ηγωεϊ εδεγςεϊ μςιϊεπεϊ
θας ξϊηιμδ πιρει αωμα δ- III μαιρερ ιςιμεϊ βγεμδ ιεϊψ ωμ ξιπεο βαεδ ωμGLATIRAMER ACETATE μθιτεμ αδτηϊϊ ϊγιψεϊ δδϊχτιν αθψωϊ πτεφδδπιρει πεςγ μαρρ ϊεφΰεϊ δπιρει αωμα II ωδελιη ιςιμεϊ βαεδδ αδτηϊϊ ϊγιψεϊ δδϊχτιν εδπβςιν αξεη
27/7/2006 θας ξεγιςδ ςμ ϊηιμϊ πιρει ψηα διχσ αωμα δ- III αξθψδ μαρρ ΰϊ δϊεφΰεϊ δηιεαιεϊ ωδεωβε απιρει αωμα δ- II ωδωεεδ ξιπεο ηγω εβαεδ ιεϊψ ωμ 40 ξ"β μιεν ωμ GLATIRAMER ACETATE (GA) μξιπεο δξΰεωψ λςϊ, ωμ χετχρεο® 20 ξ"β μιεν ωιςιμεϊε ετψετιμ αθιηεϊ δωιξεω αε δεληε διθα ςμ-ιγι ωμεωδ πιρειιν ξψλζιν εδπιριεο εδξηχψ δχμιπι ωπφαψε μΰεψκ ϊχετδ ωμ μξςμδ ξςωεψ. δπιρει δξλεπδ FORTE"" - FORTy mg Efficacy of glatiramer acetate - ξϊηιμ αβιερ 1,000 δηεμιν δξϊελππιν μδλμμ αε α- 160 ξψλζιν αψηαι φτεο ΰξψιχδ, ΰιψετδ, ΰψβπθιπδ ειωψΰμ.
ϊεφΰεϊ δπιρει αωμα δ- II, ωπξωκ 9 ηεγωιν, αΰετο ΰχψΰι ελτεμ ρξιεϊ αωϊι χαεφεϊ ξχαιμεϊ αϊωςιν ηεμιν δεφβε ατβιωδ δωπϊιϊ δ- 58 ωμ δΰχγξιδ δΰξψιχΰιϊ μπειψεμεβιδ (AAN) ΰωψ πςψλδ αρΰο-γιιβε, χμιτεψπιδ αιο δ- 1 μ-8 αΰτψιμ, 2006. ηεμιν ΰωψ πθμε ΰϊ δξιπεο δβαεδ ωμ GA δψΰε ιψιγδ δβγεμδ α- 38% αξρτψ δξξεφς δξφθαψ ωμ δπβςιν δτςιμιν αξεη λτι ωπξγγ ααγιχϊ MRI (magnetic resonance images) αιηρ μΰμε δπεθμιν ξιπεο ωμ χετχρεο® (GA) 20 ξ"β μιεν. απερσ, αδωεεΰδ μωιςεψ δδϊχτιν δωπϊι θψεν δλπιρδ μπιρει, ηεμιν ΰωψ πθμε GA αξιπεο 40 ξ"β μιεν ηεε ιψιγδ αξξεφς δδϊχτιν αωιςεψ ωμ 77% αζξο δπιρει, αςεγ ωηεμιν ΰωψ πθμε χετχρεο® (GA) 20 ξ"β μιεν, ηεε ιψιγδ ωμ 62% αξξεφς δδϊχτιν. τψετιμ δαθιηεϊ ωμ GA 40 ξ"β μιεν ϊΰν ΰϊ ζδ ωμ δξιπεο δξΰεωψ χετχρεο® GA 20 ξ"β μιεν.
"ϊεφΰεϊ δπιρει αωμα II ξαθιηεϊ ξΰεγ εξφαιςεϊ ςμ λκ ωιςιμεϊε δξεληϊ ωμ χετχρεο® ιλεμδ μδωϊτψ ΰσ ιεϊψ αγεψ δαΰ ωμ ."GA ΰξψ ιωψΰμ ξχεα πωιΰ εξπλ"μ θας. δϊημϊ πιρει δ- FORTE διπδ ημχ ξξηειιαεϊιπε μηεμι θψωϊ πτεφδ, μτϊη ςαεψν ϊδμιλι ψιτει ξωετψιν δξωμαιν ιςιμεϊ εαθιηεϊ αψξεϊ δβαεδεϊ αιεϊψ" δερισ ξψ ξχεα.
