Pub­lic com­bat over US drug prices cen­ters on Prop 61 as rhetoric heats up to fever pitch

A week ago, Propo­si­tion 61 looked like a sure win­ner for its ad­vo­cates. With sen­ti­ment run­ning strong­ly against Big Phar­ma com­pa­nies, polls showed plen­ty of sup­port for a bal­lot mea­sure in Cal­i­for­nia that would cap drug prices for the state at the lev­el that the Vet­er­ans Ad­min­is­tra­tion reach­es through price ne­go­ti­a­tions.

Eli Lil­ly CEO John Lech­leit­er

But with the vote now just hours away, the in­dus­try is see­ing the polling re­sults lean­ing to a dead heat af­ter throw­ing more than $100 mil­lion in­to the fight, which is reach­ing a fever pitch in the hours be­fore fi­nal vot­ing be­gins.

As Eli Lil­ly CEO John Lech­leit­er made crys­tal clear in his Q3 call with an­a­lysts a few days ago, he and oth­er in­dus­try lead­ers are dead set against Propo­si­tion 61 for a va­ri­ety of rea­sons. Here’s what he had to say:

Prop 61, we’re fight­ing that tooth-and-nail in Cal­i­for­nia. It’s not on­ly bad leg­is­la­tion, it’s bad for your health. And we’re try­ing to im­press that on the vot­ers. What we’ve found is that the more peo­ple be­come aware of what’s at stake here and what’s the like­ly out­comes of Propo­si­tion 61, the more they’re prone to vote against it and vote it down. So we have a pret­ty big cam­paign un­der­way in Cal­i­for­nia right now to in­crease that lev­el of aware­ness and hope­ful­ly to con­tin­ue to shift vot­ers to­ward a po­si­tion of be­ing against it for a whole va­ri­ety of rea­sons.

One of the ar­gu­ments that’s be­ing thrown against the mea­sure is that the VA isn’t go­ing to find it so easy to ne­go­ti­ate the big dis­counts it’s been win­ning — around 40% — if that num­ber be­comes the cap that state pay­ers are fo­cused on. And the prospect that the end re­sult of Prop. 61 is that vets will pay more as a re­sult has helped turn the tide in Cal­i­for­nia.

But it’s im­pos­si­ble to say now who’s on top.

Pro­po­nents, mean­while, aren’t about to give up now, and they’re turn­ing up the al­ready heat­ed rhetoric. In a new re­lease out to­day, they opt­ed to vil­i­fy Lech­leit­er and a group of Big Phar­ma CEOs for their com­pa­nies’ past mar­ket­ing in­frac­tions. New 15-sec­ond ads fea­tured 6 phar­ma ex­ecs on “Want­ed” posters: Alex Gorsky at J&J; Ken Fra­zier at Mer­ck; Ian Read at Pfiz­er; Richard Gon­za­lez at Ab­b­Vie; Robert Brad­way at Am­gen and even Brent Saun­ders at Al­ler­gan, cit­ed for a 2010 vi­o­la­tion on pro­mot­ing Botox — long be­fore Saun­ders bought the com­pa­ny.

Or­ga­niz­ers say that the CEOs have “the morals and ethics of junk­yard dogs.”

Gar­ry South, a lead strate­gist who’s be­ing out­spent by about $10 to $1, cit­ed the sup­port of Bernie Sanders in the fight. He said:

Are you go­ing to trust Sen. Bernie Sanders, the Cal­i­for­nia Nurs­es Assn., AARP and Con­sumer Watch­dog, who strong­ly back Prop. 61? Or are you go­ing to trust the crim­i­nal drug com­pa­nies – con­vict­ed of all sorts of il­le­gal be­hav­ior – who are now spend­ing $126 mil­lion of their ill-got­ten gains to lie about Prop. 61?

What­ev­er hap­pens in Cal­i­for­nia, af­ter the elec­tion these same phar­ma ex­ecs are like­ly to face a gru­el­ing de­bate in Wash­ing­ton DC over drug prices, where ex­ecs from My­lan, Valeant and Tur­ing have al­ready had to face dys­pep­tic law­mak­ers. Right now, the in­dus­try will have to wait and see who comes up a win­ner on elec­tion day Tues­day. But no mat­ter who wins the votes, this is one is­sue that will not be go­ing away any­time soon.

