Trump is kick­ing the can down the road to­day, avoid­ing any tough pre­scrip­tions on drug pric­ing

BIOREG­NUM — The view from John Car­roll

John Car­roll

Pres­i­dent Don­ald Trump has found the en­e­my on drug prices, and they’re out­side our bor­ders.

Ad­min­is­tra­tion of­fi­cials of­fered re­porters a pre­view of Trump’s speech this af­ter­noon, and the de­tailed notes pro­vid­ed in a slate of sto­ries about the back­grounder in­cludes the pres­i­dent’s as­sault on oth­er coun­tries’ sin­gle-pay­er sys­tems. Those coun­tries, or rather the rest of the in­dus­tri­al­ized world, he says, have been “free-rid­ing” on the US, where high drug prices sub­si­dize an in­dus­try forced to cut prices abroad.

It’s un­cer­tain how a full throat­ed roar against “so­cial­ist” drug pric­ing poli­cies will do any­thing to cut US prices — or if rais­ing prices abroad would even help achieve the ad­min­is­tra­tion’s goal of low­er­ing out­lays for drugs here. But po­lit­i­cal­ly the pres­i­dent’s planned speech this af­ter­noon is shap­ing up as a ma­jor win for a bio­phar­ma in­dus­try that has been scram­bling to get out of the way of a threat­ened po­lit­i­cal avalanche.

In­stead of a full-scale frontal as­sault against com­pa­nies that have been “get­ting away with mur­der,” this ad­min­is­tra­tion is kick­ing the can down the road for an­oth­er day.

There are oth­er mea­sures in­clud­ed in the Trump plan, to be sure, but they in­volve chang­ing gov­ern­ment rules that shape what Medicare re­cip­i­ents pay. I’ll get to that in a sec­ond. First, it’s im­por­tant to note what is not in the plan.

Pri­mar­i­ly, there’s no pro­vi­sion seek­ing au­thor­i­ty to get Medicare start­ed on ne­go­ti­at­ing drug prices — let alone a pro­pos­al for a Medicare for­mu­la­ry to lever­age low­er prices. There’s al­so no move to gain an ap­proval to al­low for im­port­ing drugs from oth­er coun­tries where prices are low­er.

That stands as a big win for the in­dus­try lob­by­ists, as ei­ther move could pave the way to a change­up in the pric­ing struc­ture. In the past, Trump has voiced his sup­port for Medicare price ne­go­ti­a­tions, trig­ger­ing con­sid­er­able fret­ting among man­u­fac­tur­ers who re­ly on this coun­try to pro­vide the bulk of their prof­its.

The thrust of the pres­i­dent’s pro­posed poli­cies will be to get “gov­ern­ment rules out of the way that are pre­vent­ing se­niors from get­ting bet­ter deals.”

To do that, it ap­pears the pres­i­dent wants to con­tin­ue a push that would al­low Medicare Part D plans some room to fash­ion more cre­ative drug plans, end rules that en­cour­age doc­tors to pre­scribe prici­er meds and try to force phar­ma­cy ben­e­fit man­agers to share more of their re­bates from man­u­fac­tur­ers with mem­bers. Look for more out­comes pric­ing strate­gies in Medicare.

When you in­flate drug prices it gives ben­e­fit man­agers a chance to take a slice of a big­ger dis­count for them­selves, while al­so adding to out-of-pock­et ex­pens­es. This gets at the in­dus­try’s crit­i­cism that much of the prob­lem with the cur­rent pric­ing sys­tem is that ben­e­fit man­agers rigged the game to line their own pock­ets at con­sumers’ ex­pense. 

But you’ll no­tice that Trump’s fo­cus is on some of the rules for how the game is played, rather than on the game it­self. This tweet from Walid Gel­lad — an as­so­ciate pro­fes­sor of med­i­cine and health pol­i­cy at the Uni­ver­si­ty of Pitts­burgh, where he leads the Cen­ter for Phar­ma­ceu­ti­cal Pol­i­cy and Pre­scrib­ing — un­der­scores the gist of it, where the fo­cus is on who pays rather than on what every­one pays.

In ad­di­tion, it looks like we’ll see a push­back against any prac­tices that al­low man­u­fac­tur­ers to de­lay or pre­vent cheap­er com­pe­ti­tion from gener­ics and biosim­i­lars. FDA com­mis­sion­er Scott Got­tlieb has been help­ing on that front by tack­ling a back­log of gener­ics ap­pli­ca­tions.

Add it all up, and what you see here is some im­por­tant, though lim­it­ed, tin­ker­ing with a sys­tem that leaves the cur­rent drug pric­ing sys­tem baked in. Bio­phar­ma com­pa­nies will like­ly cel­e­brate all this qui­et­ly to­day. 

At some point, as an­a­lysts like David Maris have not­ed, the pres­sure to re­form drug prices may grow to the point where price con­trols are adopt­ed. 

But af­ter rail­ing against drug prices for months, Trump’s un­will­ing­ness to push Medicare price ne­go­ti­a­tions leaves pric­ing pow­er in the hands of the in­dus­try. And that means old drugs like Hu­mi­ra will con­tin­ue to cost more each year, while the stick­er shock for new ones will con­tin­ue to rat­tle the pub­lic.

This is­sue is far from re­solved. 

Im­age: Pres­i­dent Don­ald Trump in 2017. SHUT­TER­STOCK

Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.