ηγωεϊ εδεγςεϊ μςιϊεπεϊ
θας ε- Active Biotech ξεγιςεϊ λι δεβωδ μ- FDAαχωδ μΰιωεψ LAQUINIMOD λϊψετδ πιριεπιϊ (IND) αξϊο γψκ δτδ μθιτεμ αθψωϊ πτεφδ28/6/2005 θας ϊςωιεϊ τψξφαθιεϊ ας"ξ ε- AB Active Biotech δεγιςε διεν λι δεβωδ μψωεϊ δξζεο εδϊψετεϊ δΰξψιχΰιϊ (FDA) αχωδ μΰιωεψ LAQUINIMOD λϊψετδ πιριεπιϊ Investigational New Drug IND)), ςμ ξπϊ μδϊηιμ απιρει χμιπι ωξθψϊε μχαες ΰν ξϊψηωεϊ ϊβεαεϊ αιο laquinimod μαιο ϊψετεϊ ΰηψεϊ ((drug-drug interaction. ϊεφΰεϊ πιρει ζδ επιρει ωμα IIb δξϊαφς αΰιψετδ (ψΰδ μδμο), ϊδεεπδ αριρ μπιρειιν δτιαεθμιιν (ωμα (IIIδγψεωιν μΰιωεψ διςιμεϊ εδαθιηεϊ ωμ laquinimod αηεμιν ςν θψωϊ πτεφδ αωμα δδϊχτι. φτει λι πιρειιν ΰμδ ιημε α- 2006.
laquinimod διπε ηεξψ ΰιξεπε-ξεγεμθεψι ηγωπι, δπιϊο γψκ δτδ, ωτεϊη ςμ-ιγι Active Biotech. μΰηψεπδ, ηϊξδ θας ςν Active Biotech ςμ δρλν δξχπδ μθας ΰϊ δζλεϊ μτιϊεηε δβμεαμι εωιεεχε ωμ laquinimod.
"ΰπε ωξηιν ξΰεγ μγεεη ςμ φιεο γψκ ξωξςεϊι ζδ", ΰξψ ιωψΰμ ξχεα, πωιΰ εξπλ"μ θας. "δβωϊ αχωδ ζε μΰιωεψ διΰ φςγ ηωεα μχψΰϊ δδϊημδ ωμ δπιρειιν δτιαεθμιιν (ωμα III) ςν laquinimod, ΰωψ ιηγ ςν τιϊεη δχετχρεο® δΰεψΰμι, ξηζχιν ΰϊ ριλειιδ ωμ θας μδιεϊ ψΰωεπδ αωεχ ςν ϊψετδ αξϊο γψκ δτδ εξξηιωιν ΰϊ ξηειαεϊπε μτιϊεη θιτεμιν ηγωιν ςαεψ ηεμιν αθψωϊ πτεφδ εμωιτεψ ΰιλεϊ ηιιδν. "
"ΰπε ωξηιν ξΰεγ ςμ δϊχγξεϊδ ωμ θας αϊλπιϊ δτιϊεη ωμ laquinimod μχψΰϊ πιρειιν χμιπιιν ωμα IIIαΰψδ"α εαΰιψετδ." ΰξψ Sven Andreasson, πωιΰ εξπλ"μ Active Biotech. "μ- laquinimod τψετιμ αθιηεϊ ειςιμεϊ δξϊΰιν μθιτεμ αθψωϊ πτεφδ, αξϊο γψκ δτδ, μθεεη ΰψεκ."
laquinimod ςωει μδιεϊ δϊψετδ δψΰωεπδ αξϊο γψκ δτδ μθιτεμ αθψωϊ πτεφδ, βν λθιτεμ ιηιγ εβν αωιμεα ςν ζψιχϊ δ χετχρεο®, ωτεϊηδ ςμ-ιγι θας εδιπδ λιεν ΰηγ δθιτεμιν δξεαιμιν αωεχ ζδ. απιρει phase IIb λτεμ-ρξιεϊ εξαεχψ ωξϊαφς λςϊ αξρτψ ξγιπεϊ αΰιψετδ, παγχεϊ δραιμεϊ εδιςιμεϊ ωμ laquinimod αξϊο γψκ δτδ, αξιπεο ιεξι μξωκ 9 ηεγωιν ωμ 0.3 ε-0.6 ξ''β αδωεεΰδ μϊψετϊ γξδ.
