טבע הציגה נתונים חדשים בקונגרס האקדמיה האירופית לנוירולוגיה הבוחנים את הניסיון של AJOVY® (fremanezumab) באוכלוסיות עם מיגרנה קשה לטיפול

ניתוחים נוספים בוחנים את ההשפעה של מיגרנה בצרפת, ספרד ובריטניה

תל אביב, 25 במאי 2020 - טבע תעשיות פרמצבטיות בע"מ (NYSE  ו- TASE:TEVA) הציגה מגוון רחב של נתונים חדשים וחשובים על (AJOVY® (fremanezumab וההשפעה החברתית והכלכלית של מיגרנה באירופה בקונגרס השישי של האקדמיה האירופית לנוירולוגיה (EAN). קונגרס ה- EAN השנה היה מפגש וירטואלי בגלל מגיפת נגיף הקורונה.

נתוני fremanezumab כללו ניתוחים מאוחדים של הניסויים הקליניים בשלב 3 של AJOVY (FOCUS, HALO-מיגרנה ארעית  (EM) ו- HALO- מיגרנה כרונית (CM)), שהתמקדו בבטיחות, יעילות ושיפור איכות החיים של חולים שחווים מיגרנה קשה לטיפול. ניתוחי פוסט-הוק הוערכו גם בקרב מטופלים העלולים להיתקל בקשיים בעת ניהול המיגרנה שלהם בגלל ריבוי מחלות (קומורבידיות)

מיגרנה יוצרת נטל מחלה ונטל כלכלי משמעותיים. עם יותר ממיליארד אנשים המושפעים ברחבי העולם, מיגרנה היא הסיבה השנייה המובילה בעולם של שנים של חיים עם מוגבלות והעלויות השנתיות של המחלה בארה"ב ובאיחוד האירופי הן 200 מיליארד דולר. 

"מיגרנה מטילה עומסים גופניים, רגשיים וחברתיים ברחבי העולם ועל אף זאת אפשרויות הטיפול הזמינות לרוב אינן מספקות עבור חולים רבים," אמר ד"ר ג'ושוע מ. כהן, מנהל תחום המיגרנה וכאבי הראש במינהל הרפואי בטבע. "כמובילה בתחום הנוירולוגיה והטיפול במיגרנה, מטרתה של טבע היא להמשיך ולהעריך את ההשפעה של AJOVY על אוכלוסיות שונות של מטופלים כדי להבטיח שמידע אמין ורלוונטי יהיה זמין לאנשי מקצוע בתחום הבריאות כאשר נשקלות אפשרויות טיפול".

Pooled Analysis Shows Impact of AJOVY in Patients with Migraine

Pooled analyses of the Phase 3 FOCUS, HALO-EM and HALO-CM clinical trials in patients 60 years of age or older with EM or CM, examined treatment with fremanezumab versus placebo over 12 weeks. Reductions from baseline in monthly migraine days, headache days of at least moderate severity, and days with acute headache medication use over 12 weeks were significantly greater with quarterly and monthly fremanezumab versus placebo (all P≤0.0103).

The analyses also examined early onset of efficacy and improved headache-related disability, health-related quality-of-life, productivity, and satisfaction in this patient population. Additionally, the analyses looked at cardiovascular adverse events in fremanezumab and placebo treated patients in this group, regardless of whether or not they had a cardiovascular medical history.

Cardiovascular Safety of AJOVY

Additional pooled analyses of the Phase 3 trials were also conducted to examine cardiovascular safety across all patients. The analyses  were performed in migraine patients with cardiovascular/cerebrovascular risk factors (e.g., diabetes mellitus, hyperlipidemia, obesity, hypertension, hormonal birth control pill use) (n=499). The overall incidence of cardiovascular adverse events in these patients were low and comparable between fremanezumab and placebo treated groups. An increase in the number of risk factors did not seem to correlate with an increase in frequency of cardiac and vascular adverse events. Additionally, the analyses examined patients with migraine using cardiovascular medications at baseline (n=280), and patients using concomitant triptans (n=1,123) with those who did not use triptans. Similar to the overall trial populations, the most common adverse events reported in all of these subgroups were injection site reactions. 

Disease and Economic Burden of Migraine in Europe

Two analyses evaluated the economic and disease burden of migraine across patients in the United Kingdom, France and Spain. The first analysis found that CM patients experienced greater disability caused by migraine versus EM patients. CM patients also reported lower health status than EM patients for their most recent migraine. The second evaluation, which included examining electronic medical records from 84,266 adult patients with EM and CM, found CM patients had more migraine-related consultations with their general practitioners than EM patients. Additionally, average quarterly treatment costs were higher for CM patients in all three countries.

These results point to substantial migraine disability and unmet treatment needs across the three countries. They also associate migraine with a significant healthcare and economic burden that includes higher costs for CM patients.  

Accessing Teva EAN Presentations

The ePresentations and ePosters shared by Teva at EAN can be accessed by healthcare professionals through the EAN conference website. The sessions will be available at no cost and will also be on-demand for EAN members from 27 May onward.

Additional resources on migraine, including articles, videos, publications summaries, podcasts and webinars can be accessed on Neurologybytes. Neurologybytes is a platform published by Teva to support neurologists in accessing timely, bite-sized content on the latest research developments and clinical care perspectives in the world of migraine and multiple sclerosis (MS).

Information for Europe about AJOVY®qcan be found here.

qAdverse 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.hpra.ie. Adverse events should also be reported to Teva – please refer to local numbers.

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) מפתחת ומייצרת תרופות לשיפור חייהם של אנשים מזה למעלה ממאה שנה. אנו מובילים גלובליים בגנריקה ובתרופות ייחודיות, עם פורטפוליו הכולל יותר מ- 2,400 מוצרים בכמעט כל תחום טיפולי. בכל יום, קרוב ל-200 מיליון אנשים ברחבי העולם נוטלים תרופה של טבע, הודות לאחת ממערכות התפעול הגדולות והמורכבות בתעשייה הפרמצבטית. נוסף על מעמדנו המבוסס בגנריקה, יש לנו פעילות מחקר חדשני משמעותית התומכת בפורטפוליו המוצרים הייחודיים והביופרמצבטיים הגדל שלנו. למידע נוסף על החברה, בקרו באתר www.Teva.co.il

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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