The lat­est emails from Hillary Clin­ton’s cam­paign re­leased by Wik­iLeaks in re­cent days un­der­scores that the cam­paign tried to care­ful­ly cal­i­brate its at­tacks on phar­ma. And not all her ad­vis­ers were con­tent with the idea.

This is what Mandy Grun­wald, a se­nior com­mu­ni­ca­tions ad­vis­er, had to say when told that the cam­paign was di­al­ing down the at­tack on bio­phar­ma:

On Medicare, it’s not clear that it is ac­tu­al­ly against the law for Medicare to use its pur­chas­ing pow­er to ne­go­ti­ate for low­er prices — the way the VA does. That’s what’s com­plete­ly crazy. On Ad­ver­tis­ing, you’re miss­ing the out­rage that tax­pay­ers are help­ing to pay for those ads we all hate. On in­no­va­tion — boy I think you’ve gone too far in suck­ing up to these com­pa­nies. Re­mem­ber Joel and An­zo’s polling shows that peo­ple think these guys are big­ger vil­lains than Wall Street bankers. We should take it as a point of pride that they are go­ing to at­tack her — but her be­lief is that all com­pa­nies should be held ac­count­able if they’re rip­ping off the Amer­i­can peo­ple — whether its drug com­pa­nies or oil com­pa­nies or for prof­it col­leges or wall street….



Once fu­ri­ous over No­var­tis’ da­ta ma­nip­u­la­tion scan­dal, the FDA now says it’s noth­ing they need to take ac­tion on

Back in the BP era — Before Pandemic — the FDA ripped Novartis for its decision to keep the agency in the dark about manipulated data used in its application for Zolgensma while its marketing application for the gene therapy was under review.

Civil and criminal sanctions were being discussed, the agency noted in a rare broadside at one of the world’s largest pharma companies. Notable lawmakers cheered the angry regulators on, urging the FDA to make an example of Novartis, which fielded Zolgensma at $2.1 million — the current record for a one-off therapy.

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Covid-19 roundup: GSK, Am­gen tai­lor R&D work to fit the coro­n­avirus age; Doud­na's ge­nomics crew launch­es di­ag­nos­tic lab

You can add Amgen and GSK to the list of deep-pocket drug R&D players who are tailoring their pipeline work to fit a new age of coronavirus.

Following in the footsteps of a lineup of big players like Eli Lilly — which has suspended patient recruitment for drug studies — Amgen and GSK have opted to take a more tailored approach. Amgen is intent on circling the wagons around key studies that are already fully enrolled, and GSK has the red light on new studies while the pandemic plays out.

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In a stun­ning set­back, Amarin los­es big patent fight over Vas­cepa IP. And its high-fly­ing stock crash­es to earth

Amarin’s shares $AMRN were blitzed Monday evening, losing billions in value as reports spread that the company had lost its high-profile effort to keep its Vascepa patents protected from generic drugmakers.

Amarin had been fighting to keep key patents under lock and key — and away from generic rivals — for another 10 years, but District Court Judge Miranda Du in Las Vegas ruled against the biotech. She ruled that:
(A)ll the Asserted Claims are invalid as obvious under 35 U.S.C.§ 103. Thus, the Court finds in favor of Defendants on Plaintiff’s remaining infringementclaim, and in their favor on their counterclaims asserting the invalidity of the AssertedClaims under 35 U.S.C. § 103.

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Covid-19 roundup: J&J, BAR­DA set ear­ly 2021 fin­ish line for $1B vac­cine race; FDA al­lows emer­gency drug use, ahead of piv­otal da­ta

J&J has zeroed in on a Covid-19 vaccine candidate that it hopes to begin testing in humans by September this year — with the extraordinary goal of getting it ready for emergency use in early 2021. And together with BARDA, it’s committing $1 billion to make it happen.

