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.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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James Sabry

'We're in': Roche and Genen­tech join forces on a multi­bil­lion-dol­lar dis­cov­ery pact with a brash AI up­start

Over the past couple of years, the top execs at Roche and Genentech have inked a flurry of deals aligning the global pair with several of the new players that have emerged in the booming AI and machine learning world. That strategy was supercharged in the spring of 2020 by their decision to recruit Aviv Regev out of the computational world she occupied at the Broad. And today they’re taking that computational approach in R&D to a whole new level.

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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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Covid-19 roundup: Plant-based shot proves safe, 71% ef­fi­ca­cious in PhI­II; Bourla ex­pects an­tivi­ral to launch this month

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.