ηγωεϊ εδεγςεϊ μςιϊεπεϊ
θας ξεγιςδ ςμ χαμϊ ΰιωεψ ρετι μιφεψ εωιεεχ θαμιεϊ ;Fenofibrate θας ϊεαςϊ ξ-Abbott τιφειιν ξεβγμιν αβεαδ τι ωμεωδ ξΰεαγο δψεεηιν ςμ αριρ ηεχ δδβαμιν δςρχιιν16/5/2005 θας ξεγιςδ λι χιαμδ ΰιωεψ ξψωεϊ δξζεο εδϊψετεϊ δΰξψιχΰιϊ (FDA) μιιφεψ εωιεεχ θαμιεϊ Fenofibrate, αξιπεο ωμ 54 ξ"β ε- 160 ξ"β.
θαμιεϊ Fenofibrate διπε δβιψρδ δβπψιϊ ωμ θαμιεϊ ®Tricor ωμ ηαψϊ Abbott μθιτεμ αιϊψ λεμρθψεμ ειϊψ θψιβμιφψιγιν αγν.
ΰιωεψ ζδ δεΰ αδξωκ μτριχϊ αιϊ δξωτθ δξηεζι α- Delaware ΰωψ χας αργψ γιο ξχεφψ (Summary Judgment) λι θας ΰιπδ ξτψδ θςπεϊ ξρειξεϊ αγαψ δτθπθ ωαξημεχϊ. αιϊ δξωτθ τρχ λι αχωϊ θας μΰιωεψ θαμιεϊ Fenofibrate, ΰωψ πςωϊδ αδμικ διγες λ- Paragraph IV ωμ ηεχ Hatch-Waxman, ΰιπδ ξτψδ ΰϊ τθπθ ξρτψ 6,589,552 ε- 6,074,670 εΰϊ τθπθ ξρτψ 6,277,405.
αξψυ 2004, δ- FDA δςπιχ μθας ΰιωεψ ξεϊπδ μξεφψ. αζξπε, πΰμφδ θας μδξϊιο ϊχετδ ωπιδ ωμ 30 ηεγωιν αιηρ μτθπθ ξρτψ 6,589,552, ΰωψ λςϊ πξφΰ λι θας ΰιπδ ξτψδ τθπθ ζδ. αιϊ δξωτθ ςγιιο φψικ μτρεχ μβαι τθπθιν ξρτψ 6,277,405 ε- 6,652,881. ξεςγ φτει μξωτθ μβαι τθπθιν ΰμε δεΰ 6 αιεπι, 2005.
ηαψϊ Abbott , αξδμκ ϊχετϊ δδϊγιιπεϊ ατθπθ εϊχετϊ δξϊπδ ωμ 30 ηεγωιν, δτριχδ μωεεχ ΰϊ δθαμιεϊ αξιπεπιν ωμ 54 ξ"β ε- 160 ξ"β εδξιψδ ΰϊ ®Tricor θαμιεϊ μξιπεπιν ωμ 48 ξ"β ε- 154 ξ"β. ζεδι δτςν δωπιδ ω - Abbott δξιψδ ΰϊ δξεφψ. μτπι δξψδ ζε, δξλιψεϊ ωμ δξεφψ δξχεψι διε λ- 800 ξμιεο $.
αρεσ ωπϊ 2001, δημδ Abbott μδξιψ ΰϊ δξιπεπιν ωμ λξερεϊ Fenofibrate μθαμιεϊ αξιπεπιν ωμ 54 ξ"β ε- 160 ξ"β. αΰεϊδ δςϊ διϊδ μθας αχωδ μΰιωεψ λξερεϊ Fenofibrate. θας χιαμδ ΰϊ ΰιωεψ ξδ- FDA μωιεεχ δβιψρδ δβπψιϊ ωμ δλξερεϊ αςχαεϊ τριχδ αργψ γιο ξχεφψ (Summary Judgment) ΰεγεϊ λμ δτθπθιν δψωεξιν αOrange Book, ΰαμ ψχ μΰηψ ω-Abbott δτριχδ λαψ ΰϊ ξλιψϊ δλξερεϊ επχθδ αφςγιν μξπες ξθας ΰϊ διλεμϊ μωεεχ ΰϊ δξεφψ λβπψι.
ζξο χφψ μΰηψ δεγςϊδ ωμ Abbott ωδιΰ ξϊλππϊ μδξιψ ΰϊ δξεφψ μτεψξεμφιδ ωεπδ ωμ θαμιεϊ, δβιωδ θας αχωδ μαιϊ δξωτθ μϊχο ΰϊ λϊα δϊαιςδ αϊωεαδ λγι μλμεμ ϊαιςϊ λπβγ Abbott αςπιο δβαμιν ςρχιιν αθςπδ ωτςεμεϊιδ ωμ Abbott τεβςεϊ αϊηψεϊ δβπψιϊ ςμ-ιγι ωϊι δδξψεϊ ωμ δτεψξεμφιεϊ ωςωϊδ Abbott επιφεμ μψςδ ωμ ηεχ .Hatch-Waxman ςμ-ιγι λκ Abott ξπςδ ξδφψλπιν ΰμθψπθιαδ βπψιϊ μξεφψ δξχεψι ωμ Abbott. θας ξαχωϊ μϊαες τιφειιν ξεβγμιν αβεαδ τι ωμεωδ λεμμ ΰεαγο ψεεηιν εωλψ θψηϊ ςεψλι-γιο ςμ αριρ ηεχ δδβαμιν δςρχιιν.
θας ϊςωιεϊ τψξφαθιεϊ ας"ξ διπδ ηαψδ βμεαμιϊ ωαριρδ αιωψΰμ εΰηϊ ξ- 25 δηαψεϊ δτψξφαθιεϊ δξεαιμεϊ αςεμν. θας, δξϊξηδ αιιφεψ ϊψετεϊ βπψιεϊ ειιηεγιεϊ εαιιφεψ ηεξψιν τςιμιν μϊςωιδ δτψξφαθιϊ, διπδ ΰηϊ ξδξεαιμεϊ αςεμν αϊηεν δβπψιχδ. μθας ΰϊψι ιιφεψ, ξηχψ, ωιεεχ εδτφδ αιωψΰμ, αφτεο εξψλζ ΰξψιχδ εαΰιψετδ. χψεα μ- 90% ξξλιψεϊιδ ωμ δχαεφδ δο μφτεο ΰξψιχδ εΰιψετδ.
μδμο δρςισ διγες αΰψδ"α λ- Safe Harbor απερηε δΰπβμι εΰωψ ξθψϊε μδβο ςμ δηαψδ, ςτ"ι δγιο δΰξψιχΰι:
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 managements current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva`s 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 Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic products ,the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the expected reintroduction of Tysabri® into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva`s ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities ,environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its 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 publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on managements current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva`s 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 Teva's ability to rapidly integrate Ivax Corporation's operations and achieve expected synergies, Teva`s ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic products ,the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a resolution of outstanding litigation, including that relating to the generic versions of Allegra®, Neurontin®, Oxycontin® and Zithromax®, the effects of competition on Copaxone® sales, including as a result of the expected reintroduction of Tysabri® into the market, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva`s ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism or major hostilities ,environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its 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 publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
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