Gilead’s Covid-19 treat­ment Vek­lury props up first quar­ter gains amid $2.7B Trodelvy write­down

Gilead got a sales boost from its Covid-19 treat­ment for the first quar­ter — to the tune of $1.5 bil­lion. The like­ly tem­po­rary bump came just in time though as Gilead re­assessed its can­cer drug Trodelvy’s val­ue and took a $2.7 bil­lion R&D im­pair­ment charge.

The an­tic­i­pat­ed reck­on­ing for Trodelvy came af­ter a Phase III read­out last month that met its pri­ma­ry end­point, but left an­a­lysts ques­tion­ing the lack of de­tails. Gilead ac­quired the drug through its $21 bil­lion deal for Im­munomedics in 2020 with the hopes of shak­ing up the stan­dard of care for triple-neg­a­tive breast can­cer.

An­drew Dick­in­son

“While no fi­nal de­ci­sions have been made pend­ing dis­cus­sions with reg­u­la­to­ry au­thor­i­ties, as a re­sult of the (March read­out) da­ta, we have tak­en a $2.7 bil­lion im­pair­ment to re­flect the like­li­hood of a de­layed launch of Trodelvy for third line plus HR+/HER2- breast can­cer in the Unit­ed States and Eu­rope, and the pos­si­bil­i­ty of a re­duced mar­ket share in late­line pa­tients giv­en the emerg­ing com­pet­i­tive land­scape,” Gilead’s chief fi­nan­cial of­fi­cer An­drew Dick­in­son ex­plained.

He cush­ioned the blow with the caveat that the ini­tial val­ue of the Trodelvy was cal­cu­lat­ed on a po­ten­tial four in­di­ca­tions, even though Gilead “knew” there were more po­ten­tial in­di­ca­tions. As he point­ed out, Gilead is con­tin­u­ing to ex­plore op­por­tu­ni­ties in prostate, en­dome­tri­al and sol­id tu­mor can­cers as well as with com­bi­na­tions, for a to­tal of 13 Trodelvy pro­grams set to launch through 2023. Trodelvy notched $146 mil­lion in Q1 sales for its cur­rent breast can­cer and blad­der can­cer in­di­ca­tions.

“We re­main con­fi­dent Trodelvy will de­liv­er an at­trac­tive re­turn for share­hold­ers over time,” Dick­in­son said.

Mean­while, Gilead did post a strong first quar­ter in Vek­lury sales. How­ev­er, the $1.5 bil­lion pop was tinged with un­cer­tain­ty as well amid the dropoff in the num­ber of peo­ple hos­pi­tal­ized with Covid — which as Dick­in­son not­ed is for­tu­nate. It al­so puts Gilead in a wait-and-see mode for fu­ture sales. Gilead plans to mon­i­tor de­mand through the sec­ond quar­ter and eval­u­ate Vek­lury full-year guid­ance then, the CFO said.

Vek­lury had picked up a new FDA ap­proval on Mon­day for pe­di­atric use in ba­bies at least 28 days old and weigh­ing at least 7 pounds. Chief com­mer­cial of­fi­cer Jo­han­na Merci­er said that nod high­light­ed Gilead’s com­mit­ment to ex­tend the reach of the treat­ment wher­ev­er it can, al­though she al­so not­ed the phar­ma does not ex­pect an­oth­er Covid surge in the US this year.

The Vek­lury sales heaped on top of in­creased HIV med Bik­tarvy sales of $2.2 bil­lion for the first quar­ter, an jump of 18% year over year.

Mer­dad Parsey

In the HIV pipeline, Gilead chief med­ical of­fi­cer Mer­dad Parsey ad­dressed its re­cent re­jec­tion let­ter for po­ten­tial first-in-class lenaca­pavir, point­ing out as pre­vi­ous­ly re­port­ed that the prob­lem re­gard­ed the pro­posed con­tain­er vials, not the drug it­self. Gilead is talk­ing to the FDA about an al­ter­na­tive vial and will re­sub­mit its NDA, which had been grant­ed pri­or­i­ty re­view, as soon as it re­solves the is­sue, he said.

In oth­er Covid treat­ment news, Gilead is con­tin­u­ing its Phase I in­ves­ti­ga­tion for its oral Covid-19 an­tivi­ral GS-5245, CEO Daniel O’Day said, with re­sults po­ten­tial­ly lead­ing to a reg­is­tra­tional tri­al. When pressed by an an­a­lyst about why Gilead isn’t mov­ing faster on the treat­ment, com­par­ing it to Pfiz­er’s Paxlovid and Mer­ck’s mol­nupi­ravir, O’Day coun­tered that it is “ab­solute­ly mov­ing with tremen­dous fo­cus and speed,” and lean­ing on its ex­pe­ri­ence with the tri­als and FDA reg­u­la­to­ry moves for Vek­lury, then known as remi­di­sivir be­fore its ap­proval.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; 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.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

Some­one old, some­one new: Mod­er­na pro­motes CTO, raids No­var­tis for re­place­ment amid pipeline push

Moderna CEO Stéphane Bancel made clear on the last quarterly call that “now is not the time to slow down.” On Thursday, he made a bit more room in the cockpit.

The company unveiled a new executive role on Thursday, promoting former chief technical operations and quality officer Juan Andres to president of strategic partnerships and enterprise expansion, and poaching a former Novartis exec to take his place.

Gilead names 'k­ing­pin­s' in coun­ter­feit HIV med law­suit

Gilead is mounting its counterfeit drug lawsuit, naming two “kingpins” and a complex network of conspirators who allegedly sold imitation bottles of its HIV meds, some of which ended up in US pharmacies.

The pharma giant on Wednesday provided an update on what it called a “large-scale, sophisticated counterfeiting conspiracy,” accusing two new defendants of “leading and orchestrating” a scheme to sell hundreds of millions of dollars in illegitimate drugs posing as meds such as Biktarvy and Descovy.

Tar­sus looks to raise aware­ness of eye­lid mite dis­ease in cam­paign aimed at eye­care spe­cial­ists

Eyelid mite disease may be “gross” but it’s also fairly common, affecting about 25 million people in the US.

Called demodex blepharitis, it’s a well-known condition among eyecare professionals, but they often don’t always realize how common it is. Tarsus Pharmaceuticals wants to change that with a new awareness campaign called “Look at the Lids.”

The campaign and website debut Thursday — just three weeks after Tarsus filed for FDA approval for a drug that treats the disease.

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