September 22, 2025 • 48 mins
A takeout that could be worth as much as $7.3 billion has Pfizer back in the obesity drug development race. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Pfizer’s acquisition of Metsera and its obesity assets. Plus: Editor in Chief Simone Fishburn gives a recap of BioCentury’s Grand Rounds — Europe meeting, which included a fireside chat with Patrick Vallance on the state of the life sciences ecosystem in the country. The BioCentury analysts also assess the state of hot-button policy issues in Washington, such as drug pricing and China. Finally, they analyze the state of play among therapies for narcolepsy on the heels of the World Sleep Congress in Singapore. Check out BIO Chairman Fritz Bittenbender’s conversation with BioCentury Washington Editor Steve Usdin on BioCentury This Week’s sister podcast, The BioCentury Show. This episode of BioCentury This Week is sponsored by IQVIA Biotech.
View full story: https://www.biocentury.com/article/657065
#ObesityDrugs #PharmaDeals #BiotechDeals #MergersAndAcquisitions #DrugDevelopment #Narcolepsy
00:01 - Sponsor Message: IQVIA Biotech
03:46 - Pfizer’s Obesity M&A
14:54 - U.K. in Focus
28:20 - U.S. Drug Pricing, China Policy
40:07 - Narcolepsy Pipeline
To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.
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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
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Jeff Cranmer (00:49):
After years of falling behind in the obesity
race, Pfizer is back in the gamewith a $5 billion acquisition
of obesity startup Metsera.
We'll take a look at the dealand what it does for Pfizer's.
Chances to catch up to EliLilly and Novo Nordisk.
(01:11):
Also on the latest by Centurythis week podcast, U.K. Science
Minister Patrick Valance agreesthat U.K. drug pricing needs a
fix, but he's confident industrycan come back to the table.
We'll discuss why.
And Donald Trump's deadline fornearly 20 biopharma companies
(01:32):
to make drug pricing concessionsis rapidly approaching.
We'll get the take of the newchair of BIO on the scramble to
avoid international referencepricing, And former FDA
Commissioner Scott Gottliebwarns against restricting
in-licensing drugs from China.
Finally, what'snext for narcolepsy?
(01:54):
We look at the datafrom the World Sleep
Congress in Singapore.
I'm Jeff Cranmer, oneof the executive editors
here at BioCentury, andtoday I am joined by.
Simone Fishburn (02:07):
Simone Fishburn, editor in chief.
Steve Usdin (02:10):
Steve Usdin, Washington editor.
Lauren Martz (02:12):
Lauren Martz, executive Director of
Biopharma Intelligence.
Stephen Hansen (02:15):
And Stephen Hansen, director
of Biopharma Intelligence.
Jeff Cranmer (02:19):
All right.
We have a, uh, packedpodcast for you and,
uh, it's good to have.
The team back.
We had a lot of folks, over atGrand Rounds, our, debut grand
rounds on European soil, uh,over in the U.K. and Cambridge.
But, uh, first if you couldredesign FDA from the ground
(02:42):
up, what would it look like?
That's the fundamentalquestion underlying the 2025.
BioCentury's Back toSchool Essay authored by
our very own Steve Usdin.
Our Washington editor.
Steve has been a leading voiceon regulation and policy,
for nearly three decades now.
(03:04):
if you're interested inreading back to school, visit
BioCenturybacktoschool.comfor immediate access.
To the eight part series.
That's if you're a subscriber.
Uh, if you're not yet asubscriber but are interested,
a complimentary trial toBioCentury awaits, it's
available via the same link,BioCenturybacktoschool.com.
(03:28):
And that will grant you accessto the in-depth data and
analysis, which is essentialfor navigating today's
rapidly evolving sector.
You'll get the back toschool report and, a lot of
other cool stuff, includingwhat we're about to talk
about on this podcast.
And that is Pfizer makingits comeback in obesity.
(03:51):
Stephen you wrote that Pfizer'skind of been in the game before,
but kind of fell out of it.
what happened and, and whyis Metsera This 3-year-old
startup, the thing that's gonnaput Pfizer back on the map.
Stephen Hansen (04:05):
Thanks, Jeff.
So you're right, Pfizer was,so, they were at one point
one of the leading companiesin obesity with respect to,
uh, the small molecule race.
So small moleculesfor A GLP-1 agonist.
they had been developing aprogram called danuglipron.
but uh, they ran intosome, uh, tolerability
(04:25):
issues with that program.
And it was also, at thetime, it was formulated
as a twice a day pill.
which I think theyfinally realized was not
really a commerciallycompetitive profile.
so they ditched thatfor a follow-up program.
but then that oneran into issues.
So that one ran into someliver toxicity issues as
we, uh, sometimes know fromthese small molecule, assets.
(04:46):
And so then they moved backto danuglipron, uh, this time
looking to reformulate it as aonce a day pill, which they did.
They moved thatinto phase three.
but then earlier this yearin April, they announced
that they were discontinuingthat program, also due to,
uh, liver toxicity issues.
So, they've had multiplegoes at it in the small
molecule side, but theydidn't really get into the
(05:08):
injectable, you know, peptideside of the obesity, sort of
competitive race as of yet.
but clearly, obviously, despitethe setbacks that they saw with
their oral GLP-1's, this isa pretty big move to try and,
uh, sort of catch them up andget them back into the race.
Jeff Cranmer (05:24):
Yeah.
Deal terms I think 4.9billion in enterpirse value
and then there's, uh, somecontingent value rights.
Stephen, is that correct thatif those all hit, and that's
not always the case if you'vebeen following the CVR space,
but if they do, I think, um, thedeal would be over $7 billion.
(05:45):
Am I correct in that Stephen?
Yeah, no, that's
Stephen Hansen (05:46):
about right.
It's um, you know, it's.
4.9 billion upfront.
So that's what everyone'sgonna be getting straight away.
And then you're right, basedon sort of if there's a Phase
III trial start, I believefor the combination plus,
if they hit on a couple ofapprovals, yeah, it could be
another more than 2 billionon top of that for the CVR.
So it's a pretty hefty,option on top of that.
(06:07):
But sort of getting backto your question about
sort of why Metsera.
I mean, I think, you know,obviously it's, it's early, but
the data that we have seen have,have been pretty impressive.
So they have kind oftwo lead injectable
programs, um, MET-097,which is a GLP-1R agonist
but the early data we havefor that, so they have,
(06:27):
12 week data out from thatprogram that showed 11.3%
placebo adjusted weightloss, which is pretty good
for three months, especiallyfor a GLP-1, only agonist.
And then they also havean amylin agonist, uh,
MET-233 which showed 8.4%placebo adjusted weight
loss after just five weeks.
(06:49):
which, you know, if, if thatwere to continue to trend down,
you know, that's potentially abest in class, uh, amylin asset.
So you have those two, uh,you know, showing pretty
strong efficacy, efficacyearly, plus the way that
the programs are formulated.
Um, they're getting pretty long,half lives, so they're looking
at potentially moving to oncemonthly dosing, you know, which
(07:12):
would be pretty strong so far interms of a, commercial profile.
Then on top of that, theyhave other follow on programs.
So they have a pro drugof the GLP-1 that they're
saying could be even longerthan once a monthly dosing.
and then they have anoral program as well.
you know, we've talked on thispodcast quite a bit about some
of the challenges with theoral peptides and obesity.
(07:34):
a lot of that revolvesaround the fact that.
If they're once daily oralpeptides and they come at pretty
high doses, and so there aresome real questions around
how scalable those are from acommercial standpoint in terms
of whether you could reallymanufacture enough API to
supply a market like obesity.
When you're talking about50 or a hundred milligrams
(07:57):
per day of a peptide.
