Trump slams Pfiz­er’s drug price hikes, promis­es to re­tal­i­ate — but how?

Pfiz­er’s re­cent round of drug price hikes in the wake of Pres­i­dent Don­ald Trump’s promise of cas­cad­ing costs has drawn the at­ten­tion of the com­man­der-in-chief.

The Fi­nan­cial Times first re­port­ed that Pfiz­er had hiked prices on 100 prod­ucts at right around 9% for most, fit­ting un­der a 10% cap that most man­u­fac­tur­ers are hap­py to com­ply with. Just a few weeks ago, though, Trump caught the at­ten­tion of the in­dus­try when he promised that phar­ma com­pa­nies were about to de­liv­er “vol­un­tary mas­sive drops in prices.”

Turns out, the in­dus­try hadn’t been alert­ed, and HHS Sec­re­tary Alex Azar was left with the task to ex­plain that deep price cuts weren’t re­al­ly in the cards. Te­va and Roche al­so raised prices re­cent­ly, ac­cord­ing to a re­port from Reuters.

Pfiz­er CEO Ian Read is prob­a­bly the last chief in Big Phar­ma to suc­cumb to pres­sure from the gov­ern­ment on pric­ing. Near­ing the end of his reign, he’s been out­spo­ken about boost­ing prices as need­ed for his busi­ness and re­quired a change in tax pol­i­cy from the Oba­ma ad­min­is­tra­tion to stop a planned M&A deal to shift his tax base to a more ap­peal­ing en­vi­ron­ment — like what the UK has to of­fer.

In­ter­est­ing­ly, Bern­stein’s Ron­ny Gal put out a note ear­li­er to­day that says Azar has been look­ing for some cov­er on pric­ing — with­out tam­per­ing with the bot­tom line.

We learned from in­dus­try con­tacts that Trump’s promise for ma­jor price cuts has blind­sided HHS. In re­sponse, HHS in­vit­ed mul­ti­ple in­dus­try com­pa­nies to meet­ings over the past two weeks ask­ing them to re­duce list prices ma­te­ri­al­ly, clar­i­fy­ing the agency does not ex­pect re­duc­tion in net prices or in pa­tient out of pock­et costs. BERN: this da­ta point rais­es our con­fi­dence this ad­min­is­tra­tion will not in­tro­duce poli­cies that will ma­te­ri­al­ly neg­a­tive­ly im­pact the drug in­dus­try. It sug­gests that the cur­rent fo­cus is on po­lit­i­cal­ly-vis­i­ble ‘points’ rather than ad­dress­ing drug costs (we strug­gled for a bit with find­ing ways to say this po­lite­ly 🙂 ). We ex­pect the drug in­dus­try to look for ways to ac­com­mo­date the ad­min­is­tra­tion (per­haps with PBM help – they are al­so look­ing for ways out of the cross-fire).

These an­nu­al price hikes have be­come stan­dard op­er­at­ing pro­ce­dure in Big Phar­ma, par­tic­u­lar­ly at Pfiz­er. But in re­sponse to the pres­i­dent’s Tweet, Pfiz­er had this to say in its de­fense:

The list price re­mains un­changed for the ma­jor­i­ty of our med­i­cines. Our port­fo­lio in­cludes more than 400 med­i­cines and vac­cines; we are mod­i­fy­ing prices for ap­prox­i­mate­ly 10% of these, in­clud­ing some in­stances where we’re de­creas­ing the price. Im­por­tant­ly, list prices do not re­flect what most pa­tients or in­sur­ance com­pa­nies pay.  In the first quar­ter of 2018 the net sell­ing price in­crease was 0% due to the grow­ing amount of re­bates paid back to stake­hold­ers in the bio­phar­ma­ceu­ti­cal sup­ply chain.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq Ko­dak's $765M deal is on hold un­til al­le­ga­tions are cleared — US gov­ern­ment

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Eric Shaff (Seres)

Af­ter a 4-year so­journ, a strug­gling mi­cro­bio­me pi­o­neer claims a break­out PhI­II come­back. And they're tak­ing it straight to the FDA

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, 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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No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine — so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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Levi Garraway, Roche CMO (Source: Genentech)

UP­DAT­ED: FDA hands out a quick OK for po­ten­tial SMA block­buster ris­diplam, giv­ing Genen­tech and Roche a chance to chal­lenge ri­vals on the price

US regulators handed Roche and Genentech a big win Friday afternoon, one that has market-shaping potential for its high-priced rivals from Novartis and Biogen.

The FDA has green-lit the companies’ spinal muscular atrophy drug risdiplam, which will be marketed as Evrysdi in the US, for use in patients two months and older. It’s the first SMA drug that can be taken orally, as Biogen’s Spinraza is injected into the spine while Novartis’ Zolgensma is a gene therapy.

Moncef Slaoui, Getty Images

When will it end? Big Phar­ma's top vac­cine ex­pert at OWS of­fers a speedy time­line for a Covid-19 vac­cine — ei­ther be­fore or right af­ter the elec­tion

Moncef Slaoui hasn’t started making plans for his summer vacation next year. But he offers high odds that all Americans will be able to do that in the not too distant future.

In an interview with a pair of sympathetic podcasters at the conservative American Enterprise Institute, Slaoui provides an education to listeners on how any drug or vaccine can be sped through trials. And he leaves the door wide open to the notion that the leading vaccine developers can demonstrate efficacy and safety in a compelling fashion as early as October — or as late as the end of this year.