ηγωεϊ εδεγςεϊ μςιϊεπεϊ
θας ε- Lundbeck ξεγιςεϊ λι ®Azilect (rasagiline) μθιτεμ αξημϊ τψχιπρεο δεωχ αΰπβμιδ δωχεϊ περτεϊ αΰιψετδ φτειεϊ αχψεα27/6/2005 θας ϊςωιεϊ τψξφαθιεϊ ας"ξ (θας) ε- H. Lundbeck A/S (Lundbeck) ξεγιςεϊ λι ®Azilect, δπιϊο τςν αιεν λθιτεμ ιηιγ αηεμι τψχιπρεο αωμα δδϊημϊι ωμ δξημδ ελθιτεμ ξωεμα μηεμιν αωμα αιπεπι εξϊχγν ωμ δξημδ, δεωχ αΰπβμιδ. δωχδ ζε διπδ δψΰωεπδ αξγιπεϊ δΰιηεγ δΰιψετΰι εδϊΰτωψδ αςχαεϊ ΰιωεψ μωιεεχ ®Azilect ωδϊχαμ ξψωεϊ δϊψετεϊ δΰιψετΰιϊ (European Medicines Agency EMEA) ξεχγν ιεϊψ δωπδ. ΰιωεψ ζδ ϊχσ αλμ ξγιπεϊ δΰιηεγ δΰιψετΰι εδωχεϊ αξγιπεϊ περτεϊ ξϊελππεϊ αδξωκ δωπδ εα- 2006. δδωχδ δαΰδ ωμ ®Azilect φτειδ μδιεϊ αβψξπιδ αϊεκ ξρτψ ωαεςεϊ.
ιωψΰμ ξχεα, πωιΰ εξπλ"μ θας, ΰξψ:" ΰπε ωξηιν ξΰεγ μδεγις ςμ δδωχδ δψΰωεπδ ωμ ®Azilect αΰιψετδ. ΰπε ηωιν ριτεχ ψα ξτιϊεη ξεφμη ζδ ωμ ξεφψ ηγωπι ωιιϊο ξςπδ μηεμι τψχιπρεο αϊηεξιν ωςγ λδ μΰ διδ μδν τϊψεο ειωτψ ξΰεγ ΰϊ ΰιλεϊ ηιιδν." ξψ ξχεα δερισ: "δωχϊ ®Azilect διΰ φςγ ηωεα αωιϊεσ δτςεμδ δτεψδ ςν ωεϊτπε δωιεεχι Lundbeck λξε βν αωιϊεσ δτςεμδ δδγεχ ωμ θας ςν ξεργεϊ ΰχγξΰιν ιωψΰμιιν αςμι ων ςεμξι."
"®Azilect διπδ ϊψετδ ιςιμδ, τωεθδ μωιξεω εαςμϊ τψετιμ ραιμεϊ θεα ξΰεγ, μθιτεμ αηεμι τψχιπρεο αωμα δδϊημϊι εαωμα δξϊχγν ωμ δξημδ." ΰξψ Ole Chrintz, ρξπλ"μ αλιψ ωμ Lundbeck δξξεπδ ςμ ξλιψεϊ εωιεεχ αΰιψετδ. ξψ Chrintz δερισ: "®Azilect δεΰ δξεφψ διιηεγι δωμιωι ω- Lundbeck ξωιχδ αΰιψετδ αϊεκ ϊχετδ χφψδ ωμ ωμεω ωπιν. Azilect ιδεεδ ϊψεξδ ηωεαδ μρμ δξεφψιν εμΰρθψθβιδ ΰψελϊ δθεεη ωμ Lundbeck μδιεϊ ξεαιμδ βμεαμιϊ αϊηεν δτριλιΰθψιδ εδπειψεμεβιδ."