But what Metsera at leastpre-clinically, thinks, kind
of sets their oral programapart is that it has sort of
a higher, much higher potency,better bioavailability and
sort of an enhanced uptake,technology that they think kind
of combined, you know, at leastaccording to their modeling.
You know, they think theycan get sort of a 92% lower
(08:18):
dose as compared to like,for instance, 50 milligram
oral semaglutide, which Novohad tested in Phase III, but
decided not to bring forwardto the regulators because they
just thought it was too highof a dose to be able to, you
know, be able to manufacture.
so Metsera thinks thatit has an oral platform.
Despite being a peptide, theythink could be, commercially
(08:41):
viable just from a manufacturingscalability perspective.
So I think that's prettyintriguing because, you know,
I I, if people would've pickedup on, I've been pretty,
uh, skeptical, let's sayof the, uh, chances for an
oral peptide in, in obesity.
But if the data they haveholds, uh, it could, could be
a pretty interesting story.
Jeff Cranmer (09:02):
And, where is this one in the clinic, Stephen?
Stephen Hansen (09:04):
Yeah, so the, uh, the most advanced
program is the MET-097 Soit's the GLP-1 agonist, uh,
they're supposed to be havingthey had before this deal.
Metsera was expecting toannounce Phase IIb data this
month, with more phase two Bdata coming early next year.
Which would likely set thatprogram up, you know, if
(09:25):
everything was positive,to move into Phase III,
uh, sometime next year.
And then they've got, theamylin program is also in
Phase I/II, and a coupleothers that are moving as well.
So I think there arefour clinical programs
in all in total.
That are being tested right now.
So, should those phase two Bsread out quite well, I mean,
gets Pfizer right back intophase three pretty quickly.
(09:46):
Um, which I think, youknow, is a, is is a pretty
intriguing opportunity for them.
Jeff Cranmer (09:50):
Yeah, and this is one of those companies
that gets you excited about.
Biotech founded in 2022based in New York City.
the company had announcedtwo private fundings
totaling, over 500 million,uh, that was last year.
Went public in January, and,you know, it, it hasn't been,
(10:11):
uh, easy sailing for, uh.
For IPOs this year,but they've done well.
they priced at 18.
Uh, share price went upas high as, 47 40 and
who'd we have in this?
Was it Arch, Stephen?
Stephen Hansen (10:26):
Yeah, this was, this was one of a Arch company,
uh, launched it, and I thinkthere was others, like, um,
Population Health Partners wasin there as well as, Fidelity.
But yeah, as you say, the, uh,the takeout price is about.
10 cents higher than their,their all time high that
they traded out this year.
so it, it basically, getsa takeout at what happened
their all time high basically.
Plus then you have theCVR as sort of the,
(10:48):
uh, sort of the upside.
frankly, I was a bit bitsurprised, you know, given
that Metsera was really oneof the stronger, I think,
obesity companies out there.
But, um, maybe they justgot a deal where they,
they just thought thiswas too good to be true.
Jeff Cranmer (11:00):
well, you know, it's gotta be tough for these
independents to go toe to toecommercially with Lily and Novo.
Stephen Hansen (11:06):
No, I think that's a good point, Jeff.
I think that's something elseis, you know, the, the amount of
money that needs to be investedin these companies, not only
to run the Phase IIIs, but thento invest in the manufacturing,
especially if you're biotechor the amount of money that you
would have to spend trying to,you know, get access to a CDMO.
And I know that's alreadya pretty competitive space
trying to buy up CDMO spaces,uh, in peptide manufacturing.
(11:28):
So.
It might've been just asituation where, um, Metsera
just looked at it and said,you know, given the amount of
money that we would need toinvest to be competitive, maybe
we're better off, you know,taking this deal with Pfizer
and having Pfizer make thoseinvestments where there's, you
know, maybe they have a betterchance of, uh, of really being
commercially competitive Here.
