Te­va falls on dis­ap­point­ing sales fore­cast; Akcea and PTC take two drugs to Latin Amer­i­ca

→ Te­va $TE­VA upped its prof­it out­look for the year to­day, but nev­er­the­less saw its share price drop by about 5% as an­a­lysts high­light­ed the con­tin­ued ero­sion of gener­ic drug rev­enue. The Is­raeli com­pa­ny al­so not­ed that it ex­pects to see a de­ci­sion from the FDA on its mi­graine drug fre­manezum­ab in mid-Sep­tem­ber af­ter reg­u­la­tors de­layed their re­view over man­u­fac­tur­ing is­sues.

→ Akcea $AK­CA, the grow­ing Io­n­is $IONS spin­out, is rolling out two of its drugs in Latin Amer­i­ca with the help of a new part­ner. PTC Ther­a­peu­tics $PTC, the Duchenne com­pa­ny that’s re­cent­ly been nab­bing up gene ther­a­pies, will sell Akcea’s Tegse­di and Waylivra in the re­gion. Tegse­di has been ap­proved by the Eu­ro­pean Com­mis­sion to treat polyneu­ropa­thy in hAT­TR amy­loi­do­sis pa­tients, and Waylivra is un­der reg­u­la­to­ry re­view in the US, Eu­rope, and Cana­da to treat fa­mil­ial chy­lomi­crone­mia syn­drome. “One of the key mu­ta­tions that leads to hAT­TR amy­loi­do­sis oc­curs more fre­quent­ly in in­di­vid­u­als of Por­tuguese de­scent,” said Mar­cio Souza, chief op­er­at­ing of­fi­cer at PTC, in a state­ment. “There are ap­prox­i­mate­ly 6,000 pa­tients with polyneu­ro­path­ic hAT­TR amy­loi­do­sis in Latin Amer­i­ca, mak­ing it a strate­gi­cal­ly im­por­tant re­gion for Tegse­di. We are well po­si­tioned to file for reg­is­tra­tion in key Latin Amer­i­can coun­tries in the short term.”

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