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Teva Pharmaceutical Industries Ltd. Earnings Release 2017
7082_rns_2017-06-27_23ac148c-f9ae-4f46-a360-b48c4c01b201.pdf
Earnings Release
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Teva and Xenon Announce Phase II Study of Topical TV-45070 in Patients with Post-Herpetic Neuralgia (PHN) Did Not Meet Primary Endpoint
Jerusalem & Burnaby, British Columbia -- June 27, 2017 -- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Xenon Pharmaceuticals Inc. (Nasdaq: XENE) announce top-line results in a Phase II study of topical TV-45070 in patients with post-herpetic neuralgia (PHN). TV-45070 did not meet the primary endpoint of a statistically significant change in pain from baseline to week four as assessed by the numeric rating scale (NRS). Secondary endpoints were also not met. There were no safety concerns in the study.
This was a Phase II proof of concept study seeking to understand the potential for a topical route of Nav1.7 blockade in PHN. Dr. Simon Pimstone, Xenon's President and Chief Executive Officer, said: "While these results are disappointing for us from a scientific perspective and for patients needing new therapies to treat chronic neuropathic pain, Xenon remains focused on advancing its pipeline of neurology -related development candidates, with multiple programs anticipated to enter clinical development in 2017."
The companies plan to further analyze the data from this study to determine the next steps for TV-45070, and may look to present study data at a relevant forthcoming scientific conference.
About TV-45070
TV-45070 is a small-molecule inhibitor of the sodium channel Nav1.7, and other sodium channels, expressed in the pain-sensing peripheral nervous system. TV-45070 was licensed by Xenon to Teva in December 2012.
This Phase II trial was a randomized, double-blind, placebo controlled, parallel group, multicenter study to evaluate the efficacy and safety of TV-45070 in patients with PHN. The study included three treatment groups that received topical ointment containing 4% or 8% TV-45070 or placebo, dosed twice daily. The primary endpoint of this study was the change of average daily pain scores from baseline to week four, measured using an 11-point (0-10) numeric rating scale (NRS).
Secondary endpoints included the percentage of patients with greater than 30% and greater than 50% improvement in pain scores, quality of life measurements and adverse events measurements. The study was carried out at 48 centers in the US and involved 300 patients randomized to 100 patients receiving 4% TV-45070, 100 patients receiving 8% TV-45070 and 100 patients receiving placebo.
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 approximately 200 million patients in 100 markets 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 the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were \$21.9 billion. For more information, visit www.tevapharm.com.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical stage biopharmaceutical company focused on developing innovative therapeutics to improve the lives of patients with neurological disorders. Building upon our extensive knowledge of human genetics and diseases caused by mutations in ion channels, known as channelopathies, we are advancing – both independently and with our pharmaceutical collaborators – a novel product pipeline of ion channel modulators to address therapeutic areas of high unmet medical need, such as pain and epilepsy. For more information, please visit www.xenon-pharma.com.
Teva 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 regarding TV-45070 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 forwardlooking statements. Important factors that could cause or contribute to such differences include risks relating to:
- challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals;
- 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 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 restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; and variations in patent laws that may adversely affect our ability to manufacture our products;
- 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;
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.
Xenon's Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated timing of IND submissions with regulatory agencies, the initiation of future clinical trials, the future development plans for TV-45070 and the progress and potential of ongoing development programs. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our discovery platform or ongoing collaborations may not yield additional product candidates; our efforts to expand our current pipeline may not be successful; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones pursuant to our collaboration agreements; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements..
"Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.
| Teva Contacts: | |
|---|---|
| ---------------- | -- |
| 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 Nancy Leone |
Israel United States United States |
972 (3) 926-7208 (215) 591-8974 (215) 284-0213 |
| Xenon Contact: | |||
| IR & PR Contact: | Jodi Regts | North America | 604-484-3353 ([email protected]) |
טבע ו-XENON מודיעות כי מחקר שלב 2 לבחינת -45070TV טופיקאלי )מקומי( במטופלים הסובלים מנוירלגיה פוסט-הרפטית לא עמד ביעד המרכזי
ירושלים וברנבי, בריטיש קולומביה, 27 ביוני, 2017 - טבע תעשיות פרמצבטיות בע"מ )NYSE ו-TASE: TEVA )ו.-Inc Pharmaceuticals Xenon( XENE :Nasdaq )הודיעו היום כי מחקר שלב 2 לבחינת -TV 45070 טופיקאלי )מקומי( במטופלים הסובלים מנוירלגיה פוסט-הרפטית לא עמד ביעד המרכזי של מובהקות סטטיסטית של שינוי בכאב מהנתונים ההתחלתיים ועד לשבוע הרביעי, כפי שנקבע באמצעות מדד מספרי. יעדים משניים גם כן לא הושגו. לא עלו בעיות בטיחות במחקר.
