ηγωεϊ εδεγςεϊ μςιϊεπεϊ
θας ξςγλπϊ ςμ ϊεφΰεϊ πιρει χμιπι ωμα II μθιτεμ α ALS αΰξφςεϊ glatiramer acetate αξιπεο 40 ξ"β13/3/2008 δπιρει δψΰδ λι glatiramer acetate αξιπεο 40 ξ"β αθεη μθιτεμ αηεμι ALS ΰκ μΰ ςξγ αιςγ ωδεβγψ ξψΰω θας ξηειαϊ μδξωκ τιϊεη ΰτωψειεϊ θιτεμ ηγωπιεϊ ςαεψ δηεμιν α ALS
ιψεωμιν, ιωψΰμ 13 αξψυ 2008 - θας ϊςωιεϊ τψξφαθιεϊ ας"ξ, δεγιςδ διεν ςμ ϊεφΰεϊ πιρει χμιπι ωμα II δξλεπδ GoALS. δπιρει ϊελπο μΰξεγ ΰϊ ιςιμεϊ εαθιηεϊ δθιτεμ α-glatiramer acetate (GA) αξιπεο 40 ξ"β, δπιϊο αδζψχδ ϊϊ-ςεψιϊ ξγι ιεν, μδτηϊϊ δδϊγψγψεϊ δϊτχεγιϊ αηεμι ALS. ϊεφΰεϊ δπιρει δψΰε λι θιτεμ ιεξιεξι α- GA 40 ξ"β διδ αθεη επραμ διθα (well-tolerated) ς"ι ηεμι ALS(λτι ωδιδ φτει ξψΰω ελτι ωβν ΰεωψ ξρτψ τςξιν αξδμκ δπιρει ςμ ιγι εςγϊ ξςχα δαθιηεϊ ωμ δπιρει), ΰκ δξηχψ μΰ δωιβ ΰϊ διςγ δχμιπι δψΰωεπι λτι ωδεβγψ ξψΰω ελο ιςγιν χμιπιιν περτιν. "μξψεϊ ϊχεεϊιπε εψφεπεϊιπε, glatiramer acetate (GA) αξιπεο 40 ξ"β μΰ δελιη ιςιμεϊ αθιτεμ αξημδ, αγεξδ μξρτψ ψα ωμ ξεμχεμεϊ ψαεϊ ΰηψεϊ ωτεϊηε επαγχε αηεμι ALS ςγ λδ. ϊεφΰεϊ δπιρει ξςιγεϊ ωδθιτεμ α- GA διδ αθεη επραμ διθα ("well-tolerated)" ΰξψ τψετρεψ ειπρπθ ξιιπιπβ'ψ (Professor Vincent Meininger) ξαιϊ δηεμιν Hopital de la Salpetriere ατψιρ, εδηεχψ δψΰωι (Principal Investigator) ωμ δπιρει. "δχδιμδ δξγςιϊ αϊηεν δ-ALS ξαψλϊ ςμ ξηειαεϊδ ωμ θας μδξωικ εμτϊη ΰτωψειεϊ θιτεμ ηγωπιεϊ ςαεψ δηεμιν αξημδ χωδ ζε".
ΰεγεϊ δξηχψ
ξηχψ δ-GoALS διπε πιρει ωμα II βμεαμι, ψα ξψλζι, ΰχψΰι, λτεμ ρξιεϊ, ωπςψκ αχαεφεϊ ξηχψ ξχαιμεϊ (λεμμ χαεφϊ αιχεψϊ), εδϊχιιν α-13 ξψλζιν δξξεχξιν αιωψΰμ, αμβιδ, φψτϊ, βψξπιδ, ΰιθμιδ εαψιθπιδ. δξηχψ δχισ 366 ηεμι ALS, λΰωψ μημχν πιϊο GA αξιπεο 40 ξ"β εμημχν πιϊο τμφαε. δϊψετεϊ πιϊπε μλμ δηεμιν αδζψχδ ϊϊ-ςεψιεϊ μΰεψκ 52 ωαεςεϊ. αιωψΰμ πςψκ δξηχψ ααιϊ δηεμιν ΰιλιμεα εδωϊϊτε αε 13 ηεμιν. δξγγ δςιχψι μδφμηϊ δπιρει διδ ωιπει αξγγ δ-ALSFRS-R. λξε λο, παγχε δαθιηεϊ εδραιμεϊ μϊψετδ. ϊεφΰεϊ δξηχψ δψΰε λι δθιτεμ α-GA αξιπεο 40 ξ"β αθεη επραμ διθα.
