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.

Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Pfizer CEO Albert Bourla (Drew Angerer/Getty Images)

Pfiz­er is on the verge of claim­ing a multi­bil­lion-dol­lar first-mover ad­van­tage with their Covid-19 vac­cine — an­a­lyst

From the beginning, Pfizer CEO Albert Bourla eschewed government funding for his Covid-19 vaccine work with BioNTech, willing to take all the $1 billion-plus risk of a lightning-fast development campaign in exchange for all the rewards that could fall its way with success. And now that the pharma giant has seized a solid lead in the race to the market, those rewards loom large.

SVB Leerink’s Geoff Porges has been running the numbers on Pfizer’s vaccine, the mRNA BNT162b2 program that the German biotech partnered on. And he sees a $3.5 billion peak in windfall revenue next year alone. Even after the pandemic is brought to heel, though, Porges sees a continuing blockbuster role for this vaccine as people around the world look to guard against a new, thoroughly endemic virus that will pose a permanent threat.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

CRISPR Ther­a­peu­tics gets a snap­shot of off-the-shelf CAR-T suc­cess in B-cell ma­lig­nan­cies — marred by the death of a pa­tient

Just days after scientific founder Emmanuelle Charpentier shared the Nobel prize for her work on CRISPR/Cas9, CRISPR Therapeutics $CRSP is showing off a snapshot of success in their early-stage study for an off-the-shelf CAR-T approach to CD19+ B cell malignancies — a snapshot marred by the death of a patient who had been given a high dose of the treatment.

Using their gene editing tech, researchers for CRISPR engineered cells from healthy donors into an attack vehicle aimed at cancer, something that has been achieved with great success using patients’ own cells — the autologous approach. But autologous CAR-T is hampered by the more complex vein-to-vein requirement that delays treatment, and now CRISPR Therapeutics along with other players like Allogene are determined to replace the pioneers with CAR-T 2.0.

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Un­fazed by PhII miss, Roche ush­ers Prothena's Parkin­son's drug in­to late-stage tri­al — a $60M move

Prothena’s prasinezumab may not have met the primary endpoint in Phase II, but its partners at Roche are seeing enough to move it into a late-stage trial for Parkinson’s disease.

The Phase IIb will build on the Phase II PASADENA study, adding a subgroup of early Parkinson’s patients on stable levodopa therapy to the population.

It’s a significant milestone for a $600 million deal that dates back to 2013, as dosing of the first patient — expected next year — will trigger a $60 million milestone payment to Prothena.

CEO Grace Colón (InCarda)

Look­ing to re­pur­pose an old drug to treat ir­reg­u­lar heart­beats, In­Car­da rais­es $30M in first Se­ries C close

A little less than two years after completing its $42 million Series B round, InCarda has returned to the venture well.

The San Francisco-based biotech announced the first portion of its Series C on Wednesday, pulling in $30 million in new funding. Most of the money will give enough runway for InCarda’s InRhythm program, an inhaled therapeutic aiming to treat sudden episodes of irregular heartbeats, through its Phase II trials and prepare it for Phase III.

RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Covid-19 roundup: Ab­bott prof­its soar on test­ing kits; As­traZeneca could soon re­sume US vac­cine tri­als

Abbott Laboratories, one of the companies at the forefront of Covid-19 testing, is seeing big windfalls as a result of the pandemic.

The company reported its third-quarter results Wednesday morning, noting that overall profit went up 26.9% over the same period in 2019 as well as 28.2% in the first nine months of 2020 compared to that timeframe last year. Abbott’s Covid-19 tests drove the profits after seeing strong demand and helped the company beat quarterly estimates.

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