improvement in response over time with fremanezumab in patients who reverted from a chronic to an episodic migraine classification
  • Long-term impact of fremanezumab on patients who reverted from a chronic to an episodic migraine classification
  • Long-term efficacy and safety of fremanezumab in migraine: results of a 1-year study
  • Long-term efficacy of fremanezumab in patients with chronic migraine with concomitant preventive medication use
  • Long-term impact of fremanezumab on response rates: results of a 1-year study
  • Long-term safety of fremanezumab: results of a 1-year study
  • Quarterly administration of fremanezumab does not show “wearing off” effect during third month after injection

 

Comorbidity/Disability

  • Long-term efficacy of fremanezumab in patients with chronic migraine and comorbid moderate to severe depression
  • Long-term impact of fremanezumab on response rates, acute headache medication use, and disability in patients with chronic migraine: results of a 1-year study
  • Long-term impact of fremanezumab on headache-related disability, quality of life, and patient satisfaction in episodic migraine and chronic migraine 
  • Long-term impact of fremanezumab on response rates, acute headache medication use, and disability in patients with episodic migraine: results of a 1-year study

Meta analyses

  • Reduction in monthly migraine days (MMDs) with fremanezumab and erenumab among patients with chronic migraine (CM) with 2 to 4 prior treatment failures: A Network Meta-Analysis
  • Reduction in monthly migraine days (MMDs) with fremanezumab and erenumab among patients with episodic migraine (EM) with 2-4 prior treatment failures: A Network Meta-Analysis
  • Comparison of responder rates between fremanezumab, erenumab and onabotulinumtoxinA among patients with migraine with ≥3 prior treatment failures: A Network Meta-Analysis

 

Teva Symposium

 

Migraine Burden in Europe: What Role Can Innovations Play?

 

Chair: Professor Dimos D. Mitsikostas, MD, PhD, FEAN

 

Friday 31st May, 15:45 – 17:00, ‘Megaron’ Athens International Conference Centre (MAICC), Alexandra Trianti Hall

 

Educational Symposium Program Overview:

Migraine remains a leading cause of disability in the European Union (EU) and is associated with a substantial economic and societal burden. However, the recent introduction of monoclonal antibodies (mAbs) that target calcitonin gene-related peptide into the treatment armamentarium offers a potential means to ease the burden of migraine on both patients and the EU healthcare system. This program will examine the epidemiology of migraine, along with its social and financial impacts; explain the scientific advancements behind the clinical utility of mAbs; and discuss findings from 2 clinical studies of the mAb fremanezumab for migraine prevention; a long-term study and a study in patients with refractory episodic and chronic migraine.

 

The full online programme can be accessed via the congresses official website: https://www.ehf2019.com/calendar

 

About FOCUS

The Phase IIIb FOCUS study is a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy, safety, and tolerability of quarterly and monthly treatment with fremanezumab, compared to placebo. Adult patients with chronic migraine or episodic migraine who have responded inadequately to two to four classes of prior preventive treatments were enrolled in the study.

 

Inadequate response is defined as: lack of efficacy after at least three months of therapy at a stable dose; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of medications include: beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproic acid.

 

In the study, chronic migraine and episodic migraine patients were randomized in blinded-fashion 1:1:1 into one of three treatment groups – a quarterly dosing regimen, a monthly dosing regimen or matching placebo. An open-label extension of three months (weeks 13-24) followed the placebo-controlled portion of the study.

 

 

About Migraine

Migraine is a disabling neurological disease characterized by severe head pain, nausea and vomiting.[i] With more than 1 billion people affected worldwidei, migraine is the third most prevalent disease in the world.[ii]

 

 

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא מובילה עולמית בגנריקה, עם טיפולים חדשניים בתחומים נבחרים, כולל מערכת העצבים המרכזית, כאב ונשימה. אנו מספקים תרופות גנריות באיכות גבוהה בכמעט כל תחום טיפולי בכדי להתמודד עם צרכי מטופלים אשר אינם זוכים למענה. יש לנו נוכחות מבוססת בגנריקה, תרופות מקור, תרופות ללא מרשם וייצור חומרים כימיים פעילים, ובונים על גבי מורשת בת יותר מ-115 שנה עם מערך מו"פ מאוחד, בסיס תפעולי חזק ותשתית גלובלית נרחבת. אנו חותרים לפעול באופן אחראי ברמה החברתית והסביבתית. המטה שלנו ממוקם בישראל, יש לנו מתקני ייצור ומחקר בכל העולם, ואנו מעסיקים 43,000 עובדים המחויבים לאפשר לשפר את חייהם של מיליוני מטופלים. למידע נוסף על החברה, בקרו באתר www.Teva.co.il



[i] Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed November 2018.

[ii] Migraine Trust. Facts and Figures. https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/. Accessed November 2018.

 

 

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Teva’s Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995:

January 1st 0001 | Reading time: 3 Min

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.

 

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