Rep. Carolyn Maloney (D-NY) (Bill Clark/CQ Roll Call via AP Images)

House com­mit­tee calls on DOJ to in­ves­ti­gate com­pa­nies' opi­oid set­tle­ment tax ben­e­fits

Four com­pa­nies that al­leged­ly helped fu­el the opi­oid epi­dem­ic re­cent­ly agreed to pay about $26 bil­lion to set­tle thou­sands of re­lat­ed law­suits, but they al­so may use cer­tain tax ben­e­fits for their set­tle­ment ex­pens­es, House Over­sight Com­mit­tee Chair Car­olyn Mal­oney and col­leagues re­cent­ly wrote to At­tor­ney Gen­er­al Mer­rick Gar­land and Trea­sury Sec­re­tary Janet Yellen.

Last March, the Over­sight lead­ers ques­tioned the com­pa­nies — Car­di­nal Health, McKesson, Amerisource­Ber­gen, and John­son & John­son — on re­port­ed plans to use a tax pro­vi­sion in the Coro­n­avirus Aid, Re­lief, and Eco­nom­ic Se­cu­ri­ty (CARES) Act to in­crease de­duc­tions for set­tle­ment costs re­lat­ed to their role in fu­el­ing the US opi­oid cri­sis.

“The Com­mit­tee re­mains deeply con­cerned that these com­pa­nies will be al­lowed to claim bil­lions in tax ben­e­fits re­sult­ing from great harm to the Amer­i­can peo­ple,” De­mo­c­rat Reps. Mal­oney (NY), Jim­my Gomez (CA), and Mark De­Saulnier (CA) wrote.

They al­so sug­gest­ed that the De­part­ments of Jus­tice and Trea­sury should look in­to whether Car­di­nal Health, specif­i­cal­ly, is im­prop­er­ly tak­ing ad­van­tage of the CARES Act’s loss car­ry­back pro­vi­sion.

The pro­vi­sion pro­vides for com­pa­nies to car­ry back any net op­er­at­ing loss­es from 2017 to 2021, to each of the five tax­able years pre­ced­ing the tax­able year in which the loss aris­es.

Car­di­nal Health not­ed in its re­sponse last year to the com­mit­tee, when ques­tioned on the tax ben­e­fits, that “even if the CARES Act were not in place, and Car­di­nal Health did not have in­sur­ance cov­er­age pur­chased through its whol­ly-owned in­sur­ance com­pa­ny, the ap­plic­a­ble pay­ments un­der the Set­tle­ment Frame­work still would be tax de­ductible as li­a­bil­i­ties are fixed and pay­ments are made.”

But oth­ers, like J&J and McKesson, made clear to the com­mit­tee they have no plans to use the CARES Act to car­ry back net op­er­at­ing loss­es at­trib­ut­able to any po­ten­tial opi­oid lit­i­ga­tion-re­lat­ed loss­es.

“The Com­mit­tee re­quests that your De­part­ments ex­am­ine any de­duc­tion McKesson Cor­po­ra­tion, Amerisource­Ber­gen, John­son & John­son, or Car­di­nal Health may claim based on their set­tle­ment ex­pens­es and whether Car­di­nal is im­prop­er­ly tak­ing ad­van­tage of the CARES Act loss car­ry­back pro­vi­sion. The Com­mit­tee fur­ther re­quests that you brief Com­mit­tee staff re­gard­ing your find­ings,” the let­ter notes.

More than 500,000 peo­ple in the US have died from the opi­oid epi­dem­ic since 1999, and more than 100,000 died last year alone.

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.

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.

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.

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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