Gilead de­tails its case for a new HIV flag­ship triple, with megablock­buster po­ten­tial

Gilead $GILD laid out a de­tailed case for its HIV triple to­day, jour­ney­ing to a sci­en­tif­ic con­fer­ence in Paris to present the da­ta from a pair of Phase III stud­ies that demon­strat­ed the com­bo pill lined up quite nice­ly along­side Glax­o­SmithK­line’s do­lute­gravir.

Adding bicte­gravir to its back­bone HIV drugs emtric­itabine/teno­fovir alafe­namide (200/25mg) (FTC/TAF) pro­duced sim­i­lar high ef­fi­ca­cy re­sults with the GSK ri­val with a sim­i­lar safe­ty pro­file.

Gilead has al­ready laid out its case to the FDA and EMA, look­ing to con­vince reg­u­la­tors. An­a­lysts note that this is an odds-on fa­vorite for an ap­proval in both mar­kets, where Gilead is a dom­i­nant play­er.

“These re­sults sug­gest that the com­bi­na­tion of bicte­gravir with FTC/TAF has the po­ten­tial to be ap­pro­pri­ate for a broad range of HIV pa­tients, in­clud­ing those with mild to mod­er­ate re­nal im­pair­ment,” said Paul Sax, the clin­i­cal di­rec­tor of the Di­vi­sion of In­fec­tious Dis­eases at Brigham and Women’s Hos­pi­tal.

No big sur­pris­es here will help Gilead com­pete against GSK’s Vi­iV, which has proven to be a ma­jor ri­val in the megablock­buster field. The triple could well be worth bil­lions in an­nu­al rev­enue, an­a­lysts spec­u­late, which is par­tic­u­lar­ly im­por­tant to Gilead as it looks to ex­pand its pipeline fol­low­ing dwin­dling sales of its hep C fran­chise drugs, which have proved ef­fec­tive in cur­ing that dis­ease.

Eval­u­atePhar­ma has pegged 2022 sales of the Gilead triple at $4.4 bil­lion while GSK is ex­pect­ed to rake in $5.4 bil­lion at the same time with its com­bo.

One of Gilead’s cham­pi­ons, Umer Raf­fat at Ever­core ISI, sees the new drug from Gilead as a core part of its plans to stay dom­i­nant in HIV in the 2020s.

“GILD al­ready has an in­te­grase in­hibitor on the mar­ket (Stri­bild/Gen­voya), but this new in­te­grase in­hibitor is ex­pect­ed to have bet­ter bar­ri­er to re­sis­tance (i.e., more com­pet­i­tive vs GSK) + bet­ter IP,” notes Raf­fat. “Da­ta to­day con­firms that GILD’s new in­te­grase in­hibitor is gen­er­al­ly com­pa­ra­ble to GSK’s do­lute­gre­vir as stand­alone.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

CDC’s Robert Redford, NIAID’s Anthony Fauci, Admiral Brett Giroir at HHS, and FDA’s Stephen Hahn prepare to testify at a House hearing on June 23 (Getty)

'Ex­treme­ly po­lit­i­cal' — Trump neuters FDA's at­tempt to strength­en vac­cine EUA, ques­tions need to length­en process

Stephen Hahn went before a Senate committee Wednesday and declared he’s fighting. “Every one of the decisions we have reached has been made by career FDA scientists based on science and data, not politics,” he exclaimed, adding that “FDA will not permit any pressure from anyone to change that. I will fight for science.”

A few hours later, he was undermined by President Donald Trump when a reporter asked if he was okay with stricter vaccine guidelines that the FDA was said to be cooking up. “That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” he decided.

David Berry (Flagship)

Flag­ship's next big tech­no­log­i­cal bet? The cloud

Earlier this month, Flagship announced their big bet on the software half the industry is talking about, launching the AI and machine learning startup. Now, they and a couple other investors are gambling $100 million on a software that much of the public generally thinks of as a cool, IT afterthought: cloud computing.

