טבע מודיעה על השקת הגרסה הגנרית של ®VAGIFEM בארה"ב
טבע תעשיות פרמצבטיות בע"מ הודיעה היום על השקת הגרסה הגנרית של ®Vagifem, במינון 10 מק"ג בארה"ב.
ירושלים, 24 ביולי, 2017– טבע תעשיות פרמצבטיות בע"מ(NYSE: TEVA) הודיעה היום על השקת הגרסה הגנרית של ®Vagifem (התקן estradiol תוך-נרתיקי), במינון 10 מק"ג בארה"ב.
התקן estradiol תוך-נרתיקי הוא אסטרוגן המותווה לטיפול באטרופיה נרתיקית הנגרמת בשל הפסקת וסת.
"הפורטפוליו המתרחב של אמצעי מניעה אוראליים וטיפולים הורמונליים תחליפיים שלנו מעניק לנשים אפשרות רחבה יותר לניהול צרכי הבריאות שלהם באופן כלכלי מושכל," אמר אנדי בוייר, נשיא ומנכ"ל קבוצת הגנריקה הגלובלית של טבע בצפון אמריקה. "באמצעות המוצר, מטופלים ונותני שירותי בריאות המעדיפים את אופן מתן התרופה הייחודי הזה יזכו לאופציית טיפול נוספת וברת השגה."
התקן estradiol תוך-נרתיקי מתווסף לפורטפוליו של יותר מ-70 מוצרים בבריאות האישה של טבע. 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 6 מרשמים גנריים הניתנים בארה"ב הוא למוצר של טבע.
המכירות השנתיות של ®Vagifem בארה"ב עמדו על כ-379 מיליון דולר, על פי נתוני ה-IMS נכון למאי 2017.
About Estradiol Vaginal Inserts
Estradiol vaginal inserts are indicated for the treatment of atrophic vaginitis due to menopause.
Important Safety Information
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA. There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke and deep vein thrombosis (DVT) and increased risk of probable dementia in postmenopausal women 65 years of age and older have been reported with estrogen-alone therapy.
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. Increased risks of stroke, DVT, pulmonary embolism (PE), myocardial infarction (MI), and invasive breast cancer and an increased risk of probable dementia in postmenopausal women 65 years of age and older have been reported with estrogen plus progestin therapy. Estradiol should not be used in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease (for example, stroke, and myocardial infarction), or a history of these conditions; known anaphylactic reaction or angioedema to estradiol; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; or known or suspected pregnancy. Systemic absorption occurs with the use of estradiol. The warnings, precautions, and adverse reactions associated with the use of systemic estrogen-alone therapy should be taken into account. Other serious adverse reactions associated with estrogen administration include: increased risk of gallbladder disease; severe hypercalcemia in women with breast cancer and bone metastases; retinal vascular thrombosis; elevated blood pressure; hypertriglyceridemia; increased thyroid-binding globulin (TBG) levels; fluid retention; and hypocalcemia. Estrogen administration may exacerbate: endometriosis, symptoms of angioedema in women with hereditary angioedema, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. A few cases of local abrasion induced by the estradiol applicator have been reported, especially in women with severely atrophic vaginal mucosa. In prospective, randomized, placebo-controlled, double-blind studies the most common adverse reactions (incidence ≥ 5 percent) were upper respiratory tract infection, headache, abdominal pain, back pain, genital pruritus, moniliasis, vulvovaginal mycotic infection and diarrhea.
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 ב-100 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.