1. No category

TEVA STRENGTHENS INJECTABLES PORTFOLIO WITH THE LAUNCH OF AN AUTHORIZED
®
GENERIC OF CUBICIN (DAPTOMYCIN FOR INJECTION) IN THE UNITED STATES
Jerusalem, September 15, 2016 – Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
®1
announced the launch of an authorized generic of Cubicin (daptomycin for injection) 500 mg per vial in
the United States.
Daptomycin for injection is an antibacterial drug indicated in adults for the treatment of complicated skin
and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive
bacteria: Staphylococcus aureus (including methicillin-resistant isolates), Streptococcus pyogenes,
Streptococcus agalactiae, Streptococcus dysgalactiae subspecies equisimilis, and Enterococcus faecalis
(vancomycin-susceptible isolates only).
Daptomycin for injection is indicated in adults for the treatment of Staphylococcus aureus bloodstream
infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillinsusceptible and methicillin-resistant isolates.
Daptomycin for injection is not indicated for the treatment of pneumonia. Daptomycin for injection is not
indicated for the treatment of left-sided infective endocarditis (LIE) due to S. aureus. Daptomycin for
injection has not been studied in patients with prosthetic valve endocarditis.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of daptomycin for
injection and other antibacterial drugs, daptomycin for injection should be used only to treat infections that
are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility
information is available, it should be considered in selecting or modifying antibacterial therapy. In the
absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric
selection of therapy. Empiric therapy may be initiated while awaiting test results.
Teva remains committed to strengthening its generic injectable business globally with continued
investment in newer, higher-value generic injectable products. Teva currently has 338 product
registrations pending FDA approval and holds the leading position in first-to-file opportunities, with over
100 pending first-to-files in the U.S. Currently, 1-in-5 generic prescriptions dispensed in the U.S. is filled
with a Teva generic product.
Daptomycin for injection had annual sales of approximately $1.2 billion in the United States, according to
IMS data as of July 2016.
1
Cubicin® is a registered trademark of Merck Sharp & Dohme Corp.
IR Contacts:
Kevin C. Mannix
Ran Meir
Tomer Amitai
United States
United States
Israel
(215) 591-8912
(215) 591-3033
972 (3) 926-7656
PR Contacts:
Iris Beck Codner
Denise Bradley
Israel
United States
972 (3) 926-7687
(215) 591-8974
Selected Important Safety Information
Anaphylaxis/hypersensitivity reactions, which may be life-threatening, have been reported with
daptomycin for injection use. If an allergic reaction occurs, discontinue daptomycin for injection and treat
appropriately.
Myopathy and rhabdomyolysis have been reported with daptomycin for injection use. Monitor for
muscle pain or weakness, particularly of the distal extremities. Monitor creatine phosphokinase (CPK)
levels weekly and more frequently in patients with CPK elevations while on daptomycin for injection
treatment and in those who received recent prior or concomitant HMG-CoA reductase inhibitors. In
patients with renal impairment, monitor renal function and CPK levels more than once weekly.
Discontinue daptomycin for injection in patients with unexplained signs and symptoms of myopathy with
CPK levels >1,000 U/L (~5× ULN), and in patients without symptoms and CPK levels >2,000 U/L (≥10×
ULN). In addition, consider temporarily suspending agents associated with rhabdomyolysis, such as
HMG-CoA reductase inhibitors.
Eosinophilic pneumonia has been reported with daptomycin for injection use. Promptly evaluate
patients who develop fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary
infiltrates and discontinue daptomycin for injection immediately. Treatment with systemic steroids is
recommended. Recurrence of eosinophilic pneumonia upon re-exposure has been reported.
Peripheral neuropathy has been reported with daptomycin for injection use. Monitor for signs and
symptoms of peripheral neuropathy.
Potential nervous and/or muscular system effects in patients younger than 12 months: Avoid use
of daptomycin for injection in patients younger than 12 months due to the risk of potential effects on
muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal
dogs.
