TEVA PHARMACEUTICALS AND PERRIGO COMPANY ANNOUNCE THE U.S. LAUNCH OF GENERIC TEMOZOLOMIDE
Jerusalem and Allegan, Mich. – August 12, 2013 – Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) and Perrigo Company (NYSE: PRGO;TASE) today announced the launch of the generic equivalent to Temodar® (temozolomide). Teva will manufacture, market and distribute the product in the U.S. and both companies will equally share in the cost and profitability of the product in the U.S. Teva was first to file, making the product eligible for 180 days of marketing exclusivity.
This product is the generic equivalent to Temodar® (temozolomide), indicated for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment and refractory anaplastic astrocytoma patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine. Temodar® had annual sales of approximately $423 million in the United States, according to IMS data as of December 31, 2012. The launch of this product provides a quality alternative, making cancer therapy more cost effective for patients who suffer from this devastating cancer.
Perrigo’s Chairman, President and CEO Joseph C. Papa stated, “This first-to-file launch with our partner Teva is another example of our focus to manufacture complex API’s. We are pleased to offer this important product to patients in the United States.”
“We are pleased to partner with Perrigo to offer patients a high-quality, less expensive alternative of this important medicine. This launch demonstrates Teva’s commitment to continue to pursue first-to-market opportunities and enhance the value of our portfolio by concentrating on high-margin, low competition markets,” stated Allan Oberman, President and CEO of Teva Americas Generics.
About Teva Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.
About Perrigo From its beginnings as a packager of generic home remedies in 1887, Allegan, Michigan-based Perrigo Company has grown to become a leading global provider of quality, affordable healthcare products. Perrigo develops, manufactures and distributes over-the-counter (OTC) and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, animal health, dietary supplements and active pharmaceutical ingredients (API). The Company is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market. The Company’s primary markets and locations of logistics operations have evolved over the years to include the United States, Israel, Mexico, the United Kingdom, India, China and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements 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, including our ability to develop, manufacture, market and sell biopharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our specialty, including innovative, R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation. our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with complex Medicare and Medicaid reporting and payment obligations, governmental investigations into sales and marketing practices (particularly for our specialty pharmaceutical products), uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology-based products, adverse effects of political or economical instability, corruption, major hostilities or acts of terrorism on our significant worldwide operations, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, any failure to retain key personnel or to attract additional executive and managerial talent, the impact of continuing consolidation of our distributors and customers, variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities, the termination or expiration of governmental programs or tax benefits, environmental risks and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2012 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Perrigo’s Safe Harbor Statement: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward- looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward- looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control. These and other important factors, including those discussed under “Risk Factors” in the Company’s Form 10-K for the year ended June 30, 2012, as well as the Company’s subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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
PR Contacts: Iris Beck Codner Israel 972 (3) 926-7246 Denise Bradley United States (215) 591-8974
Perrigo IR Contacts: Arthur J. Shannon (269) 686-1709 [email protected] Bradley Joseph (269) 686-3373 [email protected]
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טבע ופריגו מודיעות על השקת טמוזולומיד גנרי בארה"ב
ירושלים, ישראל, ואלגן, מישיגן – 21 באוגוסט, 1122 – טבע תעשיות פרמצבטיות בע"מ )NYSE: TEVA( וחברת פריגו )NYSE: PRGO;TASE( הודיעו היום על השקת הגירסה הגנרית ל- ®Temodar )טמוזולומיד(. טבע תייצר, תשווק ותפיץ את המוצר בארה"ב, ועלות המוצר ורווחיו בארה"ב יתחלקו שווה בשווה בין שתי החברות. טבע הייתה הראשונה להגיש בקשה לשיווק התרופה ) First to File(, ועל כן היא זכאית ל083- ימי בלעדיות בשוק. מוצר זה הוא הגירסה הגנרית של ®Temodar )טמוזולומיד(, לטיפול במבוגרים שקיבלו אבחנה חדשה של גליובלסטומה רב-צורנית (GBM - Glioblastoma multiforme) בשילוב עם טיפול בהקרנות ולאחר מכן כטיפול אחזקתי, ובמטופלים עם אסטרוציטומה אנאפלסטית עיקשת ) refractory anaplastic astrocytoma( שחוו התקדמות של המחלה בעודם מטופלים בתרופות המכילות nitrosourea ו- procarbazine. תרופת המקור, ®Temodar, רשמה מכירות שנתיות של כ360- מיליון דולר בארה"ב, על פי נתוני IMS נכון ל00- בדצמבר 6306. השקת מוצר זה מספקת אלטרנטיבת טיפול איכותית, המציעה טיפול אונקולוגי במחיר תחרותי למטופלים הסובלים מסרטן קשה זה. יו"ר נשיא ומנכ"ל פריגו, ג'וזף פאפא, אמר כי "ההשקה הבלעדית של המוצר, בשיתוף עם טבע, היא דוגמה נוספת להתמקדותנו בייצור חומרי גלם פעילים מורכבים. אנו שמחים להציע מוצר חשוב זה למטופלים בארה"ב." "אנו מרוצים מההזדמנות לשתף פעולה עם פריגו ולהציע למטופלנו אלטרנטיבה לתרופה חשובה זו, באיכות גבוהה ובמחיר נמוך יותר. ההשקה מעידה על המחויבות של טבע להמשיך ולאתר הזדמנויות להגשה ראשונה ולהגביר את ערך סל המוצרים שלנו על ידי התמקדות בשווקים עם שולי רווח גבוהים ותחרות נמוכה," אמר אלן אוברמן, נשיא ומנכ"ל תחום הגנריקה בטבע אמריקה.