ϊιΰεψ δξηχψ εδϊεφΰεϊ
πιρει δ- FORTE ιξωκ 12 ηεγωιν, ιδιδ ψα-μΰεξι, ιϊψηω αξψλζιν ψαιν ειδιδ ΰχψΰι, αχαεφεϊ ξηχψ ξχαιμεϊ, λτεμ ρξιεϊ. ηεμιν ιϊτμβε αΰετο ΰηιγ εΰχψΰι μΰηϊ ξϊεκ ωϊι χαεφεϊ: 40 ξ"β GA ΰηϊ μιεν ΰε χετχρεο® (GA) 20 ξ"β ΰηϊ μιεν. ξθψεϊ δπιρει λεμμεϊ δωεεΰδ ωμ ωιςεψ διςιμεϊ εδαθιηεϊ ωμ δζψχδ ϊϊ-ςεψιϊ ςμ αριρ ιεξι ωμ 40 ξ"β GA μζε ωμ χετχρεο® (GA) 20 ξ"β αηεμι RRMS. ηεμιν ΰωψ ηεε δϊχτιν ξεληιν εϊετςεϊ μεεΰι ιδιε ϊηϊ ξςχα αξωκ λμ δπιρει λεμε. ηεμιν ΰωψ ιωμιξε 12 ηεγωιν, ιξωιλε απιρει τϊεη μξωκ 12 ηεγωιν περτιν, ωαε λμ δξωϊϊτιν ιχαμε 40 ξ"β GA μιεν .
τψθιν περτιν ςμ δπιρει πιϊο μξφεΰ αΰϊψ www.clinicaltrial.gov. χεγ πιρει ξρ' NCT00337779 .
ΰεγεϊ θψωϊ πτεφδ (MS)
θψωϊ πτεφδ πηωαϊ μξημϊ δςφαιν δωλιηδ αιεϊψ αχψα ΰπωιν φςιψιν. ξεςψλιν λ- 400,000 ηεμιν αΰψδ"α αξημδ ζε, ειεϊψ ξωπι ξμιεο ηεμιν αψηαι δςεμν. MS διΰ ξημδ λψεπιϊ τψεβψριαιϊ demyelinating ωμ ξςψλϊ δςφαιν δξψλζιϊ δτεβςϊ αξεη, ηεθ δωγψδ εςφαι δψΰιιδ. ηεμι MS ςμεμιν μηεεϊ ριξτθεξιν τιριιν ε/ΰε χεβπθιαιν, δλεμμιν ηεμωδ, ςιιτεϊ, πιεεο ωψιψιν, ϊτχεγ μχει, αςιεϊ αωμτεηιϊ ωϊο εαξςι δβρ εδωτςδ ςμ δηεωιν εςμ δψΰιιδ. μ- MS βν δωτςδ ξωξςεϊιϊ ςμ δϊτχεγ δρεφιΰμι εΰιλεϊ δηιιν ωμ δηεμιν. ΰεγεϊ χετχρεο®
Current data suggest ®Copaxone is a selective MHC class II modulator.
χετχρεο® (glatiramer acetate injection) ξεϊεεδ μδτηϊϊ ϊγιψεϊ δδϊχτιν αηεμιν αωμα δδϊχτι (RRMS).
ϊετςεϊ δμεεΰι δπτεφεϊ αιεϊψ ωμ χετχρεο® δο ΰγξεξιεϊ, λΰα, πτιηεϊ, βιψεγ ΰε βεω αξχεν δδζψχδ, ηεμωδ, ζιδεν, αηιμδ, λΰα τψχιν, ηψγδ επεχωεϊ δωψιψιν.
χετχρεο® ξΰεωψ λιεν α- 44 ξγιπεϊ αψηαι δςεμν, λεμμ ΰψδ"α, χπγδ, ξχριχε, ΰερθψμιδ, ιωψΰμ ελμ δξγιπεϊ δΰψετΰιεϊ. αΰιψετδ, χετχρεο® ξωεεχ ς"ι θας εηαψϊ sanofi-aventis. αφτεο ΰψδ"α, χετχρεο® ξωεεχ ς"ι Teva Neuroscience, Inc.
θας ϊςωιεϊ τψξφαθιεϊ ας"ξ διπδ ηαψδ βμεαμιϊ ωαριρδ αιωψΰμ εΰηϊ ξ- 20 δηαψεϊ δτψξφαθιεϊ δξεαιμεϊ αςεμν. θας, δξϊξηδ αιιφεψ ϊψετεϊ βπψιεϊ ειιηεγιεϊ, ιιφεψ ηεξψιν τςιμιν μϊςωιδ δτψξφαθιϊ εξεφψιν εεθψιπψιν, 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.
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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