Clostridium difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been
reported with nearly all systemic antibacterial agents, including daptomycin for injection. Evaluate all
patients who present with diarrhea following antibacterial use. Careful medical history is necessary
because CDAD has been reported to occur more than two months after the administration of antibacterial
agents. If CDAD is suspected or confirmed, antibacterial use not directed against C. difficile should be
discontinued, if possible.
Patients with persisting or relapsing S. aureus bacteremia/endocarditis, possibly due to reduced
daptomycin susceptibility, or poor clinical response should have repeat blood cultures. Appropriate
surgical intervention and/or change in antibacterial regimen may be required. Failure of treatment due to
persisting or relapsing S. aureus bacteremia/endocarditis may be due to reduced daptomycin
susceptibility.
In the cSSSI and S. aureus bacteremia/endocarditis trials, decreased efficacy was observed in
daptomycin for injection-treated patients with moderate baseline renal impairment (CrCL <50 mL/min).
IR Contacts:
Kevin C. Mannix
Ran Meir
Tomer Amitai
United States
United States
Israel
(215) 591-8912
(215) 591-3033
972 (3) 926-7656
PR Contacts:
Iris Beck Codner
Denise Bradley
Israel
United States
972 (3) 926-7687
(215) 591-8974
Adverse Reactions: The most clinically significant adverse reactions observed with daptomycin for
injection 4 mg/kg (cSSSI trials) and 6 mg/kg (S. aureus bacteremia/endocarditis trial) were abnormal liver
function tests, elevated CPK, and dyspnea.
CrCL=creatinine clearance; HMG-CoA=3-hydroxy-3-methylglutaryl-coenzyme A; ULN=upper limit of normal.
For more information, please see the accompanying Full Prescribing Information.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical
company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every
day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its
portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every
therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for
disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its global research and development
division to create new ways of addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net revenues in 2015 amounted to $19.7
billion. For more information, visit www.tevapharm.com.
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 specialty products, especially Copaxone® (which faces competition from orally-administered alternatives and a
generic version); our ability to integrate Allergan plc’s worldwide generic pharmaceuticals business (“Actavis
Generics”) and to realize the anticipated benefits of the acquisition (and the timing of realizing such benefits); the fact
that following the consummation of the Actavis Generics acquisition, we are dependent to a much larger extent than
previously on our generic pharmaceutical business; potential restrictions on our ability to engage in additional
transactions or incur additional indebtedness as a result of the substantial amount of debt incurred to finance the
Actavis Generics acquisition; the fact that for a period of time following the Actavis Generics acquisition, we will have
significantly less cash on hand than previously, which could adversely affect our ability to grow; 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 investments in our pipeline of specialty
and other products; 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
IR Contacts:
Kevin C. Mannix
Ran Meir
Tomer Amitai
United States
United States
Israel
(215) 591-8912
(215) 591-3033
972 (3) 926-7656
PR Contacts:
Iris Beck Codner
Denise Bradley
Israel
United States
972 (3) 926-7687
(215) 591-8974
pharmaceutical pricing, reimbursement and coverage; competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental pricing pressures; 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 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, 2015 and in our other filings with
the U.S. Securities and Exchange Commission (the "SEC"). 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, whether as a result of new information, future events or otherwise.