אודות טבע טבע תעשיות פרמצבטיות בע"מ )NYSE: TEVA( היא חברת תרופות גלובלית המחויבת לפיתוח ולשיווק תרופות באיכות גבוהה בהישג יד בכל מקום בעולם. החברה, שבסיסה בישראל, עוסקת ביצור תרופות גנריות, תרופות ייחודיות וממותגות ובייצור חומרי גלם פעילים לתעשייה הפרמצבטית. טבע מובילה את שוק התרופות הגנריות העולמי, עם נוכחות ביותר מ23- מדינות ועם סל תרופות של למעלה מ- 0,333 מולקולות הנמכר ביותר מ063- שווקים. התרופות הייחודיות והממותגות של החברה מתמקדות בתחומי מערכת העצבים המרכזית, האונקולוגיה, הכאב, הנשימה ובריאות האישה, כמו גם בתחום התרופות הביולוגיות. טבע מעסיקה כיום כ- 32,333 איש. מכירות החברה הסתכמו בשנת 6306 ב- 63.0 מיליארד דולר.
איריס בק קודנר תקשורת התאגיד [email protected] 30-7629280 תומר אמיתי קשרי משקיעים [email protected] 30-7629222
אודות פריגו מאז היווסדה כבית אריזה לתרופות גנריות ביתיות בשנת 0889 בעיירה אלגן במישיגן, צמחה חברת פריגו להיות ספקית מובילה בעולם של מוצרי בריאות איכותיים במחירים סבירים. פריגו מפתחת, מייצרת ומפיצה תרופות גנריות במרשם וללא מרשם )OTC(, תחליפי חלב, מוצרי תזונה, בריאות בעלי חיים, תוספי מזון וחומרי גלם פעילים לתעשייה הפרמצבטית )API(. החברה היא היצרנית הגדולה בעולם של מוצרים פרמצבטיים ללא מרשם לשוק מותגי החנויות. השווקים העיקריים של החברה ואתרי הפעילות הלוגיסטית שלה התפתחו לאורך השנים וכוללים כיום את ארצות הברית, ישראל, מקסיקו, בריטניה, הודו, סין ואוסטרליה. בקרו באתר פריגו באינטרנט )http://www.perrigo.com(.
Teva's Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements 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, including our ability to develop, manufacture, market and sell biopharmaceutical products, competition for our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential purported generic equivalents), competition for our generic products (including from other pharmaceutical companies and as a result of increased governmental pricing pressures), competition for our specialty pharmaceutical businesses, our ability to achieve expected results through our specialty, including innovative, R&D efforts, the effectiveness of our patents and other protections for innovative products, decreasing opportunities to obtain U.S. market exclusivity for significant new generic products, our ability to identify, consummate and successfully integrate acquisitions, the effects of increased leverage as a result of recent acquisitions, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our potential exposure to product liability claims to the extent not covered by insurance, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation. our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, any failures to comply with complex Medicare and Medicaid reporting and payment obligations, governmental investigations into sales and marketing practices (particularly for our specialty pharmaceutical products), uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology-based products, adverse effects of political or economical instability, corruption, major hostilities or acts of terrorism on our significant worldwide operations, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, any failure to retain key personnel or to attract additional executive and managerial talent, the impact of continuing consolidation of our distributors and customers, variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities, the termination or expiration of governmental programs or tax benefits, environmental risks and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2012 and in our
איריס בק קודנר תקשורת התאגיד [email protected] 30-7629280 תומר אמיתי קשרי משקיעים [email protected] 30-7629222
other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Perrigo’s Safe Harbor Statement: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company’s future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “potential” or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company’s control. These and other important factors, including those discussed under “Risk Factors” in the Company’s Form 10- K for the year ended June 30, 2012, as well as the Company’s subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward- looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
איריס בק קודנר תקשורת התאגיד [email protected] 30-7629280 תומר אמיתי קשרי משקיעים [email protected] 30-7629222