Skep­tics pounce as Bio­gen de­tails pos­i­tive sub­group analy­sis on ad­u­canum­ab — and both sides are dig­ging in

“Ex­hil­a­rat­ing.” “A ma­jor ad­vance.” “A mile­stone achieve­ment.” If one had just tuned in­to the pan­el com­ments on Bio­gen’s pre­sen­ta­tion at CTAD, it would seem that the biotech had an im­pres­sive, dis­ease-mod­i­fy­ing Alzheimer’s drug in ad­u­canum­ab.

But off the stage, re­ac­tions to their ad­mit­ted­ly com­pli­cat­ed dataset and the biotech’s ex­pla­na­tion for res­ur­rect­ing a drug that failed its fu­til­i­ty analy­sis were a lot more mixed, with an­a­lysts con­tin­u­ing to ques­tion whether the ev­i­dence is sub­stan­tial enough to war­rant an FDA ap­proval and rais­ing new doubts on the safe­ty side.

In an in­vestor call lat­er in the day, ex­ecs not­ed that they are not plan­ning an­oth­er study and stood by their in­ten­tion, pub­li­cized in Oc­to­ber to much sur­prise, to sub­mit reg­u­la­to­ry fil­ings based on what they have.

“We don’t file willy nil­ly,” said Al San­drock, head of R&D. “We on­ly go to fil­ing when we be­lieve that there is a ben­e­fit-risk ar­gu­ment based on sci­ence, based on da­ta. And if you look at our his­to­ry, we haven’t done fil­ings right and left with­out good rea­son.”

Bio­gen had a the­o­ry go­ing in­to the Clin­i­cal Tri­als on Alzheimer’s Dis­ease meet­ing.

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