Jeff Cranmer (11:47):
Stephen, who else, uh, should, should folks be
watching among the independents?
I know we have Zealand.
They have that bigdeal with Roche.
anyone else out there?
Stephen Hansen (11:56):
Right.
Yeah.
I mean, I think if we'rethinking strictly on M&A, might
take them off the board justbecause as you mentioned, they
had that $1.6 billion upfrontdeal with, uh, with Roche,
uh, for their amylin program.
similarly, Gubra hada deal with, AbbVie,
pretty sizable deal.
but others to note, Imean, I think, you know,
there's obviously stilla lot of attention on
(12:17):
Viking Therapeutics.
and then after that, coupleother privates to, you
know, consider there'sVerdiva, which is doing,
injectable and oral therapies.
There's Kailera Therapeutics,which also raised I
think over $400 millionin their launch as well.
And then, you know, maybe alittle more if you're thinking
of companies working in obesity.
(12:39):
That aren't just obesitycompanies, but that might
be, you know, looking at the,uh, muscle sparing, areas.
You could think of a companylike Scholar Rock, uh, which
looks like they're on theverge of probably having a,
commercial product for SMA, butthen also, you know, look like
they're moving towards, uh,late stage testing for a, uh,
myostatin inhibitor for obesity.
So, just a couple other namesto, uh, keep your eye on.
Jeff Cranm (13:02):
Sounds good, Steven.
Thanks.
For that.
And, uh, I know a quickshout out to, uh, our
colleague Paul Bonanos, whocontributed to the piece.
we're gonna go to a quick breakand then we will be back, to
bring in Simone to talk aboutwhat's going on in the U.K.
Alanna Farro (13:19):
BioCentury This Week is brought to
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Jeff Cranmer (13:56):
We are back and partnering opens this week
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Register now at BioCenturyChina summit.com and start
scheduling your meetings soyou have a full dance card
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(14:17):
you can send me a messageon LinkedIn if you want
to apply to present, asa presenting company.
We have a great class.
Uh, Sobi will bethere Hua Medicine.
Quite a few other fromthe West and from China.
can also send a message to,uh, me or my colleague Josh
Berlin on LinkedIn If you'reinterested in joining the
(14:39):
China Summit tour of Shanghai'sZhangjiang, it is quite a site
to behold, and, uh, we hope tosee you in Shanghai or you can
register for Digital Pass ifyou can't make it out this year.
And We are gonnaturn to the U.K. now.
Simone, you just cameback from the motherland.
(14:59):
Um, our grand rounds, ourthird grand rounds meeting,
happened at your oldstomping grounds, Cambridge.
And how did the meeting go?
And, uh, give us a few ofthe highlights before we
dive into what, uh, thescience minister is saying.
Simone Fishburn (15:18):
Thank you Jeff.
Um, I will certainly go ina little depth in a couple
of minutes to what PatrickValance, who is the Minister
for Science, spoke about ina, very good fireside chat
with Kate Bingham of SV HealthInvestors and former chair of
the COVID Vaccine Task Force.
(15:38):
other highlights.
We had a great, openingkeynote by Steve Jackson,
who is of course a pioneerin the DNA damage response.
And, you know, I have totell you, it was followed
by a really good debate.
The debate was with SteveBates and Jérôme Van Biervliet.
And it was on the topic that I'mgonna talk about in a moment,
which is, can the U.K. isthis the UK's biotech moment?
(16:01):
And obviously there wassome news in the week
before that really put alot of that into doubt.
Lots of really good energy.
What I wanted to say isthat the U.K. got some sort
of body blows in terms of.
Announcements, Merckdeciding to pull back on a
billion dollar R&D facility.
(16:21):
It had, I think,broken ground on now.
Not gonna build that in London.
AstraZeneca and Lilly followingthat with announcements saying
they're also reconsidering theirinvestments in the country and
Sanofi piled in there as well.
