‘Too big to care’: Sweep­ing law­suit ac­cus­es Te­va of col­lud­ing with oth­er gener­ic mak­ers to keep prices high

Te­va has been ac­cused of be­ing a ring­leader in a mas­sive price-fix­ing con­spir­a­cy along­side 19 oth­er gener­ic drug­mak­ers in the US, caus­ing price spikes of as much as 1000% from 2013 to 2015, ac­cord­ing to an an­titrust law­suit filed by 44 states.

The law­suit, which al­so names 15 in­di­vid­u­als, is the sec­ond to be filed in an “on­go­ing, ex­pand­ing in­ves­ti­ga­tion” on the gener­ic drug in­dus­try — “the largest pri­vate sec­tor cor­po­rate car­tel in his­to­ry” ac­cord­ing to Con­necti­cut at­tor­ney gen­er­al William Tong. Un­der his pre­de­ces­sor, the state teamed up with a few­er num­ber of states in 2016 to sue some of the same com­pa­nies over two drugs. To­day, the list has grown to 114.

And count­ing. A Con­necti­cut pros­e­cu­tor lead­ing the probe told the Wash­ing­ton Post in De­cem­ber that his team is now look­ing at 300 drugs.

William Tong

While the gener­ic drug mar­ket was de­signed to bring pre­scrip­tion prices down, the ac­cused com­pa­nies — My­lan, Glen­mark, San­doz, Ac­tavis and the like — con­sis­tent­ly co­or­di­nat­ed among them­selves to keep them up for a big­ger prof­it, pros­e­cu­tors al­leged.

Their scheme, in a nut­shell:

Rather than en­ter a par­tic­u­lar gener­ic drug mar­ket by com­pet­ing on price in or­der to gain mar­ket share, com­peti­tors in the gener­ic drug in­dus­try would sys­tem­at­i­cal­ly and rou­tine­ly com­mu­ni­cate with one an­oth­er di­rect­ly, divvy up cus­tomers to cre­ate an ar­ti­fi­cial equi­lib­ri­um in the mar­ket, and then main­tain an­ti­com­pet­i­tive­ly high prices. This ‘fair share’ un­der­stand­ing was not the re­sult of in­de­pen­dent de­ci­sion mak­ing by in­di­vid­ual com­pa­nies to avoid com­pet­ing with one an­oth­er. Rather, it was a di­rect re­sult of spe­cif­ic dis­cus­sion, ne­go­ti­a­tion and col­lu­sion among in­dus­try par­tic­i­pants over the course of many years.

To make mat­ters worse, the law­suit stat­ed in brief sec­tions ti­tled “spo­li­a­tion of ev­i­dence” and “ob­struc­tion of jus­tice,” com­pa­ny ex­ecs be­gan talk­ing to each oth­er and delet­ing texts and emails once they learned about the in­ves­ti­ga­tion.

As gener­ics ac­count for 90% of pre­scrip­tions dis­pensed in the US, this is an is­sue that af­fects every Amer­i­can, Tong said in an in­ter­view with CBS60 Min­utes. For a vi­su­al il­lus­tra­tion, he raised a bot­tle of doxy­cy­cline, an an­tibi­ot­ic he takes dai­ly. The drug is one of many whose prices in­creased over the past years due to the scheme, mak­ing him “one of the vic­tims.”

Bill Whitak­er

The ef­fect of that, he said in re­sponse to a ques­tion from Bill Whitak­er, is “dev­as­tat­ing.”

“It af­fects health in­sur­ance pre­mi­ums and health in­sur­ance plans. It im­pacts Medicare and Med­ic­aid,” he told the host. “And it is a chain re­ac­tion that dri­ves up the price of Amer­i­can health­care to un­nat­ur­al heights.” He went on to say the com­pa­nies were “too big to care.”

Te­va, which saw its shares $TE­VA drop 13% to $12, de­nied the al­le­ga­tions, as did Pfiz­er, ac­cord­ing to state­ments quot­ed by Reuters and the New York Times. Mean­while, No­var­tis vowed to “vig­or­ous­ly con­test” the claims against San­doz.

Vamil Di­van of Cred­it Su­isse sees the com­plaint — re­gard­less of the mer­its of the case — read­ing neg­a­tive­ly for Te­va, as it might lead to some sort of fi­nan­cial set­tle­ment. But it would be “man­age­able” for the com­pa­ny even as it strug­gles with plung­ing rev­enue and de­clin­ing stock, tak­ing in­to con­sid­er­a­tion “the im­por­tant role gener­ic drugs play in man­ag­ing drug spend­ing in this coun­try, as well as Te­va’s cur­rent debt load.”

The As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines, an in­dus­try lob­by­ing group, re­spond­ed to the 60 Min­utes seg­ment by re­it­er­at­ing its gen­er­al con­dem­na­tion of il­le­gal be­hav­iors but em­pha­siz­ing the sav­ings that gener­ics bring com­pared to their brand­ed coun­ter­parts.

“To­day’s gener­ic drug in­dus­try is char­ac­ter­ized by in­tense com­pe­ti­tion,” the state­ment read. “As a re­sult, pric­ing da­ta from the last three years in­di­cate that gener­ic prices have de­clined over­all and saved pa­tients and tax­pay­ers lit­er­al­ly bil­lions of dol­lars com­pared to brand-name drug prices.”

