טבע מודיעה על השקה בלעדית של גרסה גנרית בשני מינונים ל- ®Solodyn בארה"ב
טבע תעשיות פרמצבטיות בע"מ(NYSE and TASE: TEVA) הודיעה היום על השקה בלעדית של גרסה גנרית בשני מינונים של ®Solodyn , טבליות בשחרור מושהה במינון 65 ו-115 מ"ג בארה"ב.
ירושלים, 20 בפברואר, 2018– טבע תעשיות פרמצבטיות בע"מ(NYSE and TASE: TEVA) הודיעה היום על השקה בלעדית של גרסה גנרית בשני מינונים של ®(minocycline HCl) Solodyn , טבליות בשחרור מושהה במינון 65 ו-115 מ"ג בארה"ב.
טבליות Minocycline Hydrochloride בשחרור מושהה הן תרופות מסוג טטרציקלין המותוות לטיפול רק בחבורות lesions) דלקתיות הנובעות מ- non-nodular moderate to severe acne vulgaris במטופלים מגיל 12 ומעלה.
"ההשקה של שני מינונים אלו עבור הגרסה הגנרית שלנו ל- ®Solodyn מביאה אפשרות טיפול יעילה וברת השגה למטופלים המתמודדים עם תופעה זו, והינה התרופה הגנרית התשיעית שלנו בקטגוריית טטרציקלין ," אמר ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה.
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 ®Solodyn בשחרור מושהה במינונים 65 ו- 115 מ"ג בארה"ב עמדו על כ-148 מיליון דולר, על פי נתוני ה-IMS נכון לדצמבר 2017.
About Minocycline Hydrochloride Extended-Release Tablets
Minocycline Hydrochloride Extended-Release Tablets are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Limitations of Use: Minocycline Hydrochloride Extended-Release Tablets did not demonstrate any effect on non-inflammatory acne lesions. Safety of Minocycline Hydrochloride Extended-Release Tablets has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Minocycline Hydrochloride Extended-Release Tablets should be used only as indicated.
Important Safety Information
Minocycline Hydrochloride Extended-Release Tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
MINOCYCLINE, LIKE OTHER TETRACYCLINE-CLASS DRUGS, CAN CAUSE FETAL HARM WHEN ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED DURING PREGNANCY OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD TO THE FETUS. Minocycline Hydrochloride Extended-Release Tablets should not be used during pregnancy or by individuals of either gender who are attempting to conceive a child.
TETRACYCLINE-CLASS DRUGS SHOULD NOT BE USED DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY AND UP TO 8 YEARS OF AGE) AS THEY MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH.
Other serious adverse reactions reported with minocycline use or associated with the use of tetracycline-class drugs include pseudomembranous colitis; hepatotoxicity; excessive systemic accumulation of drug and possible liver toxicity in patients with renal impairment; central nervous system effects, including light-headedness, dizziness or vertigo; pseudotumor cerebri (benign intracranial hypertension); autoimmune syndromes; photosensitivity; anaphylaxis, serious skin reactions (e.g., Stevens Johnson syndrome), erythema multiforme, and drug rash with eosinophilia and systemic symptoms (DRESS) syndrome; tissue hyperpigmentation; development of drug-resistant bacteria; and superinfection.
In clinical trials, the most commonly observed adverse reactions (incidence ≥ 5%) were headache, fatigue, dizziness, and pruritus.
For more information, please see accompanying Full Prescribing Information.
אודות טבע
טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה המשמשים מיליוני מטופלים 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 עמדת הובלה בפיתוח טיפולים חדשניים למחלות של מערכת העצבים המרכזית, כולל כאב, 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 2017 הסתכמו ב-22.4$ 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.