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.

A New Fron­tier: The In­ner Ear

What happens when a successful biotech venture capitalist is unexpectedly diagnosed with a chronic, life-disrupting vertigo disorder? Innovation in neurotology.

That venture capitalist was Jay Lichter, Ph.D., and after learning there was no FDA-approved drug treatment for his condition, Ménière’s disease, he decided to create a company to bring drug development to neurotology. Otonomy was founded in 2008 and is dedicated to finding new drug treatments for the hugely underserved community living with balance and hearing disorders. Helping patients like Jay has been the driving force behind Otonomy, a company heading into a transformative 2020 with three clinical trial readouts: Phase 3 in Ménière’s disease, Phase 2 in tinnitus, and Phase 1/2 in hearing loss. These catalysts, together with others in the field, highlight the emerging opportunity in neurotology.
Otonomy is leading the way in neurotology
Neurotology, or the treatment of inner ear neurological disorders, is a large and untapped market for drug developers: one in eight individuals in the U.S. have moderate-to-severe hearing loss, tinnitus or vertigo disorders such as Ménière’s disease.1 With no FDA-approved drug treatments available for these conditions, the burden on patients—including social anxiety, lower quality of life, reduced work productivity, and higher rates of depression—can be significant.2, 3, 4

Joe Jimenez, Getty

Ex-No­var­tis CEO Joe Jimenez is tak­ing an­oth­er crack at open­ing a new chap­ter in his ca­reer — and that in­cludes a new board seat and a $250M start­up

Joe Jimenez is back.

The ex-CEO of Novartis has taken a board seat on Century Therapeutics, the Versant and Bayer-backed startup focused on coming up with a brand new twist on cell therapies for cancer — a field where Jimenez made his mark backing the first personalized CAR-T approved for use.

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Can we make the an­tibi­ot­ic mar­ket great again?

The standard for-profit model in drug development is straightforward. Spend millions, even billions, to develop a medicine from scratch. The return on investment (and ideally a tidy profit) comes via volume and/or price, depending on the disease. But the string of big pharma exits and slew of biotech bankruptcies indicate that the model is sorely flawed when it comes to antibiotics.

The industry players contributing to the arsenal of antimicrobials are fast dwindling, and the pipeline for new antibiotics is embarrassingly sparse, the WHO has warned. Drugmakers are enticed by greener pastures, compared to the long, arduous and expensive path to antibiotic approval that offers little financial gain as treatments are typically priced cheaply, and often lose potency over time as microbes grow resistant to them.

Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Passage Bio — Jim Wilson’s self-described “legacy company” — has wooed a seasoned biotech executive to steer the clinical entry of its first three gene therapy programs.

Bruce Goldsmith jumps to the helm of Passage after a brief CEO stint at Civetta, a cancer-focused startup he helped launch while a venture partner at Deerfield. He takes over from OrbiMed partner and interim chief Stephen Squinto, who will now lead the R&D team.

Amber Saltzman (Ohana)

Flag­ship's first ven­ture of 2020 is out, and it's all about sperm

A couple years ago, Amber Salzman got a call as she was returning East full-time after a two-year stint running a gene therapy company in California.

It was from someone at Flagship Pioneering, the deep-pocketed biotech venture firm. They had a new company with a new way of thinking about sperm. It had been incubating for over a year, and now they wanted her to run it.

“It exactly fit,” Salzman told Endpoints News. “I just thought I had to do something.”

Pfiz­er ax­es 6 ear­ly to late-stage can­cer stud­ies from the pipeline — with one oth­er cut for sick­le cell dis­ease

Pfizer trimmed a group of 3 R&D programs using their PD-L1 Bavencio — partnered with Merck KGaA — in their latest pipeline cull.

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UP­DAT­ED: In­cyte scores much need­ed PhI­II suc­cess — and of course it’s de­liv­ered by rux­oli­tinib

Incyte’s efforts to breathe a second life into ruxolitinib — its JAK inhibitor sold in pill form as Jakafi — has been greeted with clear, if preliminary and unsurprising, Phase III success.

Topline data from the TRuE-AD2 cements ruxolitinib’s foundational importance for Incyte, and gives analysts hope that there might yet be room for growth in a pipeline that’s suffered multiple R&D setbacks.

Stephen Hahn, AP

The FDA un­veils a new reg­u­la­to­ry frame­work to speed along gene ther­a­pies, re­ward­ing the lead­ing play­ers

Bioregnum Opinion Column by John Carroll

The emphasis at the FDA over the past 5 years or so has been on assisting drug developers as much as they can to speed up regulatory reviews and push more drugs into the market. And they are now crafting a final set of regulations aimed at flagging through a whole new generation of gene therapies in clinical testing at a rapid clip.

In a set of 6 prospective guidances posted on the FDA web site Tuesday morning, FDA commissioner Stephen Hahn committed the agency to staying flexible in handing out designations that are critical to gaining early approvals for drugs that claim to be once-and-done but don’t have anything close to the data needed to prove it.

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Mike Bloomberg (AP IMAGES)

Mike Bloomberg joins a grow­ing cho­rus of De­mo­c­ra­t­ic pres­i­den­tial can­di­dates threat­en­ing to go af­ter drug patents

As the mayor of New York City, Mike Bloomberg had a few modest ideas about lowering prescription drug prices in the Big Apple that gained little traction. Now on the campaign trail on a faint hope of clinching the Democratic presidential nomination, the billionaire has some bigger plans — including one that would alter the patent system central to the biopharma business.

In a barebones drug pricing plan posted on Monday, Bloomberg came out blasting President Donald Trump for failing to deliver his promise to lower drug prices, and then making misleading claims about them. The price of over 3,000 drugs still increased at a rate five times higher than inflation in the first six months of 2019, he wrote.