דצמבר 08, 2015 חזור »

טבע ו-Eagle Pharmaceuticals הודיעו כי ה-FDA אישר את זריקת ™BENDEKA לטיפול בחולי לוקמיה לימפוציטית כרונית (CLL) ולימפומה איטית של תאי B שאינה הודג'קין (NHL).

ירושלים ו-וודקליף לייק, ניו ג'רזי – 8 בדצמבר 2015 – טבע תעשיות פרמצבטיות בע"מ (NYSE: TEVA) וחברת (Nasdaq: EGRX) Eagle Pharmaceuticals, Inc. הודיעו היום כי מנהל המזון והתרופות האמריקאי (FDA) אישר את זריקת (Bendamustine Hydrochloride) BENDEKA™, פורמולציה נוזלית של בנדמוסטין (Bendamustine) בנפח קטן (50 מ"ל) הניתנת בעירוי מהיר של 10 דקות. BENDEKA מאושרת לשימוש לצורך טיפול בחולי לוקמיה לימפוציטית כרונית (CLL) וטיפול בחולי לימפומה איטית (אינדולנטית) של תאי B שאינה הודג'קין (NHL) שהתקדמה במהלך או לאחר ששה חודשים של טיפול בריטוקסימאב (Rituximab) או בשגרה טיפולית הכוללת ריטוקסימאב. טרם נקבעה יעילות הטיפול בחולי CLL בהשוואה לטיפולי קו ראשון שאינם כלוראמבוסיל (Chlorambucil).

"אנו שמחים מאוד שה-FDA אישר את התרופה BENDEKA, ואנו מאמינים כי זו תהיה השקה מוצלחת בשיתוף עם טבע. אנו מאמינים בלב שלם כי החולים בלוקמיה לימפוציטית כרונית (CLL) או לימפומה איטית (אינדולנטית) של תאי B שאינה הודג'קין (NHL) שהתקדמה יפיקו תועלת ממגוון האפשרויות השונות של מתן התרופה, שמאפשר המוצר החדש", אמר סקוט טאריף, נשיא ומנכ"ל Eagle Pharmaceuticals.

"טבע מצפה להזדמנות להביא את מוצר ה-Bendamustine החדש לשוק. אנו מאמינים שהמוצר מייצג תועלת חשובה לחולים ולנותני שירותי בריאות", אמר פול ריטמן, סמנכ"ל בכיר ומנהל כללי, טבע אונקולוגיה. "אנו שמחים מאוד להוסיף את BENDEKA לפורטפוליו מוצרי האונקולוגיה של טבע ולזיכיון ה-Bendamustine, באופן המחזק את מחויבותנו להציע אפשרויות טיפול משופרות לחולי סרטן".

BENDEKA קיבל התוויות של תרופת יתום הן לטיפול ב-CLL והן לטיפול ב-NHL איטית (אינדולנטית) של תאי B.

על פי תנאי הסכם הרישוי הבלעדי עבור BENDEKA מפברואר 2015, טבע תהיה אחראית לכל פעילות השיווק של המוצר בארה"ב כולל קידום והפצה. טבע צופה ש-BENDEKA יהיה זמין לשיווק כתרופת מרשם במהלך הרבעון הראשון של 2016.

התוויות

BENDEKA מיועד לטיפול בחולי לוקמיה לימפוציטית כרונית (CLL). טרם נקבעה יעילות הטיפול בהשוואה לטיפולי קו ראשון שאינם כלוראמבוסיל (Chlorambucil).

BENDEKA מיועד לטיפול בחולי לימפומה איטית (אינדולנטית) של תאי B שאינה הודג'קין (NHL) שהתקדמה במהלך או לאחר ששה חודשים של טיפול בריטוקסימאב (Rituximab) או בשגרה טיפולית הכוללת ריטוקסימאב.

