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

29 יול 2020 | זמן קריאה ממוצע: 1 דקות

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®q can 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 regarding new drug application filing in Japan for AJOVY® (fremanezumab) injection, 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:

  • challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals for Ajovy in Japan;
  • our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; 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; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations 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: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
  • compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M 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 Quarterly Report on Form 10-Q for the first quarter  of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” 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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