טבע מציגה בפעם הראשונה מידע קליני חדש אודות fremanezumab והניסוי הקליני FOCUS במסגרת הקונגרס האירופי ה-13 לכאב הראש

טבע מציגה 17 פוסטרים ושלוש מצגות בעל פה הכוללים נתונים מהמחקר ארוך הטווח בשלב IIIb FOCUS

May 29th 2019

  • מצגות הפוסטר מראות את הנתונים ממחקר FOCUS בקרב מטופלים עם מיגרנה אשר כשלו בשניים עד ארבעה תרופות אחרות למניעת מיגרנה, כמו כן מוצגים נתונים קליניים נוספים לגבי היעילות והבטיחות של fremanezumab בתוך 12 חודשים של טיפול בקרב מטופלים עם מיגרנה כרונית וארעית.

ירושלים, 29 במאי 2019 – טבע תעשיות פרמצבטיות בע"מ  (NYSE and TASE: TEVA)  הודיעה היום כי נתוני מחקר IIIb FOCUS, אשר העריכו את היעילות והבטיחות של fremanezumab לצורך 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. With more than 1 billion people affected worldwidei, migraine is the third most prevalent disease in the world.

 

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.

Teva 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 regarding Fremanezumab (commercialized as AJOVY®   ), 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:

  • the uncertainty of commercial success of AJOVY®;
  •  our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY® and AUSTEDO®; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; 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 products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
  • our business and operations in general, including: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; 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; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets ;
  • 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; governmental investigations into selling and marketing practices; potential liability for patent infringement; 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; potential impairments of our intangible assets; potential 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 10-K for the year ended December 31, 2018, including the sections thereof captioned "Risk Factors." 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.

 Adverse events should be reported.

This medicinal product is subject to additional monitoring.  This will allow quick identification of new safety information.  Healthcare professionals are asked to report any suspected adverse events.

Reporting forms and information can be found at https:// www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Teva – please refer to local numbers.

 


 

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