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.

Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Covid-19 roundup: 34 AGs call for ‘march-in’ rights on remde­sivir; Hahn pleads with pub­lic to trust FDA's vac­cine re­view

A bipartisan group of 34 attorneys general have asked the federal government to bypass Gilead’s patent rights on remdesivir and begin scaling and distributing the Covid-19 antiviral, or to allow the states to do it themselves.

In a letter to HHS secretary Alex Azar, the AGs expressed frustrations over the $3,250 price tag Gilead placed on the the drug, citing the federal funding that went into its developments. And they noted the sustained difficulties hospitals have faced in getting supplies from either the California biotech or their contract manufacturer AmerisourceBergen.

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Douglas Fambrough, Dicerna CEO (Boehringer Ingelheim via YouTube)

Roche-backed Dicer­na push­es in­to the pack rac­ing to­ward the block­buster hep B goal line, armed with PhI da­ta

Dicerna has lined up a set of proof-of-concept data from a small cohort of hepatitis B patients in a match-up against some heavyweight rivals which got out in front of this race. And right in the front row you’ll find a team from Roche, which paid $200 million in cash and offered another $1.5 billion in milestones to partner with Dicerna $DRNA on their RNAi program for hep B.

Right now it’s looking competitive, with lots of big challenges ahead.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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Ab­b­Vie aban­dons a pi­o­neer­ing CRISPR R&D al­liance with Ed­i­tas as Brent Saun­der­s' deal is cast out

A little more than 3 years ago Allergan paid $90 million in a cash upfront to partner with gene editing player Editas on a CRISPR alliance focused on the eye. The lead program centered on LCA10, a rare, inherited retinal degenerative disease that appears in childhood and leads to blindness.

Allergan then went to AbbVie $ABBV in a buyout, and the pharma giant has no interest in moving forward on the gene editing front. The company punted it all back to Editas Thursday, with the biotech $EDIT noting in a statement after the market closed Thursday that it is regaining all rights for its ocular medicines, including EDIT-101.

Lund­beck sounds taps on an­oth­er CNS drug, re­treat­ing from a mine field still oc­cu­pied by a Mer­ck team

Lundbeck has snipped another clinical-stage branch of its CNS research, dumping a schizophrenia program after determining that their therapy would have no positive influence on the disease.

Designed originally as a 240-patient study, researchers set out in early 2019 to see if a homegrown drug dubbed Lu AF11167 could make it through a proof-of-concept study. The drug is a PDE10Ai inhibitor, targeting an enzyme which it said at the time offered a new pathway to retuning the body’s neurotransmitter dopamine. The big idea was that by hitting their target, the drug would modulate “dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors,” influencing negative symptoms of schizophrenia.

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