Gilead boasts of pos­i­tive remde­sivir da­ta on mor­tal­i­ty — but their analy­sis pro­vokes the skep­tics

Gilead is surg­ing again off da­ta that sug­gest its an­tivi­ral remde­sivir might im­prove sur­vival.

The new da­ta come from an analy­sis Gilead con­duct­ed com­par­ing the death rate and re­cov­ery time of pa­tients in one of its remde­sivir tri­als to a group of 800 pa­tients “with sim­i­lar base­line char­ac­ter­is­tics and dis­ease sever­i­ty” who re­ceived on­ly stan­dard-of-care around the same time. The re­sult, they said, sug­gest­ed that pa­tients who re­ceived remde­sivir had a 62% bet­ter chance at sur­viv­ing than those who did not.

Ret­ro­spec­tive looks are more sus­pect than place­bo-con­trolled tri­als, so the da­ta are far from con­clu­sive. But it does add new ev­i­dence to the ques­tion of whether remde­sivir can im­prove mor­tal­i­ty. The NIH tri­al that led the FDA to au­tho­rize remde­sivir for use in Covid-19 pa­tients on­ly showed that remde­sivir could help pa­tients re­cov­er faster. Few­er pa­tients on remde­sivir died in that tri­al than on stan­dard-of-care — 8% vs 11% — but the re­sults were not sig­nif­i­cant.

For­mer FDA chief sci­en­tist Lu­ciana Bo­rio said that da­ta from ob­ser­va­tion­al stud­ies are dif­fi­cult to in­ter­pret, but that the bulk of ev­i­dence points to remde­sivir help­ing pa­tients sur­vive Covid-19. “It is very like­ly that Remde­sivir does in­deed af­ford pa­tients a mor­tal­i­ty ben­e­fit,” she said in an email. “The gold stan­dard RCT con­duct­ed by the NIH demon­strat­ing the clin­i­cal ben­e­fit of Remde­sivir in im­prov­ing time to re­cov­er wasn’t pow­ered to de­tect a dif­fer­ence in mor­tal­i­ty. It doesn’t mean that there wasn’t one”

In a tweet, for­mer FDA chief Scott Got­tlieb called the re­sults “en­cour­ag­ing” but urged that it need­ed to be con­firmed. The com­pa­ny ac­knowl­edged in their press re­lease that a prospec­tive study was need­ed.

Gilead was up 2% pre-mar­ket on the news, from $74.71 to $76.18.

Oth­er an­a­lysts and ex­perts, though, were more skep­ti­cal and in some cas­es en­tire­ly dis­mis­sive. Pe­ter Bach, the di­rec­tor for the cen­ter for health pol­i­cy and out­comes at Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter, said on Twit­ter that com­par­ing tri­al par­tic­i­pants to re­al-world pa­tients on­ly works when doc­tors have a good un­der­stand­ing of the dis­ease, some­thing that isn’t the case with Covid-19.

Baird an­a­lyst Bri­an Sko­r­ney com­pared the study to work from Di­di­er Raoult, the French physi­cian who pub­lished in Feb­ru­ary one of the first tri­als on hy­drox­y­chloro­quine in Covid-19. That study, de­spite gin­ning up sig­nif­i­cant in­ter­est in the drug, was seen as rife with is­sues, in­clud­ing in “los­ing” 6 of the tri­al’s 26 pa­tients “in fol­low-up,” 4 of whom died.

In the study, 312 pa­tients from Gilead’s open-la­bel SIM­PLE tri­al were com­pared to 818 re­al-world pa­tients who had sim­i­lar char­ac­ter­is­tics. Pa­tients who re­ceived remde­sivir had a 7.6% chance of dy­ing, com­pared to 12.6% for those who re­ceived stan­dard-of-care. That trans­lates to 62% im­proved odds of sur­vival — or slight­ly more than dou­ble the 30% im­proved odds the NIH tri­al’s raw num­bers sug­gest­ed.

Sun­Trust an­a­lyst Robyn Kar­nauskas said the sur­vival rates in each tri­al were “com­pa­ra­ble,” while ac­knowl­edg­ing the study was “not an ap­ples-to-ap­ples com­par­i­son.”

The remde­sivir pa­tients in the analy­sis al­so had a 74.4% chance of re­cov­er­ing by day 14, ver­sus 59.9% for stan­dard-of-care.

