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.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

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Whenever a big drug pricing bill comes up, an army of the industry group’s lobbyists descend onto the Hill and either smash it outright or dismantle it piece by piece.

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Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

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The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

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Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

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The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

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Days after Enhertu reeled in another FDA nod, with the first-ever green light for HER2-low breast cancer, another antibody drug conjugate biotech claims it has secured the largest preclinical ADC pact to date for a single asset.

AstraZeneca and Daiichi Sankyo made waves with their nearly $7 billion collaboration back in spring 2019, but at that point, Enhertu was already nearing the FDA’s doors with clinical data. The latest ADC tie-up to enter the biopharma fray centers around a preclinical asset, Mersana Therapeutics’ XMT-2056.