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Teva Pharmaceutical Industries Ltd. M&A Activity 2016
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M&A Activity
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Teva and Regeneron Announce Global Collaboration to Develop and Commercialize Fasinumab, an Investigational NGF Antibody for Chronic Pain
Novel Nerve Growth Factor (NGF) Antibody Has Potential to Address Limitations of Current Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Opioid Therapies
Jerusalem and Tarrytown, NY, September 20, 2016 – Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced today a global1 agreement to develop and commercialize fasinumab, Regeneron's investigational NGF antibody in Phase 3 clinical development for osteoarthritis pain and in Phase 2 development for chronic low back pain. Under the terms of the agreement, Teva will pay Regeneron \$250 million upfront and share equally in the global1 commercial value, as well as ongoing research and development costs of approximately \$1 billion.
"This is a significant transaction for Teva, and we look forward to our collaboration with Regeneron, a leader in the research and development of innovative biologics, which aligns with our overall corporate strategy. With our commercial footprint, we will be able to widely educate healthcare providers about this new treatment option when it becomes available," said Rob Koremans, M.D., President and Chief Executive Officer of Global Specialty Medicines for Teva.
"The development of novel pain medicines, such as fasinumab, can be one important step in combating the growing opioid epidemic," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer, Regeneron and President, Regeneron Laboratories. "Fasinumab represents the culmination of more than 25 years of Regeneron scientific work in neurotrophic factors. We look forward to working with Teva, a leading global pharmaceutical company with an expertise in pain therapeutics, to advance this program for patients in need."
| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
1 Excludes Japan, Korea and nine other Asian countries, which are part of a previously announced collaboration agreement between Regeneron and Mitsubishi Tanabe Pharma.
Under the terms of the agreement, Regeneron is eligible to receive development and regulatory milestones payments and additional payments based on net sales. Regeneron will lead global development and U.S. commercialization. The companies will share U.S. commercialization efforts by utilizing sales teams and marketing expertise from both companies, and split profit equally in the U.S. In countries outside the U.S.1 with the exception of those covered by a previously announced collaboration agreement between Regeneron and Mitsubishi, Teva will be responsible for development and commercialization and pay Regeneron a purchase price, which allows both companies to retain approximately equal shares of fasinumab's global1 commercial value over time.
"Fasinumab has shown proof of concept in early clinical trials, and represents an exciting, novel target for pain relief. Adding the promise of fasinumab to our developing pipeline of pain products also provides a strong, strategic cornerstone to our pain franchise at Teva. It has the potential to provide a treatment option without the concerns of abuse, addiction and misuse of opioids. In the United States alone, it is estimated that 30 million people suffer pain from osteoarthritis and the same number with chronic low back pain," said Michael Hayden, President of Teva Global R&D and Chief Scientific Officer.
Fasinumab is a fully human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling. There is evidence that NGF levels are elevated in patients with chronic pain conditions.
Under a previously announced collaboration agreement with Regeneron, Mitsubishi Tanabe Pharma has exclusive development and commercial rights to fasinumab in Japan, Korea and nine other Asian countries.
About Osteoarthritis Pain and Chronic Low Back Pain
| Teva IR Contacts: | Kevin C. Mannix Ran Meir Tomer Amitai |
United States United States Israel |
(215) 591-8912 (215) 591-3033 972 (3) 926-7656 |
|---|---|---|---|
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner Denise Bradley Nancy Leone |
Israel United States United States |
972 (3) 926-7687 (215) 591-8974 (215) 284-0213 |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
In the U.S., more than 30 million people live with osteoarthritis pain, and a similar number with chronic low back pain, with both populations expected to grow in the low-single digit percentages annually.2,3 Many patients experience pain at moderate-to-severe levels with intolerance and/or inadequate response to current analgesic therapies such as opioids and NSAIDs.4,5 There is a great need for highly effective analgesic medications to provide patient relief without the toxicity and tolerability challenges of NSAIDs and opioids.3 Opioid prescriptions account for 40 percent of the chronic pain market and carry a well-known risk of abuse and misuse, underscoring the need for alternative pain therapies without the medical and societal challenges.3,6
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.
6 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 7
| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
2 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 120
3 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 115
4 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 148-149
5 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 147
About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL cholesterol and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, atopic dermatitis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.
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
| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
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.
