President Donald Trump speaks during a meeting with restaurant industry executives about the coronavirus response, in the State Dining Room of the White House, Monday, May 18, 2020, in Washington. (Evan Vucci, AP Images)

Covid-19 roundup: Trump says he's been tak­ing hy­drox­y­chloro­quine for days; Mod­er­na rais­es $1.3B on the heels of ground­break­ing da­ta

A cou­ple of months af­ter he start­ed tout­ing hy­drox­y­chloro­quine as a po­ten­tial treat­ment for Covid-19 on thin ev­i­dence, Pres­i­dent Don­ald Trump re­vealed that he’s been tak­ing the an­ti-malar­ia drug for a lit­tle over a week.

Trump’s pub­lic pro­mo­tion of the drug — as well as his aides’ be­hind-the-scenes work to push for wider use — has been the cen­ter of a whistle­blow­er com­plaint in which Rick Bright, the for­mer chief of BAR­DA, al­leged he was oust­ed for re­sist­ing the pres­sure to en­dorse the un­proven ther­a­py and chloro­quine, a sim­i­lar com­pound.

The FDA pro­vid­ed the emer­gency use au­tho­riza­tion that paved the way for wider use in late March but lim­it­ed the man­date to the hos­pi­tal set­ting. With­in a month, it al­so is­sued a safe­ty warn­ing with­in a month, ad­vis­ing physi­cians to close­ly screen and mon­i­tor pa­tients to help mit­i­gate the risks of heart rhythm prob­lems.

At a press con­fer­ence on Mon­day, Trump at­tacked Bright, say­ing “there’s a lot of bad things com­ing out about him” and point­ing out that he had signed the ap­pli­ca­tion for the EUA, be­fore piv­ot­ing to prais­ing hy­droxy.

The pres­i­dent said he’s tak­ing hy­drox­y­chloro­quine as a pro­phy­lac­tic, a use that’s be­ing in­ves­ti­gat­ed among front­line health­care work­ers and oth­ers at high risk of get­ting ex­posed to the virus.

“I hap­pen to be tak­ing it. I hap­pen to be tak­ing it. I’m tak­ing it, hy­drox­y­chloro­quine. Right now, yeah. A cou­ple weeks ago I start­ed tak­ing it. Be­cause I think it’s good, I heard a lot of good sto­ries … I take a pill every day,” he said, adding: “I think peo­ple should be al­lowed to.”

When pressed, he cit­ed “a lot of pos­i­tive calls about it” as the source of his con­fi­dence that the drug would have a pre­ven­ta­tive ef­fect, even though he main­tains he’s not been ex­posed. Call­ing the neg­a­tive VA study a “very un­sci­en­tif­ic re­port,” he re­it­er­at­ed the pre­vi­ous line: “What have you got to lose?” — Am­ber Tong

Bol­stered by PhI up­date, Mod­er­na quick­ly snags $1.35B raise

The fron­trun­ner sta­tus in the race to de­vel­op a vac­cine against Covid-19 is prov­ing lu­cra­tive for Mod­er­na, which has raised $1.34 bil­lion in a pub­lic of­fer­ing.

The Cam­bridge, MA-based biotech pro­posed to sell and then quick­ly priced 17,600,000 shares at $76 a pop. While that would have marked a 15% pre­mi­um on the stock price Mon­day morn­ing, the re­lease of pre­lim­i­nary re­sults from the on­go­ing Phase I tri­al of its mR­NA SARS-CoV-2 vac­cine boost­ed it well be­yond that in­to the $80 ter­ri­to­ry.

From the pro­pos­al to the pric­ing, Mod­er­na took mere­ly hours to com­plete the ex­er­cise, il­lus­trat­ing the de­mand for its shares.

It’s not just in­vestors who are bet­ting on Mod­er­na. BAR­DA has in­ject­ed $483 mil­lion in­to the clin­i­cal and man­u­fac­tur­ing ops, in the hopes of get­ting the pro­duc­tion ca­pac­i­ty in place for a large-scale roll­out.  — Am­ber Tong

Ahead of pric­ing strat­e­gy un­veil­ing, Gilead re­port­ed­ly do­nates more dos­es of remde­sivir

As an­a­lysts’ an­tic­i­pa­tion con­tin­ues to build re­gard­ing how Gilead would price remde­sivir, the com­pa­ny has pledged to do­nate more dos­es of the an­tivi­ral.

The new do­na­tion would bring the to­tal vials for the fed­er­al gov­ern­ment from 607,000 to 940,000, STAT re­port­ed cit­ing the HHS. That means 30,000 to 55,000 more pa­tients could be treat­ed, de­pend­ing on how long their course of treat­ment is.

But Gilead won’t be of­fer­ing the drug — the on­ly treat­ment to have shown clin­i­cal ben­e­fit in a place­bo-con­trolled study and one that’s been au­tho­rized for emer­gency use — for free for­ev­er. SVB Leerink an­a­lyst Ge­of­frey Porges, who host­ed a vir­tu­al fire­side chat with Gilead CFO An­drew Dick­in­son and SVP of HIV & emerg­ing in­fec­tions Di­ana Brainard, had this to re­port:

The ini­tial do­nat­ed sup­ply of remde­sivir to the US and for­eign gov­ern­ments is ex­pect­ed to be de­plet­ed in June or Ju­ly, and Gilead an­tic­i­pates un­veil­ing a pric­ing strat­e­gy be­fore that oc­curs. The com­pa­ny in­tends to piv­ot to a com­mer­cial mod­el, and stat­ed that in­vestors should ex­pect remde­sivir prod­uct sales in H2.

Am­ber Tong

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

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.