טבע תציג נתונים אודות אסטמה בכינוס המדעי של אגודת האלרגיה, אסטמה ואימונולוגיה

המצגות עוסקות בפורטפוליו הנשימה של טבע – כולל משאפי הצלה וניהול שוטף וטיפול אסטמה ביולוגי

ירושלים, 26 באוקטובר 2017 – טבע תעשיות פרמצבטיות בע"מ (NYSE ו-TASE: TEVA) הודיעה היום כי חמש תקצירים הממומנים על ידי החברה יוצגו בכינוס המדעי השנתי של אגודת האלרגיה, אסטמה ואימונולוגיה האמריקאית (ACAAI), בבוסטון, בין 26-30 באוקטובר, 2017.

בין התקצירים שנתקבלו כלולים נתונים משני ניתוחים אשר בחנו את יעילותה של זריקת ®(reslizumab) IV CINQAIR נוגדן חד שבטי נגד אינטרלוקין 5 (IL-5), לטיפול באסטמה אאוזינופילית חריפה. תקציר אחד הציג ניתוח המשך (post-hoc), לבחינת ההשפעה הישירה של ®CINQAIR על "גיל ריאה" ספירומטרי, והשני הציג ניתוח המשך לבחינת ההשפעה של ®CINQAIR על תפקוד הריאה והחרפות אסטמה קליניות בקרב מטופלים עם תפקוד ריאה נמוך.

ניתוח המשך בחן את היעילות של אבקת שאיפה ArmonAir™ RespiClick® (fluticasone propionate) ואבקת שאיפה AirDuo RespiClick® (fluticasone propionate and salmeterol) בקרב מטופלים אשר טופלו בעבר עם אותה תרופה אך באמצעות משאפים אחרים.

כמו כן יוצגו שני תקצירים של צוות חקר השלכות כלכליות ובריאותיות של טבע. אחד מתאר מודל השפעה תקציבית אשר פותח כדי לבחון את ההשפעה הכלכלית משימוש במשאפי בטה אגוניסט קצר-טווח (SABA) הכוללים מונה מינונים בקרב מטופלי Medicare עם מחלות נשימה. השני מציג מחקר רטרוספקטיבי המתבסס על תביעות ואשר בוחן את הישנותן של מחילות רקע (comorbidities) בנלוות לשימוש מרושל במכשירים על ידי מטופלים עם אסטמה ו/או מחלת ריאות חסימתית כרונית (COPD) המשתמשים במשאפי בטה אגוניסט קצר-טווח (SABA), כולל אבקת שאיפה ProAir RespiClick® (albuterol sulfate).

"קרוב ל-25 מיליון איש בארה"ב סובלים מאסטמה1 – ומספר זה ממשיך לגדול. זה מה שמניע אותנו לבחון כל העת את הטיפולים שלנו – החל מטיפולי משאפים, עבור למנגנוני מתן תרופות המופעלים באמצעות נשימה ועד לטיפולים ביולוגיים ממוקדים. מטרתנו היא לפתח טיפולים שיוכלו להביא לתוצאות טיפול חיוביות עבור המטופלים", אמר ד"ר דניאל מקבראיין, סמנכ"ל למוצרי נשימה בקבוצת התרופות הייחודיות הגלובלית של טבע. "אנו שמחים להיות כאן בכינוס המדעי השנתי של ACAAI כדי להציג ולהדגים את מחויבותנו למחקר מדעי המוכוון להתמודד עם צרכים ללא מענה אשר עדיין קיימים בקרב קהילת המטופלים הנשימתיים".