Not every tri­al, though, has found remde­sivir has a ben­e­fit. On the same day as the NIH read­out, The Lancet pub­lished a study from Chi­na that found remde­sivir im­proved nei­ther mor­tal­i­ty nor oth­er pa­tient met­rics. That study, though, was end­ed ear­ly af­ter the first out­break in Chi­na end­ed.

For hos­pi­tals that can get their hands on it, remde­sivir so far has been one of on­ly two proven treat­ments for Covid-19, along with a gener­ic steroid called dex­am­etha­sone. More an­tivi­rals and neu­tral­iz­ing an­ti­bod­ies, though, are now be­ing stud­ied, hav­ing be­come a grow­ing fo­cus of the Trump ad­min­is­tra­tion. If more ther­a­pies prove ef­fec­tive, the new Gilead da­ta could help physi­cians choose the best op­tion.

“While not as vig­or­ous as a ran­dom­ized con­trolled tri­al, this analy­sis im­por­tant­ly draws from a re­al-world set­ting and serves as an im­por­tant ad­junct to clin­i­cal tri­al da­ta, adding to our col­lec­tive un­der­stand­ing of this virus and re­flect­ing the ex­tra­or­di­nary pace of the on­go­ing pan­dem­ic,” in­ves­ti­ga­tor Su­san Olen­der of Co­lum­bia Uni­ver­si­ty Irv­ing Med­ical Cen­ter said in a state­ment.

So­cial: AP Im­ages

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2021 saw a record $600B in healthcare M&A activity. In 2022, there is an anticipated slowdown in activity, however, M&A prospects remain strong in the medium to long-term. What are future growth drivers for the healthcare sector? Where might we see innovations that drive M&A? RBC’s Andrew Callaway, Global Head, Healthcare Investment Banking discusses with Vito Sperduto, Global Co-Head, M&A.

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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.

A return to in-person conferences also marks a return to on-the-ground reporting. My colleagues Beth Synder Bulik and Nicole DeFeudis were on-site at Cannes Lions, bringing live coverage of pharma’s presence at the ad festival — accompanied by photos from Clara Bui, our virtual producer, that bring you right to the scene. You can find a recap (and links to all the stories) below.

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Abortion-rights protesters regroup and protest following Supreme Court's decision to overturn Roe v. Wade. (AP Photo/Gemunu Amarasinghe)

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Following the Supreme Court’s historic decision on Friday to overturn Americans’ constitutional right to an abortion after almost 50 years, Attorney General Merrick Garland sought to somewhat reassure women that states will not be able to ban the prescription drug sometimes used for abortions.

Following the decision, the New England Journal of Medicine also published an editorial strongly condemning the reversal, saying it “serves American families poorly, putting their health, safety, finances, and futures at risk.”

AstraZeneca's new Evusheld direct to consumer campaign aims to reach more immunocompromised patients.

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Sanofi, GSK tout 72% Omi­cron ef­fi­ca­cy in PhI­II tri­al of next-gen, bi­va­lent shot — with an eye to year-end roll­out

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GSK, newly branded and soon-to-be demerged, shared interim results from its Phase II trial on its chronic hepatitis B treatment, one that it says has the “potential to lead to a functional cure.”

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Matt Kapusta, uniQure CEO

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In seven patients with early-stage Huntington’s — four who got the treatment and three who got a placebo — mutant huntingtin protein levels in the cerebrospinal fluid decreased by an average of just over 50% in patients who got the gene therapy compared to around a 17% drop in patients who got the placebo after a year.

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Rwanda president Paul Kagame and BioNTech CEO Uğur Şahin (via BioNTech)

BioN­Tech breaks ground on first mR­NA vac­cine man­u­fac­tur­ing fa­cil­i­ty in Africa

Covid vaccine access to lower- and middle-income nations has been a concern during the length of the pandemic, but BioNTech is now pushing forward with plans to increase vaccine access for Africa.

Construction work has kicked off for an mRNA manufacturing facility in Kigali, Rwanda. According to BioNTech, the facility, dubbed the African modular mRNA manufacturing facility, has a target for the first set of manufacturing tools to be delivered to the site by the end of this year.

Stéphane Bancel (AP Photo/Charles Krupa)

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As Moderna keeps up the fight against Covid-19, recently winning authorization in the US for children under the age of five, the company is also looking to make a serious investment in the UK.

According to the UK government, Moderna will be looking to establish a vaccine research center and a manufacturing site for a series of vaccines.

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