At­tor­neys gen­er­al bring an­oth­er ‘col­lu­sion’ case against gener­ic mak­ers, nam­ing No­var­tis and Pfiz­er among over a dozen oth­ers

For the third time in the last four years, a coali­tion of at­tor­neys gen­er­al have filed an an­titrust law­suit against some of the world’s largest gener­ic drug­mak­ers, in­clud­ing Pfiz­er, My­lan and No­var­tis’ San­doz unit, al­leg­ing that for years the com­pa­nies fixed prices and ma­nip­u­lat­ed the mar­ket for over 80 drugs.

The suit, brought by 51 at­tor­neys gen­er­al — in­clud­ing those of DC and every state be­sides Cal­i­for­nia, Utah, South Dako­ta and Wyoming — is the lat­est bram­ble in a le­gal thick­et that has en­snared the gener­ics in­dus­try since 2016, when 20 state at­tor­neys gen­er­al ac­cused Te­va Phar­ma­ceu­ti­cals and My­lan for an an­tibi­ot­ic and a di­a­betes drug. “We be­lieve that this is just the tip of the ice­berg,” then-Con­necti­cut At­tor­ney Gen­er­al George Jepsen said at the time.

Since then, gener­ics com­pa­nies have found them­selves at odds not on­ly with state at­tor­neys, who filed an­oth­er suit in 2019, but al­so fed­er­al in­ves­ti­ga­tors, who have suc­cess­ful­ly pros­e­cut­ed crim­i­nal charges against at least two gener­ics mak­ers. In March, San­doz plead­ed guilty to fix­ing the price of crit­i­cal drugs from 2013 to 2015 and agreed to pay $195 mil­lion. Her­itage Phar­ma­ceu­ti­cals and Ris­ing Phar­ma­ceu­ti­cals en­tered in­to sim­i­lar agree­ments.

The lat­est suit lists 20 dif­fer­ent drug­mak­ers and sev­er­al in­di­vid­u­als and fo­cus­es on the mar­ket for gener­ic top­i­cal prod­ucts, where from “at least” 2009 to 2016, they write, “col­lu­sion has been ram­pant.” This seg­ment of the in­dus­try, the suit al­leges, was par­tic­u­lar­ly il­lus­tra­tive of the larg­er gener­ic in­dus­try’s “over­ar­ch­ing un­der­stand­ing” to avoid com­pe­ti­tion and in­stead have each com­pa­ny set­tle for a “fair share” of the mar­ket, al­low­ing them to then raise prices with­out fear of be­ing un­der­cut.

Specif­i­cal­ly, it al­leges that the largest top­i­cal mak­ers Taro, Per­ri­go, Avec­tis and San­doz (then known as Fougero) had long-stand­ing agree­ments to avoid com­ple­tion and mim­ic each oth­er’s price in­creas­es.

“In or­der to main­tain these un­law­ful agree­ments, the com­peti­tors stayed in near­ly con­stant com­mu­ni­ca­tion — meet­ing reg­u­lar­ly at trade shows and cus­tomer con­fer­ences and com­mu­ni­cat­ing fre­quent­ly by phone and text mes­sage to re­in­force their un­der­stand­ings,” the at­tor­neys gen­er­al write.  Oth­er com­pa­nies al­so “un­der­stood the rules of the road and took the nec­es­sary steps to lim­it com­pe­ti­tion.”

In an emailed state­ment, No­var­tis spokesper­son Er­ic Al­thoff said the al­le­ga­tions were “over­ly broad” and not sup­port­ed by the in­di­vid­ual in­stances of mis­con­duct San­doz plead­ed to in the fed­er­al case this year.

“The in­di­vid­ual in­stances of mis­con­duct at the core of the res­o­lu­tion we reached with the U.S. De­part­ment of Jus­tice in March do not sup­port the vast, sys­temic con­spir­a­cy the States al­lege,” he said. “We take se­ri­ous­ly our com­pli­ance with an­titrust laws, and we will con­tin­ue to de­fend our­selves in this mat­ter.”

