Eli Lil­ly has suf­fered through the biggest set­backs in late-stage drug de­vel­op­ment work for Alzheimer’s — pil­ing up high-pro­file fail­ures for sema­gace­s­tat, solanezum­ab and just months ago lan­abece­s­tat af­ter it be­came ap­par­ent that the BACE ap­proach was a non-starter in symp­to­matic pa­tients. To­day, it’s sig­nal­ing that the com­pa­ny is now ready to fold their hand ear­ly if it doesn’t look like they have a rea­son­able chance to go on to win the pot.

Out in the quar­ter­ly cleanup went a Phase II BACE com­bo in­clud­ing an an­ti­body for N3PG. And the com­pa­ny al­so axed what was termed an SEL BACE 1 Phase I study. N3PG will con­tin­ue on its own.

“There are many vari­abil­i­ties at play with the BACE class and re­cent find­ings from Lil­ly and oth­ers have chal­lenged the BACE hy­poth­e­sis,” notes a spokesper­son from Eli Lil­ly in an email fol­lowup with me. “As a field we are still eval­u­at­ing the class and will con­tin­ue to have ro­bust sci­en­tif­ic dis­cus­sions about its vi­a­bil­i­ty.”

Mer­ck dealt a de­ci­sive blow to BACE with back-to-back Phase III stud­ies in which the drug did what was ex­pect­ed in terms of turn­ing the tap off on amy­loid be­ta, the long­time cul­prit for a dis­ease that wipes out mem­o­ry. With clear ev­i­dence that the strat­e­gy is a non-starter, Lil­ly and its part­ners at As­traZeneca agreed to kill off their late-stage pro­gram for lan­abece­s­tat af­ter re­view­ing the re­sults to date.

But BACE isn’t quite fin­ished yet. 

Back in ear­ly June, Ei­sai and Bio­gen claimed a sig­nif­i­cant suc­cess for their BACE drug, elen­be­ce­s­tat. But while the bio­mark­er for amy­loid be­ta re­duc­tion was hit, the re­searchers failed to see a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in the de­cline of cog­ni­tion. That didn’t stop them from main­tain­ing that they had tracked a re­sponse “sug­gest­ing a de­lay of clin­i­cal symp­tom de­cline in ex­plorato­ry end­points.”

It wasn’t ex­act­ly a big win, rais­ing fresh doubts for two com­pa­nies that con­tin­ue to have a big stake in the amy­loid be­ta the­o­ry.

Ei­sai and Bio­gen have had their hands full de­fend­ing their da­ta on a dif­fer­ent drug, BAN2401, af­ter a change­up in the study de­sign drew a host of crit­ics sug­gest­ing that they had tilt­ed the tri­al to­ward a pos­i­tive out­come. And the crit­ics haven’t backed off af­ter a re­cent at­tempt to de­fend those re­sults.

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Ac­er Ther­a­peu­tics’ bid to re­pur­pose celipro­lol — a be­ta-block­er on the mar­ket for hy­per­ten­sion — as a treat­ment for a rare, in­her­it­ed con­nec­tive tis­sue dis­or­der has hit a se­vere set­back. The New­ton, Mass­a­chu­setts-based com­pa­ny on Tues­day said the FDA re­ject­ed the drug and has asked for an­oth­er clin­i­cal tri­al.

The com­pa­ny’s shares $AC­ER cratered near­ly 77% to $4.47 in Tues­day morn­ing trad­ing.

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.