That kind of accelerated timeline would fall on the fast side of NIAID director Anthony Fauci’s well-publicized prediction that it would be another 12 to 18 months before a vaccine can be available for public use. A Phase I trial of Moderna’s mRNA vaccine began two weeks ago, and both the biotech and fellow mRNA player CureVac have discussed similar, if not even faster, timelines for emergency use among healthcare workers.

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As­traZeneca says its block­buster Farx­i­ga proved to be a game-chang­er in CKD — wrap­ping PhI­II ear­ly

If the FDA can still hold up its end of the bargain, AstraZeneca is already on a short path to scooping up a cutting-edge win with a likely approval for their SGLT2 drug Farxiga in cutting the risk of heart failure. Now the pharma giant says it can point to solid evidence that the drug — initially restricted to diabetes — also works for chronic kidney disease, potentially adding a blockbuster indication for the franchise.

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It is 'kind of a proven tech­nol­o­gy': Hep B vac­cine mak­er joins glob­al hunt for coro­n­avirus vac­cine

Using lab-grown proteins that are engineered to mimic the architecture of viruses to induce an immune response, VBI Vaccines is joining the hunt for a coronavirus vaccine — harnessing technology that has initially been proved safe in early trials as a prophylactic for cytomegalovirus (CMV) infection.

Unlike the raft of the companies in the Covid-19 vaccine race — including Moderna, CureVac and J&J — VBI is taking a pan-coronavirus approach, by developing a vaccine that will encompass Covid-19, severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS).

Can a pair of top AveX­is alum­ni steer a new gene ther­a­py up­start to R&D glo­ry? 3 VCs bet $60M on it

VCs love few things more than a proven executive team when it comes to launching a new company. And now a group of A-listers has turned to a pair of top execs out of AveXis to steer the latest gene therapy player into the clinic.

The biotech is Waltham, MA-based Affinia and the two execs are Sean Nolan and Rick Modi — the former CEO and CBO respectively of AveXis, the gene therapy pioneer that fetched $8.7 billion in a sale to Novartis. Nolan has now taken the chairman’s role at Affinia while Modi moves up to the CEO post at the company.

Un­de­terred by a pan­dem­ic, Gilde Health­care rais­es their largest fund yet

When Pieter van der Meer started raising the capital for Gilde Healthcare’s fifth fund in the waning months of 2019, he had his eyes on a different chain of events that could change the healthcare system and perhaps even play to his firm’s advantage: The US presidential election.

Since raising their third fund in 2011, the 34-year-old Dutch firm had focused on value-based care. They chose late-stage biotechs that came up with new devices and delivery systems for de-risked established compounds, and when they chose preclinical biotechs, they spoke with potential pharma partners, payers and regulators to ask where and at what prices the drug made sense. As the Democratic primary became a contest over how to lower healthcare costs, it looked like a strategy that could pay off.

Daniel O'Day (AP Images)

Gilead CEO Dan O'­Day of­fers a de­tailed ex­pla­na­tion on remde­sivir ac­cess — re­as­sur­ing an­a­lysts that Covid-19 da­ta are com­ing fast

After coming under heavy fire from consumer groups ready to pummel them for grabbing the FDA’s orphan status for remdesivir — reserved to encourage the development of rare disease therapies — Gilead CEO Daniel O’Day had some explaining to do about the company’s approach to providing access to this drug to patients suffering from Covid-19. And he set aside time over the weekend to patiently explain how they are making their potential pandemic drug available in a new program — one he feels can better be used to address a growing pack of infected patients desperately seeking remdesivir under compassionate use provisions.

In addition to trying to reassure patients that they will once again have an avenue to pursue access, O’Day also reassured some analysts who had been fretting that China’s quick comeback from the coronavirus outbreak could derail its ultra-fast schedule for testing the drug in patients. The data are still expected in a few weeks, he says in the letter, putting the readout in April.

O’Day emphasizes that Gilead intends to pursue a pricing approach that will make this drug widely available — if it proves effective and safe. But no one is quite sure just what the longterm value would be, given the work being done on a variety of vaccines that may be rolled out as early as this fall — at least to the most heavily threatened groups.

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