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ηγωεϊ εδεγςεϊ μςιϊεπεϊ

θας ξεγιςδ ςμ χαμϊ ΰιωεψ μΰζιμχθ® (RASAGILINE) μθιτεμ αξημϊ δτψχιπρεο

17/5/2006 θας ϊςωιεϊ τψξφαθιεϊ ας"ξ (Nasdaq:TEVA) ξεγιςδ λι χιαμδ ΰιωεψ ξδψωεϊ δΰξψιχΰιϊ μξζεο εϊψετεϊ (FDA) μωιεεχ δϊψετδ ΰζιμχθ® (θαμιεϊ ψρβ'ιμιο) μξημϊ δτψχιπρεο, δο λθιτεμ ιηιγ μηεμιν αωμα δξεχγν ωμ δξημδ, ελο λθιτεμ ξωεμα ςν δϊψετδlevodopa μηεμιν αωμα αιπεπι-ξϊχγν ωμ δξημδ, αξϊο ωμ τςν αιεν. ΰζιμχθ® ιδιδ ζξιο αωεχ δΰξψιχΰι αϊεκ 8 ςγ 10 ωαεςεϊ.

ιωψΰμ ξχεα, πωιΰ εξπλ"μ θας ΰξψ: "ΰπε ξψεφιν ξΰεγ ξχαμϊ ΰιωεψ ξδ- FDA μΰζιμχθ®, δϊλωιψ διηιγι μξϊο αξιπεο ωμ τςν αιεν εΰηγ δθιτεμιν διηιγιν αΰψδ"α ωξΰεωψ μθιτεμ αλμ ωμαι ξημϊ δτψχιπρεο, δο λθιτεμ ιηιγ μηεμιν αωμα δξεχγν ωμ δξημδ, εδο λθιτεμ ξωεμα ςν δϊψετδlevodopa μηεμιν αωμαιν ξϊχγξιν ιεϊψ. ΰζιμχθ® πεϊο ξςπδ μφψλιν χιιξιν ηωεαιν ωμΰ διδ μδν ξςπδ ςγ λδ εζΰϊ αΰξφςεϊ ωιμεα ιηεγι ωμ ιςιμεϊ χμιπιϊ, ξιπεο χμ επεη ωμ τςν αιεν, ετψετιμ αθιηεϊι θεα. δδωχδ δφτειδ ωμ ΰζιμχθ® ξδεεδ φιεο γψκ ηωεα αξηειαεϊιπε μτϊη εμδαιΰ μωεχ θιτεμιν ηγωπιιν μξημεϊ πειψεμεβιεϊ".

ξψ ξχεα δερισ εΰξψ:"δϊημπε μΰηψεπδ ααιφες ξηχψ χμιπι βγεμ (ADAGIO) ΰωψ ιαγεχ ΰϊ δωτςϊε ωμ ΰζιμχθ® ςμ δΰθϊ δδϊχγξεϊ ωμ ξημϊ δτψχιπρεο. ΰν ΰλο ιελη λι ΰζιμχθ® ΰλο ξΰθ ΰϊ δϊχγξεϊ δξημδ, ζε μμΰ ρτχ ϊδιδ τψιφϊ γψκ ξωξςεϊιϊ αιεϊψ ςαεψ ηεμι ξημϊ τψχιπρεο".

δηαψδ δαϊ ωμ θας ΰψδ"α μωιεεχ ξεφψιν ιηεγιιν, Teva Neuroscience, Inc. ϊωεεχ ΰϊ ΰζιμχθ® αΰψδ"α. ηαψϊ Eisai Co., Ltd., ωξςεψαϊ ατιϊεη rasagiline ξΰζ ηεγω ξΰι 2003 ϊξωικ μωϊσ τςεμδ ςν θας ατιϊεη ξωεϊσ βμεαμι ωμ rasagiline μθιτεμ αξημϊ δΰμφδιιξψ ςν ζΰϊ, θας ξαιπδ λι αωμ ωιχεμιν ξρηψιιν εργψι ςγιτεϊ ξωμδ, Eisai ςγιιο ωεχμϊ ΰν μωεεχ αξωεϊσ ΰϊ ΰζιμχθ® μωεχ δτψχιπρεο αΰψδ"α.

αξδμκ δωπιν δΰηψεπεϊ, Teva Neuroscience δλτιμδ ΰϊ λεη δξλιψδ ωμδ εδγβιξδ ΰϊ ιλεμϊδ αϊηεν δπειψεμεβι αΰξφςεϊ ξΰξφι δξλιψεϊ εδδφμηδ δξωξςεϊιϊ ωμ χετχρεο®. ξψ ξχεα φιιο: " Teva Neuroscience δαιΰδ ΰϊ χετχρεο® μςξγϊ δξεαιμεϊ ωμε αΰψδ"α διεν εΰπε αθεηιν λι αζλεϊν δδφμηδ ϊηζεψ ςμ ςφξδ βν ςν ΰζιμχθ®".

ΰζιμχθ® διπε δϊλωιψ διηεγι δωπι διεφΰ ξφπψϊ δξεφψιν διηεγιν δξωξςεϊιϊ ωμ θας, ωπιζεπδ αξιγδ ψαδ ξωιϊεσ τςεμδ φξεγ ςν ΰεπιαψριθΰεϊ εξλεπι ξηχψ αιωψΰμ. δϊλωιψ ΰεωψ εδεωχ αδφμηδ αΰιψετδ εαιωψΰμ αωπϊ 2005. δϊλωιψ ξωεεχ λιεν α-13 ξξγιπεϊ δΰιηεγ δΰιψετι, αωιϊεσ τςεμδ ςν ηαψϊ LUNDBECK λημχ ξδρλν ΰρθψθβι ΰψεκ θεεη ςν δηαψδ.

ΰιωεψ ΰζιμχθ® δϊαρρ ςμ πϊεπιν ξωμεωδ ξηχψιν χμιπιιν βγεμιν, ψα-ξψλζιιν, ψα-μΰεξιιν, λτεμι ρξιεϊ, ΰχψΰιιν εξαεχψι τμφαε. ξηχψιν ΰμε, ωλμμε ξςμ 1,600 ηεμιν, δψΰε λι δϊλωιψ ΰζιμχθ® αξϊο ωμ τςν αιεν, διπε θιτεμ ΰτχθιαι εαςμ ραιμεϊ πΰεϊδ λΰωψ πιϊο λθιτεμ δϊημϊι ιηιγπι αωμαιν δξεχγξιν ωμ ξημϊ δτψχιπρεο ελθιτεμ ξωεμα ςν levodopa εϊψετεϊ περτεϊ αωμαιν ξϊχγξιν ιεϊψ ωμ δξημδ.

ΰεγεϊ ΰζιμχθ®
ΰζιμχθ® (θαμιεϊ ψρβ'ιμιο) 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. John’s 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.

ξεςψκ λι λ-4 ξμιεο ΰπωιν αψηαι δςεμν ρεαμιν ξδξημδ, ωαγψ"λ τεβςϊ αΰπωιν ξςμ βιμ 50, 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. χψεα μ- 90% 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 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 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.