טבע מודיעה על השקת הגרסה הגנרית של טבליות ®Letairis בארה"ב

ירושלים, 1 במאי 2019 – טבע תעשיות פרמצבטיות בע"מ (NYSE and TASE: TEVA) הודיעה היום על השקת הגרסה הגנרית של טבליות (Letairis® (ambrisentan ,  חמישה ועשרה מ"ג, בארה"ב.

Ambrisentan הוא קולטן אנדוטלין המותווה לטיפול ביתר לחץ דם ריאתי (WHO Group 1) במטרה לשפר את יכולת האימון הגופני ולדחות החמרה קלינית. בצוותא עם tadalafil, ambrisentan מותווה להפחית את הסיכונים של התקדמות המחלה והחמרתה עד כדי אשפוז, וכדי לשפר את יכולת האימון הגופני. עבור נשים מטופלות, טבליות    ambrisentan זמינות רק באמצעות תכנית מבוקרת (REMS) בשל הסיכון לעובר.

"ההשקה של טבליות ambrisentan  בארה"ב היא תוספת חשובה לצבר המוצרים הגנריים הצומח שלנו המונה כמעט 60 תרופות גנריות שונות לטיפול במחלות לב ודם", אמר ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון-אמריקה. "היכולת שלנו לטפל במחלות אלו מדגימה את מחויבותנו לספק אפשרויות טיפול גנריות ברות השגה לאנשים החיים עם מחלות כרוניות ארוכות טווח".

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.

®Letairis  רשמה מכירות שנתיות בהיקף של 247 מיליון דולר בארה"ב, על פי נתוני IQVIA, נכון לפברואר 2019.

About Ambrisentan Tablets

Ambrisentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening.  In combination with tadalafil, ambrisentan tablets are indicated to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.  Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).

IMPORTANT SAFETY INFORMATION

WARNING: Embryo-Fetal Toxicity.  Do not administer ambrisentan to a pregnant female because it may cause fetal harm.  Ambrisentan is very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals.  Exclude pregnancy before the initiation of treatment with ambrisentan.  Females of reproductive potential must use acceptable methods of contraception during treatment with ambrisentan and for one month after treatment. Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment.  Because of the risk of embryo-fetal toxicity, females can only receive ambrisentan through a restricted program called the Ambrisentan REMS program.

Ambrisentan is contraindicated in patients with Idiopathic Pulmonary Fibrosis (IPF), including IPF patients with pulmonary hypertension (WHO Group 3).  Peripheral edema is a known class effect of endothelin receptor antagonists, and is also a clinical consequence of PAH and worsening PAH.  In the placebo-controlled studies, there was an increased incidence of peripheral edema in patients treated with doses of 5 or 10 mg ambrisentan compared to placebo.  Peripheral edema/fluid retention is more common with ambrisentan plus tadalafil than with ambrisentan or tadalafil alone.  Acute pulmonary edema during initiation of therapy with vasodilating agents, such as ambrisentan, could be the possibility of pulmonary veno-occlusive disease.

Decreased sperm counts have been observed in human and animal studies with another endothelin receptor antagonist and in animal fertility studies with ambrisentan. Ambrisentan may have an adverse effect on spermatogenesis.  Decreases in hemoglobin concentration and hematocrit have followed administration of other endothelin receptor antagonists and were observed in clinical studies with ambrisentan.

In clinical trials, the most common adverse reactions for ambrisentan (>3% compared to placebo) were peripheral edema, nasal congestion, sinusitis, and flushing.  When used in combination with tadalafil, most common adverse reactions (>5% compared with either monotherapy) were peripheral edema, headache, nasal congestion, cough, anemia, dyspepsia, and bronchitis.

For more information, please see accompanying Full Prescribing Information, including the Boxed Warning.  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) 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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