Aca­cia Phar­ma did well on the R&D front — by 2017, it had con­duct­ed four pos­i­tive piv­otal clin­i­cal tri­als for its lead drug, Barhem­sys. Lat­er that year, it sub­mit­ted an FDA ap­pli­ca­tion to mar­ket the drug for res­cue treat­ment of pa­tients who de­vel­op post­op­er­a­tive nau­sea & vom­it­ing (PONV), de­spite hav­ing been giv­en pri­or antiemet­ic pro­phy­lax­is — on­ly to re­ceive a re­jec­tion in Oc­to­ber 2018.

The US agency made its de­ci­sion based on a pre-ap­proval in­spec­tion of a fa­cil­i­ty run by the con­tract man­u­fac­tur­er of the drug’s main in­gre­di­ent — amisul­pride — and not on clin­i­cal or non-clin­i­cal da­ta in the ap­pli­ca­tion, as­sured Aca­cia in a press re­lease, adding that the FDA had asked for no ex­tra stud­ies or da­ta analy­ses re­lat­ed to the treat­ment.

With re­newed en­thu­si­asm lat­er that month, Aca­cia said its con­tract man­u­fac­tur­er had agreed to “in­sti­tute a cor­rec­tive and pre­ven­tive ac­tion plan that will rec­ti­fy the de­fi­cien­cy iden­ti­fied as quick­ly as pos­si­ble. We con­tin­ue to plan for a launch in the first half of 2019,” Aca­cia chief Ju­lian Gilbert said in a state­ment.

Ju­lian Gilbert

Aca­cia then re­sub­mit­ted its mar­ket­ing ap­pli­ca­tion in De­cem­ber, in­di­cat­ing that the FDA’s con­cerns out­lined in the com­plete re­sponse let­ter had been re­solved. But on Fri­day, the com­pa­ny re­ceived an­oth­er re­jec­tion, with the FDA flag­ging the same con­cerns.

“We are on track to com­plete the qual­i­fi­ca­tion of an al­ter­na­tive sup­pli­er of amisul­pride and plan to en­gage with FDA as soon as pos­si­ble to de­ter­mine the most rapid route to ob­tain­ing ap­proval,” Gilbert said in a state­ment on Fri­day.

Barhem­sys is de­signed to help the 30-40% of sur­gi­cal pa­tients who suf­fer from PONV de­spite pri­or pro­phy­lax­is, as well as for com­bi­na­tion pro­phy­lax­is in high-risk pa­tients.

Cam­bridge, UK-based Aca­cia Phar­ma, which al­so has US op­er­a­tions in In­di­anapo­lis, was found­ed in 2007. It has an­oth­er amisul­pride-based drug — APD403 — in mid-stage de­vel­op­ment for chemother­a­py in­duced nau­sea & vom­it­ing.

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.

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.

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. 

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.