מדובר במחקר בשלב 2 המיועד להוכיח תיאוריה הבוחנת את הפוטנציאל למתן טופיקאלי של חסימת ערוץ הנתרן 1.7Navבנוירלגיה פוסט-הרפטית. ד"ר סיימון פינסטון, נשיא ומנכ"ל Xenon, אמר: "בעוד שהתוצאות הללו הן מאכזבות מהפן המדעי ומבחינת המטופלים הזקוקים לטיפולים חדשים עבור כאב נוירופטי כרוני, Xenon ממשיכה להיות ממוקדת בקידום צבר מוצריה הנוירולוגיים, עם מספר מוצרים הצפויים להיכנס לפיתוח קליני ב.2017-"
החברות מתכוונות לנתח את הנתונים מהמחקר בכדי לבחון את הצעדים הבאים עבור -45070TV ויבחנו אפשרות הצגת נתונים מהמחקר בכנס מדעי רלוונטי קרוב.
אודות -45070TV
-45070TV מבוסס על מולקולה קטנה המעכבת את פעילות ערוץ הנתרן 1.7Nav וערוצי נתרן נוספים, כולל ערוצים הבאים לידי ביטוי במערכת העצבים ההיקפית האחראית על תחושת הכאב. -45070TV הועבר לטבע במסגרת הסכם רישוי שנחתם בדצמבר .2012 הניסוי בשלב 2 היה מחקר אקראי, כפול-סמיות, מבוקר-פלצבו עם ריבוי אתרים, להערכת הבטיחות והיעילות של משחת -45070TV בקרב מטופלים עם PHN. המחקר כלל שלוש קבוצות טיפול שיקבלו מינונים של -45070TV בריכוז של 4% או 8% או פלצבו, פעמיים ביום. יעד התוצאה העיקרי עבור המחקר היה מידת השינוי מהנתונים ההתחלתיים ועד לנתונים בשבוע הרביעי מבחינת הציונים בסקאלה המספרית )0-10( לדירוג כאב )NRS).
אודות טבע
טבע תעשיות פרמצבטיות בע"מ )TEVA :TASE & NYSE )היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה המשמשים כ200- מיליוני מטופלים ב100- שווקים מדי יום. טבע, שבסיסה בישראל, היא יצרנית התרופות הגנריות הגדולה בעולם, הממנפת את צבר מוצריה הכולל יותר מ1,800- 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 com.tevapharm.www.
Xenon Pharmaceuticals Inc. אודות
Xenon היא חברת ביופרמצבטיקה לעריכת ניסויים קליניים העוסקת בגילוי ופיתוח מוצרים ייחודיים לשיפור חיי מטופלים הסובלים מהפרעות נויורולוגיות. בהתבסס על הידע הנרחב שלנו בגנטיקה אנושית ומחלות הנגרמות
כתוצאה ממוטציות בתעלות יונים, הנקראות מחלות בתעלות היונים )Channelopathies), אנו מקדמים – עצמאית ובשיתוף פעולה עם גורמים פרמצבטיים – צבר מוצרים ייחודיים בכדי להתמודד עם תחומים טיפוליים בעלי צרכים רפואיים אשר הינם ללא מענה, כמו כאב ואפילפסיה. למידע נוסף, ניתן לבקר באתר com.pharma-xenon.www.
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 regarding TV-45070 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 forwardlooking statements. Important factors that could cause or contribute to such differences include risks relating to:
- challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals;
- 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 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 restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; and variations in patent laws that may adversely affect our ability to manufacture our products;
- 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 c laims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks;
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.
Xenon's Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding the anticipated timing of IND submissions with regulatory agencies, the initiation of future clinical trials, the future development plans for TV-45070 and the progress and potential of ongoing development programs. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our discovery platform or ongoing collaborations may not yield additional product candidates; our efforts to expand our current pipeline may not be successful; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones pursuant to our collaboration agreements; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements..
"Xenon" and the Xenon logo are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions. All other trademarks belong to their respective owner.
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