CSL and Gri­fols sue US bor­der pa­trol for block­ing Mex­i­can plas­ma do­na­tions

Large plas­ma com­pa­nies CSL Behring and Gri­fols re­cent­ly sued US Cus­toms and Bor­der Pa­trol, which last sum­mer stopped al­low­ing Mex­i­can cit­i­zens from cross­ing in­to the US on tem­po­rary visas to sell their blood plas­ma.

The ban, ac­cord­ing to the Aus­tralia- and Spain-based com­pa­nies, is based “sole­ly on CBP’s new­found de­ter­mi­na­tion that do­nat­ing plas­ma is some­how ‘la­bor for hire,'” and it means that there may be plas­ma short­ages, ac­cord­ing to the suit re-filed in DC Dis­trict Court. The com­pa­nies pre­vi­ous­ly lost a pri­or suit last year as the judge dis­missed their com­plaint for lack of stand­ing.

CSL op­er­ates a net­work of 15 plas­ma col­lec­tion cen­ters near the south­ern bor­der in Texas and Ari­zona, with plans to open two more cen­ters short­ly, in­clud­ing its first on the Cal­i­for­nia bor­der. Gri­fols, mean­while, op­er­ates 24 such cen­ters in Ari­zona, Texas and Cal­i­for­nia, ac­cord­ing to the suit. The com­pa­nies es­ti­mate that these cross-bor­der do­na­tions are re­spon­si­ble for about 5-10% of all US plas­ma col­lec­tions.

“Such a dis­rup­tion in plas­ma do­na­tions is es­pe­cial­ly crit­i­cal now, when more plas­ma than ever is re­quired to meet the grow­ing need for plas­ma-based ther­a­pies, and when the Unit­ed States has al­ready suf­fered a 20% in­dus­try-wide drop in do­na­tions due to the pan­dem­ic,” the suit says.

The com­pa­nies claim that CBP “need­less­ly pulled the rug out from un­der plas­ma in­dus­try donors and em­ploy­ees as well as the pa­tients” as plas­ma is a cru­cial in­gre­di­ent for some treat­ments for se­ri­ous dis­eases that af­fect more than 125,000 Amer­i­cans, in­clud­ing pri­ma­ry and sec­ondary im­mune de­fi­cien­cies, res­pi­ra­to­ry dis­eases, neu­ro­log­i­cal dis­or­ders, and he­mo­phil­ia and oth­er blood dis­or­ders.

“For in­stance, im­munoglob­u­lin ther­a­py for a sin­gle pa­tient suf­fer­ing from one of a host of pri­ma­ry and sec­ondary im­mune de­fi­cien­cies re­quires about 130 do­na­tions of plas­ma an­nu­al­ly, and a year of ther­a­py for a sin­gle he­mo­phil­ia pa­tient re­quires about 1,200 do­na­tions,” the suit says.

But since last June, CBP has de­cid­ed that 30 years of prece­dent should be over­turned, and the agency sent back all po­ten­tial donors from Mex­i­co, claim­ing the do­na­tions are part of this “la­bor for hire” op­er­a­tion.

The com­pa­nies, how­ev­er, claim that the fact that a donor re­ceives pay­ment as part of the do­na­tion process “is in­ci­den­tal to the ser­vice trans­ac­tion and does not some­how trans­form the re­la­tion­ship in­to any­thing ‘akin to em­ploy­ment or con­tract work.'”

Ac­cord­ing to ProP­ub­li­ca, be­fore the pan­dem­ic, donors could make about $4,000 an­nu­al­ly if they do­nat­ed as of­ten as pos­si­ble. US law al­lows for 96 do­na­tions per year, where­as Eu­ro­pean law al­lows for 33 do­na­tions per year. Since the pan­dem­ic, those prices have gone up as do­na­tions be­come more scarce.

The ban has had a par­tic­u­lar­ly out­sized ef­fect on sev­er­al of the plain­tiffs, in­clud­ing Kevin Ras­mussen, who is a reg­u­lar plas­ma donor at CSL Plas­ma’s cen­ter in Dou­glas, AZ. He do­nates plas­ma about eight times per month, the max­i­mum per­mit­ted by FDA reg­u­la­tions, in or­der to help sup­port his fam­i­ly and wife, who has a chron­ic health con­di­tion and is of­ten un­able to work, the suit says.

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.

Bo Cumbo, new Solid Bio CEO

Sol­id Bio gets a new CEO, $75M cash and drops lead drug as big in­vestors ju­ry-rig a merg­er deal

Three months after Endpoints News broke the story that gene therapy outfit AavantiBio had gutted its CMC group in a reorganization, the biotech’s CEO has helped engineer a merger with struggling penny stock player Solid Bio. And he’s going to remain in charge of the combined operation, as Solid founder Ilan Ganot steps aside.

The merger news this morning features some high-profile investors.

Perceptive Advisors, RA Capital Management and Bain Capital Life Sciences are leading a $75 million raise to add to the pool of cash Solid will have after the tie-up. That will leave Solid $215 million in cash as Bain’s Adam Koppel jumps on the board — enough to pay for ops and get through some key data milestones on their way into 2025.

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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.

Elisabeth Stampa, Medicines for Europe president

As win­ter ap­proach­es, a Eu­ro­pean gener­ics group rais­es alarm over en­er­gy prices for man­u­fac­tur­ers

While colder temperatures are fast approaching, the situation surrounding the rise of energy prices in Europe is hitting businesses of every kind, including generic drug manufacturers.

Medicines for Europe, a group that represents the generic industry on the continent, sent a letter addressed to energy ministers and commissioners concerning inflation and the costs of energy on the supply of generic medicines.