טבע מודיעה על הגשת בקשה לרישום תרופה חדשה עבור AJOVY® ביפן

תל אביב, 29 ביולי 2020 - טבע תעשיות פרמצבטיות בע"מ (NYSE  ו- TASE:TEVA), הודיעה היום כי Otsuka Pharmaceutical Co., Ltd הגישה היום בקשה לרשות התרופות והמכשירים הרפואיים של יפן בכדי להשיג אישור לייצור ושיווק ביפן של AJOVY® (fremanezumab) בהזרקה, לטיפול מניעתי של מיגרנה.

"זוהי אבן דרך חשובה העונה על הייעוד הגלובלי שלנו לשפר חיי מטופלים על ידי קידום אפשרויות טיפול פוטנציאליות חדשות," אמר ג'יאנפרנקו נאזי, סמנכ"ל בכיר ומנהל החטיבה המסחרית של טבע בשווקים הבינלאומיים. "אנו שואפים להביא מוצרים בעלי ערך רב למטופלים, ושמחים להיות קרובים יותר להביא את AJOVY כאפשרות טיפול למטופלים ביפן החיים עם מיגרנה".

AJOVY מפותחת ביפן על ידי Otsuka כחלק מהסכם מסחור בלעדי ממאי 2017 לפיתוח ומכירת AJOVY ביפן. מוקדם יותר השנה, פרסמו שתי החברות תוצאות משני מחקרים קליניים בקרב מטופלים ביפן הסובלים ממיגרנה כרונית וארעית. היעדים הראשיים הושגו בשני המחקרים, עם מובהקות סטטיסטית לעומת פלצבו. שיפור מובהק סטטיסטית הוצג מול פלצבו גם עבור כל היעדים המשניים. AJOVY נקלט בצורה טובה, עם פרופיל תופעות לוואי דומה לפלצבו.

AJOVY היא התרופה בהזרקה תת-עורית מסוג anti-CGRP היחידה אשר אושרה בארה"ב ובאירופה, המיועדת לטיפול מונע של מיגרנה והמוצעת הן במינון רבעוני והן במינון חודשי.

U.S. Important Safety Information about AJOVY® (fremanezumab-vfrm) injection

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

Please click here for full U.S. Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.

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- 3,500 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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