Trump nukes bio­phar­ma, and the fall­out is ra­dioac­tive

End­points as­sess­es the big bio­phar­ma sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

The cheap shot heard around the bio­phar­ma world

Make no mis­take, Don­ald Trump dropped a nuke on JP Mor­gan in more ways than one when he sud­den­ly went off on an un­script­ed tan­gent in his press con­fer­ence and slimed the bio­phar­ma in­dus­try for its mur­der­ous pric­ing prac­tices.

We’ve heard some snip­pets be­fore from Trump as he stoked pop­ulist anger over drug prices. There were sug­ges­tions about Medicare ne­go­ti­a­tions and he clear­ly promised Time that as pres­i­dent he will rein in prices. Es­sen­tial­ly promis­ing to use the full force of the fed­er­al gov­ern­ment to ac­com­plish that, though, was the night­mare sce­nario that the in­dus­try feared was com­ing.

Can nasty tweets di­rect­ed at in­di­vid­ual drug prices be far be­hind?

And JP Mor­gan was go­ing so well…

I’ve been a reg­u­lar at JP Mor­gan long enough to know the drill. It’s a great way to start the year with a lift — no mat­ter what. If trends are aw­ful, you’ll get plen­ty of hype of bet­ter times to come. If they’re great, the news flow will con­vince you that good times will not be end­ing soon.

Sure, there are plen­ty of com­plaints. But Amer­i­cans com­plain the most when we’re win­ning. And few an­a­lysts would de­ny that most of the ba­sics in bio­phar­ma have been great — nu­mer­ous caveats and in­di­vid­ual de­feats aside.

This year was dis­tinct­ly dif­fer­ent, and that was ap­par­ent even be­fore Trump dumped all over the in­dus­try.

Busi­ness as usu­al is over in bio­phar­ma, and we all know it. I had a chance to dis­cuss this with a pan­el that in­clud­ed Brent Saun­ders, Richard Pops, Joaquin Du­a­to, Steven Pear­son and Stephen Ubl. I even snagged Bob Hug­in at the West­in for a few min­utes. And the pri­ma­ry top­ic was about change and how to man­age it.

The in­dus­try has a nar­row open­ing left to reg­u­late it­self in ways that will pro­tect the need for ag­gres­sive pric­ing on new drugs. I think we would all be hap­py to see the price gougers (Tur­ing, Valeant, My­lan) lined up against a wall and fig­u­ra­tive­ly shot for in­cit­ing on­line ri­ot­ing over drug prices. Port­fo­lio price hikes on patent­ed ther­a­pies will now be reined in, with much thanks to Saun­ders for lay­ing out the guide­lines.

Look over the price hikes you’ve seen over the past two weeks and you’ll see that Saun­ders’ pledge push has proven enor­mous­ly in­flu­en­tial.

Now the in­dus­try has to fol­low up with an un­apolo­getic, please-look-at-the-da­ta ap­proach on new drug prices. If there’s a land­mark event in drug de­vel­op­ment, you can and should ex­pect a steep price. That’s pay­ing for the in­dus­try’s R&D bill. The in­dus­try, though, has to do a much, much bet­ter job of ex­plain­ing why re­al ad­vances are worth pay­ing for. Gilead pro­vid­ed a clas­sic ex­am­ple of how not to do that when it rolled out So­val­di with its Death Star PR team at the fore­front.

The hid­den side to all of this is that once you strip away the re­mark­able an­nu­al port­fo­lio price hikes, the in­dus­try will be left to re­ly on in­no­va­tion for its fu­ture suc­cess. And can any­one doubt that some of the biggest com­pa­nies are the least pre­pared for what’s to come?

JPM kicks off with plen­ty of deals, prim­ing the pump for 2017

This time a year ago we all ex­pect­ed that 2016 would be a great year for M&A. I know I did. That proved to be flat wrong, but the con­sen­sus now is that 2017 has to be big for M&A. And the first round of deals an­nounced in and around JP Mor­gan in­di­cates that pre­mi­ums are still over the top.

