סלטריון וטבע מכריזות על אישור ה- FDA עבור ®HERZUMA

תרופה ביוסימילרית ל- ®HERCEPTIN לטיפול במספר התוויות של סרטן שד מסוג HER2-Overexpressing

אינצ'און, דרום קוריאה, וירושלים, 14 בדצמבר 2018 – סלטריון (KRX:068270) וטבע תעשיות פרמצבטיות בע"מ  (NYSE and TASE: TEVA)  הודיעו היום כי מינהל המזון והתרופות האמריקאי (FDA) אישר את ®HERZUMA

(trastuzumab-pkrb), חוסם קולטן HER2/neu  ביוסימילרי ל- HERCEPTIN®1  לטיפול בסרטן שד מסוג HER2-overexpressing בהתוויות הבאות:

  • Adjuvant Breast Cancer of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer
    • as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
    • as part of a treatment regimen with docetaxel and carboplatin
  • Metastatic Breast Cancer
    • in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer
    • as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.
  • In these indications, patients should be selected for therapy based on an FDA-approved companion diagnostic for a trastuzumab product

"תרופות ביוסימילריות הן בעלות חשיבות הולכת וגדולה לקהילת האונקולוגיה, והאישור של HERZUMA יכול לספק ליותר מטופלים גישה לטיפול חשוב זה", אמר ווסונג קי, מנכ"ל סלטריון. " זהו האישור השני שלנו עבור תרופת ביוסימילר אונקולוגית בארה"ב בחודש האחרון, דבר המחזק את היעד שלנו עבור כל מוצרינו המאושרים – לספק מגוון רחב של אפשרויות טיפוליות למטופלים ולאלו המטפלים בהם."

HERZUMA עומד בסטנדרטים המחמירים של ה-FDA  כתרופת ביוסימילר למוצר המקורי עבור התוויות מאושרות, בהתבסס על סך כל המידע. אישור ה-FDA  מתבסס על בחינת חבילת נתונים מקיפה הכוללת נתונים ביוסימילאריים אנליטיים, נתונים לא קליניים, פרמקולוגיה קלינית, אימונוגניות ויעילות קלינית ונתוני בטיחות. תוצאות תכנית הפיתוח הקליני HERZUMA הראו כי לא היו הבדלים משמעותיים מבחינה קלינית HERZUMA לבין HERCEPTIN במונחים של בטיחות, טוהר ופוטנציה של המוצר לטיפול בסרטן השד מסוג HER2-overexpressing  עבור ההתוויות המאושרות.

"אנחנו מאוד שמחים להמשיך ולבנות את נוכחותה של טבע בזירת הביוסימילר", אמר ברנדן או'גריידי, סמנכ"ל בכיר, מנהל החטיבה המסחרית בצפון אמריקה בטבע. "הוספת HERZUMA לפורטפוליו הביוסימילרי שלנו יאפשר לנו למנף את החוזקות שלנו הן באונקלוגיה והן בגנריקה."

Trastuzumab products have a Boxed Warning which states that treatment with trastuzumab may be associated with cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity. Please see the full Boxed Warning and additional Important Safety Information in this release and accompanying Prescribing Information.

סלטריון וטבע תעשיות פרמצבטיות בע"מ נכנסו לשותפות בלעדית באוקטובר 2016 במטרה למסחר את HERZUMA בארה"ב ובקנדה.

Important Safety Information and Boxed Warnings

WARNING: CARDIOMYOPATHY, INFUSION REACTIONS, EMBRYO‑FETAL TOXICITY, AND PULMONARY TOXICITY

 

Cardiomyopathy - Administration of trastuzumab products can result in sub-clinical and clinical cardiac failure. The incidence and severity was highest in patients receiving trastuzumab with anthracycline‑containing chemotherapy regimens.

 

Evaluate left ventricular function in all patients prior to and during treatment with HERZUMA. Discontinue HERZUMA treatment in patients receiving adjuvant therapy and withhold HERZUMA in patients with metastatic disease for clinically significant decrease in left ventricular function.

 

Infusion Reactions; Pulmonary Toxicity - Administration of trastuzumab products can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of HERZUMA administration. Interrupt HERZUMA infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue HERZUMA for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.

 

Embryo Fetal Toxicity - Exposure to trastuzumab products during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception.

