September 29, 2025 • 28 mins
Genmab's $8 billion acquisition of multispecifics company Merus is the Danish biotech’s largest step toward marketing its own pipeline. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the evolution of Genmab, which, for many years, relied on a partnership model that delivered blockbuster revenues but now is making a change as a patent cliff looms.
The analysts also assess the tenure of Emma Walmsley the longtime CEO of GSK, and what’s next for the U.K. pharma under incoming CEO Luke Miels. Turning to the U.S., Washington Editor Steve Usdin discusses President Donald Trump’s looming tariff threat on imports of branded drugs, which Usdin says would hurt small biotechs the most. Usdin also analyzes the response of multinational pharmaceutical companies to the president’s demand that they make “most favored nation” price concessions, now that Monday’s deadline has passed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/657131
#biotech #pharma #deals #FGF21 #MASH #Interleukin5 #asthma #PhRMA #PBM #tarriff #MFN
00:01 - Sponsor Message: IQVIA Biotech
02:26 - Genmab's Merus Buy
09:43 - CEO Switch at GSK
17:22 - Trump Tariff Threat
21:17 - MFN Drug Pricing
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
(00:00):
[AI-generated transcript.]
Eric Pierce (00:02):
BioCentury This Week is brought to
you by IQVIA Biotech.
For biotech companies strivingto bring innovative therapies
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Jeff Cranmer (00:48):
Genmab's takeout of multispecifics company
Merus is the Danish biotech's,latest and largest step toward
marketing its own pipeline.
After many years of relying ona fruitful partnership model
that delivered blockbusterrevenues, we'll discuss
the $8 billion acquisitionof Merus on the latest
(01:12):
BioCentury this week podcast.
And Emma Wamsley isstepping down after nearly
a decade at the helm of GSK.
What did she accomplish andwhat's next for the U.K. Pharma?
And it's been anothercalm week in Washington.
President Trump is threateninga hundred percent tariffs
on pharmaceuticals.
(01:33):
The deadline for industryto respond to the
administration's most favorednation drug pricing demands.
And a looming shutdowncould close the door
to new NDAs and BLAs.
But wait, there's more.
CDER Director George Tidmarshhas vowed to crack down
(01:54):
on surrogate endpoints.
I'm Jeff Cranmer.
You're listening toBioCentury's this week, and
joining me are my colleagues.
Simone Fishburn (02:03):
Simone Fishburn, editor in chief.
Steve Usdin (02:05):
Steve Usdin, Washington editor.
Stephen Hansen (02:07):
Stephen Hansen, director of
Biopharma Intelligence.
Jeff Cranmer (02:10):
All right, and coming up this week
on our sister podcast, theBioCentury's Show will have
James Li of Frazier, We'llbe talking about dealmaking
innovation and more in China.
Okay, Stephen, you've beenfollowing Genmab for safe
to say about 20 years now.
(02:32):
they've been doing someinteresting Dealmaking.
what do you make ofthis, uh, this play?
$8 billion, eh?
Stephen Hansen (02:39):
Yeah.
Thanks Jeff.
No, it's, uh, yeah, it's a,it's a big swing, isn't it?
so Genmab, think theircurrent market cap around
just shy of 18 billion.
So, um, you know, I was sortof looking back through deals
to see if I could find otherother companies, like of Genmab
size doing deals this size.
To be honest, there aren't many.
I mean, high single digitM&A takeouts, I mean,
(03:03):
is predominantly this ispharma territory usually.
it's a big swing.
I guess, you know, maybe in onesense you gotta give 'em credit
for that, but, uh, doesn't comewithout its wrist, does it?
Simone?
Simone Fishburn (03:14):
Right.
Well, let's get intothe risks in a minute.
First of all, I'm delighted,Ste you've been covering Genmab
since you were three years old.
Stephen Hansen (03:24):
is far too kind of you,
Simone Fishburn (03:26):
yeah Um, yeah, you know, we did write
about Genmab in our back toschool as a sort of example of a
tear jumper because they reallyhad this strategy of growth.
And I feel like we aregoing to find out if
this is a new trajectory.
So last year they didtheir first M&A with
(03:47):
about a billion plus,
Stephen Hansen (03:49):
1.8
Simone Fishburn (03:50):
$1.8 billion acquisition.
Stephen Hansen (03:54):
That's right.
Of ProfoundBio, which broughtin an ADC asset for them.
Simone Fishburn (03:59):
Exactly.
I love it when youfinish my sentences.
Um, um, but this one, as yousay, is a different order of
magnitude and this is likeplaying like the big kids.
Okay.
And, you know, we'll findout if this is what sends
them on a trajectory.
Let's just before I know you,it's highly leveraged and
(04:19):
there is some risk in that.
But let's just talkfor a minute about the.
the positive side of this, whichis they went for a bispecific
in head and neck cancer, andthat is incredibly synergistic,
I would say adjacent.
A little bit overlapping,but that's fine in my mind
with their core technology.
And so I feel like theirability to capitalize on
(04:40):
this and synergize withtheir own internal expertise.
It should be quite good.
And I contrast that to somethinglike, say Gilead when it
brought in CAR T, when itbrought in kite for CAR T as
it tried to go into cancer.
But that's just sort of abolt on that just involved
a whole set of differentexpertise and you know,
(05:03):
was a lot harder going.
how do you think about the.
Match of this for whatGenmab's core capabilities are.
Stephen Hansen (05:12):
Oh, no, it, it definitely fits.
I mean, this is definitelyright in their, as I would
say, right in their wheelhouse.
Um, I guess the, the, theone thing that surprised me
was the fact that it was.
Another bispecific because asyou say, they have their own
duo body platform, which is abispecific technology platform.
But I think the point here isthat this, moves them along
faster and gives them anotherlate stage asset that they just
(05:35):
wouldn't have had, organically.
They, you know, the pipelinejust wasn't there to be
producing another asset tohelp them push this along.
And just to reference whatyou said about, you know,
what we wrote about the, um.
Company and Back to School.
A lot of the focus of thatprofile was around their ability
to, basically transform thecompany through a partnership
model and sort of leveragetheir, their partnerships
(05:56):
and their assets to be ableto build out the company.
And what I think we'reseeing here, and what this
sort of helps to point tois Genmab looking to now
transition from being apredominantly partnership
driven company historically.
To now really wanting totry and push their own
commercial commercial weight.
I know, you know, havingbeen spoken to Jan van
(06:16):
de Winkel several times.
I know just a couple years agothey'd already started some of
that transition where they werelooking to co-develop, some
of their internal assets andstart to build sort of, their
own commercial capabilities.
But I think this is justreally them trying to speed up
that process in terms of, youknow, building out their own.
Wholly owned commercial assetsand, and really drive that.