Regeneron Forward-Looking Statements and Use of Digital Media
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements.
| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation fasinumab (REGN475) and the collaboration agreement with Teva Pharmaceutical Industries Ltd. discussed in this news release; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators (including without limitation the development of fasinumab conducted pursuant to the collaboration agreement discussed in this news release) may lead to therapeutic applications; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates, including without limitation fasinumab for pain due to osteoarthritis and chronic low back pain and other potential indications; unforeseen safety issues and possible liability resulting from the administration of products and product candidates in patients; serious complications or side effects in connection with the use of Regeneron's products and product candidates in clinical trials, such as the current and contemplated global clinical development programs evaluating fasinumab; ongoing regulatory obligations and oversight impacting Regeneron's marketed products, research and clinical programs, and business, including those relating to the enrollment, completion, and meeting of the relevant endpoints of post-approval studies; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates (such as fasinumab) and new indications for marketed products; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare, Medicaid, and pharmacy benefit management companies; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare LLC (or their respective affiliated companies, as applicable) and the collaboration agreement with Teva Pharmaceutical Industries Ltd. discussed in this news release, to be cancelled or terminated without any product success; and risks
| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
associated with intellectual property of other parties and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2015 and its Form 10-Q for the quarterly period ended June 30, 2016. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
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| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
טבע ו-Regeneron מודיעות על שיתוף פעולה גלובלי לפיתוח ומסחור של Fasinumab, נוגדן NGF ניסיוני לטיפול בכאב כרוני
נוגדן חדשני של גורם הגדילה העצבי )NGF )עשוי להתגבר על מגבלות הטיפולים הקיימים של נוגדי דלקת שאינם סטרואידים )NSAID )ותרופות אופיואידיות
ירושלים וטאריטאון, ניו יורק, 20 בספטמבר 2016 – טבע תעשיות פרמצבטיות בע"מ )NYSE ו-TASE: TEVA )וחברת .Inc ,Pharmaceuticals Regeneron( NASDAQ: REGN )הודיעו היום כי חתמו על הסכם 7 גלובלי לפיתוח ומסחור של Fasinumab, נוגדן ה-NGF הניסיוני של Regeneron שנמצא במחקר קליני שלב ,3 לטיפול בכאבים הנובעים מאוסטיאוארטריטיס )דלקת מפרקים ניוונית(, כמו גם במחקר קליני שלב 2 עם תכנון למחקר שלב 3 לטיפול בכאבים כרוניים בגב התחתון. במסגרת תנאי ההסכם, טבע תשלם ל-Regeneron מקדמה של 250 מיליון דולר, תקבל חלק שווה מהערך המסחרי הגלובלי, וכן תקבל על עצמה חלק שווה מעלויות המחקר והפיתוח השוטפות בשווי של כמיליארד דולר.
"זוהי עסקה משמעותית לטבע ואנו מצפים לשיתוף הפעולה עם Regeneron, חברה מובילה בתחום המחקר והפיתוח של תרופות ביולוגיות חדשניות, תחום התואם לאסטרטגיה הכללית שלנו. הודות לנוכחות המסחרית שלנו, נוכל לספק באופן נרחב מידע לרופאים ומטפלים אודות אפשרות טיפול חדשה זו, כאשר תהפוך לזמינה," אמר ד"ר רוב קורמנס, נשיא ומנכ"ל קבוצת התרופות הייחודיות הגלובלית של טבע.
"הפיתוח של תרופות חדשניות לשיכוך כאבים ללא פוטנציאל של שימוש לרעה, כדוגמת Fasinumab, יכול להיות צעד חשוב במאבק נגד מגפת השימוש לרעה באופיואידים," אמר ד"ר ג'ורג' ד. יאנקופולוס, המדען הראשי של Regeneron ונשיא Laboratories Regeneron." Fasinumab הוא תוצאה של יותר מ25- שנות מחקר מדעי שערכה Regeneron בנושא גורמים נוירוטרופיים )חלבון חיוני לשמירה על רקמת עצב(. אנחנו שמחים להזדמנות
| Teva IR Contacts: | Kevin C. Mannix Ran Meir Tomer Amitai |
United States United States Israel |
(215) 591-8912 (215) 591-3033 972 (3) 926-7656 |
|---|---|---|---|
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner Denise Bradley Nancy Leone |
Israel United States United States |
972 (3) 926-7687 (215) 591-8974 (215) 284-0213 |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
7 על פי התנאים של הסכם שיתוף פעולה קודם שהוכרז עם Regeneron, חברת Pharma Tanabe Mitsubishi היא בעלת זכויות בלעדיות לפיתוח ומסחור של Fasinumab ביפן, קוריאה ותשע מדינות אחרות באסיה, לא כולל סין.
