טבע מודיעה על השקת הגרסה הגנרית של טבליות ®EXJADE להשעיה אוראלית בארה"ב

טבליות Deferasirox להשעיה אוראלית הן מסוג קושר ברזל המותוות לטיפול בעודף ברזל כרוני כתוצאה מעירוי דם במטופלים מגיל שנתיים ומעלה

ירושלים, 22 במרץ 2019 – טבע תעשיות פרמצבטיות בע"מ (NYSE and TASE: TEVA) הודיעה היום על השקת הגרסה הגנרית של טבליות (EXJADE®  (deferasirox להשעיה אוראלית, 125 ו250 ו-500 מ"ג, בארה"ב.

טבליות Deferasirox להשעיה אוראלית הן מסוג קושר ברזל המותוות לטיפול בעודף ברזל כרוני כתוצאה מעירוי דם במטופלים מגיל שנתיים ומעלה.

"אנו גאים להציע אופציית טיפול גנרית ברת השגה באמצעות ההשקה של טבליות Deferasirox להשעיה אוראלית בארה"ב", אמר ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון-אמריקה. "אנחנו ממשיכים לחתור לאפשר גישה לתרופות עבור אנשים החיים עם מחלות כרוניות מורכבות".

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.

®EXJADE רשמה מכירות שנתיות בהיקף של 134 מיליון דולר בארה"ב, על פי נתוני IQVIA, נכון לדצמבר 2018.


About Deferasirox Tablets for Oral Suspension

Deferasirox Tablets for Oral Suspensionare indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.  

Limitations of Use: Controlled clinical trials of deferasirox with myelodysplastic syndromes (MDS) and chronic iron overload due to blood transfusions have not been performed.  The safety and efficacy of deferasirox when administered with other iron chelation therapy have not been established.

IMPORTANT SAFETY INFORMATION

WARNING: Renal Failure, Hepatic Failure, and Gastrointestinal Hemorrhage.  Deferasirox can cause acute renal failure and death, particularly in patients with comorbidities and those who are in the advanced stages of their hematologic disorders.  Deferasirox can cause hepatic injury including hepatic failure and death.  Deferasirox can cause gastrointestinal (GI) hemorrhages, which may be fatal, especially in elderly patients who have advanced hematologic malignancies and/or low platelet counts.

Deferasirox is contraindicated in patients with: estimated GFR less than 40 mL/min/1.73m2; poor performance status; high-risk myelodysplastic syndromes; advanced malignancies; platelet counts less than 50 x 109/L; or known hypersensitivity to deferasirox or any component of deferasirox tablets for oral suspension.

Nonfatal upper GI irritation, ulceration and hemorrhage have also been reported in patients, including children and adolescents, receiving deferasirox. The risk of gastrointestinal hemorrhage may be increased when administering deferasirox in combination with drugs that have ulcerogenic or hemorrhagic potential, such as nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, oral bisphosphonates, or anticoagulants. There have been reports of ulcers complicated with gastrointestinal perforation (including fatal outcome).  Neutropenia, agranulocytosis, worsening anemia, and thrombocytopenia, including fatal events, have been reported in patients treated with deferasirox. Preexisting hematologic disorders may increase this risk.

Deferasirox has been associated with serious and fatal adverse reactions in the postmarketing setting among adults, predominantly in elderly patients. Deferasirox has been associated with serious and fatal adverse reactions in pediatric patients in the postmarketing setting. Deferasirox may cause serious hypersensitivity reactions (such as anaphylaxis and angioedema), with the onset of the reaction usually occurring within the first month of treatment.  Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) which could be life-threatening or fatal have been reported during deferasirox therapy. Cases of erythema multiforme have been observed.  Rashes may occur during deferasirox treatment.

Auditory disturbances (high frequency hearing loss, decreased hearing), and ocular disturbances (lens opacities, cataracts, elevations in intraocular pressure, and retinal disorders) were reported at a frequency of less than 1% with deferasirox therapy in the clinical studies. The frequency of auditory adverse events irrespective of causality was increased among pediatric patients who received deferasirox doses greater than 25 mg/kg/day when serum ferritin was less than 1,000 mcg/L.

In clinical trials of patients with transfusional iron overload, the most frequently occurring (greater than 5%) adverse reactions for deferasirox were diarrhea, vomiting, nausea, abdominal pain, skin rashes, and increases in serum creatinine.

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) 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 כ- 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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