Gilead scores a $33M set­tle­ment from its cam­paign against ‘colos­sal fi­nan­cial fraud’

More than 18 months and 860 court fil­ings lat­er, Gilead has bagged a new set­tle­ment in its cam­paign against a group of com­pa­nies that par­tic­i­pat­ed in an al­leged fraud aimed at its free meds pro­gram for peo­ple at risk of HIV.

Gilead, along with health­care clin­ic Well Care and ex­ecs Willie Pea­cock and Sha­juan­drine Gar­cia, reached a set­tle­ment worth $33 mil­lion last week. Gilead is drop­ping its al­le­ga­tions against the clin­ic, and the par­ties in­volved will pay their own at­tor­ney fees.

The saga be­gan in 2020, af­ter Gilead sued more than 50 Flori­da-based phar­ma­cies, providers and clin­ics in No­vem­ber that year for al­leged­ly schem­ing to ex­ploit the phar­ma’s “Ad­vanc­ing Ac­cess Med­ica­tion As­sis­tance Pro­gram,” which pro­vides free HIV PrEP med­i­cines to cer­tain unin­sured in­di­vid­u­als to pre­vent them from con­tract­ing HIV.

Ac­cord­ing to Gilead’s ini­tial 138-page fil­ing, the schemes in­clud­ed a com­mon modus operan­di:

…re­cruit­ing in­di­vid­u­als who earn low in­comes or are home­less to serve as place­hold­er “pa­tients”; pre­scrib­ing those “pa­tients” med­ical­ly un­nec­es­sary, in­ap­pro­pri­ate, and of­ten un­want­ed PrEP med­ica­tion; false­ly cer­ti­fy­ing to Gilead’s rep­re­sen­ta­tives that the pre­scrip­tions are med­ical­ly nec­es­sary and ap­pro­pri­ate; seek­ing re­im­burse­ment from Gilead, un­der false pre­tens­es, for the cost of those fraud­u­lent­ly dis­pensed med­ica­tions; un­law­ful­ly re­mov­ing PrEP med­ica­tion from its orig­i­nal, FDA-ap­proved pack­ag­ing and sep­a­rat­ing it from its orig­i­nal, FDA-ap­proved la­bel­ing; repack­ag­ing PrEP med­ica­tion in an un­law­ful, trade­mark-in­fring­ing, and po­ten­tial­ly dan­ger­ous man­ner for dis­pen­sa­tion to the re­cruit­ed “pa­tients”; and un­law­ful­ly re­pur­chas­ing those med­ica­tions back from “pa­tients” for pen­nies on the dol­lar so they can be resold at a high­er price on the black mar­ket. In ad­di­tion to de­fraud­ing Gilead out of tens of mil­lions of dol­lars and jeop­ar­diz­ing Gilead’s hard-earned good­will, De­fen­dants’ schemes have placed at risk the health — and even the lives—of Florid­i­ans who are eco­nom­i­cal­ly chal­lenged.

Gilead fur­ther blast­ed the de­fen­dants in its orig­i­nal fil­ing, call­ing the schemes “a colos­sal fi­nan­cial fraud.”

In a state­ment to End­points News, a Gilead spokesper­son said, “Well Care and its pres­i­dent, Mike Pea­cock, played a cen­tral role in the con­spir­a­cy by part­ner­ing with one of the main de­fen­dant groups to ex­pand the fraud­u­lent scheme to Jack­sonville and en­rich them­selves at Gilead’s ex­pense. The Well Care de­fen­dants ac­tive­ly re­cruit­ed and paid thou­sands of vul­ner­a­ble Florid­i­ans to en­roll in Gilead’s free-drug pro­gram for PrEP re­gard­less of whether they want­ed or need­ed PrEP med­ica­tion, putting pa­tient safe­ty at risk.”

As part of the judg­ment that Gilead and Well Care agreed to, Well Care is per­ma­nent­ly en­joined from ever par­tic­i­pat­ing in Gilead’s free drug pro­gram again.

Kei­th Sil­ver­stein, one of the at­tor­neys that rep­re­sent­ed Well Care in the law­suit heard in dis­trict court in the South­ern Dis­trict of Flori­da, con­firmed the set­tle­ment, but de­clined to com­ment for this sto­ry.

This is on­ly the most re­cent set­tle­ment Gilead has made in the case so far, with a Gilead spokesper­son telling End­points that of the 58 de­fen­dants named in the orig­i­nal com­plaint, on­ly 12 re­main.

Flori­da had a re­cent is­sue it­self with an HIV drug op­er­a­tion, af­ter a Flori­da man was re­port­ed to be fac­ing more than a cen­tu­ry in prison af­ter dis­trib­ut­ing more than $230 mil­lion in adul­ter­at­ed and mis­la­beled HIV med­i­cines.

The Fac­tors Dri­ving a Rapid Evo­lu­tion of Gene & Cell Ther­a­py and CAR-T Clin­i­cal Re­search in APAC

APAC is the fastest growing region globally for cell & gene therapy trials representing more than a third of all cell & gene studies globally, with China leading in the region. 

