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.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Argentine President Alberto Fernandez at an Aug. 12, 2020 press conference (Juan Mabromata/Pool via AP)

Covid-19 roundup: Sor­ren­to threat­ens to sue crit­ic of their coro­n­avirus ‘cure’; No­vavax signs with SK bio­science

Sorrento Therapeutics has come under fire for how they’ve characterized their Covid-19 research, taking heat in May from researchers, bio-ethicists and even some investors for claiming they had a Covid-19 “cure.” Now, Sorrento is threatening “legal action” against an investment research firm critical of its work.

Hindenburg Research first criticized the company for the “cure” claim in a lengthy report in May, and then on Tuesday, wrote on Twitter that CEO Henry Ji’s claims and CNBC coverage of a spit test Sorrento licensed from Columbia University had more than doubled its stock value. Hindenburg cited an unnamed Columbia official who called Sorrento’s claims “a complete joke.”

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