Gilead, Bris­tol My­ers face law­suit from ma­jor phar­ma­cies over HIV gener­ic drug de­lays

Ma­jor phar­ma­cy chains CVS and Rite Aid re­cent­ly sued Gilead Sci­ences, Te­va and Bris­tol My­ers Squibb, claim­ing the phar­ma com­pa­nies de­lib­er­ate­ly stalled the in­tro­duc­tion of cheap­er gener­ic ver­sions of sev­er­al block­buster HIV drugs.

The suit specif­i­cal­ly goes af­ter bil­lions of dol­lars worth of re­verse-pay­ment agree­ments be­tween the phar­ma com­pa­nies that with­held from the mar­ket gener­ic ver­sions of HIV drugs Viread, Atripla, Tru­va­da and Evotaz.

“From 2004 to 2017, Gilead made tens of bil­lions of dol­lars from HIV med­ica­tions while in­tro­duc­ing on­ly a sin­gle new phar­ma­ceu­ti­cal com­pound,” the suit al­leges. “In con­nec­tion with these set­tle­ment agree­ments, col­lu­sive col­lab­o­ra­tions and prod­uct-hop­ping schemes, Gilead un­fair­ly in­creased the al­ready ex­or­bi­tant pric­ing for its HIV med­ica­tions to wring the last bit of avail­able prof­its from its HIV fran­chis­es when faced with im­mi­nent gener­ic com­pe­ti­tion.”

In the case of Viread, the suit al­so ex­plains how Gilead and Te­va dropped a clause from their for­mal patent set­tle­ment that would have forced Gilead to not launch an au­tho­rized gener­ic, as part of an at­tempt to avoid scruti­ny from the Fed­er­al Trade Com­mis­sion. But the suit claims that the two com­pa­nies “con­tin­ued to hon­or the clause in pur­pose and ef­fect.”

In oth­er in­stances, the suit ex­plains some of Gilead’s schemes, adding:

By un­fair­ly sup­press­ing com­pe­ti­tion for TDF [teno­fovir diso­prox­il fu­marate] and act­ing to pro­tect its prof­its from the sale of TDF as a com­po­nent of FDC HIV med­ica­tions like Tru­va­da and Atripla, Gilead was able to main­tain prof­its with­out in­no­vat­ing and rolling out safer and more ef­fec­tive TAF. Gilead with­held TAF-based HIV med­ica­tions from the mar­ket un­til the en­try of gener­ic TDF was im­mi­nent. In the in­ter­im, Gilead launched mul­ti-lay­ered schemes to stall gener­ic com­pe­ti­tion and max­i­mize prof­its for its TDF-based drugs to the detri­ment of pur­chasers of those drugs.

The suit al­so goes af­ter the fact that Gilead, which col­lab­o­rat­ed with Bris­tol My­ers Squibb on de­vel­op­ing some of the drugs, is not the in­ven­tor of teno­fovir, which came from Czech in­sti­tu­tions in the 1980s.

CVS and Rite Aid lawyers, who are seek­ing over­charge dam­ages among oth­er pro­vi­sions, al­so note that nu­mer­ous courts have agreed with the FTC and found that “no au­tho­rized gener­ic” claus­es can and do con­sti­tute an­ti­com­pet­i­tive re­verse pay­ments to fil­ers of gener­ic drug ap­pli­ca­tions.

Gilead said in a state­ment to End­points News: “The law­suits filed against Gilead, along with two oth­er com­pa­nies, dis­torts and mis­states Gilead’s his­to­ry, its col­lab­o­ra­tions with its part­ners, and its set­tle­ment agree­ments. Gilead be­lieves this law­suit and its an­titrust al­le­ga­tions are with­out mer­it. The al­le­ga­tions against Gilead are mis­guid­ed and do not ac­cu­rate­ly re­flect an­titrust laws or Gilead’s his­to­ry of in­no­v­a­tive col­lab­o­ra­tion and com­pe­ti­tion in HIV med­i­cines.”

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Klick Health agency employees appear in its annual holiday greeting video with this year's theme to #SpreadJoy (via Klick Health)

Klick Health hands out $100 bills in an­nu­al hol­i­day greet­ing that’s turned in­to de­fault re­cruit­ing tool

Editor’s Note: For more news, analysis and exclusive coverage from the marketing beat, subscribe to the Endpoints MarketingRx weekly report in your reader profile.

What would you do with $100 and the simple instruction to “spread joy?” That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits.

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Warren Huff, Reata CEO

FDA slams Reata's kid­ney drug as in­ef­fec­tive ahead of ad­comm meet­ing

The FDA on Monday offered an overwhelmingly negative opinion on Reata Pharmaceuticals’ potential drug to slow the loss of kidney function in those with the rare disease Alport syndrome, according to briefing documents released ahead of an advisory committee meeting Wednesday.

The agency’s review team said it “does not believe the submitted data demonstrate that bardoxolone is effective in slowing the loss of kidney function in patients with AS and reducing the risk of progression to kidney failure.” Originally developed as a cancer drug, bardoxolone was later scuttled by Reata almost a decade ago as a chronic kidney disease drug due to deaths in a Phase III trial.

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No­var­tis pe­ti­tions FDA to block 18 gener­ic com­peti­tors for its megablock­buster heart drug un­til 2024

Novartis is looking to milk one of its most prized possessions a little while longer without any generic competition, mostly because of a newly approved use that the Big Pharma won earlier this year for its megablockbuster heart drug Entresto.

In addition to battling (and winning) litigation last month to block a handful of Indian generics from entering the market early alongside Entresto, the company last week petitioned the FDA to try to stop a total of 18 Entresto generics from launching before 2024 at the earliest.