So, you know, when wetalk to people, that was
kind of, certainly a, avery big blow, but on the
(16:42):
other hand you wouldn'tknow it from the energy.
Like there's justtremendous energy.
People really talking alot about their science.
There's really a very.
high level of engagementbetween scientists,
between investors, farmers.
I mean, the, the meetingwas focused on translational
bottlenecks, and once we weren'ttalking about the policy issues,
(17:05):
it was incredible actually.
So people are not walkinground with long faces at all.
Actually.
They were pretty optimisticabout their science and
their potential to actuallytranslate that science.
Jeff Cranmer (17:18):
Uh, that sounds brilliant.
Simone.
Uh, I've, been hearing ravereviews from, some of the
folks that, helped connect uswith some of the presenting
companies who were there.
And, I appreciated yousending me pictures of the
buttery and other cool spotswhere we held the meeting.
But tell me a bit aboutthis fireside chat
you had with, PatrickValance and Kate Bingham.
Simone Fishburn (17:42):
Right.
Well, they call him LordValance over there, but we
don't do that at BioCenturyand she's Dame Bingham.
We don't do that either.
just to make it clear, KateBingham knows Patrick Valance
very well, and so it wasreally a very frank, she did
not hold back from askinghim the difficult questions,
but it was a, a very frank,he was, he was very open.
He was, very articulateabout their policy and.
(18:05):
He has a background from GSK.
He worked there for like over adecade and for about six years
or so, he was head of R&D.
So he really understands theissues the issues are as such,
and I know Steve agrees withme on this, these farmers
who are saying that pullingback Investment because
there's not enough investmentin U.K. life sciences and
(18:27):
listing a panoply of reasons.
Steve, I think we agree.
This is all aboutdrug pricing, right?
Steve Usdin (18:32):
it is obviously, I mean, the other things
are important, but I alwayssay when people say it's,
uh, it's not the money, it'sthe principle of the thing.
It's the money
Simone Fishburn (18:39):
Yeah.
Steve Usdin (18:40):
and, and that, and that, that's
what it is here, you know?
So as I wanna cut to the chase,you know, Patrick Valens said
that, he agreed that somethinghas to be done in the U.K.
so that NHS spendsmore on drugs.
the other way to look at itis so, so they claw back less.
The question I have is,does he have the power
to make that happen?
(19:01):
He's the, he is thescience minister.
He is not, uh, thefinance ministry, he
is not the head of NHS.
Simone Fishburn (19:06):
So he obviously doesn't have the
power to make that happen,but what is clear to me from
conversations with variouspeople who were in attendance,
there is at least that thegovernment has taken notice.
So I was hearing that RachelReeves, who's the chancellor,
(19:26):
was sending messages saying sortof explain this to me and so on.
So this is, this is notsomething that has only gone
as far as Patrick Valance.
Okay.
This is certainly going allthe way to the top in terms of
understanding its importance.
you know, it was all overthe papers that, I will say
though, that in the days thatI spent with my family and
(19:47):
friends who are not in ourecosystem, they had no idea.
So I'm not sure that the Joepublic really knows, but you
know, I think the main pointis that Patrick Valance said.
He is on the phone to Pascal.
That's Pascal Soriot, of course,who's CEO of AstraZeneca.
that there are a lot ofbackroom conversations
(20:07):
going on right now.
He categorically said thathe can, you know, he thinks
they can bring industryback to the table on this.
I don't think anybody thinksthat Merck is gonna restart,
digging its billion dollarfacility that it pulled back on.
And that's, you know, as we'vetalked about partly on Merck.
the real question, Steve,I mean, it's not just that
Patrick balance doesn't havethe power, it's really where
(20:31):
is the money gonna come from ifthey've got, the money's gotta
come from somewhere, if they'regonna spend more on drugs And
industry's contention, whichis correct and true, is that
NHS spend has gone down to 9%of its spend being on drugs.