APAC is the leading location globally for CAR-T trials with China attracting ~60% of all CAR-T trials globally between 2015-2022. The number of CAR-T trials initiated by Western companies has rapidly increased in recent years (current CAGR of about 60%), with multiple targets being explored including CD19, CD20, CD22, BCMA, CD30, CD123, CD33, CD38, and CD138.

The End­points 11; blue­bird's $3M gene ther­a­py; Bio­gen tout new neu­ro da­ta; Harsh re­views for can­cer drugs; 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.

Reading about John Carroll’s pick of biotech’s most promising startups has become a treasured tradition. If you ever get curious about previous classes of the Endpoints 11, you can find all of them (plus a number of our other regular specials) here.

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EMA warns of short­ages of two Boehringer heart drugs due to a spike in de­mand

The EMA is putting EU member states on alert over the shortage of two drugs that counter heart attacks due to an uptick in demand.

On Friday, the EMA sent out a warning that two Boehringer Ingelheim drugs are experiencing a shortage: Actilyse and Metalyse. The drugs are used as emergency treatments for adults experiencing acute myocardial infarction, or a heart attack, by dissolving blood clots that have formed in the blood vessels.

The End­points 11: The top pri­vate biotechs in pur­suit of new drugs. Push­ing the en­ve­lope with pow­er­ful new tech­nolo­gies

Right around the beginning of the year, we got a close-up look at what happens after a boom ripples through biotech. The crash of life sciences stocks in Q1 was heard around the world.

In the months since, we’ve seen the natural Darwinian down cycle take effect. Reverse mergers made a comeback, with more burned out shells to go public at a time IPOs and road shows are out of favor. And no doubt some of the more recent arrivals on the investing side of the business are finding greener pastures.

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Solicitor General Elizabeth Prelogar

Should SCO­TUS hear Am­gen's Repatha case? So­lic­i­tor gen­er­al says no

Back in April, Amgen said it was encouraged by the solicitor general’s anticipated review of its Supreme Court petition to rehear a Repatha patent case. They’re likely much less optimistic about the outcome now.

Solicitor General Elizabeth Prelogar wrote in a recent 27-page brief that Amgen’s arguments “lack merit and further review is not warranted.”

The case traces back to a suit filed in 2014 against Sanofi and Regeneron’s Praluent, which ended up beating Amgen’s PCSK9 blockbuster Repatha to market by a month just a year later.

Klick Health gath­ers biotech and phar­ma lu­mi­nar­ies to dis­cuss in­dus­try in­no­va­tions, in­vest­ments and fu­ture

At Klick Health’s first Ideas Exchange conference with biotech and pharma industry insiders since before the pandemic began, it was no surprise many conversations included Covid topics. Yet while vaccines and treatments were discussed, so too were the effects on drug development, federal responses, health inequities — and what to do now and next.

George Yancopoulos, chief scientist and cofounder of Regeneron, opened the conference responding to a question from Acorda CEO Ron Cohen about the spotlight on the industry during Covid and some of the “flak” biopharma has taken in the past.

FDA's out­side ex­perts vote in fa­vor of Fer­ring's fe­cal trans­plant for C. dif­fi­cile, set­ting the stage for Seres

FDA’s outside advisors voted in favor of Ferring Pharmaceuticals’ RBX2660, an experimental poop-based drug implant that the company says would be the first microbiota-based live biotherapeutic to receive an FDA green light.

That was a point repeatedly discussed during the Vaccines and Related Biological Products Advisory Committee, or VRBPAC, meeting Thursday when evaluating Ferring’s fecal microbiota transplant, or FMT, for reducing the recurrence of Clostridioides difficile infection in adults who have received antibiotics. Multiple members brought up the need for a regulated product amid a landscape of unregulated FMTs already happening in clinical care.

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Vas Narasimhan, Novartis CEO (Simon Dawson/Bloomberg via Getty Images)

No­var­tis un­veils 'US-first' strat­e­gy ahead of San­doz spin­off

Weeks after announcing the spinoff of generics arm Sandoz, Vas Narasimhan paints a picture of the new, slimmer Novartis — with a “US-first mindset,” he said at an investor event on Thursday.

The CEO unveiled ambitious plans to become a top-five player in the US by 2027 at Novartis’ “Meet the Management” event in Basel, Switzerland, which means ramping up clinical trials in the states and “building capability and talent, among other things.” The company’s also shooting for a top-three ranking in China.

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Pfiz­er sacks phar­ma com­pe­ti­tion in ear­ly NFL TV ad­ver­tis­ing sea­son

If pharma advertising had a fantasy football league, Pfizer would be crushing the competition. A dive into the National Football League’s TV commercial buys across early season games by iSpot shows a hefty lead with its Covid-19 Comirnaty vaccine ads.

More than 175 million impressions with $9.5 million in media spending put Pfizer in the top spot with a 65% share of voice across NFL pharma spending, according to the real-time TV ad tracker. In a distant second place is Bristol Myers Squibb’s Opdivo with 44 million impressions, $5.2 million in spending and a 16% share, followed by BMS’ Zeposia with 31 million impressions, $3.3 million in media buys and an 11% share.

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