No­vavax shares are rout­ed af­ter its big PhI­II RSV vac­cine tri­al flops

No­vavax $NVAX says that its big Phase III study of its RSV vac­cine failed bad­ly among old­er sub­jects, flop­ping on the pri­ma­ry as well as sec­ondary out­comes and leav­ing the biotech strug­gling to ex­plain how it fell short here.

The com­pa­ny re­cruit­ed 11,856 peo­ple over the age of 60 for this study, look­ing for clear ev­i­dence to sup­port a claim that the vac­cine could sig­nif­i­cant­ly pre­vent RSV-as­so­ci­at­ed low­er res­pi­ra­to­ry tract dis­ease – the pri­ma­ry goal – or at least in­ci­dents of all symp­to­matic res­pi­ra­to­ry dis­ease due to RSV. It didn’t work.

Gre­go­ry Glenn, No­vavax

Shares of No­vavax were crushed by the news, plung­ing 83% and wip­ing out the bulk of its $2.2 bil­lion mar­ket cap.

Com­pa­ny ex­ecs spec­u­lat­ed that the fail­ure may have been re­lat­ed to a par­tic­u­lar­ly mild RSV sea­son. They al­so stressed that they don’t have any plans to drop the RSV vac­cine at this stage.

R&D chief Gre­go­ry Glenn said:

“His­tor­i­cal­ly, an­nu­al sea­son­al RSV ARD at­tack rates be­tween 3% and 7% have been ob­served in old­er adults. In our Phase 2 tri­al, we ob­served an RSV ARD at­tack rate of 4.9% and an RSV msLRTD at­tack rate of 1.8%. In con­trast, we ob­served an RSV ARD at­tack rate of 2.0% and an msLRTD at­tack rate of 0.4% in our Phase 3 tri­al.”

Glenn, though, was singing a com­plete­ly dif­fer­ent tune on May 4, when he said that the RSV sea­son was play­ing out as ex­pect­ed. RSV gen­er­al­ly tracks the flu sea­son, be­gin­ning in the fall and wind­ing up by the time he had this to say on the Q1 call with an­a­lysts:

With re­spect to this year’s at­tack rate, we will con­tin­ue to close­ly mon­i­tor sev­er­al dif­fer­ent RSV sur­veil­lance sys­tems for the 2015-2016 sea­sons. Un­like in­fluen­za, the in­ten­si­ty of the an­nu­al na­tion­al RSV sea­son can be rel­a­tive­ly con­sis­tent year-in and year-out. And to­day, this RSV sea­son has re­mained con­sis­tent with pre­vi­ous years. Based on da­ta pro­vide RSVAlert and CDC’s Na­tion­al Res­pi­ra­to­ry and En­teric Virus Sur­veil­lance Sys­tem, the per­cent of RSV pos­i­tive tests is gen­er­al­ly con­sis­tent with the 2014-2015 sea­son and the pri­or five years. This gives us ad­di­tion­al con­fi­dence that we will have [ph] enough events to eval­u­ate the ef­fi­ca­cy of our vac­cine in this pop­u­la­tion over this sea­son.

Gaithers­burg, MD-based No­vavax was on a roll last year with this pro­gram, pick­ing up an $89 mil­lion grant from the Gates Foun­da­tion and launch­ing a sep­a­rate Phase III at the end of the year to see if the vac­cine would work among in­fants through a ma­ter­nal vac­ci­na­tion. The biotech re­port­ed pos­i­tive Phase II da­ta in that group a year ago, along with the big grant for its nanopar­ti­cle tech.

RSV re­search goes back 60 years, but at­tempts to de­vel­op an ef­fec­tive vac­cine have been in­ef­fec­tive so far, leav­ing a big un­met med­ical need and, as yet, noth­ing to stop it.

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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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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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.

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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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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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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David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Merck dived into the R&D fray for a Covid-19 vaccine earlier this week, execs made it clear that they’re not necessarily looking to be first — with CEO Ken Frazier throwing cold water on the hotly-discussed 12- to 18-month timelines. But when it does emerge from behind, the pharma giant clearly expects to play a significant part.

Part of that will depend on next-generation delivery technology that reshapes the world’s imagination of a vaccine.

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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