טבע מודיעה על השקת גרסה גנרית של ®SYPRINE בארה"ב
טבע תעשיות פרמצבטיות בע"מ(NYSE and TASE: TEVA) הודיעה היום על השקת גרסה גנרית של טבליות ®Syprine , 250 מ"ג בארה"ב
ירושלים, 9 בפברואר, 2018 – טבע תעשיות פרמצבטיות בע"מ(NYSE and TASE: TEVA) הודיעה היום על השקת גרסה גנרית של טבליות ®Syprine (trientine hydrochloride) , 250 מ"ג בארה"ב.
Trientine hydrochloride משמש לטיפול במטופלים עם מחלת ווילסון אשר לא מסוגלים לקבל penicillamine.
מחלת ווילסון היא מחלה גנטית המונעת מהגוף להסיר מעצמו עודף נחושת. הגוף זקוק לכמות קטנה של נחושת ממזון כדי להישאר בריא, אך לאורך זמן, רמות גבוהות של נחושת עלולות להוביל לנזק מסכן חיים לאיברים. מחלת ווילסון היא תופעה נדירה המשפיעה על כ-1 מתוך 30,000 אנשים .
"ההשקה של טבליות trientine hydrochloride מדגימה את מחויבותה של טבע לשרת אוכלוסיות מטופלים עם צרכים מיוחדים – בין אם לתרופה אשר עשויה להילקח על ידי מיליוני אנשים, או כזו המתמקדת בתופעה נדירה כמו מחלת ווילסון," אמר ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה.
"טבליות trientine hydrochloride נכללו בפרסום האחרון של ה- FDA בנוגע לרשימה של מוצרים אשר אינם מוגני פטנט אך משווקים כגרסאות מקור ללא גנריקה מאושרת," אמרה הפרון פרידריקסדוטיר, סמנכ"לית בכירה, מנהלת המו"פ הגלובלי. "טבע הגישה את הבקשה המקוצרת לאישור תרופה (ANDA) לפני יותר משנתיים ואנו מרוצים שה- FDA אישר כעת את הבקשה שלנו, וכעת אנו יכולים להציע חלופה גנרית זולה יותר למטופלים. אנו מצפים להמשך עבודה הדוקה עם ה- FDA לבחינת הבקשות הרבות הנוספות שלנו."
עם קרוב ל-600 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.
המכירות השנתיות של trientine hydrochloride בארה"ב עמדו על כ-155 מיליון דולר, על פי נתוני ה-IMS נכון לנובמבר 2017.
About Trientine Hydrochloride Capsules
Trientine hydrochloride capsules are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Clinical experience with trientine hydrochloride is limited and alternate dosing regimens have not been well-characterized; all endpoints in determining an individual patient's dose have not been well defined. Trientine hydrochloride and penicillamine cannot be considered interchangeable. Trientine hydrochloride should be used when continued treatment with penicillamine is no longer possible because of intolerable or life endangering side effects.
Unlike penicillamine, trientine hydrochloride is not recommended in cystinuria or rheumatoid arthritis. The absence of a sulfhydryl moiety renders it incapable of binding cystine and, therefore, it is of no use in cystinuria. In 15 patients with rheumatoid arthritis, trientine hydrochloride was reported not to be effective in improving any clinical or biochemical parameter after 12 weeks of treatment. Trientine hydrochloride is not indicated for treatment of biliary cirrhosis.
Important Safety Information
Trientine hydrochloride capsules are contraindicated in patients with hypersensitivity to this product. Patients should be observed closely for signs of possible hypersensitivity. There have been reports of asthma, bronchitis and dermatitis occurring after prolonged environmental exposure with other uses of trientine hydrochloride.
Patient experience with trientine hydrochloride is limited. Patients receiving trientine hydrochloride capsules should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia. Trientine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus. In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis. The following adverse reactions have been reported in a clinical study for another use of trientine hydrochloride capsules: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis.
For more information, please see accompanying Full Prescribing Information.
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:
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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;
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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;
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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;
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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;
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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;
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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;
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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.