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טבע מדווחת על תוצאות ראשונות מניסויים בשלב 3 של Reslizumab

טבע מדווחת על תוצאות ראשונות מניסויים בשלב 3 של Reslizumab במתן תת עורי למטופלים הסובלים מאסטמה אאוזנופילית חריפה

ירושלים, 22 בינואר, 2018– טבע תעשיות פרמצבטיות בע"מ(NYSE and TASE: TEVA) הודיעה היום כי ניסוי רישום בשלב 3 אשר בחן את reslizumab (110 מ"ג) במתן תת עורי של מזרק מוכן מראש לא עמד ביעד הראשי של הפחתה משמעותית של הישנות החרפה קלינית של אסטמה בקרב מטופלים הסובלים מאסטמה בלתי נשלטת ומרמות גבוהות של אאוזנופילים (>300/mcL). ניסוי תומך קביעה בשלב 3 אשר בחן את reslizumab במתן תת עורי למטופלים הסובלים מאסטמה התלויה ב- corticosteroid (OCS) אוראלי לא עמדה ביעד הראשי של הפחתת מינון יומי של OCS.

"אנו מאוכזבים מכך שהניסויים של reslizumab במתן תת עורי במינון קבוע של 110 מ"ג על עמדו ביעדים הראשוניים שלהם. עם זאת, תוצאות אלו ממחישות את התפקיד של אאוזנופילים בביולוגיית המחלה של אסטמה חריפה ואת החשיבות של הצבת יעד סף של אאוזנופילים בדם לצורך בחינת מטופלים. אנו ממשיכים לראות את ההשפעה החיובית של הפורמולציה במתן ורידי כמינון מבוסס משקל 3mg/kg אפקטיבי קליני עבור מטופלים הסובלים מאסטמה ומרמות גבוהות בדם של אאזנופילים אשר לא נשלטים דיו על ידי הטיפול השגרתי," אמר ד"ר טושאר שאה, סמנכ"ל בכיר לפיתוח קליני ועניינים רפואיים בטבע.

בניסוי הרישום, ניתוח קבוצת משנה של 80% מהאוכלוסיה האקראית של מטופלים הסובלים מאסטמה חריפה, עם רמות אאוזנופילים בדם של ≥ 400/mcL הציגו הפחתה משמעותית של סיכון CAE (p <0.025). קבוצת מטופלים זו דומה לזו שנבחנה בניסוי הקליני בשלב 3 עבור CINQAIR®/CINQAERO® (reslizumab) בהזרקה, שהיא הפורמולציה המאושרת כיום למתן ורידי, והשתמשה גם היא ברמת אאוזנופילים בדם של ≥ 400/mcL.

טבע תבחן את הנתונים המלאים בכדי לקבוע את צעדיה הבאים.

בבחינת הנתונים בניסויים אלו לא התגלו כל בעיות בטיחות מעבר לפרופיל הבטיחות הידוע של reslizumab, ולא דווחו מקרים של anaphylaxis הקשורים ל- reslizumab.

About the Studies

Study NCT02452190was a registration Phase III, 52-week, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of reslizumab administered subcutaneously in 468 patients with uncontrolled asthma and elevated blood eosinophils. Its primary objective was to demonstrate the efficacy of reslizumab (110 mg) fixed, subcutaneous dosing every 4 weeks, as assessed by the reduction in frequency of clinical asthma exacerbations (CAEs). For further details on the study, please visit: https://clinicaltrials.gov/ct2/show/NCT02452190?term=NCT02452190&cntry1=NA%3AUS&rank=1

Study NCT02501629was a claim-support Phase III, 24-week, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of reslizumab administered subcutaneously in 177 patients with oral corticosteroid (OCS) dependent asthma and elevated blood eosinophils. Its primary objective was to demonstrate the efficacy of reslizumab (110 mg) fixed, subcutaneous dosing every 4 weeks, as assessed by reduction in daily OCS dose compared with baseline. For further details on the study, please visit: https://clinicaltrials.gov/ct2/show/NCT02501629?term=reslizumab&cntry1=NA%3AUS&draw=2&rank=10

 

About CINQAIR®/CINQAERO®(reslizumab) injection for intravenous use

CINQAIR (reslizumab) Injection is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.

Limitations of Use: CINQAIR is notindicated for:

  • treatment of other eosinophilic conditions
  • relief of acute bronchospasm or status asthmaticus

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS

  • Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR.
  • Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis.

CONTRAINDICATIONS

  • CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients.

WARNINGS AND PRECAUTIONS

  • Acute Asthma Symptoms or Deteriorating Disease: CINQAIR should not be used to treat acute asthma symptoms or acute exacerbations. Do not use CINQAIR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with CINQAIR.
  • Malignancy: In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group. The observed malignancies in CINQAIR-treated patients were diverse in nature and without clustering of any particular tissue type. The majority of malignancies were diagnosed within less than six months of exposure to CINQAIR.
  • Reduction of Corticosteroid Dosage: No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of CINQAIR. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
  • Parasitic (Helminth) Infection: Eosinophils may be involved in the immunological response to some helminth infections. Treat patients with pre-existing helminth infections before initiating CINQAIR. If patients become infected while receiving treatment with CINQAIR and do not respond to anti-helminth treatment, discontinue treatment with CINQAIR until infection resolves.

ADVERSE REACTIONS

  • Adverse reactions that occurred at ≥2% incidence and more commonly than in the placebo group included 1 event: oropharyngeal pain (2.6% vs. 2.2%).
  • Elevated baseline creatine phosphokinase (CPK) was more frequent in patients randomized to CINQAIR (14%) versus placebo (9%). Transient CPK elevations in patients with normal baseline CPK values were observed more frequently with CINQAIR (20%) versus placebo (18%) during routine laboratory assessments.
  • Myalgia was reported in 1% (10/1028) of patients in the CINQAIR 3 mg/kg group compared to 0.5% (4/730) of patients in the placebo group.
  • Immunogenicity: In placebo-controlled studies, a treatment-emergent anti-reslizumab antibody response developed in 53/983 (5.4%) of CINQAIR-treated patients (3 mg/kg). The antibody responses were of low titer and often transient. There was no detectable impact of the antibodies on the clinical pharmacokinetics, pharmacodynamics, clinical efficacy, and safety of CINQAIR.

Please click here for Full Prescribing Information

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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