Like a num­ber of play­ers, Ipsen has a new CEO in­ter­est­ed in mak­ing a rep for the com­pa­ny. So he start­ed by buy­ing out a Mer­ri­mack drug that has un­der­per­formed since launch. That $1 bil­lion deal sets the stage for what will be a busy year in ac­qui­si­tions, as Take­da proved with Ari­ad (pay­ing a 74% pre­mi­um). And we all know that Pfiz­er plans to be ac­tive.

Sanofi, Gilead, Bio­gen and many oth­ers are all but re­quired to per­form this year, if they want to get a pack of un­hap­py an­a­lysts off their backs.

Mer­ck sur­pris­es us all once again, in a good way

Once again the amaz­ing im­muno-on­col­o­gy team at Mer­ck is break­ing new ground and com­plete­ly wreck­ing all the ex­pec­ta­tions of their ri­vals and an­a­lysts. This week the wreck­ing ball came in the form of a swift FDA em­brace of their ap­pli­ca­tion for Mer­ck’s com­bo ther­a­py for lung can­cer.

Mer­ck has con­sis­tent­ly been shoved in­to sec­ond place with Keytru­da, and Roger Perl­mut­ter’s crew has con­sis­tent­ly proven that they won’t ac­cept that.

Up­set­ting ex­pec­ta­tions in R&D has be­come a habit for a Big Phar­ma out­fit that was once so mori­bund that it could nev­er fig­ure out how to jump off the tracks ahead of a fast-ap­proach­ing train. They’re on a roll now, and this time no one will un­der­es­ti­mate what the Keytru­da group can ac­com­plish.

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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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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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.

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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Covid-19 roundup: Gates Foun­da­tion pours $150M in­to In­dia’s Serum In­sti­tute; Pfiz­er teams with Gilead on remde­sivir

By CEO and scion Adar Poonawalla’s estimation, the Serum Institute in India has already poured hundreds of millions of dollars into scaling up the unproven Covid-19 vaccine being developed by AstraZeneca and Oxford for use in low and middle income countries. It’s meant taking on a risk that other companies, including AstraZeneca, have mitigated with huge amounts of government funding.

Now, for the first time, Poonawalla is getting some outside help. The Gates Foundation has agreed to pay the institute $150 million to supply 100 million vaccines to India and other emerging economies next year, Reuters reported. That includes both the vaccine being developed by AstraZeneca and the one being developed by Novavax. Those vaccines will be available in 92 countries and be priced at $3 per dose.

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UP­DAT­ED: 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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Bio­haven adds near­ly $1B in Nurtec deals with Roy­al­ty Phar­ma, Sixth Street

Biohaven just added nearly $1 billion to their balance sheet.

On Friday morning, the neuroscience biotech announced a pair of creative agreements with Royalty Pharma and the investment firm Sixth Street to bolster the commercial launch of their new migraine drug, Nurtec. Biohaven will sell a sliver of its royalties on Nurtec and 3% of the royalties on their experimental migraine drug zavegepant to Royalty Pharma as part of a larger agreeement that will pay $450 million. At the same time, the company announced they took out a $500 million loan from Sixth Street.

Ab­b­Vie set­tles in­sur­ance fraud suit, agrees to tweak nurse am­bas­sador pro­gram; CStone aims for NSCLC OK with pos­i­tive PhI­II da­ta

AbbVie has resolved a California lawsuit alleging insurance fraud in the promotion of its cash cow Humira, paying $24 million to settle things with the state’s insurance regulator.

The settlement comes almost four years after a whistleblower first reported AbbVie’s practice of deploying registered nurses to visit patients at home or call them by phone to ensure that Humira prescriptions are filled. AbbVie was also charged with providing illegal kickbacks to doctors in an attempt to encourage them to prescribe Humira for a range of anti-inflammatory diseases.