ηγωεϊ εδεγςεϊ μςιϊεπεϊ
αθας ε- Barr ξεγιςεϊ ςμ δωχϊ δβιψρδ δβπψιϊ ωμ θαμιεϊ Allegra ς"ι θας αξρβψϊ δρλν ςν Barr6/9/2005 θας ε- Barr ξεγιςεϊ λι ηϊξε ςμ δρλν μδωχϊ θαμιεϊ Fexofenadine Hydrochloride αηεζχιν ωμ 30 ξ"β, 60 ξ"β ε- 180 ξ"β, δβιψρδ δβπψιϊ ωμ θαμιεϊ ®Allegra ωμ ηαψϊ Aventis Pharmaceuticals. δξλιψεϊ δωπϊιεϊ ωμ θαμιεϊ Allegra διε λ- 1.4 ξμιΰψγ $, αδϊαρρ ςμ πϊεπι IMS, μ-12 δηεγωιν ωδρϊιιξε αιεπι 2005.
αξρβψϊ δδρλν, Barr πχθδ αδμιλιν δγψεωιν ςμ-ξπϊ μΰτωψ μθας μχαμ ΰιωεψ ρετι ξψωεϊ δξζεο εδϊψετεϊ δΰξψιχΰιϊ (FDA) μθαμιεϊ Fexofenadine Hydrochloride εωϊελμ μξλεψ ΰϊ δξεφψ αξρβψϊ 180 ιξι δαμςγιεϊ ωμ Barr. αϊξεψδ, Barr ϊχαμ ξθας αξδμκ εμΰηψ ριεν ϊχετϊ δαμςγιεϊ, ΰηεζιν ξερλξιν ξδψεεη δβεμξι ωμ δξεφψ. θας ϊψωεν ΰϊ δξλιψεϊ δπεαςεϊ ξξλιψϊ δξεφψ.
αιεπι 2004, Barr εθας χιαμε αδμικ αργψ γιο ξχεφψ (summary judgment) φε μθεαϊν απεωΰ ΰι-δτψϊ δτθπθ απεβς μωμεωδ τθπθιν εαΰτψιμ 2005 πιϊο φε μθεαϊν αδμικ περσ, ΰσ δεΰ αργψ γιο ξχεφψ, απεωΰ ΰι-ϊχτεϊ τθπθ περσ. τθπθιν περτιν πξφΰιν ςγιιο αδϊγιιπεϊ ξωτθιϊ. μξψεϊ ωθψν πχας ϊΰψικ μγιεο ξωτθι, δηαψεϊ φετεϊ λι γιεο ζδ ιϊχιιν αξδμκ 2006.
"δρλν ζδ εδωχϊ δξεφψ ξιιφβιν δζγξπεϊ ιεφΰϊ γετο μφψλπιν εμωϊι δηαψεϊ" ΰξψ Bruce L. Downey ιε"ψ εξπλ"μ Barr, "μξψεϊ ωαιϊ δξωτθ ςγιιο μΰ γο αξρτψ τθπθιν ϊμειιν εςεξγιν. δδρλν ςν θας ξΰτωψ μπε μξχρν δζγξπεϊ ζε εμημεχ ΰϊ δριλεο δχωεψ αδϊγιιπεϊ ξωτθιϊ".
ιωψΰμ ξχεα, πωιΰ εξπλ"μ θας ΰξψ: "δωχϊ Fexofenadine ηεϊξϊ ηεγωιν ψαιν ωμ ςαεγδ αιο θας μ-Barr εξΰτωψϊ μπε μδχγιν ΰϊ ζξιπεϊε ωμ ξεφψ ηωεα ζδ μμχεηεϊιπε. ξεφψ ζδ ΰσ ξβγιμ ΰϊ ρμ δξεφψιν δβπψιιν δψηα ξξιμΰ ωΰπε ξφιςιν μφψλπιν αΰψδ"α".
Barr διϊδ δηαψδ δψΰωεπδ μδβιω αχωδ μΰιωεψ δβπψι ωμ δξεφψ ((ANDA ϊηϊ δδμικ διγες λ- PIV εμτιλκ χιαμδ αβιπε χιαμδ 180 ιξι αμςγιεϊ, ωλΰξεψ δεςαψε μθας. θαμιεϊ Allegra (Fexofenadine Hydrochloride) ξιεςγεϊ μδχμϊ δϊρξιπιν ωμ πζμϊ ΰμψβιϊ ςεπϊιϊ εμθιτεμ αξημεϊ ςεψ λψεπιεϊ ωριαϊο μΰ ιγεςδ , αξαεβψιν εαιμγιν ξβιμ 6 ωπιν εξςμδ .
ΰεγεϊ θας:
θας ϊςωιεϊ τψξφαθιεϊ ας"ξ διπδ ηαψδ βμεαμιϊ ωαριρδ αιωψΰμ εΰηϊ ξ- 20 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 εαξψλζ ΰξψιχδ εαΰιψετδ. χψεα μ- 90% ξξλιψεϊιδ ωμ δχαεφδ δο μφτεο ΰξψιχδ εΰιψετδ.
About Barr
Barr Pharmaceuticals, Inc. (NYSE: BRL) is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals
Barr Pharmaceuticals, Inc. (NYSE: BRL) is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals
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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