Af­ter NIH tri­al, EMA be­gins rolling re­view for remde­sivir, set­ting up po­ten­tial au­tho­riza­tions in US and Eu­rope

A day af­ter the NIH re­leased pos­i­tive re­sults from their tri­al test­ing remde­sivir in Covid-19, the EMA has an­nounced the start of a rolling re­view process for the drug. With an FDA de­ci­sion ex­pect­ed to ar­rive in the com­ing days, the news sets the stage for the Gilead an­tivi­ral to be­come the stan­dard-of-care for the dead­ly virus in both the US and Eu­rope.

Yes­ter­day morn­ing, Gilead is­sued a press re­lease that the NIH would soon is­sue pos­i­tive da­ta on a much-an­tic­i­pat­ed tri­al test­ing their an­tivi­ral remde­sivir against a place­bo in Covid-19 pa­tients. The news prompt­ed im­me­di­ate spec­u­la­tion of whether an emer­gency use au­tho­riza­tion (EUA) — a clear­ance from the FDA that by­pass­es the lengthy ap­proval process — would fol­low. The agency had con­tro­ver­sial­ly is­sued an EUA for the an­ti­malar­i­als hy­drox­y­chloro­quine and chloro­quine in March, a de­ci­sion that was tak­en with­out the sup­port of a ran­dom­ized con­trolled tri­al.

“Remde­sivir would ap­pear to meet or ex­ceed stan­dard for au­tho­riza­tion un­der EUA, es­pe­cial­ly rel­a­tive to oth­er EUAs is­sued,” for­mer FDA chief Scott Got­tlieb said on Twit­ter an hour af­ter Gilead’s press re­lease.

Af­ter the da­ta came out — show­ing a 31% im­prove­ment in re­cov­ery time and a nu­mer­i­cal, but not sta­tis­ti­cal­ly sig­nif­i­cant, im­prove­ment in mor­tal­i­ty for pa­tients tak­ing the drug — The New York Times re­port­ed that the FDA could au­tho­rize the drug that day. In a state­ment to End­points News, the FDA didn’t com­ment on the re­port but said the agency has “been en­gaged in sus­tained and on­go­ing dis­cus­sions with Gilead Sci­ences re­gard­ing mak­ing remde­sivir avail­able to pa­tients as quick­ly as pos­si­ble, as ap­pro­pri­ate.”

An­tho­ny Fau­ci, di­rec­tor of the Na­tion­al In­sti­tute of Al­ler­gy and In­fec­tious Dis­eases, in an Oval Of­fice press con­fer­ence, said that the drug should be­come the “new stan­dard of care” for all Covid-19 clin­i­cal tri­als.

The EMA, how­ev­er, has tak­en a hard­er stance on emer­gency au­tho­riza­tions for Covid-19. Four days af­ter the FDA is­sued its let­ter al­low­ing the use of an­ti­malar­i­als, the EMA is­sued a con­trast­ing state­ment. They cau­tioned physi­cians against pre­scrib­ing the drug out­side their ap­proved use or spe­cif­ic na­tion­al pro­to­cols, cit­ing both po­ten­tial side ef­fects and not­ing that, “ef­fi­ca­cy in treat­ing COVID-19 is yet to be shown in stud­ies. (Sub­se­quent da­ta on the drug have yet to clear the pic­ture, al­though large ran­dom­ized con­trol stud­ies are un­der­way.)

The agency said they be­gan the rolling re­view process for remde­sivir in re­sponse to the da­ta from the NIH tri­al, which was the largest ran­dom­ized, place­bo-con­trolled study to read­out on a po­ten­tial Covid-19 drug and the first to show ef­fi­ca­cy. They said they will al­so con­sid­er oth­er da­ta around the drug, in­clud­ing a Chi­nese study pub­lished in The Lancet yes­ter­day that showed no sig­nif­i­cant ef­fi­ca­cy for the drug but in a far small­er pa­tient pop­u­la­tion.

The agency said they could not of­fer a time­line for when a de­ci­sion would be made, al­though the process would be faster than the stan­dard ap­proval process for new drugs.

An emer­gency use au­tho­riza­tion would po­ten­tial­ly al­low for more pa­tients to ac­cess the drug. To date, the an­tivi­ral, orig­i­nal­ly de­vel­oped for he­pati­tis C,  has on­ly been avail­able to pa­tients in clin­i­cal tri­als or un­der spe­cif­ic com­pas­sion­ate use or ex­pand­ed ac­cess pro­to­cols.

In an open let­ter yes­ter­day, Gilead CEO Daniel O’Day said the com­pa­ny has been ramp­ing up sup­ply of the drug since Jan­u­ary and now have about 1.5 mil­lion dos­es on hand. That would be enough for 140,000 cours­es of 10-day treat­ment or 280,000 cours­es of 5-day treat­ments — a Gilead study al­so re­leased yes­ter­day sug­gest­ed both of­fered sim­i­lar ef­fi­ca­cy.

“On the sup­ply side, we are work­ing to build a glob­al con­sor­tium of phar­ma­ceu­ti­cal and chem­i­cal man­u­fac­tur­ers to ex­pand glob­al ca­pac­i­ty and pro­duc­tion,” he said. “In the event of reg­u­la­to­ry ac­tion, we are in dis­cus­sions with var­i­ous groups about how we might bring remde­sivir to the de­vel­op­ing world.”

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

So­cial im­age: An­tho­ny Fau­ci and Deb­o­rah Birx, AP Im­ages

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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