Where it used to be 14or 15%, and that's what
peer countries are at.
And so they're like, it'scompletely unacceptable
(20:52):
that this is your levelof spend and why would we
carry on investing there?
so the question is how arethey change the V bag scheme?
Steve Usdin (21:00):
And that, and, and I would interrupt and say it's
not just a matter of amountof revenues that pharma and,
and, big biotech companiesare making in the U.K. It's
also patient access to drugs.
I think patient accessto drugs and, in the U.K.
arguably, is worse than itis in, in pure countries.
Certainly worse than it is in.
the United States.
And the other thing I thinkthat's important that Patrick
(21:21):
Valance said in, in theinterview, and we've got the
story, everybody should, shouldread it, that he acknowledged
that there also, that thereare geopolitical concerns
that are, affecting the U.K.
in particular the demandsfrom the Trump administration.
The companies invest more in theUnited States, and that they,
demonstrate their commitment tothe United States by investing
in manufacturing, investingin R&D in the United States.
(21:43):
And you know, like I said in thelast time that we talked about
this, it's a zero sum game.
If companies are investingmore in the United States,
unless their, global marketsare increasing, and global
revenue's increasing, whichfor many of these companies
certainly isn't the case.
they're gonna have tocut back somewhere.
So for the U.K. to becompetitive, to get a piece
of that action is gonnabecome increasingly difficult.
(22:04):
And they're gonna have to makeit worth it, to these companies.
Simone Fishburn (22:07):
Right.
And so, and you know, youwrote about that previously,
like Merck at the same time aspulling back in the U.K. has
invested a certain amount in theU.S. but to your other points.
Okay.
this is an area where I actuallydo think Valance can have
some influence and that istalking about clinical care,
talking about patient access.
He was quite articulate aboutgetting community hospitals
(22:31):
and more patients into clinicaltrials, and that being a key
and core parameter for the NHS.
he talked a lot about dataand how they're going to be
creating a 600 million pound.
health data research service,which is sort of gonna be
run as a government company,but is actually independent
(22:51):
from government in the wayit, you know, it operates.
It'll have its ownCEO and everything.
but it's sort of a nonprofit,so the money will get sent back
to the NHS and It's going tobe used to enable hospitals
throughout the NHS to getaccess to appropriate levels
of anonymized data and forpeople in the NHS themselves
(23:12):
to be closer to the innovationenterprise and actually
enter innovating themselves.
And he talked about two AIbased research computing
resources that they've opened.
There's a lot of thingsgoing on beyond this question
of the negotiations overthe drug pricing, so.
Steve Usdin (23:30):
And there's also, yeah.
Then there's also the thingsthat I spoke with Lawrence
Tallon about, that we talkedabout MHRA trying to, expand.
Its.
Its reach globally tryingto be more innovative.
it's interesting, we're gonnatalk about this later, in the
podcast because Scott Gottlieb,the former FDA commissioner,
was trying to position, theargument for reforming FDA.
(23:53):
As being something that'sgoing to make the United States
more competitive, in terms ofthe competition with China.
it sounds like in theU.K. they're trying to
make a similar argument.
They're saying, you know, wecan do regulatory reforms,
and regulatory in the U.K.
means both, approvals or,or reviews of, medicines.
But also the, the pricing.
'cause the, yeah, the pricingis part of the regulatory
scheme there, so that they're,they're saying that they can
(24:15):
make themselves more competitiveand attract companies there.
it's really a, uh, a debatableproposition as to whether,
countries are going to be ableto innovate themselves out of.
the problem that they have, interms of competition from China.
I think that, the Chinese,have got certain structural
advantages and certain,competitive advantages.
(24:37):
and they're not gonnalet go of those.
I'm not sure that the thingsthat are being done in the west
are of a magnitude, that they'regoing to, to offset them.
I would also say thatmy contention is that.