(06:37):
Um, and a lot of thatobviously is with, they have
their own patent cliff comingbasically in some ways.
they're expecting toget 3.5 to 3.7 billion
in revenue this year.
The vast majority of thatare royalties from the sales
of Darzalex and Darzalex.
You know, that's now like a 12,13, $14 billion a year drug.
(06:58):
But.
Those patents are gonnastart expiring, I think in
20 29, 20, 20, 30, period.
they're looking to replace someof that, some of that revenue.
And so I think this is justthem helping to, uh, helping
to try and, in their mind,try and speed that along.
Simone Fishburn (07:10):
I think that's absolutely right and
I think we're gonna knowin, a few years, maybe not
a couple of years, whetherthis was a turning point
and it could be a very smartmove by Jan, by the CEO.
But there is also the risk side.
So just talk us through.
How much money they borrowedto make this happen,
Stephen Hansen (07:30):
Sure.
Simone Fishburn (07:30):
and the history of borrowing money to grow
Stephen Hansen (07:33):
So that's, I mean, so that's, so
that's the risk, right?
I mean, so they're,they're taking on five and
a half billion in debt,to finance this deal.
it's a pretty highly leverageddeal
Simone Fishburn (07:43):
pretty highly leveraged.
Stephen Hansen (07:45):
um, and I'm not saying that these are, that
these are akin and that they'rethe same, but it, it reminded
me of, you know, you're sayingcovered Genmab for 20 years.
It's not exactly 20 years,but I, I do remember covering
the company back in 2007when they were gearing up
to start commercializingtheir own products.
They built a big manufacturingfacility in my home state of
(08:05):
Minnesota, that they spent alot of money on, and they were.
getting ready to, you know,launch multiple products
that were, you know, theyhad multiple products in
Phase III, and they hadseveral Phase III failures.
One of them ended up basically,ended up being a commercial
dud, and essentially the companyhad sort of overextended itself
in terms of kind of shiftingto that commercialization
(08:25):
strategy so fast.
And that ended up being whythey turned to partnerships
because they wanted to takea safer, more, more, um,
what they thought was abetter, better road forward.
Simone Fishburn (08:36):
there's a fundamentally different risk
analysis though when you areleveraging yourself to buy
a manufacturing facility tocommercialize your own things
versus levering yourself tobring in a whole new asset?
seems to me to bea different set of equations
Stephen Hansen (08:51):
we're also talking, I mean, you know,
Genmab was a differentcompany then, I mean, that
was a much smaller company.
$18 billion company now it's,potentially, you know, it's had
a much larger market cap, youknow, in a couple years prior.
So it's a different animal now.
And so I, I can, I can fullyunderstand how, you know, the,
as as I've said, they've alreadygot some of their own sales
through Epkinly, and Tivdak,which they're co-marketing
(09:12):
with partners, so it's adifferent animal, but yeah, it
doesn't come, without risks.
What I like about thedeal is they've got the
runway to figure this out.
They've got four or fiveyears in which to see whether
this, this works or not.
And if it doesn't,then you pivot again.
Simone Fishburn (09:28):
So it's not kind of existential for
Stephen Hansen (09:30):
I don't think it's existential.
I think it's, it'saggressive, but,
um, I think, that'sprobably a good thing.
You'd rather be aggressive
Simone Fishburn (09:36):
We like bold over here.
Bold is, bold iswelcome at BioCentury.
Reckless not somuch, but bold yes.
Jeff Cranmer (09:43):
All right, well, let's, uh, let's head down
to the U.K. uh, where EmmaWalmsley, is departing GSK,
Stephen, Simone, thoughts?
Simone Fishburn (09:54):
Uh, you take this one
first, Stephen, because.
Stephen Hansen (10:00):
So.
let's see.
She started therein April, 2017.
I believe she was head of theconsumer products, division at
the time, which at the timeI remember we were surprised.
I think they were bringingsomeone in from the
consumer side of thebusiness to run everything.
Simone Fishburn (10:17):
How right.
We turned out to be.
Yes.
Keep
Stephen Hansen (10:19):
I was just gonna say, I think I, I don't
think we were alone either inthat, belief, but, um, yeah,
I, I can't say it's gone great.
I mean, they've gone throughseveral iterations of what
they kind of wanted to do.
They brought, didn't HalBarron come in with the idea
of revolutionizing R&D at GSK?
That didn't turn out so well.
I guess the only major thingthat's really happened is
(10:40):
they've hived off the consumerbusiness and now GSK is
much more of a pure play,biopharma company, which that
went
Simone F (10:49):
channel here, Stephen.
who will be listening.
And on their behalf, I'm gonnabe quite critical of GSK.
at the end of the day, inEmma Wamsley's tenure, she
did hive off the Haleondivision, which you could
call a low hanging fruit.
(11:09):
I think a few of the pharmasin that same time have,
streamlined away from sortof consumer products or
veterinary products or whatever.
so they've gone from $103billion market cap when she
joined roughly to roughly80 billion now for GSK
plus 40 billion for Haleon.
(11:31):
So you could call it up 20%in how many years did you say?
Eight years,
Stephen Hansen (11:36):
Eight years.
Simone Fishburn (11:37):
I just wanna point out that in that same
amount of time, their friends,AstraZeneca have roughly tripled
from 77 and a half billion to227 billion, 228 billion or so.
And obviously otherpharmas haven't done quite
as well as AstraZeneca.
But it's really hard tolook at this tenure as a
(11:58):
success in my mind and inthe mind of many people.
I think a lot of peoplehave wondered why
it's taken until now.
That's a question really forthe board, you know, they've had
some good readouts recently and.
I think that there arestill some very talented,
smart people at GSK.
I think it's also true thatthey have lost many talented,
(12:21):
smart people in that time,and I think there's been a
certain amount of disarray.
I'm talking about anR&D in particular.
Um, but Steve, I think youhave contacts even beyond R&D.
I hope this is a good new page.
Um.
People that I've spokento in the past have said
good things about LukeMiels, the incoming CEO.
(12:41):
I don't know enough totalk about that, you know,
we'll look into that.
Stephen Hansen (12:45):
Yeah.
No, I mean, I, I guess thething that's always sort of, I
guess especially over the lastcouple years, you know, GSK has
kind of come to be what theydo HIV, well, they do vaccines.
Well, it didn't really feellike they did much else,
all that well, at least froma R&D new product launch,
sort of like commercialsuccess point of view.
(13:06):
now that obviously could change.
they're expecting five newproduct approvals this year.
Simone Fishburn (13:12):
They've done some nice acquisitions
Stephen Hansen (13:14):
They've done some nice acquisitions, so they
brought in an FGF21 for MASH,which we've seen some good data
from that target class in MASH.
they've got a new sort oflong-acting six month dose,
IL-5 that's expecting to getapproved by the end of the year
for asthma, Depemokimab, um,that I think some people have,
decent expectations for interms of what it could do there.