ΰεγεϊ laquinimod
laquinimod δεΰ ηεξψ ΰιξεπε- ξεγεμθεψι ηγωπι δξτεϊη λϊψετδ μξϊο γψκ δτδ μθψωϊ πτεφδ, επαηψ ςμ-ιγι Active Biotech λξεμχεμδ δξεαιμδ ξϊεκ ϊελπιϊ δ- SAIK ςμ-ρξκ διηρ δΰετθιξμι αιο αθιηεϊ ετςιμεϊ. ϊεφΰεϊ πιρει Phase II ωδρϊιιν μΰηψεπδ δψΰε λι θιτεμ αξωκ 6 ηεγωιν αξιπεο ιεξι ωμ 0.3 ξ"β βψν μδεψγδ ωμ 44% ατςιμεϊ δξημδ, λτι ωξωϊχτϊ αξρτψ πβςι δ- MRI αξεη. αηεμιν ςν ξημδ τςιμδ αϊηιμϊ δπιρει πφτϊδ ιψιγδ ωμ 52%. απερσ, δελιη δπιρει λι μ- laquinimodβν τψετιμ αθιηεϊ ξαθιη δξϊΰιν μθιτεμ μθεεη ΰψεκ. (Neurology 2005; vol 64, No. 6 p 987)
ΰεγεϊ θψωϊ πτεφδ (MS)
θψωϊ πτεφδ διπδ ξημδ λψεπιϊ τψεβψριαιϊ ωμ ξςψλϊ δςφαιν δξψλζιϊ (,(CNS δβεψξϊ μπλεϊ ϊτχεγιϊ επηωαϊ μξημϊ δςφαιν δωλιηδ αιεϊψ αχψα ΰπωιν φςιψιν. δξημδ ξρεεβϊ λξημδ ΰεθε-ΰιξεπιϊ, λιεο ωδιΰ ΰηϊ ξξημεϊ ψαεϊ δπβψξεϊ ςχα λκ ωδξςψλϊ δηιρεπιϊ ωμ δβεσ ϊεχτϊ ΰαψιν αψιΰιν, λΰιμε διε βεσ ζψ. αθψωϊ πτεφδ δϊχτεϊ ΰμε ξλεεπεϊ λπβγ ξςθτϊ δξιιμιο ωμ ϊΰι δςφα αξςψλϊ δςφαιν δξψλζιϊ. λωξςθτϊ δξιιμιο πτβςϊ ΰε πδψρϊ, ϊΰι δςφα ΰιπν ξρεβμιν μωμεη ξρψιν ςφαιιν ξδξεη εΰμ δξεη αιςιμεϊ δγψεωδ , ελκ πβψξιν ϊρξιπι δξημδ.
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 εμξημεϊ ΰεθε-ΰιξεπιεϊ.
ΰεγεϊActive Biotech
Active Biotechδιπδ ηαψδ αιεθλπεμεβιϊ ωαγιϊ δξϊξχγϊ αξηχψ ετιϊεη ωμ ϊψετεϊ. μηαψδ φιπεψ ξεφψιν ξαθιη αϊηεν δξημεϊ δΰεθε-ΰιξεπιεϊ/γμχϊιεϊ εδρψθο. δτψειιχθιν δξϊχγξιν αιεϊψ λεμμιν ΰϊ laquinimod - ξεμχεμδ χθπδ μξϊο γψκ δτδ αςμϊ ξπβπεο τςεμδ ιιηεγι μθιτεμ αθψωϊ πτεφδ, λξε βν ANYARA, μθιτεμ αρψθο αΰξφςεϊ ξςψλϊ δηιρεο αΰιπγιχφιδ ψΰωεπιϊ ωμ ϊΰ μΰ χθο αρψθο δψιΰεϊ. τψειιχθιν ςιχψιιν περτιν αωμαι τιϊεη χμιπι λεμμιν ωμεωδ ξεφψιν αξϊο γψκ δτδ: TASO μρψθο αμεθϊ δςψξεπιϊ, 57-57 μθιτεμ α- SLE ε- ®RhuDex μθιτεμ α- RA.
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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