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

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

Cap­i­tal­iz­ing Pablo: The world’s biggest drug roy­al­ty buy­er is go­ing pub­lic. And the low-key CEO di­vulges a few se­crets along the way

Pablo Legorreta is one of the most influential players in biopharma you likely never heard of.

Over the last 24 years, Legorreta’s Royalty Pharma group has become, by its own reckoning, the biggest buyer of drug royalties in the world. The CEO and founder has bought up a stake in a lengthy list of the world’s biggest drug franchises, spending $18 billion in the process — $2.2 billion last year alone. And he’s become one of the best-paid execs in the industry, reaping $28 million from the cash flow last year while reserving 20% of the cash flow, less expenses, for himself.

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As­traZeneca trum­pets the good da­ta they found for Tagris­so in an ad­ju­vant set­ting for NSCLC — but many of the ex­perts aren’t cheer­ing along

AstraZeneca is rolling out the big guns this evening to provide a salute to their ADAURA data on Tagrisso at ASCO.

Cancer R&D chief José Baselga calls the disease-free survival data for their drug in an adjuvant setting of early stage, epidermal growth factor receptor-mutated NSCLC patients following surgery “momentous.” Roy Herbst, the principal investigator out of Yale, calls it “transformative.”

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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No­var­tis jumps in­to Covid-19 vac­cine hunt, as Big Phar­ma and big biotech com­mit to bil­lions of dos­es

After spending most of the pandemic on the sidelines, Novartis is offering its aid in the race to develop a Covid-19 vaccine.

AveXis, the Swiss pharma’s gene therapy subsidiary, has agreed to manufacture the vaccine being developed by Massachusetts Eye and Ear and Massachusetts General Hospital. The biotech will begin manufacturing this month, while the vaccine undergoes further preclinical testing. They’ve agreed to provide the vaccine for free for clinical trials beginning in the second half of 2020, but have not disclosed financials for after.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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