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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER