טבע מודיעה על השקת גרסה גנרית ל- ®Uceris בארה"ב

טבע תעשיות פרמצבטיות בע"מ (NYSE and TASE: TEVA)  הודיעה היום על השקת  הגרסה הגנרית של ®Uceris, טבליות בשחרור מושהה במינון 9 מ"ג, בארה"ב. 

9 יול 2018 | זמן קריאה ממוצע: 3 דקות

ירושלים, 9 ביולי, 2018 – טבע תעשיות פרמצבטיות בע"מ(NYSE and TASE: TEVA)  הודיעה היום על השקת  הגרסה הגנרית של ®budesonide) Uceris), טבליות בשחרור מושהה במינון 9 מ"ג, בארה"ב. 

טבליות budesonide בשחרור מושהה הן גלוקוקורטיקוסטרואיד המותווה לגרימת נסיגה בקרב מטופלים הסובלים מקוליטיס כיבית (ulcerative colitis) קלה עד בינונית. 

"ההשקה של טבליות budesonide בשחרור מושהה מהווה תוספת חשובה לפורטפיליו הגנרי של טבע," אמר ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה. "אנחנו ממשיכים להתמקד בהבאת טיפולים גנריים ברי השגה עבור המטופלים שלנו, כולל אלו החיים עם תופעות כרוניות המלוות אותם לכל חייהם, כמו קוליטיס כיבית." 

עם קרוב ל-550 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 בארה"ב של ®Uceris עמדו על כ-196 מיליון דולר, על פי נתוני ה-IMS נכון למאי 2018.

 About Budesonide Extended-Release Tablets

Budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

 

Important Safety Information

Budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. Anaphylactic reactions have occurred with other budesonide formulations.

When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. Since budesonide extended-release tablets are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.

 Care is needed in patients who are transferred from glucocorticosteroid treatment with higher systemic effects to glucocorticosteroids with lower systemic effects, such as budesonide extended-release tablets, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop.

Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of glucocorticosteroids. In patients who have not had these diseases, particular care should be taken to avoid exposure.  Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections. 

Reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis.  Caution should be taken in patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where glucocorticosteroids may have unwanted effects.

The most common adverse reactions (≥ 2%) in clinical trials were headache, nausea, decreased blood cortisol, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, and constipation.

 

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

January 1st 0001 | Reading time: 4 Min

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding Teva's generic version of Uceris®, 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:

  • The uncertainty of the commercial success of our generic version of budesonide, including due to a potential launch of an Authorized Generic version;
  • our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; 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 products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; 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 further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
  • our business and operations in general, including: failure to effectively execute the restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; 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; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
  • 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; governmental investigations into sales and marketing practices; potential liability for patent infringement; 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; potential impairments of our intangible assets; potential 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 10-K for the year ended December 31, 2017, 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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