Shares rock­et up as Nabri­va Ther­a­peu­tics touts a PhI­II win for an­tibi­ot­ic

Two weeks af­ter its chief med­ical of­fi­cer re­signed, spark­ing jit­ters among the more hope­ful an­a­lysts fol­low­ing the com­pa­ny, Nabri­va Ther­a­peu­tics $NBRV an­nounced that its key Phase III study for the an­tibi­ot­ic lefa­mulin hit the pri­ma­ry end­point in prov­ing non-in­fe­ri­or to mox­i­floxacin for com­mu­ni­ty-ac­quired pneu­mo­nia.

Col­in Broom

The sched­uled de­par­ture of CMO El­yse Seltzer at the end of this month cre­at­ed some un­cer­tain­ty among the an­a­lysts like Leerink’s Paul Mat­teis, who had cred­it­ed Nabri­va — a No­var­tis spin­out helmed by Col­in Broom — with a 60% shot at suc­cess in this first-of-two Phase III stud­ies, dubbed LEAP I. Those fears proved un­found­ed, which ig­nit­ed a big ral­ly for its shares. Nabri­va’s stock soared 100% in pre-mar­ket trad­ing to­day.

Re­searchers tracked an 87.3% ear­ly clin­i­cal re­sponse rate for IV-to-oral lefa­mulin com­pared to 90.2% for mox­i­floxacin with or with­out line­zol­id. And switch­ing to a mod­i­fied in­tent to treat stan­dard, the biotech al­so laid claim to hit­ting the pri­ma­ry need­ed for the EMA.

In ad­di­tion, the safe­ty pro­file looked good in com­par­i­son, with a sig­nif­i­cant­ly low­er rate of di­ar­rhea in the new an­tibi­ot­ic group.

Leerink’s Paul Mat­teis of­fered a quick thumbs up:

 IV-to-oral lefa­mulin demon­strat­ed non-in­fe­ri­or­i­ty to mox­i­flox­i­cin with or with­out line­zol­id, while a con­sid­er­able amount of dis­clo­sure on safe­ty/tol­er­a­bil­i­ty in the press re­lease sug­gests a fair­ly clean – and like­ly ap­prov­able – pro­file, in our view.

LEAP II is ex­pect­ed to read out top-line oral da­ta in ear­ly 2018, which Nabri­va is hop­ing will set up ap­pli­ca­tions with the key agen­cies.

The biotech’s shares start­ed the day trad­ing at a lit­tle more than half its 2017 high, set in ear­ly March. The stock nose dived abrupt­ly Fri­day af­ter­noon by close to 20%, with no news in ad­vance of the top-line read­out.

Nabri­va pulled off a down­sized IPO with $92 mil­lion about two years ago, which fol­lowed a $120 mil­lion ven­ture round led by Vi­vo Cap­i­tal and Or­biMed that cen­tered on its lead an­tibi­ot­ic.

“These Phase III da­ta pro­vide strong ev­i­dence of the po­ten­tial of lefa­mulin to treat adults with CABP and pro­vide an al­ter­na­tive to a cur­rent gold stan­dard treat­ment reg­i­men,” said Broom in a state­ment. “Due to lefa­mulin’s flex­i­ble dos­ing and tar­get­ed spec­trum of ac­tiv­i­ty against the pathogens most com­mon­ly as­so­ci­at­ed with CABP, in­clud­ing mul­tidrug-re­sis­tant strains, we be­lieve that lefa­mulin is well suit­ed to be a first-line em­pir­ic monother­a­py. I am ex­treme­ly proud and ap­pre­cia­tive of the Nabri­va Ther­a­peu­tics team that has ad­vanced lefa­mulin, which has the po­ten­tial to be the first in a new class of an­tibi­otics for CABP in more than 15 years, from ini­tial dis­cov­ery in our labs to this im­por­tant mile­stone. We con­tin­ue to ex­e­cute on our sec­ond piv­otal tri­al eval­u­at­ing oral lefa­mulin for the treat­ment of CABP, with en­roll­ment ex­pect­ed to com­plete in the fourth quar­ter of 2017 and topline re­sults an­tic­i­pat­ed in the spring of 2018.”

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations. 

UP­DAT­ED: Watch out Bay­er, Roche is com­ing for you with a dis­count price ri­val to the tu­mor ag­nos­tic drug you got from Loxo

Just ahead of schedule the FDA has come through with a key approval for Genentech’s tumor agnostic entrectinib — now headed to the market as Rozlytrek.

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