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.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

Pro­tect­ing the glob­al phar­ma­ceu­ti­cal in­no­va­tion ecosys­tem – what’s at stake?

We are living in a new era of healthcare that is rapidly advancing progress impacting patient outcomes and experiences. We’ve seen a remarkable pace of transformational innovation, applied research, and advanced clinical development over the last decade.

Despite this tremendous progress, there is much more work to be done, and patients are counting on us – now more than ever – to continue that momentum. At the heart of our industry is a focus on developing and delivering medicines for some of the world’s most challenging diseases, including those that have few or no effective treatments today.

End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; 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.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Mi­rati’s drug sitra­va­tinib flops PhI­II in com­bo with Op­di­vo for cer­tain lung can­cer

Mirati Therapeutics’ path to a second drug approval will likely have to wait. The San Diego biotech company said Wednesday that its investigational lung cancer drug failed a Phase III trial testing it in combination with Bristol Myers Squibb’s Opdivo.

The drug, sitravatinib, and Opdivo weren’t better than the chemo drug docetaxel at keeping patients alive, Mirati said in a press release. The spectrum-selective kinase inhibitor missed the primary goal of overall survival in patients with second- or third-line advanced non-squamous, non-small cell lung cancer.

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Teresa Bitetti, Takeda's president of the global oncology business unit

Take­da wins pri­or­i­ty re­view for $400M col­orec­tal can­cer drug, li­censed from Hutchmed in Jan­u­ary

Takeda and Hutchmed scored a priority review Thursday afternoon for a colorectal cancer drug, the companies announced.

The experimental drug in question is fruquintinib, previously approved in China in 2018 to treat metastatic colorectal cancer. Takeda and Hutchmed are aiming to bring fruquintinib to the US and other countries outside China in the same indication, and the FDA set its decision date for Nov. 30 of this year.

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