טבע מודיעה על השקת הגרסה הגנרית של משחת ®ELIDEL בארה"ב

משחת Pimecrolimus היא תרופת מרשם לשימוש מקומי הניתנת כקו טיפולי שני לטיפול קצר-טווח או טיפול כרוני לא מתמשך של אקזמה קלה עד בינונית (atopic dermatitis) בקרב ילדים מגיל 2 ומעלה ובוגרים אשר לא סובלים מבעיות במערכת החיסונית, אשר לא הגיבו באופן מספק לטיפולי מרשם מקומיים אחרים, או במקרים שטיפולים אלו אינם רצויים.

ירושלים, 27 בדצמבר, 2018 – טבע תעשיות פרמצבטיות בע"מ הודיעה היום על השקת הגרסה הגנרית של משחת  Elidel® ,(pimecrolimus), 1%,  בארה"ב.

משחת Pimecrolimus 1%, היא תרופת מרשם לשימוש מקומי הניתנת כקו טיפולי שני לטיפול קצר-טווח או טיפול כרוני לא מתמשך של אקזמה קלה עד בינונית (atopic dermatitis) בקרב ילדים מגיל 2 ומעלה ובוגרים אשר לא סובלים מבעיות במערכת החיסונית, אשר לא הגיבו באופן מספק לטיפולי מרשם מקומיים אחרים, או במקרים שטיפולים אלו אינם רצויים.

ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה, אמר, "אנו גאים להציע עוד אופציית טיפול ברת השגה. השקה זו מהווה תוספת חשובה לפורטפוליו הגנרי שלנו וממחישה את מחויבותנו להבטיח מגוון רחב יותר של טיפולים עבור המטופלים שלנו."

עם קרוב ל-550 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 7 מרשמים גנריים הניתנים בארה"ב הוא למוצר של טבע.

למשחת ®Elidel היו מכירות שנתיות של כ-218.4 מיליון דולר בארה"ב, נכון לאוקטובר 2018, על פי נתוני IQVIA.

About Pimecrolimus Cream, 1%

Pimecrolimus Cream, 1% is indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adults and children 2 years of age and older, who have failed to respond adequately to other topical prescription treatments, or when those treatments are not advisable.

IMPORTANT SAFETY INFORMATION

WARNING: Long-term Safety of Topical Calcineurin Inhibitors Has Not Been Established.  Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%.  Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided, and application limited to areas of involvement with atopic dermatitis.  Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age.

Pimecrolimus Cream, 1% is contraindicated in individuals with a history of hypersensitivity to pimecrolimus or any of the components of the cream.  Pimecrolimus Cream, 1% should not be used in immunocompromised adults and children, including patients on systemic immunosuppressive medications. The use of pimecrolimus cream, 1% should be avoided on malignant or pre-malignant skin conditions. Malignant or pre-malignant skin conditions, such as cutaneous T-cell lymphoma (CTCL), can present as dermatitis. Pimecrolimus Cream, 1% should not be used in patients with Netherton’s Syndrome or other skin diseases where there is the potential for increased systemic absorption of pimecrolimus. The safety of Pimecrolimus Cream, 1% has not been established in patients with generalized erythroderma.

Before commencing treatment with Pimecrolimus Cream, 1%, bacterial or viral infections at treatment sites should be resolved.  The use of Pimecrolimus Cream, 1% may cause local symptoms such as skin burning (burning sensation, stinging, soreness) or pruritus. During the course of treatment, it is prudent for patients to minimize or avoid natural or artificial sunlight exposure, even while Pimecrolimus Cream, 1% is not on the skin.  The potential effects of Pimecrolimus Cream, 1% on skin response to ultraviolet damage are not known.

In clinical trials, cases of lymphadenopathy were reported while using Pimecrolimus Cream, 1%.  The safety and efficacy of Pimecrolimus Cream, 1% in immunocompromised patients have not been studied.  In clinical trials, the most commonly reported adverse reactions (greater than or equal to 1%) were application site burning, headache, nasopharyngitis, cough, influenza, pyrexia and viral infection.

For more information, please see accompanying Full Prescribing Information, including Boxed Warning. A copy may be requested from Teva US Medical Information at 888-4-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) 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 45,000 עובדים המחויבים לאפשר לשפר את חייהם של מיליוני מטופלים. למידע נוסף על החברה, בקרו באתר www.Teva.co.il

[1] ELIDEL® is a registered trademark of Meda Pharma S.A.R.L. used under license © 2017 Valeant Pharmaceuticals North America LLC.

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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