(13:35):
And, they kind of big up14 in total programs that
they think over the, likethe next six years could be,
you know, 2 billion poundplus, peak sale programs.
But I, there's not a lot that Isee like in their pipeline that
sort of has me wild in termsof like, oh, this is really
cutting edge, or this is, Thatthis is gonna draw a ton of
investor attention, essentially.
(13:57):
see what Luke does.
I mean, he's basically beenthe commercial, the chief
commercial officer for almostthe entire time that Emma's,
you know, been at the helm.
So, does that bring changesor, you know, are you gonna
see a major strategic changefor someone who's been on the
inside for same amount of time?
I don't know.
I don't know.
Simone Fishburn (14:16):
Yeah, I mean, I think in the history, not
just of our industry but ofother industries, there's plenty
of examples of both right.
The insider who then did take itin a new direction, the insider
who just carried on the same,you know, it's really hard to
know when you're on the out.
you're not in that boardroom.
but obviously we're hopingfor, good things from there.
Stephen Hansen (14:35):
Fingers crossed.
Jeff Cranmer (14:36):
Okay.
Good stuff guys.
hey, it's China'sinnovation moment.
We have the China HealthcareSummit kicking off, later,
next month, October 22 to 24at the St. Regis in Shanghai.
You can get a firsthand lookat China's biotech ecosystem.
(14:58):
And build your networkwith the right biopharmas,
investors and CDMOs, we'vegot a stacked lineup.
It is a great way to tapright in to the people
on the cutting edge ofChina's innovation moment.
Meet them, talk to keydealmakers and investors.
(15:20):
Go to BioCenturyChinaSummit.com to learn more.
We still have a fewpresenting company slots left.
You can drop me aline on LinkedIn.
Happy to tell you moreabout that opportunity.
Okay, we're gonna take aquick break and then, blue
skies over Washington.
We will, uh, bring Stevein, and, figure out
(15:40):
what he's been covering.
Alanna Farro (15:42):
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Jeff Cranmer (16:18):
we're back on the BioCentury's this
week podcast, if you couldredesign FDA from the ground
up, what would it look like?
That's the fundamental questionunderlying the 2025 BioCentury
Back to School essay, authoredby our very own Washington
editor, Steve Usdin, whohas been a leading voice on
regulation and policy for overtwo decades, almost
(16:40):
three decades now sincehe was three years old.
Much, much like Stephen,Uh, subscribers.
Go to BioCenturybacktoschool.comfor immediate access to
our eight part series.
Not yet a subscriber, acomplimentary trial to
BioCentury is availablevia the same link granting
access to the in-depth dataand analysis Essential for
(17:05):
navigating today's rapidlyevolving sector, including
the back to school report.
And Simone, uh, atthe top of the show
mentioned, tier jumpers.
That was the theme behind,back to school, a couple of
years back, and you wouldget access to that too.
Okay, Steve?
You sent such lovely picturesto me of your weekend picking
(17:27):
apples and wandering aroundthe, the beauty that is the,
greater Washington area.
and then you told me what youwanted to talk about today
and where, where to begin.
Steve Usdin (17:39):
Let's start with the tariffs, right?
so last week in a 63 word,social media posting.
President Trump threatenedto impose a hundred percent
tariffs on imports of brandeddrugs starting October one.
he also said he wouldexempt companies that have
pharmaceutical plants that arequote breaking ground or already
under construction in the U.S.
That leaves a lot of questions.
(18:00):
Will countries and regionsthat have trade deals covering
pharmaceuticals be exempt?
If that's the case,and it seems to be.
That means that these ahundred percent tariffs
would not be imposed onpharmaceuticals manufactured
in the European Union, Japan,the United Kingdom, or South
Korea that leaves China,Singapore, and Switzerland.
Which brings upthe next question.
(18:21):
Will companies that have brokenground on U.S. manufacturing
plants have all of theirproducts exempt are just those
that they plan to make in theU.S. If it's all, and that's
what some people seem to think.
Then most of the Swiss based andSingapore based manufacturing
is off the hook because a lotof that manufacturing is from
big multinational pharmaceuticalcompanies that have announced
(18:43):
or will soon announce, bigmanufacturing investments
in the United States.
What does that leave China?
Here's the rub, becauseChinese manufacturing's
essential for small biotechsthat want to bring their own
products to the U.S. market.
If they're cut off, ifthis option is cut off.
The hammer is gonna fallon those companies, on the
small biotech companiesthat see Chinese contract
(19:04):
manufacturing as their onlyoption for getting onto the U.S.
getting their own productsonto the U.S. market.
That may create a situationwhere small biotechs feel
pressure to sell theirassets or even sell the,
the, the companies to bigpharmas that have exemptions.
If that's an option, ifthese exemptions carry
through, kind of creates anumbrella for everything that
(19:27):
those, big pharmas, sell.
All of this isreally speculative.
The White House should bereleasing details soon.
and I wouldn't be amazed if.
The tariffs get, um, delayed.
That seems to be a Patten,with this administration of
announcing something bold,in bold, um, letters and
capital letters actually.
And then, when it gets time tomake the nitty gritty details,
(19:48):
then things get delayed alittle bit, but we don't know.
lots of other thingson the, docket too.
Yeah.
Simone Fishburn (19:54):
Yeah, Steve, I mean, in a minute
we can do the thoughtexercise of if this carried
through, what would it mean?
But I think that's heavilycaveated or cautioned by
whether it happens and evenif it gets reversed in the
future, because a scenariothat makes it really difficult
for small companies to taketheir own products to market.
(20:17):
Means that, it's muchharder to grow the Genmabs
of the future, right?
It's much harder to growbig biotechs if companies
can ever commercialize bythemselves because of this.
And then there's the flipside of that, which is if
it's really only the smallcompanies that are gonna get
kind of affected by this,how much actual revenue.
(20:38):
to the treasury, arewe even talking about?
But I agree with you thatthere's a lot of things
that can still happen.
Steve Usdin (20:43):
Yeah, many.
Uh, uh, many, uh,
Simone Fishburn (20:46):
Many a slip.
Twix, the Twix,the lip in the cup.
Steve Usdin (20:50):
exactly, exactly.
That's what I was trying to,that's what I was reaching for.
So, look, um, and justone more, point on this.
If it is the small companies,then the thing that will be
hurt the most, I think will bethe small companies that are
manufacturing orphan drugs forvery small populations because.
Those assets aren'treally attractive for
big, multinationalpharmaceutical companies.
(21:10):
The revenues aresimply too small.
and that would be reallykind of a tragedy for those
patients and their families.
Well, let's move on.
MFN, right?
Jeff Cranmer (21:19):
So Yeah.