להלן הנתונים שיוצגו מתוך המחקרים שערכה טבע:

CINQAIR®(reslizumab)

  • #P216: Efficacy of reslizumab in eosinophilic asthma patients with low lung function
    • This abstract will be presented as an ePoster presentation on Saturday, October 28, 2017 at 10:30 AM on Monitor 5
  • #P223: Reslizumab improves spirometric lung age in patients with severe eosinophilic asthma
    • This abstract will be presented as an ePoster presentation on Saturday, October 28, 2017 at 1:10 PM on Monitor 5

ArmonAir™ RespiClick®(fluticasone propionate) and AirDuo RespiClick®(fluticasone propionate and salmeterol)

  • #P209: Fluticasone Propionate and Fluticasone/Salmeterol Multidose Dry Powder Inhalers in Patients Previously Treated Through Alternative Devices
    • This abstract will be presented as an ePoster presentation on Friday, October 27, 2017 at 4:50 PM on Monitor 5

Health Economics Outcomes and Research

  • #P236: Comorbidities Associated with Poor Short-Acting Beta-Agonist Inhaler Handling Among United States Respiratory Patients
    • This abstract will be presented as an ePoster presentation on Sunday, October 29, 2017 at 1:10 PM on Monitor 5
  • #P235: Budgetary Impact Model on a Medicare Plan Adopting Short-Acting Beta-Agonist Inhalers with Integrated Dose Counters
    • This abstract will be presented as an ePoster presentation on Sunday, October 29, 2017 at 1 PM on Monitor 5

אודות זריקת ® CINQAER

®(reslizumab) CINQAER הוא נוגדן חד שבטי נגד אינטרלוקין 5 (IL-5) (IgG4 kappa) המותווה לטיפול תחזוקה בקרב מטופלים מעל גיל 18 עם אסטמה חריפה ועם פנוטיפ אאוזינופילי.

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

אודות ProAir® RespiClick 

(Albuterol Sulfate) ProAir® RespiClick היא אבקת שאיפה המותווית למטופלים מגיל ארבע ומעלה לטיפול או למניעה של ברונכוספאזם המתרחש במחלת ריאות חסימתית הפיכה ולמניעת ברונכוספאזם בעקבות מאמץ.

IMPORTANT SAFETY INFORMATION

  • ProAir RespiClick® (albuterol sulfate) Inhalation Powder is contraindicated in patients with hypersensitivity to albuterol or patients with a severe hypersensitivity to milk proteins. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. There have been reports of anaphylactic reactions in patients using inhalation therapies containing lactose
  • ProAir® RespiClick® can produce paradoxical bronchospasm that may be life-threatening. Discontinue ProAir® RespiClick® and institute alternative therapy if paradoxical bronchospasm occurs
  • Need for more doses of ProAir® RespiClick® than usual may be a marker of acute or chronic deterioration of asthma and requires reevaluation of treatment
  • ProAir® RespiClick® alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids
  • ProAir® RespiClick®, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and/or symptoms. If such effects occur, the drug may need to be discontinued
  • ProAir® RespiClick®, as with all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), convulsive disorders, hyperthyroidism, and diabetes
  • Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. Do not exceed the recommended dose
  • Immediate hypersensitivity reactions may occur. Discontinue ProAir® RespiClick® immediately
  • ProAir® RespiClick® may produce significant hypokalemia in some patients, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation
  • Potential drug interactions can occur with beta-blockers, diuretics, digoxin, or monoamine oxidase inhibitors, and tricyclic antidepressants
  • In controlled studies of ProAir® RespiClick® in patients 12 years of age and older, adverse events that occurred at an incidence rate of at least 1% and greater than placebo included back pain (2% vs 1%), pain (2% vs <1%), gastroenteritis viral (1% vs <1%), sinus headache (1% vs <1%), and urinary tract infection (1% vs <1%)
  • In controlled studies of ProAir® RespiClick® in patients 4 to 11 years of age, adverse events that occurred at an incidence rate of at least 2% and greater than placebo included nasopharyngitis (2% vs 1%), oropharyngeal pain (2% vs 1%), and vomiting (3% vs 1%)

Please click here for Full Prescribing Information

אודות ®AirDuoTM RespiClick (אבקה לשאיפה Fluticasone Propionate ו-Salmeterol)

®AirDuo™ RespiClick מיועד לטיפול באסטמה בקרב חולים בגיל 12 ומעלה. AirDuo RespiClick מיועד רק לחולים שמחלתם לא נמצאת בשליטה מספקת חרף טיפול במשאף קורטיקו-סטרואיד (ICS) או שמחלתם חמורה ודורשת בבירור טיפול משולב ב-ICS/LABA.

