טבע מודיעה על השקת הגרסה הגנרית של AndroGel® (ג'ל טסטוסטרון) 1.62% בארה"ב

ג'ל טסטוסטרון 1.62% CIII מותווה כטיפול תחליפי עבור גברים בוגרים לתופעות הקשורות בחוסר או היעדר של טסטוסטרון אנדוגני: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism.

ירושלים, 11 באפריל 2019 – טבע תעשיות פרמצבטיות בע"מ (NYSE and TASE: TEVA) הודיעה היום על השקת הגרסה הגנרית של ®AndroGel (ג'ל טסטוסטרון) 1.62% CIII, בארה"ב.

ג'ל טסטוסטרון 1.62% CIII מותווה כטיפול תחליפי עבור גברים בוגרים לתופעות הקשורות בחוסר או היעדר של טסטוסטרון אנדוגני: primary hypogonadism (congenital or acquired), and hypogonadotropic hypogonadism.

עם קרוב ל-500 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 8 מרשמים גנריים הניתנים בארה"ב הוא למוצר של טבע.

®AndroGel רשם מכירות שנתיות בהיקף של 911 מיליון דולר בארה"ב, על פי נתוני IQVIA, נכון לפברואר 2019.

About Testosterone Gel 1.62% CIII

Testosterone gel 1.62% is indicated for replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone:

Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range.

Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum concentrations, but have gonadotropins in the normal or low range.

Limitations of use: Safety and efficacy of testosterone gel 1.62% in men with “age-related hypogonadism” (also referred to as “late-onset hypogonadism”) have not been established. Safety and efficacy of testosterone gel 1.62% in males less than 18 years old have not been established. Topical testosterone products may have different doses, strengths, or application instructions that may result in different systemic exposure.

Due to the lack of controlled evaluations in women and potential virilizing effects, testosterone gel 1.62% is not indicated for use in women.

IMPORTANT SAFETY INFORMATION

WARNING: Secondary Exposure to Testosterone. Virilization has been reported in children who were secondarily exposed to testosterone gel. Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. Healthcare providers should advise patients to strictly adhere to recommended instructions for use.

Testosterone gel 1.62% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate. Testosterone gel 1.62% is contraindicated in women who are or may become pregnant, or who are breastfeeding. Testosterone gel 1.62% may cause fetal harm when administered to a pregnant woman. Testosterone gel 1.62% may cause serious adverse reactions in nursing infants. Exposure of a fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of testosterone from men treated with testosterone gel 1.62%. If a pregnant woman is exposed to testosterone gel 1.62%, she should be apprised of the potential hazard to the fetus.

Other serious risks include: worsening of benign prostatic hyperplasia, potential risk of prostate cancer, polycythemia, venous thromboembolism, cardiovascular risk, potential for adverse effects on spermatogenesis, hepatic adverse effects, edema, gynecomastia, sleep apnea, changes in serum lipid profile, hypercalcemia, and decreased thyroxine-binding globulin.

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions.

Alcohol based products, including testosterone gel 1.62%, are flammable; therefore, patients should be advised to avoid fire, flame or smoking until the testosterone gel 1.62% has dried.

In clinical trials, the most common adverse reaction (incidence greater than or equal to 5%) was an increase in prostate specific antigen (PSA).

For more information, please see accompanying Full Prescribing Information, including Boxed Warning. A copy may be requested from Teva U.S. Medical Information at 888-TEVA-USA (888-838-2872), druginfo@tevapharm.com, or Teva’s Public Relations or Investor Relations contacts.

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא מובילה עולמית בגנריקה, עם טיפולים חדשניים בתחומים נבחרים, כולל מערכת העצבים המרכזית, כאב ונשימה. אנו מספקים תרופות גנריות באיכות גבוהה בכמעט כל תחום טיפולי בכדי להתמודד עם צרכי מטופלים אשר אינם זוכים למענה. יש לנו נוכחות מבוססת בגנריקה, תרופות מקור, תרופות ללא מרשם וייצור חומרים כימיים פעילים, ובונים על גבי מורשת בת יותר מ-115 שנה עם מערך מו"פ מאוחד, בסיס תפעולי חזק ותשתית גלובלית נרחבת. אנו חותרים לפעול באופן אחראי ברמה החברתית והסביבתית. המטה שלנו ממוקם בישראל, יש לנו מתקני ייצור ומחקר בכל העולם, ואנו מעסיקים כ- 43,000 עובדים המחויבים לאפשר לשפר את חייהם של מיליוני מטופלים. למידע נוסף על החברה, בקרו באתר www.Teva.co.il

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:

  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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;
  • 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. 

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