###
IR Contacts:
Kevin C. Mannix
Ran Meir
Tomer Amitai
United States
United States
Israel
(215) 591-8912
(215) 591-3033
972 (3) 926-7656
PR Contacts:
Iris Beck Codner
Denise Bradley
Israel
United States
972 (3) 926-7687
(215) 591-8974
‫טבע מחזקת את פורטפוליו המוצרים להזרקה עם השקת גרסה גנרית מאושרת של ®‪CUBICIN‬‬
‫(‪ DAPTOMYCIN‬להזרקה) בארצות הברית‬
‫ירושלים‪ 15 ,‬בספטמבר ‪ – 2016‬טבע תעשיות פרמצבטיות בע"מ (‪ NYSE‬ו‪ )TEVA :TASE-‬הודיעה היום על‬
‫השקת גרסה גנרית מאושרת של ‪ daptomycin( Cubicin®2‬המיועד להזרקה)‪ 500 ,‬מ"ג לבקבוקון‪ ,‬בארצות‬
‫הברית‪.‬‬
‫‪ Daptomycin‬להזרקה היא תרופה אנטי‪-‬בקטריאלית המיועדת לטיפול במבוגרים הסובלים מדלקות עור מורכבות‬
‫ומדלקות ברקמות רכות (‪ ,)cSSSI‬שנגרמו על ידי חלבוני איזולאטים הרגישים לחיידקים גרם‪-‬חיוביים הבאים‪:‬‬
‫‪( Staphylococcus aureus‬כולל איזולאטים העמידים למתיצילין)‪,Streptococcus pyogenes ,‬‬
‫‪ Streptococcus dysgalactiae ,Streptococcus agalactiae‬תת‪-‬מין ‪ ,equisimilis‬ו‪Enterococcus -‬‬
‫‪( faecalis‬איזולאטים הרגישים לוונקומיצין בלבד)‪.‬‬
‫‪ Daptomycin‬להזרקה מיועד לטיפול במבוגרים הסובלים מאלח דם כתוצאה מהדבקה ב‪Staphylococcus -‬‬
‫‪( aureus‬בקטרמיה)‪ ,‬כולל חולים הסובלים מאנדוקרדיטיס בצד ימין הנגרם על ידי איזולאטים רגישים למתיצילין‬
‫ועמידים למתיצילין‪.‬‬
‫‪ Daptomycin‬להזרקה אינו מיועד לטיפול בדלקת ריאות‪ Daptomycin .‬להזרקה אינו מיועד לטיפול בדלקת פנים‬
‫הלב זיהומית בצד שמאל (‪ )LIE‬הנגרמת כתוצאה מהדבקה ב‪ .S. aureus-‬השפעת הטיפול ב‪Daptomycin-‬‬
‫להזרקה לא נחקרה עבור חולים הסובלים מאנדוקרדיטיס של מסתם לב תותב (מלאכותי)‪.‬‬
‫על מנת להפחית את התפתחות החיידקים העמידים לתרופות ולשמור על היעילות של ‪ Daptomycin‬להזרקה ועל‬
‫יעילותן של תרופות אנטיבקטריאליות אחרות‪ ,‬יש להשתמש ב‪ Daptomycin-‬להזרקה לטיפול בדלקות רק כאשר‬
‫קיים חשד מבוסס או כאשר הוכח שהדלקות נגרמו על ידי החיידק הרגיש לתרופה‪ .‬כאשר זמינים נתונים לגבי‬
‫תרביות חיידקים ורגישות לתרופות‪ ,‬יש לשקול נתונים אלה בעת בחירה או שינוי של הטיפול האנטי‪-‬בקטריאלי‬
‫הניתן‪ .‬אם לא קיימים נתונים כאלה‪ ,‬מגמות אפידמיולוגיות ומגמות לגבי נפיצות הרגישות לתרופה עשויות לתרום‬
‫לבחירה של טיפול אמפירי‪ .‬ניתן להתחיל בטיפול אמפירי בזמן המתנה לתוצאות הבדיקות‪.‬‬
‫טבע מחויבת להמשיך ולחזק את עסק המוצרים הגנריים להזרקה של החברה בכל העולם‪ ,‬וממשיכה להשקיע‬
‫במוצרים גנריים המיועדים להזרקה חדשים יותר ובעלי ערך גבוה יותר‪ .‬לטבע יש כיום ‪ 338‬מוצרים ברישום‬
‫הממתינים לאישור ‪ FDA‬ומחזיקה בעמדת הובלה בהזדמנויות הגשה ראשונה (‪ )first to file‬עם יותר מ‪100 -‬‬
‫בארה"ב‪ .‬כיום‪ 1 ,‬מכל ‪ 5‬מרשמים בארה"ב ממולא במוצר גנרי של טבע‪.‬‬
‫‪2‬‬
‫®‪ Cubicin‬הוא סימן מסחרי רשום של ‪Merck Sharp & Dohme Corp.‬‬
‫‪(215) 591-8912‬‬
‫‪(215) 591-3033‬‬
‫‪972 (3) 926-7656‬‬
‫‪United States‬‬
‫‪United States‬‬
‫‪Israel‬‬
‫‪Kevin C. Mannix‬‬
‫‪Ran Meir‬‬
‫‪Tomer Amitai‬‬
‫‪IR Contacts:‬‬
‫‪972 (3) 926-7687‬‬
‫‪(215) 591-8974‬‬
‫‪Israel‬‬
‫‪United States‬‬
‫‪Iris Beck Codner‬‬
‫‪Denise Bradley‬‬
‫‪PR Contacts:‬‬
-‫ על פי נתוני ה‬,‫ מיליארד דולר בארה"ב‬1.2 -‫ להזרקה הגיעו לסכום של כ‬daptomycin ‫המכירות השנתיות של‬
.2016 ‫ נכון ליולי‬IMS
Selected Important Safety Information
Anaphylaxis/hypersensitivity reactions, which may be life-threatening, have been reported with