Important Limitation of Use: AirDuo RespiClick is NOT indicated for the relief of acute bronchospasm.

  • Contraindications: AirDuo RespiClick is contraindicated in:
  • Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
  • Patients with known severe hypersensitivity to milk proteins or any ingredients of AirDuo RespiClick
  • Deterioration of Disease and Acute Episodes: AirDuo RespiClick should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma. AirDuo RespiClick is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not AirDuo RespiClick, should be used to relieve acute symptoms such as shortness of breath
  • Excessive Use and Use with Other Long acting Beta2-Agonists: AirDuo RespiClick should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medicines containing LABA, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using AirDuo RespiClick should not use another medicine containing a LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate, indacaterol) for any reason
  • Local Effects of Inhaled Corticosteroids: Oropharyngeal candidiasis has occurred in patients treated with AirDuo RespiClick .Advise patients to rinse the mouth with water without swallowing following inhalation
  • Immunosuppression: Patients who use corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections
  • Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to AirDuo RespiClick
  • Hypercorticism and Adrenal Suppression may occur with high doses of inhaled corticosteroids, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue AirDuo RespiClick slowly
  • Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with AirDuo RespiClick is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur
  • Paradoxical Bronchospasm and Upper Airway Symptoms: If paradoxical bronchospasm occurs, discontinue AirDuo RespiClick immediately and institute alternative therapy
  • Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of AirDuo RespiClick. Discontinue AirDuo RespiClick if such reactions occur
  • Cardiovascular and Central Nervous System Effects: Salmeterol, a component of AirDuo RespiClick, can produce clinically significant cardiovascular effects in some patients as measured by pulse rate, blood pressure, and/or symptoms. If such effects occur, AirDuo RespiClick may need to be discontinued. AirDuo RespiClick should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension
  • Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of products containing inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care
  • Effect on Growth: Inhaled corticosteroids, as well as poorly controlled asthma, may cause a reduction in growth velocity, and the long-term effect on final adult height is unknown. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients
  • Glaucoma and Cataracts: Long-term use of inhaled corticosteroids, including fluticasone propionate, a component of AirDuo RespiClick, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered
  • Eosinophilic Conditions and Churg Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy
  • Coexisting Conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines
  • Hypokalemia and Hyperglycemia: Be alert to hypokalemia and hyperglycemia
  • Adverse Reactions: Most common adverse reactions (≥3%) in patients taking AirDuo RespiClick 55/14 mcg twice daily, 113/14 mcg twice daily, 232/14 mcg twice daily, and placebo, respectively, were nasopharyngitis (8.6%, 4.8%, 6.9%, 4.4%), oral candidiasis (1.6%, 2.2%, 3.4%, 0.7%), back pain (3.1%, 0.7%, 0%, 1.8%), headache (5.5%, 4.8%, 2.8%, 4.4%), and cough (2.3%, 3.7%, 0.7%, 2.6%)

Please click here for full Prescribing Information, including Boxed WARNING.

About ArmonAirTM RespiClick® (Fluticasone Propionate) Inhalation Powder

ArmonAir™ RespiClick® is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years of age and older.
Important Limitation of Use: ArmonAir RespiClick is NOT indicated for the relief of acute bronchospasm.