לעבוד עם טבע, חברת פארמה גלובלית מובילה המתמחה בתחום הטיפול בכאב, במטרה לקדם את תכנית הפיתוח לטובת מטופלים הזקוקים לאופציה טיפולית זו."
על פי תנאי ההסכם, Regeneron זכאית לקבל תשלומים על פי אבני דרך של פיתוח והשגת אישורים רגולטוריים וכן תשלומים נוספים המבוססים על רווחי הנטו ממכירות. Regeneron תוביל את הפיתוח הגלובלי והמסחור בארה"ב. שתי החברות יחלקו ביניהן את מאמצי המסחור וירתמו לצורך כך את צוותי המכירות ואת הידע השיווקי 1 שלהן, ויתחלקו ברווחים שווה בשווה מהמכירות בארה"ב. במדינות מחוץ לארה"ב , פרט לאלו המכוסות על ידי שיתוף פעולה שפורסם בעבר בין Regeneron ומיצובישי, טבע תהיה אחראית לפיתוח ולמסחור ותשלם ל- Regeneron מחיר רכישה אשר יאפשר לשתי החברות להמשיך להחזיק בחלקים שווים, פחות או יותר, מהערך המסחרי הגלובלי של Fasinumab כפי שיתפתח לאורך זמן.
"כבר בשלב מוקדם במחקרים הקליניים, Fasinumab הציג הוכחת היתכנות כיעד חדשני ומבטיח לטיפול בכאבים. Fasinumab הוא אפשרות טיפולית מבטיחה במיוחד. הוספת ההבטחה של Fasinumab לצבר מוצרי הכאב בפיתוח שלנו מספקת אבן פינה אסטרטגית וחזקה לתחום הכאב של טבע. לתרופה יש פוטנציאל להעניק אפשרות טיפול ללא הסכנות של שימוש לרעה, התמכרות ושימוש לא נכון באופיואידים. על פי ההערכות, בארצות הברית לבדה כ30- מיליון איש סובלים מכאבים הקשורים לאוסטיאוארטריטיס, ומספר דומה של אנשים סובלים מכאבים כרוניים בגב התחתון," אמר ד"ר מייקל היידן, נשיא המו"פ הגלובלי והמדען הראשי של טבע.
Fasinumab הוא נוגדן חד-שבטי מואנש המתמקד ב-NGF, חלבון הממלא תפקיד מרכזי בוויסות של איתותי כאב. יש ראיות שאצל אנשים הסובלים מכאב כרוני רמות ה- NGF גבוהות.
על פי התנאים של הסכם שיתוף פעולה קודם שהוכרז עם Regeneron, חברת Pharma Tanabe Mitsubishi היא בעלת זכויות בלעדיות לפיתוח ומסחור של Fasinumab ביפן, קוריאה ותשע מדינות אחרות באסיה, לא כולל סין.
אודות כאבים כרוניים הנלווים לאוסטיאוארטריטיס וכאבים כרוניים בגב התחתון
| Teva IR Contacts: | Kevin C. Mannix Ran Meir Tomer Amitai |
United States United States Israel |
(215) 591-8912 (215) 591-3033 972 (3) 926-7656 |
|---|---|---|---|
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner Denise Bradley Nancy Leone |
Israel United States United States |
972 (3) 926-7687 (215) 591-8974 (215) 284-0213 |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
8 בארצות הברית יותר מ30- מיליון איש מתמודדים יום יום עם כאבים הנובעים מאוסטיאוארטריטיס , ומספר דומה 9 של אנשים מתמודדים עם כאבים כרוניים בגב התחתון . על פי התחזיות, שתי אוכלוסיות אלו ימשיכו לגדול חולים רבים חווים כאב בעוצמה בינונית עד חמורה, עם בעיה של חוסר 2,3 בהתמדה באחוזים בודדים כל שנה. לטיפולים במשככי כאב קיימים, כגון אופיואידים ונוגדי דלקת שאינם 11 ו/או היענות לא מספקת 10 סבילות סטרואידים )NSAID). קיים צורך משמעותי בתרופות יעילות לשיכוך כאבים, שיעניקו הקלה למטופלים ללא 3 הסיכונים של הרעלה ושינויים בסבילות הנלווים לנטילת אופיואידים ונוגדי דלקת שאינם סטרואידים. מרשמים ונטילתם כרוכה בסיכונים ידועים של שימוש לא 12 לאופיואידים מהווים %40 משוק התרופות נגד כאבים כרוניים 3 נכון ושימוש לרעה . עובדה זו מדגישה ביתר שאת את הצורך בטיפולים חלופיים לשיכוך כאבים, שלא מציבים אתגרים רפואיים וחברתיים.
