ינואר 21, 2010 חזור »

טבע מודיעה על קבלת אישור מותנה לגרסה הגנרית של טבליות ®Femara
טבע הודיעה היום כי קבלה אישור מותנה מרשות המזון והתרופות האמריקאית (FDA) לבקשת החברה לייצור ושיווק הגרסה הגנרית של טבליות 2.5 מ"ג של (letrozole) Femara®   של חברת Novartis לטיפול בסרטן השד. האישור הסופי לטבליות ה- letrozole של טבע צפוי להינתן עם פקיעת ההגנה הפטנטית על מוצר המקור ביוני 2011.

על פי נתוני המכירות של IMS, המכירות השנתיות של מוצר המקור בארה"ב היו כ-556 מיליון דולר.

אודות טבע
טבע תעשיות פרמצבטיות בע"מ הינה חברה גלובלית שבסיסה בישראל ואחת מ-20 החברות הפרמצבטיות המובילות בעולם. טבע, המתמחה בייצור תרופות גנריות וייחודיות וייצור חומרים פעילים לתעשייה הפרמצבטית, הינה החברה המובילה בעולם בתחום הגנריקה. לטבע אתרי ייצור, מחקר, שיווק והפצה בישראל, בצפון ובמרכז אמריקה ובאירופה. יותר מ-80% ממכירותיה של הקבוצה הן לצפון אמריקה ואירופה.
 
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 successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products and regulatory changes that may prevent us from utilizing exclusivity periods, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Neurontin®, Lotrel®, Protonix® and Eloxatin®, the current economic conditions, competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic products, the effects of competition on our innovative products, especially Copaxone® sales, dependence on the effectiveness of our patents and other protections for innovative products, the impact of consolidation of our distributors and customers, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, our ability to achieve expected results through our innovative R&D efforts, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority approvals, the uncertainty surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, the regulatory environment and changes in the health policies and structures of various countries, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, our ability to successfully identify, consummate and integrate acquisitions, the potential exposure to product liability claims to the extent not covered by insurance, our exposure to fluctuations in currency, exchange and interest rates, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, our ability to enter into patent litigation settlements and the intensified scrutiny by the U.S. government, the termination or expiration of governmental programs and tax benefits, impairment of intangible assets and goodwill, environmental risks, and other factors that are discussed in this report and in our other filings with the U.S. Securities and Exchange Commission ("SEC").