ηγωεϊ εδεγςεϊ μςιϊεπεϊ
θας ϊδιδ ξωεεχϊ αμςγιϊ ωμ ®AZILECT , μθιτεμ αξημϊ δτψχιπρεο, αΰψφεϊ δαψιϊ12/7/2006 θας ϊςωιεϊ τψξφαθιεϊ ας"ξ (Nasdaq:TEVA) εηαψϊ Eisai Co., Ltd Tokyo Stock Exchange/Osaka) (Securities Exchange: 4523 ξεγιςεϊ λι δο δρλιξε μριιν ΰϊ δρλν ωιϊεσ δτςεμδ αιπδο ξξΰι 2003 μωεεχ αξωεϊσ αΰψδ"α ΰϊ ΰζιμχθ® (θαμιεϊ rasagiline) ωμ θας μθιτεμ ατψχιπρεο.
λϊεφΰδ ξλκ, μηαψϊ δαϊ ωμ θας ΰψδ"α μωιεεχ ξεφψιν ιηεγιιν, Teva Neuroscience, Inc. ϊδιδ ΰηψιεϊ αμςγιϊ μωεεχ ΰϊ ΰζιμχθ® αΰψδ"α εμλο ϊδπδ θας ξδϊεφΰεϊ δτιππριεϊ ωιπαςε ξξλιψεϊ ΰζιμχθ® αΰετο ξμΰ. ξΰζ 2003, Teva Neuroscience ιεϊψ ξδλτιμδ ΰϊ ΰπωι δξλιψεϊ ωμδ αδλπεϊ μχψΰϊ δωχδ ζε εδγβιξδ ΰϊ ιλεμεϊιδ ςμ-ιγι δδφμηδ δξωξςεϊιϊ ωμ χετχρεο® δξωξω μδτηϊϊ δϊχτιν μηεμιν αθψωϊ πτεφδ αωμα δδϊχτι.
λτι ωλαψ πΰξψ αδεγςδ ξδ- 17 αξΰι, 2006, θας χιαμδ ΰιωεψ ξδψωεϊ δΰξψιχΰιϊ μξζεο εϊψετεϊ (FDA) μωιεεχ δϊψετδ ΰζιμχθ® αξιπεο ωμ τςν αιεν μξημϊ δτψχιπρεο, δο λθιτεμ ιηιγ μηεμιν αωμα δξεχγν ωμ δξημδ, εδο λθιτεμ ξωεμα ςν levodopa μηεμιν αωμα αιπεπι-ξϊχγν ωμ δξημδ, αξϊο ωμ τςν αιεν. ΰζιμχθ® ιδιδ ζξιο αωεχ δΰξψιχΰι ςγ ρεσ δηεγω.
ξηχψ ωαε rasagiline πιϊο λθιτεμ ξωεμα αηεμι ΰμφδιιξψ δξθετμιν α- ®Aricept ωμ ηαψϊ Eisai δημ α- 2004 επξφΰ αωμα II.
ΰεγεϊ ΰζιμχθ®
ΰζιμχθ® ξΰεωψ μδϊεειδ ωμ θιτεμ αϊρξιπιν ωμ ξημϊ τψχιπρεο ΰιγιετθιϊ (ξξχεψ μΰ ιγες) λθιτεμ ιηιγπι δϊημϊι ΰε λθιτεμ ξωεμα ςν levodopa.
μΰζιμχθ® δϊεειϊ πβγ μωιξεω αιηγ ςν δϊλωιψιν: meperidine, other MAO inhibitors, tramadol methadone, propoxyphene, dextromethorphan, St. Johns wort, mirtazapine, cyclobenzaprine, sympathomimetic amines including over-the-counter cold preparations, and local anesthetics containing sympathomimetic vasoconstrictors. ςμ ηεμιν δπεθμιν ΰζιμχθ® μδξπς ξφψιλϊ ξζεπεϊ ςωιψιν αθιψξιο. ιω μπδεβ αξωπδ ζδιψεϊ εμδξπς ξπθιμδ αε ζξπιϊ ωμ ΰζιμχθ® ςν ϊλωιψιν πεβγι γιλΰεο. λΰωψ ΰζιμχθ® πμχη ιηγ ςν ξςλαι CYP1A2 λξε φιτψετμεχρφιο, δψιλεζ αγν ωμ ψρβ'ιμιο ςμεμ μςμεϊ ςγ τι 2. ΰιο μθτμ αΰζιμχθ® αηεμιν αςμι τβιςδ λαγιϊ αγψβδ αιπεπιϊ ςγ ηξεψδ.
ϊετςεϊ δμεεΰι ωμ ΰζιμχθ® λθιτεμ ιηιγπι λεμμεϊ λΰαι ξτψχιν εδτψςεϊ αςιλεμ; εαθιτεμ ξωεμα α-levodopa λεμμεϊ μιχει αϊπεςεϊ δψφεπιεϊ (γιρχιπζιδ), τφιςεϊ ξχψιεϊ (αςιχψ ςχα πτιμεϊ), ιψιγδ αξωχμ, ϊϊ μηυ γν αςξιγδ,δχΰεϊ, λΰαι ξτψχιν, αηιμδ, ςφιψεϊ, ιεαω ατδ, τψιηδ, ιωπεπιεϊ.
ΰζιμχθ® τεϊη ςμ ιγι θας ςμ αριρ ξηχψ ωξχεψε αθλπιεο ξλεο ιωψΰμι μθλπεμεβιδ.
ΰεγεϊ ξημϊ δτψχιπρεο
ξημϊ δτψχιπρεο διπδ ξημδ λψεπιϊ πιεεπιϊ ωμ δξεη. μΰ ιγες ξδε δβεψν δξγειχ μξημδ, ΰκ ξωςψιν ωξγεαψ αξρτψ βεψξιν ξωτιςιν, δλεμμιν ϊεψωδ, βεψξιν ραιαϊιιν εβιμ.
ϊρξιπι δξημδ λεμμιν ψςγ, πεχωεϊ, ΰιθιεϊ αϊπεςδ εδτψςεϊ αδμιλδ εαιφιαδ. ςν δϊχγξεϊ δξημδ ξηξιψιν δϊρξιπιν εδηεμδ φτει μραεμ ξριαελιν δχωεψιν αϊπεςδ, εΰσ ατβιςδ αιλεμϊ δϊτχεγ δλμμιϊ.
ξρτψ δΰπωιν αψηαι δςεμν δρεαμιν ξδξημδ, ωαγψ"λ τεβςϊ αΰπωιν ξςμ βιμ 50, ξεςψκ αλ-4 ξμιεο ξδν λξμιεο ΰιω αΰψδ"α. δξλιψεϊ δβμεαμιεϊ αωπϊ 2005 ωμ ϊλωιψιν μθιτεμ αξημϊ δτψχιπρεο δρϊλξε αλ- 3 ξμιΰψγ γεμψ. ΰζιμχθ® (θαμιεϊ ψρβ'ιμιο) διπε ριξο ξρηψι ψωεν ωμ θας ϊςωιεϊ τψξφαθιεϊ ας"ξ.
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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