Am­gen's block­buster hope­ful Lumakras sees slow­er than ex­pect­ed sales in lat­est da­ta, an­a­lyst says

It’s been on­ly about one year since Am­gen’s KRAS-tar­get­ed NSCLC drug Lumakras has been mar­ket­ed in the US, and al­ready an­a­lysts are warn­ing of wan­ing sales for the block­buster hope­ful.

A re­port from SVB Se­cu­ri­ties on Mon­day said Lumakras’ Q2 sales didn’t come in as high as ex­pect­ed, with the an­a­lysts low­er­ing US sales pro­jec­tions by 8%, from $60 mil­lion to $55 mil­lion, for the last quar­ter.

Al­so known as so­tora­sib, the drug won ap­proval last May to treat types of non-small cell lung can­cer with the KRAS G12C mu­ta­tion, beat­ing com­peti­tor Mi­rati Ther­a­peu­tics to the reg­u­la­to­ry fin­ish line. At the time, an­a­lysts pre­dict­ed the drug would se­cure more than $1 bil­lion in peak sales, with a list price of $17,900 a month.

But ac­cord­ing to this lat­est re­port, an­a­lysts took a look at script da­ta from IQVIA and not­ed that “script growth” seemed to be well be­low the con­sen­sus es­ti­mates, which were pro­ject­ed to grow 30% se­quen­tial­ly from Q1 to Q2.

That said, the an­a­lysts re­vised their es­ti­mates:

We are low­er­ing our 2QE US sales from 25% seq growth ($60mm) to 15% se­quen­tial growth $55mm. The rea­son we are not low­er­ing it more is that Lumakras had a 3% US price in­crease on Ju­ly 1 which could have yield­ed some ex­tra whole­saler buy­ing in June. Our 2Q glob­al Lumakras sales est is $72mm, 8% be­low cons’ $78mm. Our full-year 2022 glob­al sales est. is $326mm, 9% be­low con­sen­sus $347mm.

An Am­gen spokesper­son dis­missed the con­cerns, telling End­points News that Am­gen is “pleased with the launch progress of Lumakras.” How­ev­er, Am­gen did point out that it is an­gling to try and im­prove up­take by “en­sur­ing that physi­cians writ­ing sec­ond line pre­scrip­tions (where Lumakras is cur­rent­ly in­di­cat­ed) have ac­cess to re­view KRAS G12C test re­sults, for pa­tients that progress be­yond first line (with the goal of con­vert­ing high test­ing rates in­to ad­di­tion­al Lumakras pre­scrip­tions in sec­ond line).”

Be­yond that, SVB al­so not­ed an FDA-re­quired post-mar­ket­ing study to com­pare two dif­fer­ent dos­es of so­tora­sib as doc­tors have ques­tioned if the cur­rent dose is cor­rect. The re­sults from that study are ex­pect­ed to read out by year’s end, as the an­a­lysts write:

In pre­sen­ta­tions and in our dis­cus­sions with KOLs [key opin­ion lead­ers] around AS­CO, some physi­cians raised the ques­tion of whether KRAS(G12C) in­hibitors are be­ing dosed prop­er­ly, es­pe­cial­ly giv­en on­go­ing com­bi­na­tion tri­als.

An Am­gen spokesper­son told End­points that the post-mar­ket­ing study was orig­i­nal­ly tak­en up to see if there was an im­proved risk ben­e­fit with Lumakras at a low­er dose as part of the FDA’s on­col­o­gy-fo­cused Pro­ject Op­ti­mus. How­ev­er, Am­gen still touts that the drug is safe and ef­fi­ca­cious, point­ing to two-year fol­low-up da­ta that the phar­ma pre­sent­ed at AACR ear­li­er this year.

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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