I was gonna ask Steve, um,is this kind of a tactic as
part of the MFN strategy ofthe Trump administration?
Steve Usdin (21:27):
Well, it hasn't been explicitly,
stated that way.
at least not inthe last few days.
Um, commerce Secretary,Howard Lutnick did say a while
ago that the tariffs werepart of the MFN strategy.
so we, it remains to be seenhow that's gonna be tied in.
But, so today's a deadline,um, for MFN so far.
We've heard from PhRMA, thetrade association, but not
from the 17 companies thatreceived letters from Trump
(21:48):
requesting massive priceconcessions to match OECD
pricing across their portfolios.
The PhRMA response fell farshort of Trump's demands.
It touted huge commitmentsto invest in U.S.
manufacturing and R&D.
Again, that's probablytied to the tariff threats.
They save $500 billionover the next decade.
This includes someinvestments that haven't
yet been announced, so Iguess we're gonna be hearing
(22:10):
about some more very soon.
But the PhRMA announcementcontains some very
interesting qualifiers.
Basically it said thoseinvestments are contingent
on a favorable businessclimate, and it said
tariffs and price controlsaren't good for business.
We've seen recently in the U.K.
how companies can pull back fromsplashy commitments in the face
of a deteriorating public policyand commercial environment.
(22:32):
So we'll see how that plays out.
PhRMA also said that it'screating a website to
connect patients to directto consumer purchases
from individual companies.
That's intended to cutPBMs out from sales, to un
and underinsured patients.
It remains to be seenhow significant that is.
but I should say anotherannouncement, this morning
(22:53):
from Novartis puts a wholething, another, a kind of
spin on the whole thing.
So Novartis said that they'restarting direct to consumer
sales of one of their drugs.
But here's the key thing.
They said that they mayextend that to big employers.
so big employers might geta, you know, 55% discount
from list, basicallycutting out the PBMs.
If other companies do this,this model of, doing direct
(23:18):
you know, kind of business tobusiness sales basically, and
cutting out the PBMs, for, uh,big employers, I think that that
could have a really big impact.
So what's next?
Who knows?
As I said, pharma'sresponse falls far short
of Trump's demands.
Maybe some of the 17companies are gonna
make bigger concessions.
Likely, I think we'regonna see a CMS mandatory
demonstration project ormaybe projects that attempt
(23:40):
to impose price controls.
There was a hint of thislast week, CMS sent a
proposed rule on a globaldrug pricing benchmark
rule to the White House.
Details haven't been released,but this seems to be a CMS Part
B demo imposing MFN pricing.
I'm hearing there could alsobe a Part D demo, but that's,
uh, much harder to pull offso it's not completely clear
(24:02):
what the, what that could be.
Simone Fishburn (24:03):
Hey Steve, one question.
I know we have to wrap in aminute, but going back to the
Novartis thing, which I thinkis really interesting, you
know, the pharmas generallyare so annoyed with the
PBMs, like going back years.
That's another area ofmounting frustration.
What are the chances thatthat kind of strategy,
even outlasts or outlives,this sort of MFN scenario?
Steve Usdin (24:28):
Oh, I think there's a good chance, I think, this
could be, the start of a trend.
there's a lot wedon't know about it.
There's a lot wedon't know about.
how it's going to work, andyou have to remember this,
there's a reason why PBMs werecreated in the first place,
which is, to create a kindof centralized mechanism for,
negotiating for bargainingwith drug companies over drug
(24:48):
prices, because it was felt thatit wasn't, um, efficient, or
practical for every, employer.
For example, or every,insurance plan to negotiate
prices one by one with eachdrug company over each drug.
We'll see, I think this, I thinkthis could be the beginning
of a, of a shift, toward,cutting out, um, the PBMs.
(25:09):
it's also important to remember,and I discussed this on the,
The BioCentury Show recentlywith Fritz Bittenbender, the
chairman of Bio and SVP ofGenentech, that, there are
unintended consequences.
to cutting out PBMs.
one of them is the fact thatsome of the PBM money goes
to subsidizing premiums.
If they're, cut out completely,then premiums are going to rise.
(25:31):
And that's somethingthat, is very difficult.
It's difficult for employers,it's difficult for employees,
and it's politically difficult.
Jeff Cranmer (25:38):
And the Bittenbender conversation,
was on our sister podcast,the BioCentury Show.
You can find it whereveryou get your podcast.
Steve, quickly, shut down.
We don't really know what'sgonna happen, but are the key
things that would be affected?
Steve Usdin (25:54):
we don't know if it's gonna happen.
It's looking likely now.
Similar to previous shutdowns.
FDA will retain a largepercentage of its workforce
either because thereare funds available from
user fees or because theyare deemed essential.
It's likely that it won'taccept new marketing
applications as long asthe shutdown is in effect.
it won't be doing any research,it won't be doing any work
on guidance documents.
(26:16):
Uh, I wonder if we'll beseeing any more videos
from Commissioner, Makaryduring a, during a shutdown.
He hasn't made anyrecently actually.
so, uh, you know, we'll see.
Jeff Cranmer (26:26):
And, and very quickly, uh, we just,
we just have minute left.
what's with, uh, CDER Director,Tidmarsh vowing to crack
down on surrogate endpoints.
Steve Usdin (26:36):
So it's sort of like, uh, Trump's
social media posting.
We've got a very brief,announcement that
he made on LinkedIn.
He says, CDER will beevaluating surrogate endpoints
used for FDA approval.
Well, there's no doubt thatthe use of such endpoints
has benefited patients bybringing valuable treatments
to patients sooner.
There have been notablefailures in confirmatory
trials such as those forexon skipping therapies
(26:57):
in DMD and some diseasessuch as lupus nephritis.
Companies have not runtrials to demonstrate a
benefit on hard clinicalendpoints like progression
end stage renal disease.
So we have approved drugswith significant toxicity
like Voclosporin, that has notbeen shown to provide a direct
clinical benefit for patients.
know, I think this is kindof extraordinary, uh, for
(27:20):
the CDER director to bemaking a statement like
this, and especially tobe doing it in this forum.
His statement about, exonskipping therapies, in
DMD that Sarepta drugs.
I've put out a queryto them, haven't heard
back from them yet.
It hasn't been very long.
Jeff Cranmer (27:35):
you'll following then.
Steve Usdin (27:36):
My understanding is that those trials are ongoing,
they haven't, read out yet.
It has been very, verymany years and people
are very frustrated.
But I think, it's interestingthat he says that there
have been failures inthose confirmatory trials.
if the trials have failed,those readouts haven't
been made public yet.
Jeff Cranmer (27:54):
Alright, Steve, gonna have a busy week.
Look forward to editingyour copy and, uh, thank
you for that update.
Stephen and Simone,appreciate your insights
today and we'd like to thank.
Kendall Square Orchestra,which provides the music
for BioCentury this weekand the BioCentury show.