If they don't need to,that, there's room in the
world for innovation, nomatter where it comes from.
and that, probably the bestpolicies are gonna be those
that, promote, innovation,wherever it comes from,
(25:00):
and, promote access forpatients to that innovation.
Simone Fishburn (25:04):
Right.
So Steve, you know, IIIactually wanted to say this.
There's, for the U.K.
there's three names thatpeople should remember.
One is Patrick Valent,the other is Steve Bates.
The other is Lawrence Tallon.
Sorry, everybody, three guys.
But still, so having PatrickValance, I mean the, everybody
I spoke to was very enthusiasticfeeling that somebody in this
(25:26):
position of influence reallyunderstands the industry.
I mean, this is a laborgovernment, which is not a
particularly pharma friendlygovernment, but it's got
probably the best advocate theycould have in that position.
the second one is SteveBates, who is moving into
the office for Life sciences.
Where again, these arevery difficult things.
I don't know if anybody cando it, but if anybody can,
(25:49):
Steve's the person just tounderstand how you pick up
the phone to person A andperson C and person E, and
understand that those peopleneed to understand certain
issues in order to move themfrom one position to another.
Again, Steve reallyunderstands the ecosystem
and the third person willsee what he can achieve.
Again, Lawrence Tallon, whomyou interviewed, people have
(26:12):
a very positive impressionof him heading up MHRA.
So there's no lackof good ideas.
And your points about Chinais exactly what Valance says.
He's like, we don't need tocompete with him on everything.
We need to figure out whatwe're really good at and compete
on that and deliver on that.
innovation can come fromeverywhere we need to work out.
(26:32):
He's put in more aggressivegoals, actually, I mean.
MHRA, they've talkedabout under 50 days.
Valance says he doesn't thinkthat's actually fast enough.
Right.
So, you know,hopefully that's just a
starting point.
Steve Usdin (26:45):
That's forgetting trials.
Start forgetting
Simone Fishburn (26:46):
for getting trials started, and we all know
that one of China's biggest,biggest advantages is the
speed at which you can start.
People can start trials there.
So understanding that,understanding that
the NHS is kind of.
Very broken, but at thesame time a potential
jewel in the crown.
So again, I do think thathaving smart people who
understand the ecosystem,let me put it like this, it's
(27:09):
the best chance they've got.
Doesn't mean they can doit, but the better, better
off than, than withoutthose people in place.
So I'm interested tosee how that unfolds.
Steve Usdin (27:18):
No, I, I think it's fascinating.
And also just to add on to whatyou said, one, one thing, which
what you're saying basically isthat there're, there's, they're
kind of hyper networked, right?
Everybody in the U.K.
who's involved in, doingscience and promoting
innovation and creatingpublic policy around this.
They all know each other.
They all, um, understand eachother, and now they're trying
(27:40):
to work on the same page topromote something that's gonna,
make life sciences a pillar oftheir, um, of their economy.
Simone Fishburn (27:48):
And they're doing it with a very good
substrate where they reallyhave a, a lot of biotechs
and a lot of innovation.
So let's see, we'llsee where it goes.
I don't think it's easy, butI, uh, do think it's exciting.
Jeff Cranmer (28:00):
Well, and, uh, good news for our listeners if
they wanna tuck into this more.
We have a two part q and a thatwe'll begin publishing today.
That's Monday.
Uh, as we record this, uh, parttwo will come out, soon after.
and it is the q and awith Patrick Valance
and Kate Bingham.
and it is good stuff.
(28:20):
Alright, let's stay withthe policy and head over to
Washington, Steve, uh, biopharmacompanies are under pressure
from a September 29th deadline.
That's next Monday to proposeconcessions to the White House.
(28:41):
In hopes of avoiding, uh,what is being called most
favored nation price controls.
Steve, you sat down withthe new Chair of BIO.
what did you learn?
Steve Usdin (28:54):
So, yeah, so I spoke with, uh,
Fritz Bitten Bender.
who, as I said in my,uh, introduction to the
interview, he's reallywired into Washington's life
sciences public policy scene.