daptomycin for injection use. If an allergic reaction occurs, discontinue daptomycin for injection and treat
appropriately.
Myopathy and rhabdomyolysis have been reported with daptomycin for injection use. Monitor for
muscle pain or weakness, particularly of the distal extremities. Monitor creatine phosphokinase (CPK)
levels weekly and more frequently in patients with CPK elevations while on daptomycin for injection
treatment and in those who received recent prior or concomitant HMG-CoA reductase inhibitors. In
patients with renal impairment, monitor renal function and CPK levels more than once weekly.
Discontinue daptomycin for injection in patients with unexplained signs and symptoms of myopathy with
CPK levels >1,000 U/L (~5× ULN), and in patients without symptoms and CPK levels >2,000 U/L (≥10×
ULN). In addition, consider temporarily suspending agents associated with rhabdomyolysis, such as
HMG-CoA reductase inhibitors.
Eosinophilic pneumonia has been reported with daptomycin for injection use. Promptly evaluate
patients who develop fever, dyspnea with hypoxic respiratory insufficiency, and diffuse pulmonary
infiltrates and discontinue daptomycin for injection immediately. Treatment with systemic steroids is
recommended. Recurrence of eosinophilic pneumonia upon re-exposure has been reported.
Peripheral neuropathy has been reported with daptomycin for injection use. Monitor for signs and
symptoms of peripheral neuropathy.
Potential nervous and/or muscular system effects in patients younger than 12 months: Avoid use
of daptomycin for injection in patients younger than 12 months due to the risk of potential effects on
muscular, neuromuscular, and/or nervous systems (either peripheral and/or central) observed in neonatal
dogs.
Clostridium difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been
reported with nearly all systemic antibacterial agents, including daptomycin for injection. Evaluate all
patients who present with diarrhea following antibacterial use. Careful medical history is necessary
because CDAD has been reported to occur more than two months after the administration of antibacterial
agents. If CDAD is suspected or confirmed, antibacterial use not directed against C. difficile should be
discontinued, if possible.
Patients with persisting or relapsing S. aureus bacteremia/endocarditis, possibly due to reduced
daptomycin susceptibility, or poor clinical response should have repeat blood cultures. Appropriate
surgical intervention and/or change in antibacterial regimen may be required. Failure of treatment due to
persisting or relapsing S. aureus bacteremia/endocarditis may be due to reduced daptomycin
susceptibility.
IR Contacts:
Kevin C. Mannix
Ran Meir
Tomer Amitai
United States
United States
Israel
(215) 591-8912
(215) 591-3033
972 (3) 926-7656
PR Contacts:
Iris Beck Codner
Denise Bradley
Israel
United States
972 (3) 926-7687
(215) 591-8974
In the cSSSI and S. aureus bacteremia/endocarditis trials, decreased efficacy was observed in
daptomycin for injection-treated patients with moderate baseline renal impairment (CrCL <50 mL/min).
