Daniel O'Day speaks during a meeting with President Donald Trump in the Oval Office of the White House (AP Images)

FDA cheers on Gilead­'s remde­sivir with a snap emer­gency OK, giv­ing bio­phar­ma a shot at re­demp­tion

The FDA didn’t leave much time to as­sess the pos­i­tive na­ture of the first cut of da­ta from a con­trolled study of remde­sivir in se­vere­ly af­flict­ed coro­n­avirus cas­es. On Fri­day the agency stamped their ap­proval on Gilead’s drug, which NI­AID di­rec­tor An­tho­ny Fau­ci has al­ready de­ter­mined should be­come the new stan­dard of care in treat­ing hos­pi­tal­ized pa­tients fight­ing off Covid-19.

Then on Sun­day, Gilead CEO Dan O’Day took to “Face the Na­tion” to promise that the first 1.5 mil­lion dos­es of this drug — enough to treat any­where from 100,000 to 200,000 pa­tients — would be rushed, free of charge, to US cities where it is need­ed the most.

“(W)e in­tend to get that to pa­tients in the ear­ly part of this next week, be­gin­ning to work with the gov­ern­ment, which will de­ter­mine which cities are most vul­ner­a­ble and- and where the pa­tients are that need this med­i­cine.”

While Wall Street an­a­lysts have been dis­ap­point­ed by O’Day’s lack of clar­i­ty on what it plans to charge for this drug, the com­pa­ny finds it­self in a unique po­si­tion to re­frame Amer­i­cans’ at­ti­tude to­ward drug­mak­ers. Be­fore the pan­dem­ic, phar­ma ex­ecs were held in low­er es­teem than law­mak­ers, rest­ing at the bot­tom of the totem pole in terms of pop­u­lar­i­ty. Now the com­pa­ny that shocked pay­ers in­to ac­tion on high hep C drug prices is in the dri­ver’s seat on Covid-19. If they pass muster on their price now, Gilead and the Roche vet who now helms the com­pa­ny will set the pace for the en­tire in­dus­try and go a long way for a pub­lic reap­praisal of the in­dus­try.

Any mis­han­dling of this, how­ev­er, could be a dis­as­ter.

Gilead has raised geopo­lit­i­cal con­cerns by hand­ing the ini­tial drug sup­ply over to the US gov­ern­ment. The whole world is scram­bling for ther­a­peu­tic in­ter­ven­tions, and giv­ing every­thing to Amer­i­cans won’t sit well abroad.

Af­ter re­cal­i­brat­ing the pri­ma­ry end­point, re­searchers de­ter­mined that the drug cut the av­er­age time to re­cov­ery to 11 days in the drug arm, com­pared to 15 in the con­trol group. The drug arm mor­tal­i­ty rate hit 8%, beat­ing out the con­trol group at 11%, but failed to come in at a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment on the first cut of the da­ta.

The ap­proval comes just 2 months af­ter the out­break tru­ly be­gan to rat­tle the US, and 3 months af­ter the Wuhan out­break trig­gered a pan­dem­ic that has killed peo­ple and shat­tered economies around the globe, sick­en­ing mil­lions. The FDA’s ac­tion fol­lows an emer­gency use au­tho­riza­tion for hy­drox­y­chloro­quine and chloro­quine, malar­ia meds that have al­so raised safe­ty alarms on their side ef­fects.

Stephen Hahn

As FDA com­mis­sion­er Stephen Hahn ob­served, the time it took to ramp up the tri­al and gain emer­gency au­tho­riza­tion stretched over 90 days — vir­tu­al­ly light speed in drug R&D and reg­u­la­to­ry terms. The FDA has made it clear that reg­u­la­tors will move first and ask com­plex ques­tions lat­er. And in this case, there’s still much left to learn about remde­sivir, in­clud­ing the best dose and its im­pact on dif­fer­ent pa­tient groups.

An­oth­er mys­tery is how Gilead plans to make mon­ey on the drug — and how much. An­a­lysts grilled CEO O’Day on that score on Thurs­day evening, dur­ing their Q1 call, but to no avail. All that has yet to play out, as Gilead of­fers the first 1.5 mil­lion dos­es for free.

O’Day’s em­pha­sis on re­spon­si­bil­i­ty first and prof­its sec­ond, though, has some dis­count­ing any up­side for the com­pa­ny.

Evan Seiger­man at Cred­it Su­isse was one of the first an­a­lysts to make a com­ment, not­ing:

We do not ex­pect RDV to be a sig­nif­i­cant com. biz for GILD & do not mod­el any sales.

Gilead’s stock, which has surged dra­mat­i­cal­ly from the start of the year, was down close to 5% by the clos­ing bell on Fri­day.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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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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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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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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:”.

Covid-19 roundup: Buoyed by soar­ing shares, No­vavax inks a $167M deal to buy Covid-19 vac­cine-mak­ing fa­cil­i­ty; France cools on hy­drox­y­chloro­quine

The pandemic has offered the best news Novavax has had in years. Its stock price is trading at 7x the pre-panic levels with a Covid-19 vaccine in the mix, as investors buy anything that moves in that field, and they’re flush to carve out their own pathway on the manufacturing front.

Wednesday morning Novavax reported that they are spending $167 million on the Czech-based Praha Vaccines, bagging a manufacturing facility along the way.

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