(28:16):
The group connects scienceand technology professionals
and other members of theGreater Boston community to
collaborate, innovate, andinspire through music, while
supporting causes relatedto healthcare and education.
We'll catch you next week.
Alanna (28:31):
BioCentury would like to thank IQVIA
Biotech for supporting theBioCentury This Week podcast.
To learn more about how IQVIABiotech can help you turn your
vision into venture capital, goto IQVIABiotech.com/visionaries
[AI-generated transcript.]
Eric Pierce (00:02):
BioCentury This Week is brought to
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phase of drug development.
Jeff Cranmer (00:48):
Genmab's takeout of multispecifics company
Merus is the Danish biotech's,latest and largest step toward
marketing its own pipeline.
After many years of relying ona fruitful partnership model
that delivered blockbusterrevenues, we'll discuss
the $8 billion acquisitionof Merus on the latest
(01:12):
BioCentury this week podcast.
And Emma Wamsley isstepping down after nearly
a decade at the helm of GSK.
What did she accomplish andwhat's next for the U.K. Pharma?
And it's been anothercalm week in Washington.
President Trump is threateninga hundred percent tariffs
on pharmaceuticals.
(01:33):
The deadline for industryto respond to the
administration's most favorednation drug pricing demands.
And a looming shutdowncould close the door
to new NDAs and BLAs.
But wait, there's more.
CDER Director George Tidmarshhas vowed to crack down
(01:54):
on surrogate endpoints.
I'm Jeff Cranmer.
You're listening toBioCentury's this week, and
joining me are my colleagues.
Simone Fishburn (02:03):
Simone Fishburn, editor in chief.
Steve Usdin (02:05):
Steve Usdin, Washington editor.
Stephen Hansen (02:07):
Stephen Hansen, director of
Biopharma Intelligence.
Jeff Cranmer (02:10):
All right, and coming up this week
on our sister podcast, theBioCentury's Show will have
James Li of Frazier, We'llbe talking about dealmaking
innovation and more in China.
Okay, Stephen, you've beenfollowing Genmab for safe
to say about 20 years now.
(02:32):
they've been doing someinteresting Dealmaking.
what do you make ofthis, uh, this play?
$8 billion, eh?
Stephen Hansen (02:39):
Yeah.
Thanks Jeff.
No, it's, uh, yeah, it's a,it's a big swing, isn't it?
so Genmab, think theircurrent market cap around
just shy of 18 billion.
So, um, you know, I was sortof looking back through deals
to see if I could find otherother companies, like of Genmab
size doing deals this size.
To be honest, there aren't many.
I mean, high single digitM&A takeouts, I mean,
(03:03):
is predominantly this ispharma territory usually.
it's a big swing.
I guess, you know, maybe in onesense you gotta give 'em credit
for that, but, uh, doesn't comewithout its wrist, does it?
Simone?
Simone Fishburn (03:14):
Right.
Well, let's get intothe risks in a minute.
First of all, I'm delighted,Ste you've been covering Genmab
since you were three years old.
Stephen Hansen (03:24):
is far too kind of you,
Simone Fishburn (03:26):
yeah Um, yeah, you know, we did write
about Genmab in our back toschool as a sort of example of a
tear jumper because they reallyhad this strategy of growth.
And I feel like we aregoing to find out if
this is a new trajectory.
So last year they didtheir first M&A with
(03:47):
about a billion plus,
Stephen Hansen (03:49):
1.8
Simone Fishburn (03:50):
$1.8 billion acquisition.
Stephen Hansen (03:54):
That's right.
Of ProfoundBio, which broughtin an ADC asset for them.
Simone Fishburn (03:59):
Exactly.
I love it when youfinish my sentences.
Um, um, but this one, as yousay, is a different order of
magnitude and this is likeplaying like the big kids.
Okay.
And, you know, we'll findout if this is what sends
them on a trajectory.
Let's just before I know you,it's highly leveraged and
(04:19):
there is some risk in that.
But let's just talkfor a minute about the.
the positive side of this, whichis they went for a bispecific
in head and neck cancer, andthat is incredibly synergistic,
I would say adjacent.
A little bit overlapping,but that's fine in my mind
with their core technology.
And so I feel like theirability to capitalize on
(04:40):
this and synergize withtheir own internal expertise.
It should be quite good.
And I contrast that to somethinglike, say Gilead when it
brought in CAR T, when itbrought in kite for CAR T as
it tried to go into cancer.
But that's just sort of abolt on that just involved
a whole set of differentexpertise and you know,
(05:03):
was a lot harder going.
how do you think about the.
Match of this for whatGenmab's core capabilities are.
Stephen Hansen (05:12):
Oh, no, it, it definitely fits.
I mean, this is definitelyright in their, as I would
say, right in their wheelhouse.
Um, I guess the, the, theone thing that surprised me
was the fact that it was.
Another bispecific because asyou say, they have their own
duo body platform, which is abispecific technology platform.
But I think the point here isthat this, moves them along
faster and gives them anotherlate stage asset that they just
(05:35):
wouldn't have had, organically.
They, you know, the pipelinejust wasn't there to be
producing another asset tohelp them push this along.
And just to reference whatyou said about, you know,
what we wrote about the, um.
Company and Back to School.
A lot of the focus of thatprofile was around their ability
to, basically transform thecompany through a partnership
model and sort of leveragetheir, their partnerships
(05:56):
and their assets to be ableto build out the company.
And what I think we'reseeing here, and what this
sort of helps to point tois Genmab looking to now
transition from being apredominantly partnership
driven company historically.
To now really wanting totry and push their own
commercial commercial weight.
I know, you know, havingbeen spoken to Jan van
(06:16):
de Winkel several times.
I know just a couple years agothey'd already started some of
that transition where they werelooking to co-develop, some
of their internal assets andstart to build sort of, their
own commercial capabilities.
But I think this is justreally them trying to speed up
that process in terms of, youknow, building out their own.
Wholly owned commercial assetsand, and really drive that.
(06:37):
Um, and a lot of thatobviously is with, they have
their own patent cliff comingbasically in some ways.
they're expecting toget 3.5 to 3.7 billion
in revenue this year.
The vast majority of thatare royalties from the sales
of Darzalex and Darzalex.
You know, that's now like a 12,13, $14 billion a year drug.
(06:58):
But.
Those patents are gonnastart expiring, I think in
20 29, 20, 20, 30, period.
they're looking to replace someof that, some of that revenue.
And so I think this is justthem helping to, uh, helping
to try and, in their mind,try and speed that along.
Simone Fishburn (07:10):
I think that's absolutely right and
I think we're gonna knowin, a few years, maybe not
a couple of years, whetherthis was a turning point
and it could be a very smartmove by Jan, by the CEO.
But there is also the risk side.
