Chi­na ap­proves flu drug be­ing tout­ed as a po­ten­tial coro­n­avirus treat­ment amid a rush of clin­i­cal stud­ies

One of the three drugs that Chi­na’s Min­istry of Sci­ence and Tech­nol­o­gy has tapped as po­ten­tial COVID-19 treat­ments to watch has notched its first Chi­nese OK — for the flu.

While there’s no proof yet that fapilavir, or favipi­ravir, is the cure that pa­tients and physi­cians are yearn­ing for, it stands out for a unique con­stel­la­tion of qual­i­ties. It’s been com­mer­cial­ly avail­able in Japan for sev­er­al years (un­like Gilead’s ex­per­i­men­tal remde­sivir) yet it’s new to Chi­na (un­like the malar­ia drug chloro­quine phos­phate). Per­haps more im­por­tant­ly, a do­mes­tic biotech — Zhe­jiang Hisun Phar­ma — owns the rights to man­u­fac­ture and mar­ket the drug, pre­empt­ing any con­cerns about patents.

At the same time, the Min­istry of Sci­ence and Tech­nol­o­gy sug­gest­ed that chloro­quine phos­phate, a 70-year-old drug, should be in­clud­ed in the stan­dard reg­i­men af­ter show­ing promis­ing re­sults in tri­als across 10 hos­pi­tals.

Clin­i­cal guide­lines for the treat­ment of res­pi­ra­to­ry ill­ness­es re­sult­ing from the new coro­n­avirus orig­i­nat­ing from Wuhan, now named SARS-CoV-2, are evolv­ing quick­ly while de­vel­op­ment of a vac­cine to pre­vent peo­ple from get­ting in­fect­ed in the first place speeds ahead. On Tues­day Sanofi an­nounced that its Pas­teur unit will in­ves­ti­gate a pre­clin­i­cal vac­cine they made for SARS years ago, to see if it can pro­tect against COVID-19.

BAR­DA is a col­lab­o­ra­tor for the ef­fort, which will al­so see Sanofi de­ploy­ing its re­com­bi­nant DNA plat­form to pro­duce the vac­cine.

Like remde­sivir, fapilavir at­tacks RNA virus­es by in­hibit­ing RdRp (RNA-de­pen­dent RNA poly­merase). Fu­ji­film sub­sidiary Toya­ma Chem­i­cal first notched an ap­proval in Japan in 2014 and chris­tened it Avi­gan; in 2016 it li­censed Chi­na API rights to Hisun — short­ly af­ter­ward, Toya­ma al­so sup­plied the drug for an Ebo­la study that didn’t lead any­where.

Com­bat­ing the flu re­mained fapilavir’s raisons d’être, and of­fi­cial­ly it’s sanc­tioned for adults with nov­el or re­cur­ring strains of in­fluen­za when oth­er treat­ments have failed. But Hisun’s Yue Li told Pharm­Cube that the OK means physi­cians can pre­scribe the drug on a com­pas­sion­ate use ba­sis.

Along with the flu ap­proval, the Na­tion­al Med­ical Prod­ucts Ad­min­is­tra­tion al­so gave the green light on an IND to test fapilavir against SARS-CoV-2.

Two hos­pi­tals in Shen­zhen and Hangzhou have be­gun their own tri­als com­par­ing fapilavir against oth­er po­ten­tial treat­ments, ac­cord­ing to a Chi­nese reg­istry of clin­i­cal tri­als. Oth­er com­pounds un­der con­sid­er­a­tion in­clude Kale­tra (lopinavir/ri­ton­avir), an HIV drug owned by Ab­b­Vie; Roche’s new flu drug Xofluza; and neb­u­lized al­pha-in­ter­fer­on.

Last Fri­day Shen­zhen Third Peo­ple’s Hos­pi­tal sug­gest­ed that fapilavir had bet­ter an­tivi­ral ac­tiv­i­ty and less side ef­fects than Kale­tra, based on an 80-pa­tient study.

That puts fapilavir on the same path as remde­sivir, for which clin­i­cal tri­als were re­cent­ly kicked off. But strin­gent screen­ing re­quire­ments may be slow­ing down the high­ly an­tic­i­pat­ed study, the Wall Street Jour­nal re­port­ed. The tri­als have on­ly re­cruit­ed few­er than 200 peo­ple out of the tar­get 700 plus since Feb­ru­ary 5, who couldn’t have tak­en oth­er med­ica­tions in the pri­or 30 days and must have lab con­firmed di­ag­noses.

The Gilead drug was viewed as a top con­tender in the rush to find ef­fec­tive ther­a­pies for COVID-19, as it’s been test­ed in hu­mans as part of an Ebo­la tri­al. In fact, it ap­pears so promis­ing that the Wuhan In­sti­tute of Vi­rol­o­gy has tried to patent its use against the new coro­n­avirus while Suzhou-based Bright­Gene said it’s mass-pro­duc­ing the ac­tive phar­ma­ceu­ti­cal in­gre­di­ent and ramp­ing up pro­duc­tion of the ac­tu­al drug — with plans to li­cense it from Gilead.

For its part, the US drug­mak­er said it’s fo­cused on help­ing de­ter­mine the ef­fi­ca­cy of remde­sivir en­sur­ing man­u­fac­tur­ing ca­pac­i­ty in case of ap­proval.

Re­searchers, clin­i­cians and drug­mak­ers are pulling out all the stops to help treat and con­tain a vi­ral dis­ease that’s sick­ened more than 73,000 world­wide and tak­en 1,875 lives. De­spite the lack of proven treat­ments, 13,116 pa­tients have re­port­ed­ly re­cov­ered.

Japan, which had seen its case­load rise dra­mat­i­cal­ly due to a stream of con­firmed cas­es on the Di­a­mond Princess cruise ship now docked at the port of Yoko­hama, said it is work­ing to launch its own tri­als with HIV drugs.

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Look­ing for 'ex­ter­nal in­no­va­tion,' Boehringer In­gel­heim re­serves $500M+ for new Shang­hai hub

Now that Boehringer Ingelheim’s bet on contract manufacturing in China has paid off, the German drugmaker is anteing up more to get into the research game.

Boehringer has set aside $507.9 million (€451 million) for a new External Innovation Hub to be built in Shanghai over five years. The site will become one of its “strategic pillars” as the team strives to get 71 approvals — either for new products or indications — by 2030, said Felix Gutsche, president and CEO of Boehringer Ingelheim China.

Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)

No­vavax snags Ben Machielse for CMC and pro­motes a trio of staffers; Mar­ty Du­vall lands an­oth­er CEO post at On­copep­tides

Novavax has been making waves recently by securing a $384 million commitment from CEPI to cover R&D and manufacturing for its Covid-19 vaccine while also spending $167 million on a 150,000 square-foot facility. The Maryland biotech continues to shore up its leadership team as well, bringing in Ben Machielse as their EVP of CMC just a couple weeks after nabbing AstraZeneca vet Filip Dubrovsky as their new CMO. Machielse was president and CEO of Vtesse from 2014-17, and before that, he also spent more than 11 years at MedImmune and was EVP of operations for the back half of his tenure.

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