אודות טבע
טבע תעשיות פרמצבטיות בע"מ )TEVA :TASE & NYSE )היא חברת תרופות גלובלית המספקת פתרונות בריאות ממוקדי-מטופל באיכות גבוהה המשמשים מיליוני מטופלים מדי יום. טבע, שבסיסה בישראל, היא יצרנית התרופות הגנריות הגדולה בעולם, הממנפת את צבר מוצריה הכולל יותר מ1000- מולקולות לייצר מגוון רחב של מוצרים גנריים ברוב התחומים הטיפוליים. בתחום התרופות הייחודיות, טבע הינה חברה מובילה בטיפולים חדשניים למחלות מערכת העצבים המרכזית, כולל כאב, והיא מחזיקה גם צבר 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 2015 הסתכמו ב\$19.7- מיליארד. למידע נוסף על החברה, בקרו באתר com.tevapharm.www.
Regeneron Pharmaceuticals, Inc. אודות
Regeneron( NASDAQ: REGN )היא חברה מדעית ביופארמצבטית מובילה שמרכז פעילותה בטאריטאון, ניו יורק. החברה עוסקת בגילוי, המצאה, פיתוח, ייצור ומסחור של תרופות לטיפול במצבים רפואיים קשים.
12 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 7
| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
8 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 120
9 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 115
10 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 148-149
11 Decisions Resources Group. Chronic Pain: Disease Landscape and Forecast. 2016; 147
Regeneron משווקת תרופות למחלות עיניים, עודף כולסטרול מסוג LDL ולמצבים נדירים של דלקות ומפתחת מוצרים בתחומים אחרים שבהם קיים צורך רפואי גבוה שאינו זוכה למענה – ביניהם אונקולוגיה, דלקת פרקים ראומטית, אסטמה ואטופיק דרמטיטיס. ניתן לקבל פרטים נוספים באתר האינטרנט של החברה .@Regeneron בכתובת בטוויטר או www.regeneron.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 acquisition of Allergan's generics 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, 2015 and in our other filings with the U.S.
| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
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.
Regeneron Forward-Looking Statements and Use of Digital Media
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements. Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation fasinumab (REGN475) and the collaboration agreement with Teva Pharmaceutical Industries Ltd. discussed in this news release; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators (including without limitation the development of fasinumab conducted pursuant to the collaboration agreement discussed in this news release) may lead to therapeutic applications; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates, including without limitation fasinumab for pain due to osteoarthritis and chronic low back pain and other potential indications; unforeseen safety issues and possible liability resulting from the administration of products and product candidates in patients; serious complications or side effects in connection with the use of Regeneron's products and product candidates in clinical trials, such as the current and contemplated global clinical development programs evaluating fasinumab; ongoing regulatory obligations and oversight impacting Regeneron's marketed products, research and clinical programs, and business, including those relating to the enrollment, completion, and meeting of the relevant endpoints of post-approval studies; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates (such as fasinumab) and new indications for marketed products; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare, Medicaid, and pharmacy benefit management companies; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement,
| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |
including Regeneron's agreements with Sanofi and Bayer HealthCare LLC (or their respective affiliated companies, as applicable) and the collaboration agreement with Teva Pharmaceutical Industries Ltd. discussed in this news release, to be cancelled or terminated without any product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto. A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2015 and its Form 10-Q for the quarterly period ended June 30, 2016. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).
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| Teva IR Contacts: | Kevin C. Mannix | United States | (215) 591-8912 |
|---|---|---|---|
| Ran Meir | United States | (215) 591-3033 | |
| Tomer Amitai | Israel | 972 (3) 926-7656 | |
| Regeneron IR Contact: |
Manisha Narasimhan, PhD [email protected] |
United States | (914) 847-5126 |
| Teva PR Contacts: | Iris Beck Codner | Israel | 972 (3) 926-7687 |
| Denise Bradley | United States | (215) 591-8974 | |
| Nancy Leone | United States | (215) 284-0213 | |
| Regeneron PR Contact: Alexandra Bowie | [email protected] | United States | (914) 847-3407 |