Important Safety Information

Contraindication: BENDEKA is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol.
Myelosuppression: Bendamustine hydrochloride caused severe myelosuppression (Grade 3-4) in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions. Monitor leukocytes, platelets, hemoglobin (Hgb), and neutrophils frequently. Myelosuppression may require dose delays and/or subsequent dose reductions if recovery to the recommended values has not occurred by the first day of the next scheduled cycle. Infections: Infection, including pneumonia, sepsis, septic shock, hepatitis and death has occurred. Patients with myelosuppression following treatment with BENDEKA are more susceptible to infections. Patients treated with Bendamustine hydrochloride are at risk for reactivation of infections including (but not limited to) hepatitis B, cytomegalovirus, Mycobacterium tuberculosis, and herpes zoster. Patients should undergo appropriate monitoring, prophylaxis, and treatment measures.
Anaphylaxis and Infusion Reactions: Infusion reactions to bendamustine hydrochloride have occurred commonly in clinical trials. Symptoms include fever, chills, pruritus, and rash. In rare instances severe anaphylactic and anaphylactoid reactions have occurred, particularly in the second and subsequent cycles of therapy. Monitor clinically and discontinue drug for severe (Grade 3-4) reactions. Ask patients about symptoms suggestive of infusion reactions after their first cycle of therapy. Consider measures to prevent severe reactions, including antihistamines, antipyretics, and corticosteroids in subsequent cycles in patients who have experienced Grade 1 or 2 infusion reactions.
Tumor Lysis Syndrome: Tumor lysis syndrome associated with bendamustine hydrochloride has occurred. The onset tends to be within the first treatment cycle with BENDEKA and, without intervention, may lead to acute renal failure and death. Preventive measures include vigorous hydration and close monitoring of blood chemistry, particularly potassium and uric acid levels. There may be an increased risk of severe skin toxicity when bendamustine hydrochloride and allopurinol are administered concomitantly.
Skin Reactions: Skin reactions have been reported with bendamustine hydrochloride treatment including rash, toxic skin reactions, and bullous exanthema. In a study of bendamustine hydrochloride (90 mg/m2) in combination with rituximab, one case of toxic epidermal necrolysis (TEN) occurred. TEN has been reported for rituximab. Cases of Stevens-Johnson syndrome (SJS) and TEN, some fatal, have been reported when bendamustine hydrochloride was administered concomitantly with allopurinol and other medications known to cause these syndromes. Where skin reactions occur, they may be progressive and increase in severity with further treatment. Monitor patients with skin reactions closely. If skin reactions are severe or progressive, withhold or discontinue BENDEKA.
Other Malignancies: There are reports of pre-malignant and malignant diseases that have developed in patients who have been treated with bendamustine hydrochloride, including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma. The association with BENDEKA therapy has not been determined.
Extravasation Injury: Extravasations resulting in hospitalizations from erythema, marked swelling, and pain have been reported with Bendamustine hydrochloride. Assure good venous access prior to starting drug infusion and monitor the intravenous infusion site for redness, swelling, pain, infection, and necrosis during and after administration of BENDEKA.
Embryo-fetal Toxicity: Bendamustine hydrochloride can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid becoming pregnant while using BENDEKA.
Most Common Adverse Reactions:

  • Adverse reactions (frequency >5%) during infusion and within 24 hours post-infusion are nausea and fatigue
  • Most common non-hematologic adverse reactions for CLL (frequency ≥15%) are pyrexia, nausea, and vomiting.
  • Most common non-hematologic adverse reactions for NHL (frequency ≥15%) are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.
  • Most common hematologic abnormalities (frequency ≥15%) are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

 

For BENDEKA Full Prescribing Information, please visit:
http://www.bendeka.com/PrescribingInformation.PDF

אודות טבע

טבע תעשיות פרמצבטיות בע"מ (NYSE & TASE: TEVA) היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה למיליוני מטופלים מדי יום. טבע, שבסיסה בישראל, היא יצרנית התרופות הגנריות הגדולה בעולם, הממנפת את צבר מוצריה הכולל יותר מ-1000 מולקולות לייצר מגוון רחב של מוצרים גנריים בכמעט כל התחומים הטיפוליים. בתחום התרופות הייחודיות, טבע הינה חברה מובילה בטיפולים חדשניים למחלות מערכת העצבים המרכזית, כולל כאב, ומחזיקה גם בצבר מוצרים חזק בתחום מחלות הנשימה. טבע משלבת את כישוריה בתחום התרופות הגנריות ובתחום התרופות הייחודיות בחטיבת המחקר והפיתוח הגלובלית שלה, במטרה ליצור דרכים חדשות לענות על צרכי המטופלים וזאת על ידי שילוב יכולות בתחום פיתוח תרופות יחד עם פיתוח תכשירים, שירותים וטכנולוגיות. הכנסות טבע בשנת 2014 הסתכמו ב-20.3$ מיליארד. למידע נוסף על החברה, בקרו באתר www.tevapharm.com.

אודות Eagle Pharmaceuticals, Inc.

Eagle היא חברת פרמצבטיקה לתרופות ייחודיות המתמקדת בפיתוח ושיווק מוצרים הניתנים בהזרקה, המטפלים בפערים – שצוינו על ידי רופאים, רוקחים ובעלי עניין אחרים – של מוצרים קיימים ומצליחים הניתנים בהזרקה. האסטרטגיה של Eagle היא למנף את המסלול הרגולטורי 505(b)(2) של ה-FDA. מידע נוסף מפורט באתר החברה בכתובת www.eagleus.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® (including competition from orally-administered alternatives, as well as from generic equivalents such as the recently launched Sandoz product) and our ability to continue to migrate users to our 40 mg/mL version and maintain patients on that version; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities (such as our pending acquisitions of Allergan’s generic business and Rimsa), or to consummate and integrate acquisitions; 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; 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.

Eagle's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This press release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995, as amended and other securities laws. Forward-looking statements are statements that are not historical facts. Words such as “will,” “may,” “intends,” “anticipate(s),” “plan,” “enables,” “potentially,” “entitles,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding future events including, but not limited to: success in gaining timely FDA approval of the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen; the timing and level of success of a future launch of the rapid infusion bendamustine product by Teva; the success of Eagle’s commercial arrangement with Teva and the parties’ ability to work effectively together; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to manufacturing facilities, products and/or businesses; and other factors that are discussed in Eagle’s Annual Report on Form 10-K for the year ended September 30, 2014, and its other filings with the U.S. Securities and Exchange Commission. All of such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond Eagle’s control, that could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Such risks include, but are not limited to: whether the FDA will ultimately approve Eagle’s NDA for the rapid infusion bendamustine product for the treatment of patients with CLL and patients with indolent B-cell NHL that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen; whether Teva will be successful at commercializing the rapid infusion bendamustine product; whether Eagle and Teva will successfully perform each of their respective obligations under the exclusive license agreement; and other risks described in Eagle’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and we do not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.