Roche dumps its late-stage SMA drug af­ter gam­bling up to $545M-plus on the pro­gram

Af­ter run­ning in­to re­peat­ed set­backs with its ex­per­i­men­tal drug for spinal mus­cu­lar at­ro­phy, Roche has opt­ed to scrap the ther­a­py it grabbed three years ago with a $545 mil­lion buy­out deal.

In a note to a pa­tients group — a fa­vorite av­enue for the Swiss phar­ma gi­ant — a Roche rep­re­sen­ta­tive ex­plained that reg­u­la­tors at the FDA and the EMA were de­mand­ing a new Phase III study of ole­soxime. That fol­lowed is­sues with man­u­fac­tur­ing and their analy­sis of the OLEOS study which “ac­tu­al­ly showed a wors­en­ing in mo­tor func­tion” among pa­tients on the drug.

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