Cardiomyopathy

  • Trastuzumab products can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. Trastuzumab products can also cause asymptomatic decline in left ventricular ejection fraction (LVEF).
  • There is a 4–6-fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving trastuzumab products as a single agent or in combination therapy compared with those not receiving trastuzumab products. The highest absolute incidence occurs when a trastuzumab product is administered with an anthracycline.
  • Withhold HERZUMA for ≥ 16% absolute decrease in LVEF from pre-treatment values or an LVEF value below institutional limits of normal and ≥ 10% absolute decrease in LVEF from pretreatment values. The safety of continuation or resumption of HERZUMA in patients with trastuzumab product-induced left ventricular cardiac dysfunction has not been studied.
  • Patients who receive anthracycline after stopping HERZUMA may also be at increased risk of cardiac dysfunction.

Cardiac Monitoring

  • Conduct thorough cardiac assessment, including history, physical examination, and determination of LVEF by echocardiogram or MUGA scan. The following schedule is recommended:
    • Baseline LVEF measurement immediately prior to initiation of HERZUMA.
    • LVEF measurements every 3 months during and upon completion of HERZUMA.
    • Repeat LVEF measurement at 4 week intervals if HERZUMA is withheld for significant left ventricular cardiac dysfunction.
    • LVEF measurements every 6 months for at least 2 years following completion of HERZUMA as a component of adjuvant therapy.

Infusion Reactions

  • Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia.
  • In post-marketing reports, serious and fatal infusion reactions have been reported. Severe reactions, which include bronchospasm, anaphylaxis, angioedema, hypoxia, and severe hypotension, were usually reported during or immediately following the initial infusion. However, the onset and clinical course were variable, including progressive worsening, initial improvement followed by clinical deterioration, or delayed post-infusion events with rapid clinical deterioration. For fatal events, death occurred within hours to days following a serious infusion reaction.
  • Interrupt HERZUMA infusion in all patients experiencing dyspnea, clinically significant hypotension, and intervention of medical therapy administered (which may include epinephrine, corticosteroids, diphenhydramine, bronchodilators, and oxygen). Patients should be evaluated and carefully monitored until complete resolution of signs and symptoms. Permanent discontinuation should be strongly considered in all patients with severe infusion reactions.
  • There are no data regarding the most appropriate method of identification of patients who may safely be retreated with trastuzumab products after experiencing a severe infusion reaction. Prior to resumption of trastuzumab infusion, the majority of patients who experienced a severe infusion reaction were pre‑medicated with antihistamines and/or corticosteroids. While some patients tolerated trastuzumab infusions, others had recurrent severe infusion reactions despite pre-medications.

Embryo-Fetal Toxicity

  • Trastuzumab products can cause fetal harm when administered to a pregnant woman. In post marketing reports, use of trastuzumab during pregnancy resulted in cases of oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death.
  • Verify the pregnancy status of females of reproductive potential prior to the initiation of HERZUMA. Advise pregnant women and females of reproductive potential that exposure to HERZUMA during pregnancy or within 7 months prior to conception can result in fetal harm. Advise females of reproductive potential to use effective contraception during treatment and for 7 months following the last dose of HERZUMA.

Pulmonary Toxicity

  • Trastuzumab product use can result in serious and fatal pulmonary toxicity. Pulmonary toxicity includes dyspnea, interstitial pneumonitis, pulmonary infiltrates, pleural effusions, non‑cardiogenic pulmonary edema, pulmonary insufficiency and hypoxia, acute respiratory distress syndrome, and pulmonary fibrosis. Such events can occur as sequelae of infusion reactions.
  • Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest, appear to have more severe toxicity.

Exacerbation of Chemotherapy-Induced Neutropenia

  • In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3 to 4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not.

Adverse Reactions

  • Adjuvant Breast Cancer - Most common adverse reactions (≥5%) are headache, diarrhea, nausea, and chills.
  • Metastatic Breast Cancer- Most common adverse reactions (≥ 10%) are fever, chills, headache, infection, congestive heart failure, insomnia, cough, and rash.

Please click here for full Prescribing Information for HERZUMA.

[1] HERCEPTIN® is a registered trademark of Genentech, Inc.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for Inflectra® and Remsima®, respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.

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

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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