Mer­ck tests an­tibi­otics wa­ters again as FDA OKs Zer­bax­a's ex­pand­ed use in pneu­mo­nia

In a rare Big Phar­ma ad­vance in the an­tibi­otics field, Mer­ck has re­vived hopes for Zer­baxa with a new ap­proval for two types of pneu­mo­nia com­mon­ly ob­served in hos­pi­tals.

Joan But­ter­ton Mer­ck via Twit­ter

The drug — which con­sists of ceftolozane and tazobac­tam — has gar­nered mea­ger sales since it was first ap­proved in 2014 for com­pli­cat­ed uri­nary tract in­fec­tions, not even enough to war­rant a men­tion in Mer­ck’s an­nu­al re­port last year.

Back when Mer­ck bought out Cu­bist for $9.5 bil­lion, Zer­baxa was a bright late-stage prospect tapped for peak sales in the lofty block­buster range of $1.2 bil­lion to $1.5 bil­lion or so.

With the ex­pand­ed la­bel, the phar­ma gi­ant could start inch­ing to­ward that goal. Joan But­ter­ton, as­so­ciate vice pres­i­dent in in­fec­tious dis­ease clin­i­cal re­search at Mer­ck, told Fier­cePhar­ma the new in­di­ca­tion is “re­al­ly what Zer­baxa was de­signed to do.”

An­drew Shorr Med­star Health

“Pneu­mo­nia in ven­ti­lat­ed pa­tients re­mains a sig­nif­i­cant clin­i­cal chal­lenge and is as­so­ci­at­ed with sub­stan­tial mor­bid­i­ty and mor­tal­i­ty,” said An­drew Shorr, head of pul­monary, crit­i­cal care and res­pi­ra­to­ry ser­vices, Med­star Wash­ing­ton Hos­pi­tal Cen­ter, added in a state­ment. “The need to cov­er di­verse pathogens in­clud­ing Pseudomonas aerug­i­nosa and cer­tain En­ter­obac­te­ri­aceae adds to the chal­lenge.”

Last Sep­tem­ber, Mer­ck re­port­ed that Zer­baxa scored in a late-stage non-in­fe­ri­or­i­ty show­down with meropen­em for ei­ther ven­ti­lat­ed hos­pi­tal-ac­quired bac­te­r­i­al pneu­mo­nia or ven­ti­la­tor-as­so­ci­at­ed bac­te­r­i­al pneu­mo­nia.

Bri­an Sko­r­ney Baird

While JP Mor­gan an­a­lysts have fore­cast sales of more than $450 mil­lion, Baird’s Bri­an Sko­r­ney was quick to point out Vi­ba­tiv, OK’d for both in­di­ca­tions, does $20 mil­lion a year. Ther­a­vance sold the an­tibi­ot­ic to Cum­ber­land Phar­ma months ago.

Mer­ck, though, is slog­ging along as one of the last Big Phar­ma work­ing on new an­tibi­otics to­geth­er with Roche and Glax­o­SmithK­line — keep­ing a small ear­ly-stage dis­cov­ery team af­ter ax­ing Cu­bist’s group. Its sub­mis­sion for a com­bo of rele­bac­tam, imipen­em and cilas­tatin to treat com­pli­cat­ed uri­nary tract in­fec­tions (cU­TI) and com­pli­cat­ed in­tra-ab­dom­i­nal in­fec­tions is un­der re­view at the FDA.


Im­age: Shut­ter­stock

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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Eu­ro­pean doc­tors di­al up dig­i­tal com­mu­ni­ca­tion with phar­mas, but still lean to­ward in-per­son med meet­ings, study finds

As in-person sales rep access declines in the big five European countries, a corresponding uptick in virtual rep access is happening. It’s not surprising, but it does run counter to pharma companies’ assessment – along with long-held sales rep sway in Europe – that in-person access hadn’t changed.

CMI Media Group and Medscape’s recent study reports that 75% of physicians in the EU5 countries of Spain, Germany, Italy, France and the UK already limit engagements with pharma sales reps, and 25% of those surveyed plan to decrease time with reps.

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Judge al­lows ex­pert tes­ti­mo­ny in GSK tri­al al­leg­ing Zan­tac link to can­cer

A California judge will allow a plaintiff in a state court case to introduce expert testimony connecting a potential carcinogen in former blockbuster medicine Zantac to cancer.

The order was handed down on Thursday from state judge Evelio Grillo, who is now allowing both parties to introduce expert testimony in an upcoming trial after what’s known as a Sargon hearing, where a judge determines the admissibility of expert witnesses and expert opinions.

The Melon family, as seen in Concussion Awareness Now's latest campaign

Ab­bott in­tro­duces the Mel­on fam­i­ly to raise con­cus­sion aware­ness

Abbott is renewing its concussion awareness campaign, weeks after the company received FDA clearance for its lab-based traumatic brain injury (TBI) blood test.

The unbranded campaign features three generations of the Melon family — animated talking melons who slip on toys or take a spill while playing pickleball.

“Don’t mess with your melon. If you hit it, get it checked,” a narrator says.

Sen. Maria Cantwell (D-WA) (Drew Angerer/Pool via AP)

Sen­ate com­mit­tee ad­vances PBM bill as bi­par­ti­san re­forms gain trac­tion

Pharmacy benefit managers are beginning to see enemies on both sides of the aisle: On Wednesday, a US Senate committee advanced to the full chamber a bill to increase PBM transparency and crack down on what lawmakers and critics say are deceptive practices.

The Senate Committee on Commerce, Science and Transportation advanced the bill by a bipartisan 18-9 vote, after hearing testimony last February documenting how PBMs control several key areas of the drug distribution and payment system. The Pharmacy Benefit Manager Transparency Act, introduced by committee chair Maria Cantwell (D-WA) and Budget Committee ranking member Chuck Grassley (R-IA), would make it unlawful for PBMs to engage in:

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