טבע מודיעה על השקת הגירסה הגנרית ל- ™ALYQ, גירסה גנרית של ®ADCIRCA בארה"ב

 הוא חוסם phosphodiesterase 5 המותווה לטיפול ביתר לחץ דם ריאתי (קטגוריה מספר 1 של ארגון הבריאות העולמי), במטרה לשפר את יכולת הפעילות הגופנית.

ירושלים, 5 בפברואר 2019 – טבע תעשיות פרמצבטיות בע"מ  (NYSE and TASE: TEVA)  הודיעה היום על השקת ™ALYQ, הגירסה הגנרית ל- (ADCIRCA®[1](tadalafil, טבליות 20 מ"ג, בארה"ב.

™ ALYQ הוא חוסם (phosphodiesterase 5 (PDE5 המותווה לטיפול ביתר לחץ דם ריאתי (קטגוריה מספר 1 של ארגון הבריאות העולמי), במטרה לשפר את יכולת הפעילות הגופנית.

ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה, אמר, "השקה זו מהווה תוספת חשובה לפורטפוליו הגנרי שלנו הנוגע במחלות מורכבות ואנו גאים להציע אופציית טיפול בר השגה למחלה נדירה זו."

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.

לטבליות ®SABRIL היו מכירות שנתיות של 490 מיליון דולר בארה"ב, נכון לנובמבר 2018, על פי נתוני IQVIA.

About ALYQ™

ALYQ™ is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Studies establishing effectiveness included predominately patients with NYHA Functional Class II – III symptoms and etiologies of idiopathic or heritable PAH (61%) or PAH associated with connective tissue diseases (23%).

IMPORTANT SAFETY INFORMATION

Do not use ALYQ™ in patients who are using any form of organic nitrate, either regularly or intermittently. ALYQ™ potentiates the hypotensive effect of nitrates. Do not use ALYQ™ in patients who are using a guanylate cyclase (GC) stimulator, such as riociguat. ALYQ™ may potentiate the hypotensive effects of GC stimulators.  ALYQ™ is contraindicated in patients with a known serious hypersensitivity to tadalafil. Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis.

Patients who experience anginal chest pain after taking ALYQ™ should seek immediate medical attention.  PDE5 inhibitors, including tadalafil, have mild systemic vasodilatory properties that may result in transient decreases in blood pressure.  Patients with severely impaired autonomic control of blood pressure or with left ventricular outflow obstruction may be particularly sensitive to the actions of vasodilators, including PDE5 inhibitors. Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD).

PDE5 inhibitors, including ALYQ™, and alpha-adrenergic blocking agents are vasodilators with blood pressure-lowering effects. When vasodilators are used in combination, an additive effect on blood pressure may be anticipated. Safety of combined use of PDE5 inhibitors and alpha blockers may be affected by other variables, including intravascular volume depletion and use of other antihypertensive drugs.  Both alcohol and tadalafil are mild vasodilators. When mild vasodilators are taken in combination, blood pressure-lowering effects are increased.

Use of ALYQ™ in patients taking ritonavir requires dosage adjustment.  Avoid use of ALYQ™ in patients taking potent inhibitors of CYP3A such as ketoconazole and itraconazole, and in patients chronically taking potent inducers of CYP3A, such as rifampin.  A lower starting dose of ALYQ™ should be used in patients with mild or moderate renal or hepatic impairment.  Avoid use of ALYQ™ in patients with severe renal or hepatic impairment.

Patients should seek immediate medical attention in the event of a sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision.  Patients should seek immediate medical attention in the event of sudden decrease or loss of hearing.

Tadalafil is also marketed as CIALIS®[2]. The safety and efficacy of taking ALYQ™ together with CIALIS® or other PDE5 inhibitors have not been studied.  Patients taking ALYQ™ should not take CIALIS® or other PDE5 inhibitors.  There have been rare reports of prolonged erections greater than 4 hours and priapism for this class of compounds.  Patients who have an erection lasting greater than 4 hours, whether painful or not, should seek emergency medical attention.

In a placebo-controlled clinical study, the most common adverse events (reported by ≥9% of patients in the tadalafil tablets 40 mg group and more frequent than placebo by 2%) were: headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, extremity pain, nausea, back pain, dyspepsia, and nasal congestion.

For more information, please see accompanying Full Prescribing Information. A copy may be requested from Teva US Medical Information at 888-TEVA-USA (888-838-2872) or 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 45,000 עובדים המחויבים לאפשר לשפר את חייהם של מיליוני מטופלים. למידע נוסף על החברה, בקרו באתר www.Teva.co.il

[1] ADCIRCA® is a registered trademark of Eli Lilly and Company.

[2] CIALIS® is a registered trademark of Eli Lilly and Company.

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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