טבע מודיעה על השקת הגרסה הגנרית של ®Depo-Provera בארה"ב
טבע תעשיות פרמצבטיות בע"מ(NYSE: TEVA) הודיעה היום על החזרה לשוק של הגרסה הגנרית של®Depo-Provera , אמצעי מניעה מוזרק (medroxyprogesterone acetate injectable suspension, USP) במינון 150 מ"ג/מ"ל בארה"ב
ירושלים, 25 בספטמבר, 2017 – טבע תעשיות פרמצבטיות בע"מ(NYSE: TEVA) הודיעה היום על החזרה לשוק של הגרסה הגנרית של®Depo-Provera , אמצעי מניעה מוזרק (medroxyprogesterone acetate injectable suspension, USP) במינון 150 מ"ג/מ"ל בארה"ב. Medroxyprogesterone acetate injectable suspension הוא פרוגסטין המותווה רק למניעת הריון.
"ההחזרה הזו לשוק מביאה מוצר נוסף לשוק אשר עד עכשיו אופיין בהיעדר אופציות," אמרה ד"ר הפרון פרידריקסדוטיר, סמנכ"לית בכירה ונשיאת המו"פ הגנרי בטבע. "נוסף על החשיבות למטופלים אשר ייהנו מגישה לתרופה זו, החזרתה לשוק הינה בעלת חשיבות משמעותית לטבע ולעדיפויות המו"פ הגנרי שלנו."
טבע מחויבת לחיזוק עסק המוצרים המוזרקים הגלובלי שלה על ידי המשך השקעות במוצרים מוזרקים חדשים יותר ובעלי ערך רב יותר. 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 medroxyprogesterone acetate injectable suspension, USP במינון 150 מ"ג/מ"ל בארה"ב עמדו על כ-211 מיליון דולר, על פי נתוני ה-IMS נכון ליולי 2017.
About Medroxyprogesterone Acetate Injectable Suspension, USP
Medroxyprogesterone acetate injectable suspension is indicated only for the prevention of pregnancy. The loss of bone mineral density (BMD) in women of all ages and the impact on peak bone mass in adolescents should be considered, along with the decrease in BMD that occurs during pregnancy and/or lactation, in the risk/benefit assessment for women who use medroxyprogesterone acetate injectable suspension long-term.
Important Safety Information
Women who use medroxyprogesterone acetate injectable suspension may lose significant bone mineral density. Bone loss is greater with increasing duration of use and may not be completely reversible. Medroxyprogesterone acetate injectable suspension should not be used as a long-term birth control method (i.e., longer than 2 years) unless other birth control methods are considered inadequate.
The use of medroxyprogesterone acetate injectable suspension is contraindicated in the following conditions: known or suspected pregnancy or as a diagnostic test for pregnancy; active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease; known or suspected malignancy of breast; known hypersensitivity to medroxyprogesterone acetate injectable suspension or any of its other ingredients; significant liver disease; or undiagnosed vaginal bleeding. Studies have shown an increased risk of breast cancer in women using medroxyprogesterone acetate injectable suspension. Serious thrombotic events; anaphylaxis and anaphylactoid reaction; injection site reactions; convulsions; weight gain; and decreased glucose tolerance have been reported with the use of medroxyprogesterone acetate injectable suspension. In clinical trials the most common adverse reactions (incidence > 5%) were: menstrual irregularities (bleeding or spotting), abdominal pain/discomfort, dizziness, headache, nervousness, and decreased libido. Medroxyprogesterone acetate injectable suspension does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
For more information, please see accompanying Full Prescribing Information, including Boxed Warning.
אודות טבע
טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה המשמשים כ-200 מיליוני מטופלים ביותר מ-60 שווקים מדי יום. טבע, שבסיסה בישראל, היא יצרנית התרופות הגנריות הגדולה בעולם, הממנפת את צבר מוצריה הכולל יותר מ-1,800 מולקולות לייצור מגוון רחב של מוצרים גנריים ברוב התחומים הטיפוליים. בתחום התרופות הייחודיות, לטבע יש את הטיפול החדשני המוביל בעולם לטיפול בטרשת נפוצה וכן תכניות מחקר מתקדמות למחלות אחרות של מערכת העצבים המרכזית, כולל הפרעות תנועה, מיגרנה, כאב ותופעות ניווניות, וכן פורטפוליו מוצרים רחב בתחום הנשימה. טבע ממנפת את יכולותיה בגנריקה ובתרופות הייחודיות במטרה לחפש דרכים חדשות לענות על צרכי המטופלים, וזאת על ידי שילוב פיתוח תרופות יחד עם פיתוח תכשירים, שירותים וטכנולוגיות. הכנסות טבע בשנת 2016 הסתכמו ב-21.9$ מיליארד. למידע נוסף על החברה, בקרו באתר www.tevapharm.com.
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.