טבע תציג נתונים חדשים בתחום מערכת הנשימה בכנס בינלאומי

הנתונים בנוגע לאבקת האינהלציה ProAir® RespiClick   יוצגו בכנס הבינלאומי לשנת 2015 של האגודה האמריקאית למחלות בית החזה

14 מאי 2015

ירושלים, 15 במאי 2015 - טבע תעשיות פרמצבטיות בע"מ (NYSE: TEVA) הודיעה היום כי שלושה תקצירים של מחקרים שמומנו על ידי החברה יוצגו בכנס הבינלאומי השנתי לשנת 2015 של האגודה האמריקאית למחלות בית החזה (ATS) הנערך ב-15-19 במאי 2015 בדנוור, קולורדו.


הנתונים שיוצגו כוללים מחקר שלב 3 הבודק את הפונקציונליות, המהימנות, הדיוק ושביעות הרצון הכללית של המטופלים מאבקת האינהלציה ProAir® RespiClick (Albuterol Sulfate), שקיבלה את אישור מנהל המזון והתרופות האמריקאי (FDA) במרץ 2015. ProAir® RespiClick זמין כעת במרשם ומותווה לטיפול או למניעה של ברונכוספאזם (עווית סימפונות) הנלווה למחלת ריאות חסימתית הפיכה ולמניעת ברונכוספאזם בעקבות מאמץ בקרב מטופלים בגיל 12 ומעלה.


נתונים נוספים של מחקר שלב 3 שיוצגו בכנס כוללים תקציר עדכני, המציג ניתוח ביניים של היעילות והבטיחות לטווח ארוך של התרופה הניסיונית של טבע נגד אינטרלוקין 5 (anti-IL-5), Reslizumab, לטיפול בחולים הסובלים מאסתמה ורמה גבוהה של אאוזינופילים בדם. תקציר שלישי שיוצג כולל נתונים ממחקר על מינונים שונים של משאף אבקה יבשה רב-מינון Fluticasone Propionate (MDPI) בקרב מתבגרים ומבוגרים הסובלים מאסתמה.


"כנס ATS הבינלאומי לשנת 2015 מעניק לטבע פלטפורמה מדעית להצגת ממצאים לגבי שלושה טיפולים חדשים או ניסיוניים שלנו לאסתמה", אמר ד"ר טושאר שאה, סמנכ"ל בכיר, מחקר ופיתוח נשימתי גלובלי בטבע. "ממצאי המחקרים מראים את ההתקדמות המשמעותית שהשגנו בהרחבת פורטפוליו המוצרים בתחום מערכת הנשימה, על ידי פיתוח אפשרויות טיפול חדשות המתמקדות בצרכים של מטופלים שאינם זוכים למענה".


הנתונים הבאים יוצגו במהלך הצגות פוסטרים ביום שלישי, ה-19 במאי 2015:


ProAir® RespiClick (albuterol sulfate) Inhalation Powder

  • #P308: A Prospective, Open-Label Study of a New Albuterol Multidose Dry Powder Inhaler With Integrated Dose Counter
    • This abstract will be presented from 11:30 AM to 1:15 PM in Area C, Hall A-B at the Colorado Convention Center.


Fluticasone Propionate MDPI

  • #P258: Dose-Ranging Study of a Fluticasone Propionate Multidose Dry Powder Inhaler in Adolescents and Adults With Asthma Uncontrolled by Noncorticosteroid Asthma Medications
    • This abstract will be presented from 11:30 AM to 1:15 PM in Area C, Hall A-B at the Colorado Convention Center.



  • #1025: Long-Term Safety and Efficacy of Reslizumab in Patients with Inadequately Controlled, Moderate-to-Severe Asthma and Elevated Blood Eosinophil Counts: An Open-Label Extension Study.
    • This late-breaking abstract will be presented from 2:15 to 4:15 PM in the Capitol Ballroom at the Hyatt Regency Denver at the Colorado Convention Center.


אודות ProAir® RespiClick

אבקת האינהלציה ProAir® RespiClick (Albuterol Sulfate) מותווית לשימוש במטופלים בגיל 12 ומעלה, לטיפול או למניעה של ברונכוספאזם הנלווה למחלת ריאות חסימתית הפיכה ולמניעת ברונכוספאזם בעקבות מאמץ.


Important Safety Information

  • Do not use ProAir® RespiClick (albuterol sulfate) Inhalation Powder if you are allergic to albuterol sulfate, lactose, or milk proteins. Report any red, itchy bumps on your skin, swelling around the lips or eyes, or rash to your healthcare professional.
  • If your symptoms become significantly worse when you use ProAir® RespiClick, seek medical attention immediately. This may indicate either a worsening of your asthma or a reaction to the medication. Either of these could be life-threatening.
  • Do not increase your dose or take extra doses of ProAir® RespiClick without first talking to your healthcare professional.
  • Before using ProAir® RespiClick, be sure to tell your healthcare professional if you have a heart, blood, thyroid or seizure disorder, high blood pressure, diabetes, are pregnant or planning to become pregnant, or are breastfeeding or planning to breastfeed.
  • ProAir® RespiClick can cause significant heart-related side effects, such as an increase in pulse, blood pressure and/or related symptoms. If you have a heart condition, your healthcare professional will determine if ProAir® RespiClick is right for you.
  • Make sure your healthcare professional knows all the medicines you are taking – especially other inhaled medicines, other asthma medicines, heart and blood pressure medicines and drugs that treat depression – because some medicines may interfere with how well your asthma medicines work.
  • Common side effects in patients taking ProAir® RespiClick include back pain, body aches and pains, upset stomach, sinus headache, and urinary tract infection.


Please click here for Full Prescribing Information

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 innovative products, especially Copaxone® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents) and our ability to migrate users to our 40 mg/mL version; 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; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; 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. 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 statement, whether as a result of new information, future events or otherwise.


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