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ηγωεϊ εδεγςεϊ μςιϊεπεϊδφμηδ απιρει ωμα II α- Laquinimod ωμ θας μθιτεμ ΰεψΰμι αθψωϊ πτεφδ, θας ιεφΰϊ μπιρει ωμα III αωπϊ 2007 01/05/2007 ϊεφΰεϊ πιρει ωςψλδ ηαψϊ θας δψΰε λι Laquinimod,αξϊο γψκ δτδ (ΰεψμι) αξιπεο ωμ 0.6 ξ"β ξγι ιεν αξωκ 36 ωαεςεϊ, δτηιϊ ξωξςεϊιϊ ΰϊ δτςιμεϊ δγμχϊιϊ αξεη εαπερσ πφτϊδ ξβξϊ ιψιγδ αωιςεψ δδϊχτιν αηεμι θψωϊ πτεφδ αωμα δδϊχτι"ϊεφΰεϊ δπιρει ξελιηεϊ τςν περτϊ ΰϊ τεθπφιΰμ διςιμεϊ εδαθιηεϊ ωμ Laquinimod αξϊο ΰεψΰμι", ΰξψ ωμξδ ιπΰι, πωιΰ εξπλ"μ ηαψϊ θας ϊςωιεϊ τψξφαθιεϊ ας"ξ. "ΰμε ξξφΰιν ξςεγγιν μχδιμϊ ηεμι θψωϊ πτεφδ. ΰπε ξφτιν μδϊηιμ αβιερ δηεμιν μπιρει ωμα III ψηα δδιχσ ωμ Laquinimodλαψ αξδμκ ωπϊ 2007". θας ϊςωιεϊ τψξφαθιεϊ ας"ξ εηαψϊ Active Biotech δωεεγιϊ δεγιςε διεν λι ϊεφΰεϊ πιρει ωςψλε αχψα ηεμι θψωϊ πτεφδ δςμε, ωηεμιν ΰωψ πθμε Laquinimod αξιπεο ωμ 0.6 ξ"β αξϊο γψκ δτδ (ΰεψΰμι) ςμ αριρ ιεξι ηεε δτηϊδ ξωξςεϊιϊ ωμ λ-38% ατςιμεϊ δγμχϊιϊ ωμ δξημδ αξεη λτι ωπξγγδ ααγιχϊ MRI εδψΰε ιλεμϊ ραιμεϊ θεαδ . απερσ, πφτε ξβξϊ ιψιγδ αωιςεψ δδϊχτιν δωπϊι αχψα δηεμιν, δβγμδ αξρτψ δηεμιν ωμΰ ηεε δϊχτιν λμμ εδΰψλϊ ξωκ δζξο ςγ μδετςϊ δδϊχσ δψΰωεο - αιηρ μχαεφδ δαχψδ (τμφαε). αχψα δηεμιν ωθετμε αξιπεο 0.3 ξ"β, μΰ πφτδ δαγμ ξωξςεϊι αιηρ μχαεφϊ δαχψδ. δπιρει, αξρβψϊ δωμα δωπι (IIb) απιρειιν α- Laquinimod, πξωκ 36 ωαεςεϊ εαεφς αχψα ηεμι θψωϊ πτεφδ ξρεβ ( RRMS )θψωϊ πτεφδ αωμα δδϊχτι, δωλιηδ αιεϊψ αιο δρεβιν δωεπιν ωμ θψωϊ πτεφδ. δθιτεμιν δχιιξιν λιεν αωεχ δςεμξι διπν θιτεμιν δπιϊπιν αδζψχδ ΰε ςιψει αμαγ. "ϊεφΰεϊ δπιρει ξελιηεϊ τςν περτϊ ΰϊ τεθπφιΰμ διςιμεϊ εδαθιηεϊ ωμ Laquinimod αξϊο ΰεψΰμι", ΰξψ ωμξδ ιπΰι, πωιΰ εξπλ"μ ηαψϊ θας ϊςωιεϊ τψξφαθιεϊ ας"ξ. "ΰμε ξξφΰιν ξςεγγιν μχδιμϊ ηεμι θψωϊ πτεφδ. ΰπε ξφτιν μδϊηιμ αβιερ δηεμιν μπιρει ωμα III ψηα δδιχσ ωμ Laguinimod λαψ αξδμκ ωπϊ 2007". "πλεο μςλωιε, χιιξεϊ ΰτωψειεϊ θιτεμ ιςιμεϊ αηεμι θψωϊ πτεφδ, ΰεμν θιτεμ α - Laquinimod, δξΰτωψϊ ξϊο γψκ δτδ, ιδεεδ ΰαο γψκ ςαεψ δηεμιν - ωλο ξγεαψ αφεψϊ θιτεμ μΰ-τεμωπιϊ ιιηεγιϊ", ΰξψ τψετ' β'ιΰπχψμε