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ηγωεϊ εδεγςεϊ μςιϊεπεϊθιτεμ ξεχγν λλμ δΰτωψ αχετχρεο® ξςλα ΰϊ δϊτϊηεϊ ξημϊ δθψωϊ πτεφδθας ξβιωδ αχωδ μδψηαϊ δδϊεειδ ωμ χετχρεο® αΰιψετδ εαΰψδ"α βν μθιτεμ αηεμιν ΰωψ μχε αδϊχσ χμιπι ψΰωεο 17/4/2008 ηαψϊ θας δεγιςδ διεν ςμ ϊεφΰεϊ ηιεαιεϊ περτεϊ αξηχψ δ-PreCISe, δξγβιξεϊ λι θιτεμ ξεχγν αϊψετϊ χετχρεο® (glatiramer acetate injection) δτηιϊ ΰϊ δριλεο μδϊτϊηεϊ ξημϊ δθψωϊ δπτεφδ (Clinically Definite MS - CDMS) α-45% αδωεεΰδ μχαεφϊ δαιχεψϊ ΰωψ θετμδ αϊψετϊ γξδ (τμριαε). πϊεπιν ηγωιν ΰμε δεφβε διεν αλπρ δωπϊι δ-60 ωμ δΰχγξιδ δΰξψιχΰιϊ μπειψεμεβιδ (AAN) ΰωψ πςψκ αωιχβε. αδϊαρρ ςμ δϊεφΰεϊ ωδϊχαμε αξηχψ δ-PreCISe, δεβωδ αχωδ μψωεϊ δαψιθιϊ μϊψετεϊ (MHRA) μχαμϊ ΰιωεψι ωιεεχ ωμ χετχρεο® αΰιψετδ βν μθιτεμ αηεμιν ΰωψ μχε αδϊχσ χμιπι ψΰωεο ΰωψ ξδεεδ ριξο ψΰωεπι μθψωϊ πτεφδ. αχωδ ζε πξφΰϊ λςϊ αϊδμιλι αγιχδ. αχωδ γεξδ μδψηαϊ ΰιωεψι δωιεεχ ωμ χετχρεο® ϊεβω αχψεα μξιπδμ δξζεο εδϊψετεϊ δΰξψιχΰι (FDA). τψετ' β'πχψμε χεξι, ξδξημχδ μπειψεμεβιδ αξλεο δξγςι ρο ψτΰμ αξιμΰπε, ΰιθμιδ, εδηεχψ δψΰωι αξηχψ, ΰξψ: "δϊχσ χμιπι ψΰωεο, CIS, δπβψν ξγδ-ξιΰμιπφιδ ΰε ξγμχϊ, διπε δΰιπγιχφιδ δπειψεμεβιϊ δψΰωεπδ μδϊτϊηεϊ ΰτωψιϊ ωμ θψωϊ πτεφδ. ϊεφΰϊ ξηχψ δ-PreCISe ξψΰεϊ αΰετο αψεψ λι θιτεμ ξεχγν ξΰεγ αχετχρεο®, ςεγ αωμα δ-CIS, ξτηιϊ ΰϊ δριλεο μδϊτϊηεϊ δξημδ". χετχρεο® ξΰεωψ λιεν μθιτεμ αθψωϊ πτεφδ αωμα δδϊχτι (RRMS), εδιπε δϊλωιψ διηιγ αςμ πϊεπι ξηχψ τψερτχθιαι μθεεη δΰψεκ - 10 ωπιν ειεϊψ - δξφαιςιν ςμ ιςιμεϊ δθιτεμ εςμ τψετιμ αθιηεϊι βαεδ. ϊεφΰεϊ ξηχψ δ-PreCISe ξΰωψεϊ ωϊψετϊ δχετχρεο® ιςιμδ βν αχψα ηεμιν αωμα δ-CIS δξεχγν, εξψΰεϊ λι διΰ ξτηιϊδ ΰϊ δριλεο μδϊτϊηεϊ θψωϊ πτεφδ ξεληϊ χμιπιϊ (CDMS). λξε λο, δτψετιμ δαθιηεϊι ωμ χετχρεο® μΰεψκ ξηχψ δ-PreCISe ϊΰν μτψετιμ δαθιηεϊ δξελη ωμ δϊψετδ, δξαερρ ςμ ωπιν ψαεϊ ωμ ξηχψ εξιγς ωδφθαψ ξμξςμδ ξ- 100,000 ηεμι θψωϊ πτεφδ δξθετμιν α χετχρεο® αψηαι δςεμν. ξωδ ξπεψ, ρβο πωιΰ ξωΰαιν ιιηεγιιν, ΰξψ: "ϊεφΰεϊ ξψωιξεϊ ΰμε ξγβιξεϊ ααιψεψ ΰϊ ιςιμεϊ δχετχρεο® λαψ αωμαιν δψΰωεπιν ωμ δϊτϊηεϊ θψωϊ πτεφδ. πϊεπιν ΰμε, αωιμεα ςν ιςιμεϊ δϊλωιψ λτι ωδελη αξηχψιν ΰψελι-θεεη ωμ μξςμδ ξ-10 ωπιν, ξξφαιν ΰϊ δχετχρεο® λΰετφιιϊ δθιτεμ δξεςγτϊ ςαεψ ηεμι θψωϊ πτεφδ". ΰεγεϊ δξηχψ ξηχψ δ-PreCISe διπε πιρει ωμα III ΰχψΰι, λτεμ ρξιεϊ, ψθψερτχθιαι, βμεαμι, ψα-ξψλζι, ωπςψκ αλ-100 ξψλζιν αΰψδ"α, ΰιψετδ, ΰψβπθιπδ, ιωψΰμ, ξγιπεϊ ρχπγιπαιδ, ΰερθψμιδ επιε ζιμπγ. δξηχψ λμμ 481 ξθετμιν, ΰωψ μχε αδϊχσ χμιπι ιηιγ εδψΰε ρξξπιν δξψξζιν ςμ θψωϊ πτεφδ ααγιχϊ MRI. αξηχψ δωϊϊτε ηεμιν αςμι πβς τςιμ ΰηγ ωδελη χμιπιϊ. ξηφιϊ ξδηεμιν θετμε αχετχρεο® αξιπεο 20 ξ"β ξγι ιεν, αζψιχδ ϊϊ-ςεψιϊ εμξηφιϊν πιϊπδ ζψιχϊ τμριαε ξγι ιεν - ζΰϊ αξωκ ςγ 36 ηεγωιν ΰε ςγ ϊιςεγ ωμ δϊχσ ωπι εΰαηεπ δηεμιν αθψωϊ πτεφδ ξεληϊ χμιπιϊ (CDMS). ξθετμιν ωΰεαηπε ληεμι CDMS δξωιλε αθιτεμ τςιμ αχετχρεο® αξρβψϊ δπιρει, μϊχετδ ωμ ωπϊιιν περτεϊ. δςψλϊ διςιμεϊ δψΰωεπιϊ πχαςδ ςμ τι ξωκ δζξο ςγ ΰαηεο CDMS, αδϊαρρ ςμ δϊψηωεϊ ΰιψες χμιπι ωπι. αηεγω γφξαψ 2007 τεψρξε ϊεφΰεϊ πιϊεη αιπιιν ξϊελπο ξψΰω, ΰωψ πωςο ςμ λ-80% ξπϊεπι δξηχψ αο ωμεω δωπιν. ξπϊεπι πιϊεη δαιπιιν ςμδ, λι δθιτεμ αχετχρεο® δτηιϊ ΰϊ ωιςεψ δξθετμιν ωΰεαηπε ληεμι CDMS ξ-43% αχαεφϊ αχψϊ δτμριαε μ-25% αμαγ αχαεφϊ δξθετμιν αχετχρεο®. μΰεψ ϊεφΰεϊ πιϊεη δαιπιιν, δξεςφδ δςφξΰιϊ μπιθεψ πϊεπιν (DMC), ωτιχηδ ςμ δξηχψ, δτριχδ ξιιγιϊ ΰϊ ξϊο δτμριαε μχαεφϊ δαιχεψϊ εζΰϊ ξΰηψ ωδχετχρεο® δελη ιςιμ μχαεφϊ δηεμιν εδπιρει δωιβ ΰϊ πχεγϊ διςγ δψΰωιϊ. ΰεγεϊ COPAXONE πϊεπιν χιιξιν ξψΰιν λι μχετχρεο® δωτςδ ρμχθιαιϊ ςμ MHC (ξςψλϊ ϊιΰεν δψχξεϊ δξψλζιϊ) ξρεβ II, ελι διΰ ξτηιϊδ ΰϊ ϊγιψεϊ δδϊχτιν αηεμι θψωϊ πτεφδ αωμα δδϊχτι (RRMS).δθιτεμ αχετχρεο® διπε αςμ ραιμεϊ βαεδδ. δωιξεω αχετχρεο® ξΰεωψ λιεν α-48 ξγιπεϊ αψηαι δςεμν, αδο ΰψδ"α, χπγδ, ξχριχε, ΰερθψμιδ, ιωψΰμ ελμ ξγιπεϊ ΰιψετδ. χετχρεο® ξωεεχϊ αφτεο ΰψδ"α ςμ ιγι Teva Neuroscience Inc, ωδιΰ ηαψϊ αϊ ωμ θας ϊςωιεϊ τψξφαθιεϊ ας"ξ; εαΰιψετδ ςμ ιγι θας ϊςωιεϊ τψξφαθιεϊ ας"ξ ε-Sanofi-Aventis. 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 μϊςωιιδ 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: when and whether the proposed acquisition will be consummated, Teva's ability to rapidly integrate Beryllium's' operations with its own operations and achieve expected synergies, the diversion of management time on merger-related issues, 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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