טבע מודיעה על השקת 1% נתרן Hyaluronate בארה"ב

ירושלים, 1 ביולי 2019 – טבע תעשיות פרמצבטיות בע"מ  (NYSE and TASE: TEVA)  הודיעה היום על השקת 1% נתרן Hyaluronate. המוצר קיבל אישור מהמרכז עבור התקנים ורפואה רדיולוגית של מנהל המזון והתרופות האמריקני (FDA).  
1% נתרן Hyaluronate מיועד לטיפול בכאב באוסטאוארתריטיס (OA) של הברך בחולים שלא הגיבו כראוי לטיפול שמרני לא תרופתי ומשככי כאבים פשוטים (למשל, אצטמינופין).

אנשים שקיבלו 1% נתרן Hyaluronate דיווחו על ירידה מובהקת סטטיסטית בציוני הכאב מתחילת המחקר ועד לשבוע 26 בהשוואה ליחידים בקבוצת הפלסבו. באופן כללי, תופעות לוואי של טיפול היו דומות בכל שלושת כלי המחקר עם הכאב הנפוץ ביותר בברך או באתר ההזרקה. תוצאות האפקטיביות היו דומות בין 1% נתרן היאלורונאט ו- Euflexxa.

"ההשקה של 1% נתרן Hyaluronate היא דוגמה מצוינת לשימוש במומחיות בתוך טבע כדי להפגיש מיומנויות מהעסק הגנרי יחד עם עסק תרופות המקור", אמר ברנדן או'גריידי, סמנכ"ל בכיר צפון אמריקה מסחרי. "אנו גאים להביא הצעת ערך נוספת לרופאים ולמטופלים המבקשים אפשרויות טיפול לכאב בברך OA".

1% Sodium Hyaluronate is supplied in a 3 mL disposable prefilled syringe containing 2 mL of 1% sodium hyaluronate, and packaged as three syringes to a carton. For details on ordering call Teva Customer Service at 1-888-838-2872.

About 1% Sodium Hyaluronate

1% sodium hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen).

IMPORTANT SAFETY INFORMATION

Do not use 1% sodium hyaluronate to treat patients who have a known hypersensitivity to hyaluronan preparations. Do not use to treat patients with knee joint infections or to treat patients with infections or skin disease in the area of the injection site.

Do not concomitantly use disinfectants containing quaternary ammonium salts or chlorhexidine for skin preparations because hyaluronan can precipitate in their presence. Do not inject intravascularly because intravascular injections of 1% sodium hyaluronate may cause systemic adverse events.

The safety and effectiveness of 1% sodium hyaluronate has not been established in pregnant women.  It is not known if 1% sodium hyaluronate is excreted in human milk. The safety and effectiveness of 1% sodium hyaluronate has not been established in lactating women or in children (21 years of age or younger).

The most common target-knee related treatment-emergent adverse event (TEAE) was arthralgia. The most common device-related and injection-related TEAE was injection site joint pain.

For more information, please see accompanying Full Prescribing Information. A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872), druginfo@tevapharm.com, or Teva’s Public Relations or Investor Relations contacts.

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

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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