טבע תעשיות פרמצבטיות בע"מ(NYSE and TASE: TEVA) הודיעה היום על השקת גרסה גנרית מאושרת של משחת ®Estrace (משחת estradiol וגינאלית, USP, 0.01%), בארה"ב.
ירושלים, 2 בינואר, 2018– טבע תעשיות פרמצבטיות בע"מ(NYSE and TASE: TEVA) הודיעה היום על השקת גרסה גנרית מאושרת של משחת ®Estrace (משחת estradiol וגינאלית, USP, 0.01%), בארה"ב.
משחת estradiol וגינאלית, USP, 0.01% מותווית לטיפול בסימפטומים בינוניים עד חריפים של אטרופיה נרתיקית הנגרמת בשל הפסקת וסת. השקה זו היא תוספת חשובה לפורטפוליו מוצרי בריאות האישה הגנרי של טבע ולשורת הטיפולים הצומחת של טבע להפסקת וסת.
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 משחת estradiol וגינאלית, USP, 0.01% בארה"ב עמדו על כ-426 מיליון דולר, על פי נתוני ה-IMS נכון לאוגוסט 2017.
INDICATIONS AND USAGE
Estradiol Vaginal Cream, USP is indicated in the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
Estradiol Vaginal Cream, USP should not be used in: women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or a history of these conditions; active arterial thromboembolic disease (for example, stroke, myocardial infarction) or a history of these conditions; known anaphylactic reaction or angioedema to Estradiol Vaginal Cream, USP; liver dysfunction or disease; thrombophilic disorders; known or suspected pregnancy.
Estrogens increase the risk of gallbladder disease. Discontinue estrogen if hypercalcemia, sudden partial or complete loss of vision, hypertriglyceridemia, or cholestatic jaundice occurs. Patients dependent on thyroid hormone replacement therapy should have their thyroid function monitored in order to maintain their free thyroid hormone levels in an acceptable range. Endometriosis may be exacerbated in women treated post-hysterectomy with estrogen-alone therapy. The addition of progestins should be considered in these patients.
The most common side effects include: headache, breast tenderness, irregular vaginal bleeding or spotting, stomach/abdominal cramps, bloating, nausea and vomiting, hair loss, and vaginal burning, irritation, and itching. Systemic absorption may occur with the use of Estradiol Vaginal Cream, USP. The warnings, precautions, and adverse reactions associated with oral estrogen treatment should be taken into account.
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:
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.