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.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Uğur Şahin, BioNTech CEO (Andreas Arnold/picture-alliance/dpa/AP Images)

BioN­Tech opens new plas­mid DNA man­u­fac­tur­ing fa­cil­i­ty in Ger­many

German mRNA player BioNTech opened the doors to a new manufacturing facility on Thursday, this one just about 75 miles north of its headquarters in Mainz, Germany.

BioNTech announced on Thursday that it has completed the construction of its first plasmid DNA manufacturing facility in Marburg, Germany. The facility will produce materials for mRNA-based vaccines and therapies along with cell therapies.

David Kirn, 4D Molecular Therapeutics CEO (via website)

FDA places hold on 4D Mol­e­c­u­lar’s Fab­ry gene ther­a­py

4D Molecular Therapeutics quietly tucked an FDA clinical hold on its Fabry gene therapy into an SEC filing.

Meanwhile, the biotech issued a press release the same day after the closing bell on Thursday touting an IND for another asset, in diabetic macular edema.

The California biotech had paused enrollment of patients in its two trials of the Fabry gene therapy (4D-310) last month after three patients experienced kidney issues, all of which were resolved within four weeks. At the time, 4DMT said it would wait until the second half of this year to look at 12-month clinical data on six patients in the Phase I/II trials, one in the US and one in Taiwan and Australia.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.

Man­u­fac­tur­ing roundup: Catal­ent caps off man­u­fac­tur­ing site in Bel­gium; Eu­roAPI restarts pro­duc­tion in Hun­gary

Catalent is opening the doors to a new plasmid DNA manufacturing site at one of its core sites in Europe.

The new 12,000-square-foot plasmid manufacturing site is located in its cell therapy center in Gosselies, Belgium, and has multiple cleanrooms meant to produce cGMP-grade plasmid DNA for clinical and commercial purposes. The site will also see Catalent producing plasmids that are intended to be used by cell and gene companies.