IMPORTANT SAFETY INFORMATION

  • Contraindications: ArmonAir RespiClick is contraindicated in:
    • Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures
    • Patients with known severe hypersensitivity to milk proteins or any ingredients of ArmonAir RespiClick
  • Local Effects: Oropharyngeal candidiasis has occurred in patients treated with ArmonAir RespiClick. Advise patients to rinse the mouth with water without swallowing following inhalation
  • Acute Asthma Episodes: ArmonAir RespiClick is not indicated for the relief of acute bronchospasm. An inhaled, short-acting beta2-agonist, not ArmonAir RespiClick, should be used to relieve acute symptoms such as shortness of breath
  • Immunosuppression: Patients on corticosteroids are at risk for potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. A more serious or even fatal course of chickenpox or measles may occur in susceptible patients. Use with caution in patients with the above because of the potential for worsening of these infections
  • Transferring Patients from Systemic Corticosteroid Therapy: Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to ArmonAir RespiClick
  • Hypercorticism and Adrenal Suppression may occur with high doses of inhaled corticosteroids, including fluticasone propionate, or at the recommended dose in susceptible individuals. If such changes occur, discontinue ArmonAir RespiClick slowly
  • Hypersensitivity Reactions, Including Anaphylaxis: Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, hypotension), including anaphylaxis, may occur after administration of ArmonAir RespiClick. Discontinue ArmonAir RespiClick if such reactions occur
  • Reduction in Bone Mineral Density (BMD): Decreases in BMD have been observed with long-term administration of inhaled corticosteroids. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care
  • Effect on Growth: Inhaled corticosteroids, as well as poorly controlled asthma, may cause a reduction in growth velocity, and the long-term effect on final adult height is unknown. Patients should be maintained on the lowest dose of inhaled corticosteroid that effectively controls their asthma. Monitor growth of pediatric patients
  • Glaucoma and Cataracts: Long-term use of inhaled corticosteroids, including ArmonAir RespiClick, may increase the risk for cataracts or glaucoma. Regular eye exams should be considered
  • Paradoxical Bronchospasm: Discontinue ArmonAir RespiClick and institute alternative therapy if paradoxical bronchospasm occurs
  • Drug Interactions with Strong Cytochrome P450 3A4 Inhibitors: The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, ketoconazole) with ArmonAir RespiClick is not recommended because increased systemic corticosteroid adverse effects may occur
  • Eosinophilic Conditions and Churg Strauss Syndrome: Systemic eosinophilic conditions, such as Churg-Strauss syndrome, may occur. Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy
  • Adverse Reactions: Most common adverse reactions (≥3%) in patients taking ArmonAir RespiClick 55 mcg twice daily, 113 mcg twice daily, 232 mcg twice daily, and placebo, respectively, were nasopharyngitis (5.4%, 5.8%, 4.8%, 4.4%), upper respiratory tract infection (5.4%, 4.7%, 5.5%, 4.8%), oral candidiasis (3.1%, 2.9%, 4.8%, 0.7%), headache (1.6%, 7.3%, 4.8%, 4.4%), and cough (1.6%, 1.8%, 3.4%, 2.6%)

Please click here for full Prescribing Information.

אודות תחום הנשימה בטבע

תחום הנשימה בטבע מפתח ומספק אפשרויות טיפול איכותיות לתופעות נשימתיות ובהן אסתמה, מחלת ריאות חסימתית כרונית ונזלת אלרגית. הפורטפוליו של תחום הנשימה בטבע ממוקד בהשגת אופטימיזציה עבור טיפולי נשימה למטופלים וספקי שירותי בריאות באמצעות פיתוח דרכי מתן תרופה וטיפולים חדשניים בכדי לענות על צרכים ללא מענה. צבר המוצרים ותכניות הפיתוח הקליני של תחום הנשימה בטבע מתבססים על מולקולות המועברות למטופל באמצעות טכנולוגיות תכשירים קנייניות של פורמולציות אבקה יבשה ומשאפים מופעלי-נשימה, כמו גם טיפולים ביולוגיים ממוקדים לטיפול באסתמה הנשלטת באופן בלתי מספק. באמצעות מחקר ופיתוח קליני, תחום הנשימה בטבע ממשיך להרחיב, לחזק ולבנות על הפורטפוליו הטיפולי שלו בכדי להשפיע לחיוב על חייהם של מיליוני מטופלים החיים עם מחלות נשימה.

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה המשמשים כ-200 מיליוני מטופלים ביותר מ-60 שווקים 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 את הטיפול החדשני המוביל בעולם לטיפול בטרשת נפוצה וכן תכניות מחקר מתקדמות למחלות אחרות של מערכת העצבים המרכזית, כולל הפרעות תנועה, מיגרנה, כאב ותופעות ניווניות, 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 2016 הסתכמו ב-21.9$ 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:

  • 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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