No­var­tis spin­off Nabri­va fi­nal­ly scores its first an­tibi­ot­ic ap­proval

In May, Nabri­va Ther­a­peu­tics suf­fered a set­back af­ter the FDA re­ject­ed its an­tibi­ot­ic for com­pli­cat­ed uri­nary tract in­fec­tions — the No­var­tis spin­off has now had some bet­ter luck with the US agency, which on Mon­day ap­proved its oth­er drug for com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia.

The drug, lefa­mulin, has been de­vel­oped as an in­tra­venous and oral for­mu­la­tion and been test­ed in two late-stage clin­i­cal tri­als. The se­mi-syn­thet­ic com­pound, whose dos­ing can be switched be­tween the two for­mu­la­tions, is en­gi­neered to in­hib­it the syn­the­sis of bac­te­r­i­al pro­tein by bind­ing to a part of the bac­te­r­i­al ri­bo­some.

Ted Schroed­er Nabri­va

It is the first new class of an­tibi­otics for pneu­mo­nia in near­ly two decades in the Unit­ed States, chief Ted Schroed­er sug­gest­ed in an in­ter­view with End­points News ahead of the ap­proval.

In 2017, the first piv­otal tri­al showed lefa­mulin was as ef­fec­tive as mox­i­floxacin, which be­longs to a fam­i­ly of broad-spec­trum, sys­temic an­tibac­te­r­i­al agents that have been used wide­ly as ther­a­py of res­pi­ra­to­ry and uri­nary tract in­fec­tions called flu­o­ro­quinolones.

In 2018, the FDA re­vised its guid­ance on flu­o­ro­quinolones, ac­knowl­edg­ing their use has been as­so­ci­at­ed with men­tal health side ef­fects and se­ri­ous blood sug­ar dis­tur­bances.

Last year, the sec­ond Nabri­va tri­al al­so showed that lefa­mulin was as ef­fec­tive as mox­i­floxacin — al­though in­vestors were con­cerned by the drug’s side-ef­fect pro­file as cas­es of di­ar­rhea were worse on the lefa­mulin arm, ver­sus in pa­tients giv­en moxi.

On Mon­day, Nabri­va said it ex­pects to launch its drug, via ma­jor spe­cial­ty dis­trib­u­tors, next month. It will car­ry a list price of $205 for the IV ver­sion, per day — while the oral for­mu­la­tion is priced at $275 per day.

The low­est price for the most com­mon ver­sion of mox­i­floxacin is around $27.00, about a 74% dis­count to the av­er­age re­tail price of $106.46, ac­cord­ing to GoodRx es­ti­mates.

Lefa­mulin will have an edge be­cause it is avail­able in an oral for­mu­la­tion — most prod­ucts launched to­day are IV on­ly or prin­ci­pal­ly de­signed for use in a hos­pi­tal, Schroed­er said. “(W)e ac­tu­al­ly think that this is re­al­ly the out­pa­tient op­por­tu­ni­ty, that will be the big dri­ver, ul­ti­mate­ly, of…sales.”

The com­pa­ny $NBRV did not pro­vide its sales ex­pec­ta­tions for the drug, which is to be brand­ed as Xen­le­ta. But H.C. Wain­wright an­a­lysts pro­ject­ed peak sales of $460 mil­lion through 2028 in a note pub­lished last week.

The be­lea­guered field of an­tibi­otics is des­per­ate for a win­ner. For one of the biggest threats to glob­al health, the li­on’s share of an­tibi­ot­ic de­vel­op­ment is tak­ing place in a hand­ful of labs of small bio­phar­ma com­pa­nies as a ma­jor­i­ty of their larg­er coun­ter­parts fo­cus on more lu­cra­tive en­deav­ors. In re­cent months, a hand­ful of an­tibi­ot­ic de­vel­op­ers — in­clud­ing Achao­gen and Tetraphase — have seen their val­ue go up in smoke as fee­ble drug sales frus­trate growth. But on av­er­age, most fresh­ly ap­proved an­tibi­otics have been more po­tent ver­sions of ex­ist­ing class­es of an­tibi­otics.

It is no se­cret that the in­dus­try play­ers con­tribut­ing to the ar­se­nal of an­timi­cro­bials are fast dwin­dling. Drug­mak­ers are en­ticed by green­er pas­tures, com­pared to the long, ar­du­ous and ex­pen­sive path to an­tibi­ot­ic ap­proval that of­fers lit­tle fi­nan­cial gain as treat­ments must be priced cheap­ly, and of­ten lose po­ten­cy over time as mi­crobes grow re­sis­tant to them. Con­se­quent­ly, un­til now there have been no new class of an­tibi­otics ap­proved since the 1980s — and to­day, rough­ly 700,000 deaths an­nu­al­ly are at­trib­uted to drug-re­sis­tant bac­te­ria, ac­cord­ing to the WHO.

“Right now, if we don’t do some­thing to sup­port the small com­pa­nies that have the in­no­v­a­tive prod­ucts, we run a re­al risk of not on­ly com­pa­nies go­ing bank­rupt — but los­ing the an­tibi­ot­ic de­vel­op­ment ex­per­tise that’s res­o­nant with­in those com­pa­nies, be­cause the sci­en­tists tend to move on and do oth­er things,” Schroed­er em­pha­sized.