So just talk us through.
How much money they borrowedto make this happen,
Stephen Hansen (07:30):
Sure.
Simone Fishburn (07:30):
and the history of borrowing money to grow
Stephen Hansen (07:33):
So that's, I mean, so that's, so
that's the risk, right?
I mean, so they're,they're taking on five and
a half billion in debt,to finance this deal.
it's a pretty highly leverageddeal
Simone Fishburn (07:43):
pretty highly leveraged.
Stephen Hansen (07:45):
um, and I'm not saying that these are, that
these are akin and that they'rethe same, but it, it reminded
me of, you know, you're sayingcovered Genmab for 20 years.
It's not exactly 20 years,but I, I do remember covering
the company back in 2007when they were gearing up
to start commercializingtheir own products.
They built a big manufacturingfacility in my home state of
(08:05):
Minnesota, that they spent alot of money on, and they were.
getting ready to, you know,launch multiple products
that were, you know, theyhad multiple products in
Phase III, and they hadseveral Phase III failures.
One of them ended up basically,ended up being a commercial
dud, and essentially the companyhad sort of overextended itself
in terms of kind of shiftingto that commercialization
(08:25):
strategy so fast.
And that ended up being whythey turned to partnerships
because they wanted to takea safer, more, more, um,
what they thought was abetter, better road forward.
Simone Fishburn (08:36):
there's a fundamentally different risk
analysis though when you areleveraging yourself to buy
a manufacturing facility tocommercialize your own things
versus levering yourself tobring in a whole new asset?
seems to me to bea different set of equations
Stephen Hansen (08:51):
we're also talking, I mean, you know,
Genmab was a differentcompany then, I mean, that
was a much smaller company.
$18 billion company now it's,potentially, you know, it's had
a much larger market cap, youknow, in a couple years prior.
So it's a different animal now.
And so I, I can, I can fullyunderstand how, you know, the,
as as I've said, they've alreadygot some of their own sales
through Epkinly, and Tivdak,which they're co-marketing
(09:12):
with partners, so it's adifferent animal, but yeah, it
doesn't come, without risks.
What I like about thedeal is they've got the
runway to figure this out.
They've got four or fiveyears in which to see whether
this, this works or not.
And if it doesn't,then you pivot again.
Simone Fishburn (09:28):
So it's not kind of existential for
Stephen Hansen (09:30):
I don't think it's existential.
I think it's, it'saggressive, but,
um, I think, that'sprobably a good thing.
You'd rather be aggressive
Simone Fishburn (09:36):
We like bold over here.
Bold is, bold iswelcome at BioCentury.
Reckless not somuch, but bold yes.
Jeff Cranmer (09:43):
All right, well, let's, uh, let's head down
to the U.K. uh, where EmmaWalmsley, is departing GSK,
Stephen, Simone, thoughts?
Simone Fishburn (09:54):
Uh, you take this one
first, Stephen, because.
Stephen Hansen (10:00):
So.
let's see.
She started therein April, 2017.
I believe she was head of theconsumer products, division at
the time, which at the timeI remember we were surprised.
I think they were bringingsomeone in from the
consumer side of thebusiness to run everything.
Simone Fishburn (10:17):
How right.
We turned out to be.
Yes.
Keep
Stephen Hansen (10:19):
I was just gonna say, I think I, I don't
think we were alone either inthat, belief, but, um, yeah,
I, I can't say it's gone great.
I mean, they've gone throughseveral iterations of what
they kind of wanted to do.
They brought, didn't HalBarron come in with the idea
of revolutionizing R&D at GSK?
That didn't turn out so well.
I guess the only major thingthat's really happened is
(10:40):
they've hived off the consumerbusiness and now GSK is
much more of a pure play,biopharma company, which that
went
Simone F (10:49):
channel here, Stephen.
who will be listening.
And on their behalf, I'm gonnabe quite critical of GSK.
at the end of the day, inEmma Wamsley's tenure, she
did hive off the Haleondivision, which you could
call a low hanging fruit.
(11:09):
I think a few of the pharmasin that same time have,
streamlined away from sortof consumer products or
veterinary products or whatever.
so they've gone from $103billion market cap when she
joined roughly to roughly80 billion now for GSK
plus 40 billion for Haleon.
(11:31):
So you could call it up 20%in how many years did you say?
Eight years,
Stephen Hansen (11:36):
Eight years.
Simone Fishburn (11:37):
I just wanna point out that in that same
amount of time, their friends,AstraZeneca have roughly tripled
from 77 and a half billion to227 billion, 228 billion or so.
And obviously otherpharmas haven't done quite
as well as AstraZeneca.
But it's really hard tolook at this tenure as a
(11:58):
success in my mind and inthe mind of many people.
I think a lot of peoplehave wondered why
it's taken until now.
That's a question really forthe board, you know, they've had
some good readouts recently and.
I think that there arestill some very talented,
smart people at GSK.
I think it's also true thatthey have lost many talented,
(12:21):
smart people in that time,and I think there's been a
certain amount of disarray.
I'm talking about anR&D in particular.
Um, but Steve, I think youhave contacts even beyond R&D.
I hope this is a good new page.
Um.
People that I've spokento in the past have said
good things about LukeMiels, the incoming CEO.
(12:41):
I don't know enough totalk about that, you know,
we'll look into that.
Stephen Hansen (12:45):
Yeah.
No, I mean, I, I guess thething that's always sort of, I
guess especially over the lastcouple years, you know, GSK has
kind of come to be what theydo HIV, well, they do vaccines.
Well, it didn't really feellike they did much else,
all that well, at least froma R&D new product launch,
sort of like commercialsuccess point of view.
(13:06):
now that obviously could change.
they're expecting five newproduct approvals this year.
Simone Fishburn (13:12):
They've done some nice acquisitions
Stephen Hansen (13:14):
They've done some nice acquisitions, so they
brought in an FGF21 for MASH,which we've seen some good data
from that target class in MASH.
they've got a new sort oflong-acting six month dose,
IL-5 that's expecting to getapproved by the end of the year
for asthma, Depemokimab, um,that I think some people have,
decent expectations for interms of what it could do there.
(13:35):
And, they kind of big up14 in total programs that
they think over the, likethe next six years could be,
you know, 2 billion poundplus, peak sale programs.
But I, there's not a lot that Isee like in their pipeline that
sort of has me wild in termsof like, oh, this is really
cutting edge, or this is, Thatthis is gonna draw a ton of
investor attention, essentially.
(13:57):
see what Luke does.
I mean, he's basically beenthe commercial, the chief
commercial officer for almostthe entire time that Emma's,
you know, been at the helm.
So, does that bring changesor, you know, are you gonna
see a major strategic changefor someone who's been on the
inside for same amount of time?
I don't know.
I don't know.
