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.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

Covid-19 vac­cine boost­ers earn big thumbs up, but Mod­er­na draws ire over world sup­ply; What's next for Mer­ck’s Covid pill?; The C-suite view on biotech; 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.

You may remember that at the beginning of this year, Endpoints News set a goal to go broader and deeper. We are still working towards that, and are excited to share that Beth Snyder Bulik will be joining us on Monday to cover all things pharma marketing. You can sign up for her weekly Endpoints MarketingRx newsletter in your reader profile.

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No­var­tis de­vel­op­ment chief John Tsai: 'We go deep in the new plat­form­s'

During our recent European Biopharma Summit, I talked with Novartis development chief John Tsai about his experiences over the 3-plus years he’s been at the pharma giant. You can read the transcript below or listen to the exchange in the link above.

John Carroll: I followed your career for quite some time. You’ve had more than 20 years in big pharma R&D and you’ve obviously seen quite a lot. I really was curious about what it was like for you three and a half years ago when you took over as R&D chief at Novartis. Obviously a big move, a lot of changes. You went to work for the former R&D chief of Novartis, Vas Narasimhan, who had his own track record there. So what was the biggest adjustment when you went into this position?

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Amit Etkin, Alto Neuroscience CEO (Alto via Vimeo)

A star Stan­ford pro­fes­sor leaves his lab for a start­up out to re­make psy­chi­a­try

About five years ago, Amit Etkin had a breakthrough.

The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.

Susan Galbraith, Executive VP, Oncology R&D, AstraZeneca

As­traZeneca on­col­o­gy R&D chief Su­san Gal­braith: 'Y­ou're go­ing to need or­thog­o­nal com­bi­na­tion­s'


Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC

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Roche's Tecen­triq cross­es the fin­ish line first in ad­ju­vant lung can­cer, po­ten­tial­ly kick­ing off gold rush

While falling behind the biggest PD-(L)1 drugs in terms of sales, Roche has looked to carve out a space for its Tecentriq with a growing expertise in lung cancer. The drug will now take an early lead in the sought-after adjuvant setting — but competitors are on the way.

The FDA on Friday approved Tecentriq as an adjuvant therapy for patients with Stage II-IIIA non small cell lung cancer with PD-(L)1 scores greater than or equal to 1, making it the first drug of its kind approved in an early setting that covers around 40% of all NSCLC patients.

Tillman Gerngross, Adagio CEO

Q&A: Till­man Gern­gross ex­plains why his Covid mAb will have an edge over an al­ready crowd­ed field

If anyone knows about monoclonal antibodies, it’s serial entrepreneur, Adimab CEO, and Dartmouth professor of bioengineering Tillman Gerngross.

Even the name of Gerngross’ new antibody startup Adagio Therapeutics is meant to reflect his vision behind the development of his Covid-19 mAb: slowly, he said, explaining that “everyone else, whether it’s Regeneron, Lilly, or AstraZeneca, Vir, they all valued speed over everything.”

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FDA's vac­cine ad­comm unan­i­mous­ly sup­ports Mod­er­na's boost­er in same pop­u­la­tions as Pfiz­er's boost­er

The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.

Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.

John Oyler, BeiGene CEO (Paul Yeung/Bloomberg via Getty Images)

Bris­tol My­ers wants to pull out of its Abrax­ane deal in Chi­na. BeiGene says no way

A year and a half after Chinese officials ordered BeiGene to stop selling Bristol Myers Squibb’s Abraxane in the wake of an alarming inspection of a US facility, the manufacturing issues at the root of the import suspension still appear unresolved.

And Bristol Myers wants to axe the Abraxane supply deal altogether.

But BeiGene, which is currently in arbitration proceedings against its Big Pharma partner, won’t let it off the hook so easily.

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