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.

Ugur Sahin, BioNTech CEO (Bernd von Jutrczenka/dpa via AP Images)

BioN­Tech is spear­head­ing an mR­NA vac­cine de­vel­op­ment pro­gram for malar­ia, with a tech trans­fer planned for Africa

Flush with the success of its mRNA Covid-19 vaccine, BioNTech is now gearing up for one of the biggest challenges in vaccine development — which comes without potential profit.

The German mRNA pioneer says it plans to work on a jab for malaria, then transfer the tech to the African continent, where it will work with partners on developing the manufacturing ops needed to make this and other vaccines.

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How one start­up fore­told the neu­ro­science re­nais­sance af­ter '50 years of shit­show'

In the past couple of years, something curious has happened: Pharma and VC dollars started gushing into neuroscience research.

Biogen’s controversial new Alzheimer’s drug Aduhelm has been approved on the basis of removing amyloid plaque from the brain, but the new neuro-focused pharma and biotechs have much loftier aims. Significantly curbing or even curing the most notorious disorders would prove the Holy Grail for a complex system that has tied the world’s best drug developers in knots for decades.

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Why is On­col­o­gy Drug De­vel­op­ment Re­search Late to the Dig­i­tal Bio­mark­ers Game?

During the recent Annual ASCO Meeting, thousands of cancer researchers and clinicians from across the globe joined together virtually to present and discuss the latest findings and breakthroughs in cancer research and care. There were more than 5000+ scientific abstracts presented during this event, yet only a handful involved the use of motion-tracking wearables to collect digital measures relating to activity, sleep, mobility, functional status, and/or quality of life. Although these results were a bit disappointing, they should come as no surprise to those of us in the wearable technology field.

Busi­ness­es and schools can man­date the use of Covid-19 vac­cines un­der EUAs, DOJ says

As public and private companies stare down the reality of the Delta variant, many are now requiring that their employees or students be vaccinated against Covid-19 prior to attending school or to returning or starting a new job. Claims that such mandates are illegal or cannot be used for vaccines under emergency use authorizations have now been dismissed.

Setting the record straight, the Department of Justice on Monday called the mandates legal in a new memo, even when used for people with vaccines that remain subject to EUAs.

Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)

Am­gen bel­lies back up to the M&A ta­ble for an­oth­er biotech buy­out, this time with a $2.5B deal for an an­ti­body play­er fo­cused on PS­MA

Five months after Amgen CEO Bob Bradway stepped up to the M&A table and acquired Five Prime for $1.9 billion, following up with the smaller Rodeo acquisition, he’s gone back in for another biotech buyout.

This time around, Amgen is paying $900 million cash while committing up to $1.6 billion in milestones to bag the privately held Teneobio, an antibody drug developer that has expertise in developing new bispecifics and multispecifics. In addition, Amgen cited Teneobio’s “T-cell engager platform, which expands on Amgen’s existing leadership position in bispecific T-cell engagers by providing a differentiated, but complementary, approach to Amgen’s current BiTE platform.”

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Art Levinson (Calico)

Google-backed Cal­i­co dou­bles down on an­ti-ag­ing R&D pact with Ab­b­Vie as part­ners ante up $1B, start to de­tail drug tar­gets

Seven years after striking up a major R&D alliance, AbbVie and Google-backed anti-aging specialist Calico are doubling down on their work with a joint, $1 billion commitment to continuing their work together. And they’re also beginning to offer some details on where this project is taking them in the clinic.

According to their statement, each of the two players is putting up $500 million more to keep the labs humming.

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Covid-19 roundup: Till­man Gern­gross inks deal to bring an­ti­body can­di­date to In­dia; At FDA's re­quest, mR­NA vac­cine mak­ers will ex­pand tri­als for chil­dren ages 5-11

A week after it was reported that India’s Covid-19 death toll could be in the millions, antibody legend Tillman Gerngross has inked a deal to develop Adagio’s lead candidate for the treatment and prevention of the virus in southern Asia.

Adagio is joining hands with Biocon Biologics to manufacture and commercialize a treatment based on ADG20 in India and “select emerging markets,” the companies announced on Monday. Under the agreement, Adagio will provide Biocon with materials and know-how to make the therapy, including data from ongoing Phase II/III trials and (if all goes well) access to its potential EUA package.

No­var­tis reshuf­fles its wild cards; Tough sell for Bio­gen? Googling pro­teins; Ken Fra­zier's new gig; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

If you enjoy the People section in this report, you may also want to check out Peer Review, my colleagues Alex Hoffman and Kathy Wong’s comprehensive compilation of comings and goings in biopharma.

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Frank Pallone (Kevin Dietsch/Pool via AP Images)

House com­mit­tee seeks more from FDA on in­spec­tion back­log, when to restart work on for­eign sites

House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.

“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.