טבע מודיעה על השקת הגרסה הגנרית של (Delzicol® (mesalamine קפליות בשחרור מושהה בארה"ב

ירושלים, 10 במאי 2019 – טבע תעשיות פרמצבטיות בע"מ (NYSE and TASE: TEVA) הודיעה היום על השקת הגרסה הגנרית של (Delzicol®  (mesalamine, קפליות בשחרור מושהה 400  מ"ג בארה"ב.

Mesalamine Delayed-Release Capsules are an aminosalicylate indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older, and for the maintenance of remission of ulcerative colitis in adults.

"דלקת כיבית (קוליטיס) של המעי הגס היא מחלה דלקתית כרונית של המעי ואנו גאים לספק עוד אפשרות טיפולית למטופלים", אמר ברנדן אוג'ריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה.

עם קרוב ל-500 תרופות גנריות זמינות, לטבע יש את פורטפוליו המוצרים הגנריים מאושרי FDA הגדול בשוק ומובילה בהזדמנויות השקה בבלעדיות (first to file), עם יותר מ-100 תיקי first to file תלויים ועומדים בארה"ב. כיום, 1 מכל 8 מרשמים גנריים הניתנים בארה"ב הוא למוצר של טבע.

קפליות  ®Delzicol בשחרור מושהה רשמו מכירות שנתיות בהיקף של 130 מיליון דולר בארה"ב, על פי נתוני IQVIA, נכון לפברואר 2019.

About Mesalamine Delayed-Release Capsules

Mesalamine Delayed-Release Capsules are indicated for the treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older and for the maintenance of remission of ulcerative colitis in adults.

Important Safety Information

Mesalamine Delayed-Release Capsules are contraindicated in patients with known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of Mesalamine Delayed-Release Capsules.

Renal impairment, including minimal change nephropathy, acute and chronic interstitial nephritis, and renal failure, has been reported in patients taking products that contain mesalamine or are converted to mesalamine.  Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from an exacerbation of ulcerative colitis.  Hypersensitivity reactions have been reported in patients taking sulfasalazine. Some patients may have a similar reaction to mesalamine or to other compounds that contain or are converted to mesalamine.  There have been reports of hepatic failure in patients with preexisting liver disease who have been administered mesalamine.

The most common adverse reactions (≥ 5%) in clinical trials were eructation, abdominal pain, constipation, dizziness, rhinitis, back pain, and rash in adults; and nasopharyngitis, headache, abdominal pain, dizziness, sinusitis, rash, cough, and diarrhea in pediatrics.

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

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) מפתחת, מייצרת ומשווקת תרופות לשיפור חייהם של אנשים מזה למעלה ממאה שנה. אנו מובילים גלובליים בגנריקה ובתרופות ייחודיות, עם פורטפוליו הכולל יותר מ-35,000 מוצרים בכמעט כל תחום טיפולי. בכל יום, כ-200 מיליון אנשים ברחבי העולם נוטלים תרופה של טבע, הודות לאחת ממערכות התפעול הגדולות והמתקדמות בתעשייה הפרמצבטית. נוסף על מעמדנו המבוסס בגנריקה, יש לנו פעילות של מחקר ופיתוח משמעותית התומכת בפורטפוליו המוצרים הייחודיים והביופרמצבטיים הצומח  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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