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.

Andre Kalil, AP Images

A 9/11-era Om­a­ha fa­cil­i­ty, an old Ebo­la drug, and the ubiq­ui­tous Dr. Fau­ci: In­side the first US nov­el coro­n­avirus tri­al

The first 11 coronavirus patients who arrived in Omaha last week, airlifted across the globe after two weeks quarantined on a cruise ship, showed only minor symptoms or none at all. And then one of them — or one of the couple of Americans who arrived later — got worse. He developed pneumonia, a life-threatening complication for coronavirus patients.

In a biocontainment room at the University of Nebraska Medical Center on Friday, doctors infused him with an experimental Gilead drug once developed for Ebola, called remdesivir. Or they gave him a placebo. For the first time in the US, neither he nor the doctors knew.

The first US novel coronavirus trial was underway and with it, a mad dash for an answer. Sponsored by the NIH, the study marked a critical point in the epidemic. Since the start of the outbreak, the agency had helped lead a global effort to contain the virus. Now, as it spread worldwide and the CDC issued warnings the US could see a major internal outbreak, they were looking at home.

“We don’t have too much time,” Andre Kalil, the trial’s lead investigator, told Endpoints News. “Everything’s moving really fast.”

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And she was good, at least good enough to win several national awards and then, at 15, a spot as Romania’s representative to an international school in Canada that accepted about one person per country.

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Brian Stuglik (file photo)

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Left out of an upbeat press release spelling out its clinical plans, and buried below news of a $100 million private placement in an SEC filing, is a planned restructuring that will claim 31 jobs. Alongside some other cost-saving measures, Verastem expects to cut expenses down by $70 million to $80 million per year.

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Olivier Brandicourt (AP Images)

Ex-Sanofi chief Olivi­er Brandi­court, cur­rent Black­stone ad­vi­sor, jumps on Al­ny­lam board

Former Sanofi chief Olivier Brandicourt, who departed his post with an unexpected early retirement last year, has made his move — as most C-suite executives inevitably do — to become a director on the board of a biopharma company.

RNAi player Alnylam is Brandicourt’s destination. Meanwhile, the Cambridge, Massachusetts-based drugmaker — which pioneered the first approval in the field — also disclosed the retirement of Alnylam co-founder Dr. Paul Schimmel from its board.

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After months of questions and speculation about when and if Gilead will make a major acquisition, a name has emerged.

The California-based drugmaker has approached Forty Seven Inc, a cancer biotech, with a takeover offer, Bloomberg News reports. With Forty Seven’s market cap at $2.3 billion, an acquisition would likely be Gilead’s largest since they acquired Kite Pharma for $11.9 billion in 2017.

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Biogen head of R&D Al Sandrock, Sangamo CEO Sandy Macrae

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While the fate of Biogen’s resurrected Alzheimer’s drug aducanumab remains uncertain, the Cambridge, MA-based drugmaker is joining forces with genome editing company Sangamo Therapeutics to develop therapies for neurological conditions.

Sangamo is set to receive a meaty $350 million upfront in cash and stock and is eligible to receive up to $2.37 billion in milestone payments, in addition to royalties. In return, Biogen gets the rights to two Sangamo preclinical compounds: ST-501 (for use in tauopathies including Alzheimer’s disease) and ST-502 (for synucleinopathies including Parkinson’s disease).

“The partnership represents a lower-cost way to expand its work in neurologic disease,” Credit Suisse’s Evan Seigerman said in a note, referring to Biogen.

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