Simone Fishburn (14:16):
Yeah, I mean, I think in the history, not
just of our industry but ofother industries, there's plenty
of examples of both right.
The insider who then did take itin a new direction, the insider
who just carried on the same,you know, it's really hard to
know when you're on the out.
you're not in that boardroom.
but obviously we're hopingfor, good things from there.
Stephen Hansen (14:35):
Fingers crossed.
Jeff Cranmer (14:36):
Okay.
Good stuff guys.
hey, it's China'sinnovation moment.
We have the China HealthcareSummit kicking off, later,
next month, October 22 to 24at the St. Regis in Shanghai.
You can get a firsthand lookat China's biotech ecosystem.
(14:58):
And build your networkwith the right biopharmas,
investors and CDMOs, we'vegot a stacked lineup.
It is a great way to tapright in to the people
on the cutting edge ofChina's innovation moment.
Meet them, talk to keydealmakers and investors.
(15:20):
Go to BioCenturyChinaSummit.com to learn more.
We still have a fewpresenting company slots left.
You can drop me aline on LinkedIn.
Happy to tell you moreabout that opportunity.
Okay, we're gonna take aquick break and then, blue
skies over Washington.
We will, uh, bring Stevein, and, figure out
(15:40):
what he's been covering.
Alanna Farro (15:42):
BioCentury This Week is brought to
you by The 12th ChinaHealthcare Summit in Shanghai.
From in-licensing to NewCoscross-border deals from Asia are
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Meet top decision makersand investors at The 12th
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(16:02):
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BioCenturyChinaSummit.com.
Jeff Cranmer (16:18):
we're back on the BioCentury's this
week podcast, if you couldredesign FDA from the ground
up, what would it look like?
That's the fundamental questionunderlying the 2025 BioCentury
Back to School essay, authoredby our very own Washington
editor, Steve Usdin, whohas been a leading voice on
regulation and policy for overtwo decades, almost
(16:40):
three decades now sincehe was three years old.
Much, much like Stephen,Uh, subscribers.
Go to BioCenturybacktoschool.comfor immediate access to
our eight part series.
Not yet a subscriber, acomplimentary trial to
BioCentury is availablevia the same link granting
access to the in-depth dataand analysis Essential for
(17:05):
navigating today's rapidlyevolving sector, including
the back to school report.
And Simone, uh, atthe top of the show
mentioned, tier jumpers.
That was the theme behind,back to school, a couple of
years back, and you wouldget access to that too.
Okay, Steve?
You sent such lovely picturesto me of your weekend picking
(17:27):
apples and wandering aroundthe, the beauty that is the,
greater Washington area.
and then you told me what youwanted to talk about today
and where, where to begin.
Steve Usdin (17:39):
Let's start with the tariffs, right?
so last week in a 63 word,social media posting.
President Trump threatenedto impose a hundred percent
tariffs on imports of brandeddrugs starting October one.
he also said he wouldexempt companies that have
pharmaceutical plants that arequote breaking ground or already
under construction in the U.S.
That leaves a lot of questions.
(18:00):
Will countries and regionsthat have trade deals covering
pharmaceuticals be exempt?
If that's the case,and it seems to be.
That means that these ahundred percent tariffs
would not be imposed onpharmaceuticals manufactured
in the European Union, Japan,the United Kingdom, or South
Korea that leaves China,Singapore, and Switzerland.
Which brings upthe next question.
(18:21):
Will companies that have brokenground on U.S. manufacturing
plants have all of theirproducts exempt are just those
that they plan to make in theU.S. If it's all, and that's
what some people seem to think.
Then most of the Swiss based andSingapore based manufacturing
is off the hook because a lotof that manufacturing is from
big multinational pharmaceuticalcompanies that have announced
(18:43):
or will soon announce, bigmanufacturing investments
in the United States.
What does that leave China?
Here's the rub, becauseChinese manufacturing's
essential for small biotechsthat want to bring their own
products to the U.S. market.
If they're cut off, ifthis option is cut off.
The hammer is gonna fallon those companies, on the
small biotech companiesthat see Chinese contract
(19:04):
manufacturing as their onlyoption for getting onto the U.S.
getting their own productsonto the U.S. market.
That may create a situationwhere small biotechs feel
pressure to sell theirassets or even sell the,
the, the companies to bigpharmas that have exemptions.
If that's an option, ifthese exemptions carry
through, kind of creates anumbrella for everything that
(19:27):
those, big pharmas, sell.
All of this isreally speculative.
The White House should bereleasing details soon.
and I wouldn't be amazed if.
The tariffs get, um, delayed.
That seems to be a Patten,with this administration of
announcing something bold,in bold, um, letters and
capital letters actually.
And then, when it gets time tomake the nitty gritty details,
(19:48):
then things get delayed alittle bit, but we don't know.
lots of other thingson the, docket too.
Yeah.
Simone Fishburn (19:54):
Yeah, Steve, I mean, in a minute
we can do the thoughtexercise of if this carried
through, what would it mean?
But I think that's heavilycaveated or cautioned by
whether it happens and evenif it gets reversed in the
future, because a scenariothat makes it really difficult
for small companies to taketheir own products to market.
(20:17):
Means that, it's muchharder to grow the Genmabs
of the future, right?
It's much harder to growbig biotechs if companies
can ever commercialize bythemselves because of this.
And then there's the flipside of that, which is if
it's really only the smallcompanies that are gonna get
kind of affected by this,how much actual revenue.
(20:38):
to the treasury, arewe even talking about?
But I agree with you thatthere's a lot of things
that can still happen.
Steve Usdin (20:43):
Yeah, many.
Uh, uh, many, uh,
Simone Fishburn (20:46):
Many a slip.
Twix, the Twix,the lip in the cup.
Steve Usdin (20:50):
exactly, exactly.
That's what I was trying to,that's what I was reaching for.
So, look, um, and justone more, point on this.
If it is the small companies,then the thing that will be
hurt the most, I think will bethe small companies that are
manufacturing orphan drugs forvery small populations because.
Those assets aren'treally attractive for
big, multinationalpharmaceutical companies.
(21:10):
The revenues aresimply too small.
and that would be reallykind of a tragedy for those
patients and their families.
Well, let's move on.
MFN, right?
Jeff Cranmer (21:19):
So Yeah.
I was gonna ask Steve, um,is this kind of a tactic as
part of the MFN strategy ofthe Trump administration?
Steve Usdin (21:27):
Well, it hasn't been explicitly,
stated that way.
at least not inthe last few days.
Um, commerce Secretary,Howard Lutnick did say a while
ago that the tariffs werepart of the MFN strategy.
so we, it remains to be seenhow that's gonna be tied in.
But, so today's a deadline,um, for MFN so far.