ΰεγεϊ ®Azilect
®Azilect διπδ ϊψετδ ηγωπιϊ ετεθπθιϊ αςμϊ τςιμεϊ ρμχθιαιϊ ωδιπδ γεψ ωπι μϊψετεϊ δξςλαεϊ αΰετο αμϊι δτικ ΰϊ δΰπζιν Monoamine Oxidase ξρεβ B ((MAO-B. ςιλεα δΰπζιν ξεπς τιψεχ γετξιο, ωδιπε δηεξψ δΰηψΰι αξεη μαχψϊ ϊπεςδ.
τιϊεη ®Azilect μθιτεμ αξημϊ δτψχιπρεο διπε ημχ ξδρλν ωιϊεσ τςεμδ ΰψεκ θεεη αιο θας ε- Lundbeck, μτιϊεη ξωεϊσ εμωιεεχε ωμ ®Azilect αΰιψετδ. αωμεωϊ δωεεχιν δΰιψετΰιν δηωεαιν, ΰπβμιδ, βψξπιδ εφψτϊ, ιωεεχ ®Azilect αξωεϊσ ςμ-ιγι θας ε- Lundbeck.
®Azilect τεϊη ςμ-ιγι ηαψϊ θας ςμ αριρ ξηχψ ωαεφς αθλπιεο - ξλεο θλπεμεβι μιωψΰμ.
ΰεγεϊ ξημϊ δτψχιπρεο:
ξημϊ τψχιπρεο διπδ ξημδ λψεπιϊ, τψεβψριαιϊ, πιεεπιϊ ωμ δξεη. μΰ ιγες ξδε δβεψν δξγειιχ μξημδ εξωςψιν ωξγεαψ αξρτψ βεψξιν ξωτιςιν, δλεμμιν: ϊεψωδ, βεψξιν ραιαϊιιν εβιμ. δϊρξιπιν λεμμιν: ψςγ, πεχωεϊ, ΰιθιεϊ αϊπεςδ εδτψςεϊ αιφιαδ. ςν δϊχγξεϊ δξημδ ξηξιψιν δϊρξιπιν εδηεμδ φτει/δ μραεμ ξριαελιν περτιν δχωεψιν αϊπεςδ, εξτβιςδ αιλεμϊ δϊτχεγ δλμμιϊ. ξημϊ τψχιπρεο τεβςϊ αβαψιν εαπωιν αωιςεψ γεξδ εδδςψλδ διΰ λι ιωπν λ- 4 ξιμιεο ηεμιν αξημδ αψηαι δςεμν. δξημδ ΰετιιπιϊ αςιχψ μβιμ δξαεβψ εωιςεψδ λ- 1% ξχψα δΰελμεριδ ωξςμ μβιμ 65. ξεςψκ λι αΰιψετδ ιωπν ξςμ μξιμιεο ηεμι τψχιπρεο. δξλιψεϊ δςεμξιεϊ ωμ ϊψετεϊ μτψχιπρεο αωπϊ 2003 δρϊλξε αλ- 2.2 ξμιΰψγ γεμψ, ξδν λ- 40% αΰιψετδ.
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 εαιιφεψ ηεξψιν τςιμιν μϊςωιδ δτψξφαθιϊ, διπδ ΰηϊ ξδξεαιμεϊ αςεμν αϊηεν δβπψιχδ. μθας ΰϊψι ιιφεψ, ξηχψ, ωιεεχ εδτφδ αιωψΰμ, αφτεο εαξψλζ ΰξψιχδ εαΰιψετδ. χψεα μ- 90% ξξλιψεϊιδ ωμ δχαεφδ δο μφτεο ΰξψιχδ εΰιψετδ. δξε"τ διηεγι ωμ θας ξϊξχγ ατιϊεη ϊψετεϊ ηγωπιεϊ μξημεϊ δτεβςεϊ αξςψλϊ δςφαιν δξψλζιϊ.
ΰεγεϊ Lundbeck:
H. Lundbeck A/S διΰ ηαψδ τψξφαθιϊ αιπμΰεξιϊ δςερχϊ αξηχψ ετιϊεη, ιιφεψ, ωιεεχ εξλιψδ ωμ ϊψετεϊ τριλιΰθψιεϊ εϊψετεϊ μθιτεμ αδτψςεϊ πειψεμεβιεϊ.
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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