Adverse Reactions: The most clinically significant adverse reactions observed with daptomycin for
injection 4 mg/kg (cSSSI trials) and 6 mg/kg (S. aureus bacteremia/endocarditis trial) were abnormal liver
function tests, elevated CPK, and dyspnea.
CrCL=creatinine clearance; HMG-CoA=3-hydroxy-3-methylglutaryl-coenzyme A; ULN=upper limit of normal.
For more information, please see the accompanying Full Prescribing Information.
‫אודות טבע‬
‫) היא חברת תרופות גלובלית המספקת פתרונות‬NYSE & TASE: TEVA( ‫טבע תעשיות פרמצבטיות בע"מ‬
‫ היא‬,‫ שבסיסה בישראל‬,‫ טבע‬.‫מטופל באיכות גבוהה המשמשים מיליוני מטופלים מדי יום‬-‫בריאות ממוקדי‬
‫ מולקולות לייצר‬1,800-‫ הממנפת את צבר מוצריה הכולל יותר מ‬,‫יצרנית התרופות הגנריות הגדולה בעולם‬
‫ טבע הינה חברה מובילה‬,‫ בתחום התרופות הייחודיות‬.‫מגוון רחב של מוצרים גנריים ברוב התחומים הטיפוליים‬
‫ והיא מחזיקה גם צבר מוצרים חזק בתחום‬,‫ כולל כאב‬,‫בטיפולים חדשניים למחלות מערכת העצבים המרכזית‬
‫ טבע משלבת את כישוריה בתחום התרופות הגנריות ובתחום התרופות הייחודיות בחטיבת‬.‫מחלות הנשימה‬
‫ במטרה ליצור דרכים חדשות לענות על צרכי המטופלים וזאת על ידי שילוב‬,‫המחקר והפיתוח הגלובלית שלה‬
2015 ‫ הכנסות טבע בשנת‬.‫ שירותים וטכנולוגיות‬,‫יכולות בתחום פיתוח תרופות יחד עם פיתוח תכשירים‬
.www.tevapharm.com ‫ בקרו באתר‬,‫ למידע נוסף על החברה‬.‫ מיליארד‬$19.7-‫הסתכמו ב‬
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 specialty products, especially Copaxone® (which faces competition from orally-administered alternatives and a
generic version); our ability to integrate Allergan plc’s worldwide generic pharmaceuticals business (“Actavis
Generics”) and to realize the anticipated benefits of the acquisition (and the timing of realizing such benefits); the fact
that following the consummation of the Actavis Generics acquisition, we are dependent to a much larger extent than
previously on our generic pharmaceutical business; potential restrictions on our ability to engage in additional
transactions or incur additional indebtedness as a result of the substantial amount of debt incurred to finance the
Actavis Generics acquisition; the fact that for a period of time following the Actavis Generics acquisition, we will have
significantly less cash on hand than previously, which could adversely affect our ability to grow; 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 investments in our pipeline of specialty
IR Contacts:
Kevin C. Mannix
Ran Meir
Tomer Amitai
United States
United States
Israel
(215) 591-8912
(215) 591-3033
972 (3) 926-7656
PR Contacts:
Iris Beck Codner
Denise Bradley
Israel
United States
972 (3) 926-7687
(215) 591-8974
and other products; 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; competition for our generic products, both from other
pharmaceutical companies and as a result of increased governmental pricing pressures; 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 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, 2015 and in our other filings with
the U.S. Securities and Exchange Commission (the "SEC"). 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, whether as a result of new information, future events or otherwise.
###
IR Contacts:
Kevin C. Mannix
Ran Meir
Tomer Amitai
United States
United States
Israel
(215) 591-8912
(215) 591-3033
972 (3) 926-7656
PR Contacts:
Iris Beck Codner
Denise Bradley
Israel
United States
972 (3) 926-7687
(215) 591-8974