We've heard from PhRMA, thetrade association, but not
from the 17 companies thatreceived letters from Trump
(21:48):
requesting massive priceconcessions to match OECD
pricing across their portfolios.
The PhRMA response fell farshort of Trump's demands.
It touted huge commitmentsto invest in U.S.
manufacturing and R&D.
Again, that's probablytied to the tariff threats.
They save $500 billionover the next decade.
This includes someinvestments that haven't
yet been announced, so Iguess we're gonna be hearing
(22:10):
about some more very soon.
But the PhRMA announcementcontains some very
interesting qualifiers.
Basically it said thoseinvestments are contingent
on a favorable businessclimate, and it said
tariffs and price controlsaren't good for business.
We've seen recently in the U.K.
how companies can pull back fromsplashy commitments in the face
of a deteriorating public policyand commercial environment.
(22:32):
So we'll see how that plays out.
PhRMA also said that it'screating a website to
connect patients to directto consumer purchases
from individual companies.
That's intended to cutPBMs out from sales, to un
and underinsured patients.
It remains to be seenhow significant that is.
but I should say anotherannouncement, this morning
(22:53):
from Novartis puts a wholething, another, a kind of
spin on the whole thing.
So Novartis said that they'restarting direct to consumer
sales of one of their drugs.
But here's the key thing.
They said that they mayextend that to big employers.
so big employers might geta, you know, 55% discount
from list, basicallycutting out the PBMs.
If other companies do this,this model of, doing direct
(23:18):
you know, kind of business tobusiness sales basically, and
cutting out the PBMs, for, uh,big employers, I think that that
could have a really big impact.
So what's next?
Who knows?
As I said, pharma'sresponse falls far short
of Trump's demands.
Maybe some of the 17companies are gonna
make bigger concessions.
Likely, I think we'regonna see a CMS mandatory
demonstration project ormaybe projects that attempt
(23:40):
to impose price controls.
There was a hint of thislast week, CMS sent a
proposed rule on a globaldrug pricing benchmark
rule to the White House.
Details haven't been released,but this seems to be a CMS Part
B demo imposing MFN pricing.
I'm hearing there could alsobe a Part D demo, but that's,
uh, much harder to pull offso it's not completely clear
(24:02):
what the, what that could be.
Simone Fishburn (24:03):
Hey Steve, one question.
I know we have to wrap in aminute, but going back to the
Novartis thing, which I thinkis really interesting, you
know, the pharmas generallyare so annoyed with the
PBMs, like going back years.
That's another area ofmounting frustration.
What are the chances thatthat kind of strategy,
even outlasts or outlives,this sort of MFN scenario?
Steve Usdin (24:28):
Oh, I think there's a good chance, I think, this
could be, the start of a trend.
there's a lot wedon't know about it.
There's a lot wedon't know about.
how it's going to work, andyou have to remember this,
there's a reason why PBMs werecreated in the first place,
which is, to create a kindof centralized mechanism for,
negotiating for bargainingwith drug companies over drug
(24:48):
prices, because it was felt thatit wasn't, um, efficient, or
practical for every, employer.
For example, or every,insurance plan to negotiate
prices one by one with eachdrug company over each drug.
We'll see, I think this, I thinkthis could be the beginning
of a, of a shift, toward,cutting out, um, the PBMs.
(25:09):
it's also important to remember,and I discussed this on the,
The BioCentury Show recentlywith Fritz Bittenbender, the
chairman of Bio and SVP ofGenentech, that, there are
unintended consequences.
to cutting out PBMs.
one of them is the fact thatsome of the PBM money goes
to subsidizing premiums.
If they're, cut out completely,then premiums are going to rise.
(25:31):
And that's somethingthat, is very difficult.
It's difficult for employers,it's difficult for employees,
and it's politically difficult.
Jeff Cranmer (25:38):
And the Bittenbender conversation,
was on our sister podcast,the BioCentury Show.
You can find it whereveryou get your podcast.
Steve, quickly, shut down.
We don't really know what'sgonna happen, but are the key
things that would be affected?
Steve Usdin (25:54):
we don't know if it's gonna happen.
It's looking likely now.
Similar to previous shutdowns.
FDA will retain a largepercentage of its workforce
either because thereare funds available from
user fees or because theyare deemed essential.
It's likely that it won'taccept new marketing
applications as long asthe shutdown is in effect.
it won't be doing any research,it won't be doing any work
on guidance documents.
(26:16):
Uh, I wonder if we'll beseeing any more videos
from Commissioner, Makaryduring a, during a shutdown.
He hasn't made anyrecently actually.
so, uh, you know, we'll see.
Jeff Cranmer (26:26):
And, and very quickly, uh, we just,
we just have minute left.
what's with, uh, CDER Director,Tidmarsh vowing to crack
down on surrogate endpoints.
Steve Usdin (26:36):
So it's sort of like, uh, Trump's
social media posting.
We've got a very brief,announcement that
he made on LinkedIn.
He says, CDER will beevaluating surrogate endpoints
used for FDA approval.
Well, there's no doubt thatthe use of such endpoints
has benefited patients bybringing valuable treatments
to patients sooner.
There have been notablefailures in confirmatory
trials such as those forexon skipping therapies
(26:57):
in DMD and some diseasessuch as lupus nephritis.
Companies have not runtrials to demonstrate a
benefit on hard clinicalendpoints like progression
end stage renal disease.
So we have approved drugswith significant toxicity
like Voclosporin, that has notbeen shown to provide a direct
clinical benefit for patients.
know, I think this is kindof extraordinary, uh, for
(27:20):
the CDER director to bemaking a statement like
this, and especially tobe doing it in this forum.
His statement about, exonskipping therapies, in
DMD that Sarepta drugs.
I've put out a queryto them, haven't heard
back from them yet.
It hasn't been very long.
Jeff Cranmer (27:35):
you'll following then.
Steve Usdin (27:36):
My understanding is that those trials are ongoing,
they haven't, read out yet.
It has been very, verymany years and people
are very frustrated.
But I think, it's interestingthat he says that there
have been failures inthose confirmatory trials.
if the trials have failed,those readouts haven't
been made public yet.
Jeff Cranmer (27:54):
Alright, Steve, gonna have a busy week.
Look forward to editingyour copy and, uh, thank
you for that update.
Stephen and Simone,appreciate your insights
today and we'd like to thank.
Kendall Square Orchestra,which provides the music
for BioCentury this weekand the BioCentury show.
(28:16):
The group connects scienceand technology professionals
and other members of theGreater Boston community to
collaborate, innovate, andinspire through music, while
supporting causes relatedto healthcare and education.
We'll catch you next week.
Alanna (28:31):
BioCentury would like to thank IQVIA
Biotech for supporting theBioCentury This Week podcast.
To learn more about how IQVIABiotech can help you turn your
vision into venture capital, goto IQVIABiotech.com/visionaries
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