χεξι (Giancarlo Comi), ξπδμ δξημχδ μπειψεμεβιδ αξψλζ δξγςι H. San Raffaele αξιμΰπε, ΰιθμιδ. "ξηχψιν χεγξιν δψΰε ζδ ξλαψ ΰϊ δωτςϊδ δηιεαιϊ ωμ Laquinimod μςεξϊ χαεφϊ δαχψδ, ΰεμν δπϊεπιν δηγωιν ξΰεωωιν ΰϊ δςεαγδ λι ξιπεο βαεδ ιςιμ ιεϊψ, εςγιιο ξΰτωψ ραιμεϊ θεαδ μηεμιν". δπιρει αηο αςζψϊ αγιχεϊ MRI ΰϊ δωτςϊ Laquinimod ςμ τςιμεϊ δξημδ αωπι ξιπεπιν - 0.3 ξ"β ε-0.6 ξ"β - αξϊο ΰεψΰμι ιεξι αξωκ ϊωςδ ηεγωιν, αξςχα ρξει,. μΰηψ ϊχετδ ζε ιιξωκ δξςχα αφεψδ βμειδ, λΰωψ λμ δηεμιν ιθετμε αξιπεο δ-0.6 ξ"β μξωκ 24 ηεγωιν περτιν. δπϊεπιν δεφβε αξρβψϊ δλπρδωπϊι δ-59 ωμ δΰχγξιδ δΰξψιχΰιϊ μπειψεμεβιδ ((AAN ΰωψ ξϊχιιν ααερθεο, ξρφ'ερθρ, ΰψδ"α, αιο δ-28 αΰτψιμ μ-5 αξΰι 2007. ΰεγεϊ δπιρει απιρει δωϊϊτε 306 ηεμι θψωϊ πτεφδ ΰωψ ηεε δϊχσ ΰηγ ΰε ιεϊψ αξδμκ δωπδ ωχγξδ μϊηιμϊ δπιρει, εωρψιχϊ MRI αξεην δψΰϊδ μτηεϊ πβς τςιμ ΰηγ. 102 ηεμιν ξϊελν παηψε αΰχψΰι μχαεφϊ αχψδ. 98 ηεμιν πθμε Laquinimod αξιπεο ωμ 0.3 ξ"β, ε-106 ηεμιν πθμε Laquinimod αξιπεο ωμ 0.6 ξ"β. ωμεω δχαεφεϊ διε γεξεϊ αϊηιμϊ δπιρει ξαηιπδ γξεβψτιϊ, ξαηιπδ χμιπιϊ εξαηιπϊ ξΰτιιπι MRI. δηεμιν παγχε ααηιπδ χμιπιϊ εςμ ιγι ρψιχεϊ MRI ΰψαςδ ωαεςεϊ μτπι ϊηιμϊ δπιρει, αϊηιμϊε εΰηϊ μηεγω δημ ξδωαες δ-12 ςγ δωαες δ-36. δξγγ δξψλζι μδφμηϊ δθιτεμ διδ δξρτψ δξφθαψ ωμ δπβςιν δτςιμιν αξεη - Gd-enhancing αωαεςεϊ 24, 28, 32 ε-36. ϊεφΰεϊ ωπιεπιεϊ ξπιρει ζδ λμμε ξγγι MRI περτιν εΰϊ λξεϊ δδϊχτιν. αχαεφϊ δηεμιν ΰωψ πθμδ Laquinimod αξιπεο 0.6 ξ"β πφτϊδ ιψιγδ αξρτψ δξφθαψ ωμ δπβςιν δτςιμιν αξεη ξρεβ Gd-enhancing αδωεεΰδ μχαεφϊ δαχψδ (ξξεφς ερθιιϊ ϊχο 2.6+-5.3 μςεξϊ 4.2+-9.2, p=0.0048;); εθιτεμ αξιπεο 0.3 ξ"β μΰ δψΰδ ωιπει ξωξςεϊι. ωιπειιν ξωξςεϊιιν μθεαϊ ΰμε ωπθμε Laquinimod αξιπεο 0.6 ξ"β πξφΰε βν αξξγιν περτιν αρψιχϊ MRI. αχαεφϊ δηεμιν ΰωψ πθμδ Laquinimod αξιπεο 0.6 ξ"β πξφΰδ απερσ ξβξϊ ιψιγδ αωιςεψ δδϊχτιν δωπϊι (0.52+/-0.92 μςεξϊ χαεφϊ δαχψδ0.77 +/- 1.25 ; p=0.21), ςμιιδ αξρτψ δηεμιν μμΰ δϊχσ (70.8% μςεξϊ 62.7 % ; p=0.33 ), εδΰψλϊ δζξο ςγ μδϊχσ δψΰωεο (4(p=0.1. δηεμιν δψΰε ραιμεϊ θεαδ μθιτεμ α-Laquinimod αξιπεο 0.3 ξ"β