אוקטובר 13, 2016 חזור »

טבע מודיעה על השקת הגרסה הגנרית של BEYAZ® בארצות הברית

ירושלים, 12 באוקטובר 2016 – טבע תעשיות פרמצבטיות בע"מ (NYSE ו-TASE: TEVA) הודיעה היום על ההשקה של RAJANITM (drospirenone, ethinyl estradiol, טבליות סידן levomefolate במינון , 3 mg/0.02 mg/0.451 mg וטבליות סידן levomefolateבמינון 0.451 mg) בארה"ב. RAJANITM, הגרסה הגנרית של Beyaz® , היא אמצעי מניעה אורלי הנמסר באריזת חלוקה של 28 ימים, לשימוש על ידי נשים לצורך:


  • מניעת הריון;
  • טיפול בסימפטומים של הפרעה דיספורית קדם וסתית (PMDD) בקרב נשים הנוטלות אמצעי מניעה אורליים;
  • טיפול באקנה מתון בקרב נשים מגיל 14 הנוטלות אמצעי מניעה אורליים; ו-
  • העלאת רמות חומצה פולית בקרב נשים הנוטלות אמצעי מניעה אורליים.

טבע ממשיכה במחויבותה לחיזוק העסק הגנרי שלה עם השקעה מתמשכת בתרופות גנריות חדשות ובאיכות גבוהה. עם קרוב ל- 600 תרופות גנריות זמינות, לטבע יש את פורטפוליו המוצרים הגנריים מאושרי FDA הגדול בשוק. מוצר זה מחזק עוד יותר את הפורטפוליו החזק כבר עתה של טבע בתחום אמצעי המניעה.

נכון להיום, לטבע יש יותר מ-300 בקשות לרישום מוצר הממתינות לאישור ה-FDA, והיא נמצאת בעמדה מובילה מבחינת הזדמנויות הגשה ראשונה (first to file), עם יותר מ-100 הגשות ראשונות הממתינות לאישור בארה"ב. כיום, 1 מכל 6 מרשמים לתרופות גנריות הניתנים בארה"ב הוא למוצר גנרי של טבע.

המכירות השנתיות שלBeyaz® בארה"ב עמדו על כ-133 מיליון דולר, על פי נתוני ה-IMS נכון ליולי 2016.

אודות RAJANITM

RAJANITM is indicated for use by women to prevent pregnancy. RAJANITM does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

RAJANITM is indicated for the treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive as their method of contraception. The effectiveness of RAJANITM for PMDD when used for more than three menstrual cycles has not been evaluated. Diagnosis is made by healthcare providers according to DSM-IV criteria, with symptomatology assessed prospectively over at least two menstrual cycles. In making the diagnosis, care should be taken to rule out other cyclical mood disorders. RAJANITM has not been evaluated for the treatment of premenstrual syndrome (PMS).

RAJANITM is indicated for the treatment of moderate acne vulgaris in women at least 14 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. RAJANITM should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control.

RAJANITM is indicated in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

Important Safety Information WARNING: Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

RAJANITM is contraindicated in women who are known to have the following: renal impairment; adrenal insufficiency; a high risk of arterial or venous thrombotic diseases; undiagnosed abnormal uterine bleeding; breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past; liver tumors, benign or malignant, or liver disease; or pregnancy.

COCs may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing the progestin levonorgestrel or some other progestins. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. RAJANITM contains 3 mg of the progestin DRSP, which has antimineralocorticoid activity, including the potential for hyperkalemia in high-risk patients. Other serious adverse reactions associated with the use of COCs include: carcinoma of breast or cervix; impaired liver function or liver tumors; hypertension; gallbladder disease; carbohydrate and lipid metabolic effects; new or worsening headaches, including migraines; bleeding irregularities; depression; elevations of binding globulins; angioedema; and chloasma.

The most frequent adverse reactions (greater than or equal to 2%) in contraception, acne and folate clinical trials are headache/migraine (5.9%), menstrual irregularities (4.1%), nausea/vomiting (3.5%) and breast pain/tenderness (3.2%).

The most frequent adverse reactions (greater than or equal to 2%) in PMDD clinical trials are menstrual irregularities (24.9%), nausea (15.8%), headache (13.0%), breast tenderness (10.5%), fatigue (4.2%), irritability (2.8%), decreased libido (2.8%), increased weight (2.5%), and affect lability (2.1%).

For more information, please see accompanying full Prescribing Information, including the boxed warnings.

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה למיליוני מטופלים מדי יום. טבע, שבסיסה בישראל, היא יצרנית התרופות הגנריות הגדולה בעולם, הממנפת את צבר מוצריה הכולל יותר מ-1000 מולקולות לייצר מגוון רחב של מוצרים גנריים בכמעט כל התחומים הטיפוליים. בתחום התרופות הייחודיות, טבע הינה חברה מובילה בטיפולים חדשניים למחלות מערכת העצבים המרכזית, כולל כאב, ומחזיקה גם בצבר מוצרים חזק בתחום מחלות הנשימה. טבע משלבת את כישוריה בתחום התרופות הגנריות ובתחום התרופות הייחודיות בחטיבת המחקר והפיתוח הגלובלית שלה, במטרה ליצור דרכים חדשות לענות על צרכי המטופלים וזאת על ידי שילוב יכולות בתחום פיתוח תרופות יחד עם פיתוח תכשירים, שירותים וטכנולוגיות. הכנסות טבע בשנת 2014 הסתכמו ב-20.3$ מיליארד. למידע נוסף על החברה, בקרו באתר www.tevapharm.com.

Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our specialty products, especially Copaxone® (including competition from orally-administered alternatives, as well as from generic equivalents such as the recently launched Sandoz product) and our ability to continue to migrate users to our 40 mg/mL version and maintain patients on that version; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities (such as our pending acquisitions of Allergan’s generic business and Rimsa), or to consummate and integrate acquisitions; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; 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; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2014 and in our other filings with the U.S. Securities and Exchange Commission.