Pfiz­er said Green­stone, their gener­ics sub­sidiary, will de­fend the charges “vig­or­ous­ly.”

“As we have pre­vi­ous­ly stat­ed in re­sponse to the States’ May 2019 com­plaint, we do not be­lieve that the Com­pa­ny or our col­leagues par­tic­i­pat­ed in un­law­ful con­duct,” a spokesper­son said in an emailed state­ment. “The claims and al­le­ga­tions in the States’ most re­cent com­plaint do not change that be­lief.”

Donald and Melania Trump watch the smoke of fireworks from the South Lawn of the White House on July 4, 2020 (via Getty)

Which drug de­vel­op­ers of­fer Trump a quick, game-chang­ing ‘so­lu­tion’ as the pan­dem­ic roars back? Eli Lil­ly and Ab­Cellera look to break out of the pack

We are unleashing our nation’s scientific brilliance and will likely have a therapeutic and/or vaccine solution long before the end of the year.

— Donald Trump, July 4

Next week administration officials plan to promote a new study they say shows promising results on therapeutics, the officials said. They wouldn’t describe the study in any further detail because, they said, its disclosure would be “market-moving.”

— NBC News, July 3

Something’s cooking. And it’s not just July 4 leftovers involving stale buns and uneaten hot dogs.

Over the long weekend observers picked up signs that the focus in the Trump administration may swiftly shift from the bright spotlight on vaccines being promised this fall, around the time of the election, to include drugs that could possibly keep patients out of the hospital and take the political sting out of the soaring Covid-19 numbers causing embarrassment in states that swiftly reopened — as Trump cheered along.

So far, Gilead has been the chief beneficiary of the drive on drugs, swiftly offering enough early data to get remdesivir an emergency authorization and into the hands of the US government. But their drug, while helpful in cutting stays, is known for a limited, modest effect. And that won’t tamp down on the hurricane of criticism that’s been tearing at the White House, and buffeting the president’s most stalwart core defenders as the economy suffers.

We’ve had positive early-stage vaccine data, most recently from Pfizer and BioNTech, playing catchup on an mRNA race led by Moderna — where every little sign of potential trouble is magnified into a lethal threat, just as every advance excites a frenzy of support. But that race still has months to play out, with more Phase I data due ahead of the mid-stage numbers looming ahead. A vaccine may not be available in large enough quantities until well into 2021, which is still wildly ambitious.

So what about a drug solution?

Trump’s initial support for a panacea focused on hydroxychloroquine. But that fizzled in the face of data underscoring its ineffectiveness — killing trials that aren’t likely to be restarted because of a recent population-based study offering some support. And there are a number of existing drugs being repurposed to see how they help hospitalized patients.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

Vas Narasimhan, Novartis CEO (Patrick Straub/​EPA-EFE/​Shutterstock)

No­var­tis pays $678M for kick­back scheme as Vas Narasimhan tries to dis­tance phar­ma gi­ant from shady be­hav­ior

Novartis has reached another large settlement to resolve misconduct allegations, agreeing to pay more than $678 million to settle claims that it had spent hundreds of millions of dollars on lavish dinners, so-called speaking fees and expensive alcohol “that were nothing more than bribes” to get doctors to prescribe Novartis medications.

The top-shelf alcohol and lavish meals included a $3,250 per person night at Nobu in Dallas, a $672-per person dinner at Washington DC’s Smith & Wollensky and a $314 per person meal at Sushi Roku in Pasadena, according to the Justice Department complaint. There were at least 7 trips to Hooters and fishing trips in Alaska and off the Florida coast. Each of these events were supposed to be “speaker programs” where doctors educated other doctors on a drug, but the DOJ alleged many were “bogus” wine-and-dine events where the drug was barely mentioned, if at all.  (“Nobody presented slides on the fishing trips,” the complaint says.)