Michel Younatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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Ryan Watts, Denali CEO

Bio­gen hands De­nali $1B-plus in cash, $1B-plus in mile­stones to part­ner on late-stage Parkin­son’s drug

Biogen is handing over more than a billion dollars cash to partner with the up-and-coming neurosciences crew at Denali on a new therapy for Parkinson’s. And the big biotech is ready to pile on more than a billion dollars more in milestones — if the alliance is a success.

For Biogen $BIIB, the move on Denali’s small molecule inhibitors of LRRK2 puts them in line to collaborate on a late-stage program for DNL151, which is scheduled to start next year.

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President Trump (AP Images)

FDA takes the lead on defin­ing es­sen­tial un­der Trump's 'Buy Amer­i­can' ex­ec­u­tive or­der — as in­dus­try warns of sup­ply chain dis­rup­tion

President Donald Trump has signed an executive order detailing how the federal government should help on-shore drug manufacturing — and the FDA will play a central role.

The agency now has three months to draw up the list of “essential medicines, medical countermeasures, and their critical inputs” that the US must have available at all times. Various departments and agencies are then directed to buy these drugs and their ingredients from American manufacturers.

Covid-19 roundup: Pfiz­er teams with Gilead on remde­si­ivr; Japan, Brazil, Switzer­land, In­dia get vac­cines

Pfizer has joined the list companies helping Gilead manufacture remdesivir. The pharma giant announced today they signed a multi-year agreement to provide Gilead with contract manufacturing services at their McPherson, Kansas plant. The deal is part of a broad effort by Gilead to scale up the drug, the only currently authorized therapy for Covid-19, to 2 million doses this year.

That effort now includes 40 different companies on 3 continents, according to a press release the biotech put out yesterday, not including the generic drugmakers the company has allowed to produce the anti-viral for low and middle-income countries. Dozens of state governments, though, have said those efforts have not been extensive enough to keep up with demand and have called upon the federal government to sidestep Gielad’s patents and begin scaling the drug itself.  – Jason Mast

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Alex­ion cre­ates new post for chief di­ver­si­ty of­fi­cer; Bar­ry Greene step­ping down at Al­ny­lam, Yvonne Green­street named as suc­ces­sor

Alexion has carved out a new position for chief diversity officer and filled it with an inside promotion.

Uzair Qadeer will now be responsible for their “diversity, inclusion and belonging” strategy, looking to reshape the biotech’s corporate culture. A veteran of Deloitte and Bristol Myers Squibb, Qadeer was working on executive coaching and helping create the diversity program he now leads.

In sur­pris­ing set­back, com­bo of Roche’s Tecen­triq and chemo fails to help pa­tients with triple-neg­a­tive breast can­cer

Roche broke ground last year when they secured the first FDA approval for a checkpoint therapy in triple-negative breast cancer, a notoriously difficult-to-treat indication that has been passed over by the wave of targeted therapies.

Now, though, doctors are puzzling over why a combination of drugs meant to make that therapy more potent instead appeared to make it less effective.

Roche said Thursday that in a Phase III trial, combining their PD-1/L1 checkpoint therapy Tecentriq with the chemotherapy paclitaxel, did not significantly improve progression-free survival for patients with locally advanced or metastatic triple-negative breast cancer over giving those patients chemotherapy alone. In fact, patients on the Tecentriq-chemo arm had lower overall survival than patients on chemo, although the drugmaker cautioned that the trial was not powered for that endpoint and the data were immature.

President Trump speaks with members of the media before boarding Marine One (AP Images)

'Oc­to­ber is com­ing,' and every­one still wants to know if a Covid-19 vac­cine will be whisked through the FDA ahead of the elec­tion

Right on the heels of a lengthy assurance from FDA commissioner Stephen Hahn that the agency will not rush through a quick approval for a Covid-19 vaccine, the President of the United States has some thoughts on timing he’d like to share.

In an exchange with Fox News’ Geraldo Rivera on Thursday, President Trump allowed that a vaccine could be ready to roll “sooner than the end of the year, could be much sooner.”

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Donald Trump, AP

Trump reach­es for his pen as long-await­ed ex­ec­u­tive or­der on drug man­u­fac­tur­ing on-shoring fi­nal­ly ar­rives — re­ports

President Trump will sign a long-rumored executive order later today that is designed to spur more made-in-the-USA therapies, according to a slate of new reports out Thursday morning.

Drug manufacturing circles have been buzzing about this EO for months now, wondering how Trump plans to require the on-shoring of certain therapies.

According to the Bloomberg report, White House trade adviser Peter Navarro told reporters that the administration will come up with a list of essential medicines Trump wants to have made inside the US. The order will direct government purchasers to buy these essential meds from US suppliers. The reports add that the order relaxes drug safety and environmental regulations to make it happen.

Yvonne Greenstreet, incoming Alnylam president (Alnylam)

Al­ny­lam pres­i­dent Bar­ry Greene leaves af­ter 17 years, hand­ing po­si­tion over to Yvonne Green­street as biotech looks to­ward prof­itabil­i­ty

After 17 years helping Alnylam steer control of buzzy but unproven science they promised could change medicine, president Barry Greene is leaving the RNAi biotech just as that technology is beginning to hit prime time.

Leaving to “pursue outside interests in the biopharmaceutical industry,” the longtime executive will hand over the reins on October 1 to current COO Yvonne Greenstreet. Greenstreet, a former Pfizer and GlaxoSmithKline executive, inherits the high-profile spot at a company that’s proven its tech can work in rare diseases but now faces the daunting task of turning a couple successes and a new mountain of cash into drugs that are broadly applicable and, crucially, profitable.

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