The idea, says founder and Flagship partner David Berry, is one of scale: The sheer magnitude of biological data that you can store on cloud technology is unprecedented. And that size, when leveraged properly, can allow you to ask questions and form insights that are similarly unprecedented.

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Chair of FDA's vac­cine ad­comm — who's al­so a lead in­ves­ti­ga­tor of Mod­er­na's vac­cine — re­cus­es her­self from Covid-19 talks

When the FDA’s Vaccines and Related Biological Products Advisory Committee meets next month to discuss the development and authorization of Covid-19 vaccines, the chairwoman won’t be there.

Hana El Sahly has recused herself from the expert panel’s review of the topic, citing her role as a lead investigator in Moderna’s Phase III trial, Reuters reported. An associate professor of virology and microbiology at Baylor College of Medicine in Houston, El Sahly was appointed the chairwoman last year.

Jim Roberts and Brian Finrow (Lumen Bioscience)

With a $4M fed­er­al grant, Lu­men jumps in­to the Covid-19 treat­ment race

It’s been less than a month since Lumen Bioscience announced a $16 million Series B to engineer spirulina — a nutrient-packed super food — for diseases like traveler’s diarrhea, norovirus and C. difficile colitis. And now, the biotech has pulled in another $4 million to do the same for Covid-19.

The approach is quite similar to other gastrointestinal targets the company is pursuing, co-founders and Brian Finrow and Jim Roberts said. The Seattle-based company is working on a camelid antibody cocktail to combat GI infection common among Covid-19 patients. In a study published in the American Journal of Gastroenterology, a majority of Covid-19 patients showed GI and respiratory symptoms, and 25% had only GI symptoms.

CEO Markus Warmuth (Monte Rosa)

Monte Rosa rakes in $96M Se­ries B as it pre­pares 'mol­e­c­u­lar glue' plat­form for IND-en­abling stud­ies

About four months after completing an extension to its Series A, Monte Rosa Therapeutics is putting its next foot forward with another heap of cash.

The Boston-based biotech is back with $96 million in Series B financing with a goal to get its lead program ready for IND-enabling studies by the end of the year. Though Monte Rosa is keeping its specific target a secret for now, the company has been researching how to utilize its protein degradation technology in breast cancer and non-small cell lung cancer, among other areas.

Vas Narasimhan (AP Images)

UP­DAT­ED: Still held down by clin­i­cal hold, No­var­tis' Zol­gens­ma falls fur­ther be­hind Bio­gen and Roche as FDA asks for a new piv­otal study

Last October, the FDA slowed down Novartis’ quest to extend its gene therapy to older spinal muscular atrophy patients by slapping a partial hold on intrathecal administration. Almost a year later, the hold is still there, and regulators are adding another hurdle required for regulatory submission: a new pivotal confirmatory study.

The new requirement — which departs significantly from Novartis’ prior expectations — will likely stretch the path to registration beyond 2021, when analysts were expecting a BLA submission. That could mean more time for Biogen to reap Spinraza revenues and Roche to ramp up sales of Evrysdi in the absence of a rival.

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FDA commissioner Stephen Hahn at the White House (AP Images)

Un­der fire, FDA to is­sue stricter guid­ance for Covid-19 vac­cine EUA this week — re­port

The FDA has been insisting for months that a Covid-19 vaccine had to be at least 50% effective – a measure of transparency meant to shore public trust in the agency and in a vaccine that had been brought forward at record speed and record political pressure. But now, with concerns of a Trump-driven authorization arriving before the election, the agency may be raising the bar.

The FDA is set to release new guidance that would raise safety and efficacy requirements for a vaccine EUA above earlier guidance and above the criteria used for convalescent plasma or hydroxychloroquine, The Washington Post reported. Experts say this significantly lowers the odds of an approval before the election on November 3, which Trump has promised despite vocal concerns from public health officials, and could help shore up public trust in the agency and any eventual vaccine.

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.