ΰεγεϊ θψωϊ ΰξιεθψετιϊ φιγιϊ (ALS)
ALS, διγεςδ βν λ"ξημϊ με βψιβ", διπδ ξημϊ δξπεεπϊ ΰϊ δϊΰιν δξεθεψιιν, ΰωψ ξεαιμδ μωιϊεχ εαρετε ωμ γαψ μξεεϊ - μψεα αξδμκ ϊχετδ ωμ 3-5 ωπιν ξδϊτψφεϊ δξημδ. αξψαιϊ δξχψιν, ριαϊ δξεεϊ διπδ λωμ πωιξϊι. ριξτθεξιν ξϊχγξιν ωμ δξημδ λεμμιν ηεμωϊ ωψιψι δβτιιν, δϊςεεϊεϊ εδϊλεεφεϊ ωψιψιν, μιχειιν αγιαεψ, χωιιν ααμιςδ εμιχει απωιξδ. ξγι ωπδ, ξΰεαηπιν μξςμδ ξ-10,000 ΰιω αΰψδ"α εαΰιψετδ αμαγ ληεμι ALS, εδδςψλδ διΰ λι μτηεϊ 50,000 ΰιω αψηαι δςεμν ηεμιν α-ALS αλμ ζξο πϊεο. αιωψΰμ ηεμιν αξημδ λ- 500 ηεμιν. ΰεγεϊ glatiramer acetate
glatiramer acetate ξεϊεεδ μθιτεμ αδτηϊϊ ϊγιψεϊ δδϊχτιν αηεμι θψωϊ πτεφδ αωμα δδϊχτι (RRMS) 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 ειιφεψ ηεξψιν τςιμιν μϊςωιδ δτψξφαθιϊ, διπδ δηαψδ δξεαιμδ αςεμν αϊηεν δβπψιχδ. μθας ΰϊψι ιιφεψ, ξηχψ, ωιεεχ εδτφδ αιωψΰμ, αφτεο εαξψλζ ΰξψιχδ εαΰιψετδ. ιεϊψ ξ-80% ξξλιψεϊιδ ωμ δχαεφδ δο μφτεο ΰξψιχδ εΰιψετδ.
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 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 CoGenesys' operations with its own operations, the diversion of management time on merger-related issues, and Teva and CoGenesys' ability to successfully develop and commercialize biopharmaceutical products, Teva's ability to accurately predict future market conditions, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel® Famvir®, and Protonix®, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, 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 impact of consolidation of our distributors and customers, the effects of competition on our innovative products, especially Copaxone® sales, 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 Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, 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 or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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 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 CoGenesys' operations with its own operations, the diversion of management time on merger-related issues, and Teva and CoGenesys' ability to successfully develop and commercialize biopharmaceutical products, Teva's ability to accurately predict future market conditions, potential liability for sales of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic versions of Allegra®, Neurontin®, Lotrel® Famvir®, and Protonix®, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the extent to which Teva may obtain U.S. market exclusivity for certain of its new generic products and regulatory changes that may prevent Teva from utilizing exclusivity periods, 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 impact of consolidation of our distributors and customers, the effects of competition on our innovative products, especially Copaxone® sales, 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 Agency and other regulatory authority approvals, the regulatory environment and changes in the health policies and structures of various countries, our ability to achieve expected results though our innovative R&D efforts, Teva's ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims to the extent not covered by insurance, dependence on the effectiveness of our patents and other protections for innovative products, significant operations worldwide that may be adversely affected by terrorism, political or economical instability or major hostilities, supply interruptions or delays that could result from the complex manufacturing of our products and our global supply chain, environmental risks, fluctuations in currency, exchange and interest rates, 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 or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
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