Akira Kato, Shionogi CEO

One year af­ter Fetro­ja ap­proval, Sh­iono­gi ex­pands la­bel to in­clude dif­fi­cult-to-treat pneu­mo­nia

A year af­ter snag­ging ap­proval in com­pli­cat­ed uri­nary tract in­fec­tions, Sh­iono­gi’s an­tibi­ot­ic Fetro­ja has added an­oth­er in­di­ca­tion to its la­bel: hos­pi­tal-ac­quired and ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia.

The FDA OK was based on Phase III da­ta which showed the drug — chem­i­cal­ly known as ce­fide­ro­col — was non-in­fe­ri­or to high-dose meropen­em in all-cause mor­tal­i­ty (ACM) af­ter two weeks. Ac­cord­ing to the Japan­ese biotech, 12.4% of mod­i­fied in­tent-to-treat pa­tients on Fetro­ja died af­ter 14 days, com­pared to 12.2% of pa­tients on meropen­em.

Par­tic­i­pants in the tri­al, dubbed APEKS-NP, were giv­en 2 grams of ei­ther Fetro­ja or meropen­em over a 3-hour pe­ri­od every 8 hours for 14 days. At Day 28, ACM was at 22.1% for Fetro­ja pa­tients, and 21.1% for high-dose meropen­em pa­tients. The rate of treat­ment-emer­gent ad­verse events was slight­ly high­er for those on Fetro­ja ver­sus meropen­em: 87.8% and 86.0% re­spec­tive­ly.

“An­timi­cro­bial re­sis­tance is a ma­jor glob­al health con­cern, and there is a clear need for new treat­ments such as FETRO­JA to give clin­i­cians more op­tions to fight life-threat­en­ing in­fec­tions caused by Gram-neg­a­tive pathogens,” Sh­iono­gi CEO Aki­ra Ka­to said in a state­ment.

Ce­fide­ro­col was ap­proved last No­vem­ber for cUTIs. It’s de­signed to bind to fer­ric iron and en­ter the out­er mem­brane of bac­te­r­i­al cells via the iron trans­porters.

In a study with 448 cU­TI pa­tients, 72.6% were clear of bac­te­ria and symp­toms af­ter 7 days, com­pared to 54.6% of pa­tients in the con­trol arm, ac­cord­ing to the FDA. But the drug came with a grim warn­ing: Some pa­tients on Fetro­ja had a high­er mor­tal­i­ty rate com­pared to those on the best avail­able ther­a­py. All-cause mor­tal­i­ty was 24.8% in noso­co­mi­al pneu­mo­nia, blood­stream in­fec­tion and sep­sis pa­tients treat­ed with Fetro­ja af­ter 28 days, ver­sus 18.4% on oth­er ther­a­pies, ac­cord­ing to the com­pa­ny. The cause of the in­creased mor­tal­i­ty is un­known, ac­cord­ing to the drug’s warn­ing la­bel.

Noso­co­mi­al pneu­mo­nia is par­tic­u­lar­ly dif­fi­cult to treat. Last May, it tripped up Swiss biotech Polyphor, which halt­ed en­roll­ment in its piv­otal Phase III tri­al for murepavadin af­ter in­ves­ti­ga­tors no­ticed high rates of acute kid­ney in­jury.

“Noso­co­mi­al pneu­mo­nia is one of the most com­mon hos­pi­tal-ac­quired in­fec­tions and a ris­ing num­ber are caused by dif­fi­cult-to-treat, mul­tidrug-re­sis­tant pathogens, which can be a dead­ly threat for pa­tients,” Richard Wun­derink, APEKS prin­ci­pal in­ves­ti­ga­tor and North­west­ern Uni­ver­si­ty Fein­berg School of Med­i­cine pro­fes­sor, said in a state­ment.

In Jan­u­ary, the WHO not­ed a lack of new an­tibi­otics in the mak­ing, as drug de­vel­op­ers are at­tract­ed to oth­er fields. “Nev­er has the threat of an­timi­cro­bial re­sis­tance been more im­me­di­ate and the need for so­lu­tions more ur­gent,” Tedros Ad­hanom Ghe­breye­sus, WHO di­rec­tor-gen­er­al, said in a state­ment.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new details of what needs fixing, Lupin disclosed last week that the FDA recently sent a warning letter to its Tarapur, India-based site.

After an inspection from March 22 to April 4, Lupin disclosed in an April stock filing that it received a Form 483 with four observations, but it didn’t offer any details on the observations.

Similar to comments made in April, the company said last week it does not believe the FDA slap will disrupt its drug supplies or the existing revenues from operations of this facility.

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Silviu Itescu, Mesoblast CEO

Mesoblast sends in im­proved po­ten­cy as­say, look­ing to re­sub­mit to FDA on acute graft-ver­sus-host dis­ease drug

In 2020, the FDA rejected Mesoblast’s remestemcel-L, or Ryoncil, its lead candidate for pediatric acute graft-versus-host disease (aGVHD) that didn’t respond to steroids. The FDA raised a number of concerns, first objecting to Mesoblast’s single arm, open-label trial, though regulators struggled to describe how a randomized trial would work, since pediatricians and parents were reluctant to put children with aGVHD in a placebo arm.

Tim Whitten, Taiho Oncology CEO

FDA green­lights Ot­su­ka sub­sidiary's bile duct can­cer drug

Otsuka subsidiary Taiho Oncology nabbed an accelerated approval on Friday for Lytgobi (futibatinib), its new kinase inhibitor to treat adults with a type of previously treated bile duct cancer, known as metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.

The accelerated approval (meaning a confirmatory trial is necessary to show clinical benefit) follows a shortened six-month review, thanks to the FDA’s Real-Time Oncology Review program.