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.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

New Chroma Medicine board member Jeff Marrazzo

Jeff Mar­raz­zo has found a buzzy new biotech cause to cham­pi­on. And once again, he's all in

Jeff Marrazzo is one of those biotech execs who has always been focused on the next big goal. He has a track record for meeting objectives, relentlessly staying on message, and breaking new ground.

The fact that he stayed around for a couple of years after Roche’s $4.3 billion Spark buyout, making sure the organization he founded weathered Covid-19, is one example. And that came after he carefully guided the company to the first-ever US approval of a gene therapy — no easy task.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Christophe Bourdon, Leo Pharma CEO

Leo Phar­ma looks 'be­yond the skin' in atopic der­mati­tis aware­ness cam­paign

As Leo Pharma aims to take on heavyweight champ Dupixent in atopic dermatitis, the company is launching “AD Days Around the World,” an awareness campaign documenting real patient stories across Europe.

The project, unveiled on Monday, spotlights four patients: Marjolaine, Laura, Julia and África from France, Italy, Germany and Spain, respectively, in short video clips on the challenges of living with AD, the most common form of eczema.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.