ε-0.6 ξ"β, μξςθ ξρτψ ξχψιν ωμ ςμιιδ ζξπιϊ αΰπζιξι λαγ ωδιιϊδ ϊμειϊ-ξιπεο. ΰεγεϊ Lanquinimod Laquinimod διπδ ϊψλεαϊ Immunomodulatory ηγωδ μωιξεω ιεξι απθιμδ γψκ δτδ, ΰωψ τεϊηδ λθιτεμ μξημϊ θψωϊ πτεφδ (MS). ηαψϊ Active Biotech τιϊηδ ΰϊ Laquinimod εψωξδ ΰεϊδ ϊηϊ ωξδ ωμ ηαψϊ θας ϊςωιεϊ τψξφαθιεϊ ας"ξ αηεγω ιεπι 2004. απιρει Phase IIa χεγν, ωπξωκ 24 ωαεςεϊ αδεαμϊ ηαψϊ Active Biotech, δελη λι Laquinimod αξιπεο 0.3 ξ"β ΰωψ πιϊο αξιπεο ιεξι γψκ δτδ, διπε αςμ ιλεμϊ ραιμεϊ θεαδ εΰσ δτηιϊ ΰϊ διεεφψεϊ δπβςιν δτςιμιν αξεην ωμ ηεμι θψωϊ πτεφδ RRMS. 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, 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. 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 Tevas 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 successfully develop and commercialize additional pharmaceutical products, the introduction of competing generic equivalents, the competition from brand-name companies that are under increased pressure to counter generic products, or competitors that seek to delay the introduction of generic product, Teva's ability to generate revenues and profits closely tied to our success in obtaining U.S. market exclusivity for generic products, the impact of consolidation of our distributors and customers, regulatory changes that may prevent Teva from utilizing exclusivity periods, 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® and Wellbutrin XL® , 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, Tevas ability to successfully identify, consummate and integrate acquisitions, potential exposure to product liability claims which are not covered by insurance, dependence on 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, the difficulty of complex manufacturing of our products and supply delays, environmental risks, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Tevas 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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