Weeks ago, the CMS un­veiled a pro­pos­al to re­struc­ture the pay­ment ap­pa­ra­tus to res­cue ex­ist­ing an­tibi­ot­ic man­u­fac­tur­ers, by clas­si­fy­ing drug re­sis­tance in a way will com­pel high­er pay­ments to hos­pi­tals treat­ing pa­tients with an­timi­cro­bial re­sis­tance, and craft­ing a path­way for doc­tors to pre­scribe ap­pro­pri­ate new an­tibi­otics with­out dis­rupt­ing hos­pi­tal bud­gets.

It’s a big step in the right di­rec­tion, Schroed­er said. “An­tibi­ot­ic stew­ard­ship re­lies on us­ing the ap­pro­pri­ate an­tibi­otics for the ap­pro­pri­ate pa­tient at the right time. And when cost is the first de­ci­sion point, it kind of un­der­mines the op­por­tu­ni­ty, un­der­mines the prin­ci­ples of good an­tibi­ot­ic stew­ard­ship.”

He al­so ex­pressed his sup­port for the DIS­ARM (De­vel­op­ing an In­no­v­a­tive Strat­e­gy for An­timi­cro­bial Re­sis­tant Mi­croor­gan­isms) leg­is­la­tion that is cur­rent­ly be­ing con­sid­ered by Con­gress. The bill is de­signed to com­pel re­im­burse­ment by Medicare of an­tibi­otics that treat stub­born in­fec­tions away from the bun­dled pay­ment sys­tem, with­in which all an­tibi­otics cur­rent­ly re­side. “I think ul­ti­mate­ly, that’s the best so­lu­tion,” Schroed­er said.

In May, Nabri­va’s com­pli­cat­ed uri­nary tract in­fec­tion drug, Con­tepo, was spurned by the FDA, which cit­ed is­sues re­lat­ed to fa­cil­i­ty in­spec­tions and man­u­fac­tur­ing de­fi­cien­cies at one of Nabri­va’s con­tract man­u­fac­tur­ers. Lefa­mulin’s man­u­fac­tur­ing ap­pa­ra­tus is com­plete­ly sep­a­rate, Schroed­er added.

Scott Gottlieb, AP Images

Scott Got­tlieb is once again join­ing a team that en­joyed good times at the FDA un­der his high-en­er­gy stint at the helm

Right after jumping on Michael Milken’s FasterCures board on Monday, the newly departed FDA commissioner is back today with news about another life sciences board post that gives him a ringside chair to cheer on a lead player in the real-world evidence movement — one with very close ties to the FDA.

Aetion is reporting this morning that Gottlieb is joining their board, a group that includes Mohamad Makhzoumi, a general partner at New Enterprise Associates, where Gottlieb returned after stepping out of his role at the FDA 2 years after he started.

Gottlieb — one of the best connected execs in biopharma — knows this company well. As head of FDA he championed the use of real-world evidence to help guide drug developers and the agency in gaining greater efficiencies, which helped set up Aetion as a high-profile player in the game.

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Deborah Dunsire. Lundbeck

UP­DAT­ED: Deb­o­rah Dun­sire is pay­ing $2B for a chance to leap di­rect­ly in­to a block­buster show­down with a few of the world's biggest phar­ma gi­ants

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Bright and early European time Monday morning the company announced that it will pay up to about $2 billion to buy Alder, a little biotech that is far along the path in developing a quarterly IV formulation of a CGRP drug aimed at cutting back the number of crippling migraines patients experience each month. In a followup call, Dunsire also noted that the company will likely need 200 to 250 reps for this marketing task on both sides of the Atlantic. And analysts were quick to note that the dealmaking at Lundbeck isn’t done, with another $2 billion to $3 billion available for more deals to beef up the pipeline.

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Tower Bridge in London [Shutterstock]

#UK­BIO19: Join GSK’s Hal Bar­ron and a group of top biotech ex­ecs for our 2nd an­nu­al biotech sum­mit in Lon­don

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Warts for the win: Aclar­is' lead drug clears piv­otal study

Aclaris Therapeutics has found a way to get rid of the warts and all.

The company — which earlier this month decided to focus on its arsenal of kinase inhibitors — on Monday unveiled positive data from a pivotal study testing its lead experimental drug for use in common warts.

The drug, A-101, was tested in a 502-patient study called THWART-2 — patients enrolled had one to six warts before qualifying for the trial. Patients either self-administered A-101 topical solution or a vehicle twice a week over a two-month period. A higher proportion of patients on the drug (a potent hydrogen peroxide topical solution) saw their warts disappear at day 60, versus the vehicle (p<0.0001) — meeting the main goal of the study.  Each secondary endpoint also emerged in favor of A-101, the company said.

Charles Nichols, LSU School of Medicine

Could psy­che­delics tack­le the obe­si­ty cri­sis? A long­time re­searcher in the field says his lat­est mouse study sug­gests po­ten­tial

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