He's the senior VP for PublicAffairs and Access at Genentech,
and he's chair of BIO.
Before joining Genentechabout nine years ago, he was
the executive Vice presidentof Public Affairs at BIO.
(29:15):
So this has really beenhis life for a long time.
First thing he said, industrybelieves that President
Trump's September 29 deadlinefor companies to come
up with voluntary steps.
To comply with his request forMFN pricing is a real deadline.
Fritz gave some insight intohow Roche and Genentech are
approaching this, and heconfirmed my reporting that the
administration has refused tonegotiate with BIO or PhRMA.
(29:39):
So Roche is making proposals fora more competitive Medicare part
B market, which is interestingbecause of course Genentech's a
big part B company is a companythat has a lot of biologics.
They're also making proposalsfor reforming Part D in
ways that narrow the gapbetween list and net prices.
And they're presenting otherideas that Fritz said will
create savings for patientsand taxpayers, but he can
(30:00):
see that they aren't MFN.
I'm hearing that othercompanies, are taking
a similar approach.
I'm also hearing concernsfrom some of the companies
that one or more of theirpeers, there are 17 companies
that are speaking with theadministration, uh, and by the
way, by the administration.
I mean, pretty much, MehmetOz uh, the head of, CMS who's
heading up these negotiations.
So anyway, there's a concernthat one of these companies
(30:23):
is gonna break ranksand offer to comply with
administration's MFN demands.
If that happened, the WhiteHouse could use it as pressure,
on the other companies.
Even if it doesn't, it'spretty smart policy for the
administration to request.
Negotiations separately witheach one of these companies.
They can't coordinatewith each other because
of antitrust concerns.
(30:43):
The administration can takesomething that one company
has offered, a concession,another concession that
another company has offered.
It can aggregate these and say,okay, well, we'll, we'll put
them all into a big packageand um, we'll try to apply
them to the entire industry.
That could be whathappens, if there isn't
some kind of an agreement.
what, uh, Fritz Bittenbendersaid, and what I'm hearing is
(31:06):
that the most likely responsefrom the Trump administration
will include, some kind ofso-called demonstration project,
which would be mandatory fromthe Center for Medicare and
Medicaid Innovation at CMS.
Um, that could be for PartD, that could be for Part
B, or it could be for both.
it could be some, furtherattempt by the administration to
(31:27):
impose MFN pricing on Medicaid.
and, Commerce Secretary HowardLutnick has said that tariffs
could play into this somehow.
Um, as a way to get MFN pricingpolicies imposed in the United
States should also say that.
One of the other thingsthat's gonna come out of this,
and, and I we're seeing someannouncements already, is
that companies are gonna startannouncing that their European
(31:49):
pricing is gonna be closelyaligned, with their US pricing.
It's gonna be really interestingto see how that plays out.
you know, are those, realprices or are those gonna be.
List prices and the companiesand the, the countries that
they're, um, negotiatingwith, will have some kind of,
undisclosed, discounting orreating or something like that.
(32:09):
We don't know howthat's gonna work.
that's gonna be really aninteresting thing, kind
of summing it all up.
You know, look, we'vegot another week.
Um, I expect that some ofthese deadlines, sometimes
when we hear these deadlinesfrom the Trump administration,
they're not real.
They kind of get blown offand, things happen a little bit
later than has been promised.
That may be the case here.
But, what I'm hearing is,at least from the company
side, they believe that,this deadline next, um,
(32:32):
Monday is a, is a real one.
And that we should hear probablyone from the companies, um,
what it is that they've,what kind of concessions
they're willing to make.
And, two, from the, uh, Trumpadministration, whether they're
willing to accept those.
or whether they're going toimpose, um, some other kind of
measures that are intended tolower the prices of drugs in
the United States, and perhapsto increase the prices that
(32:54):
are paid in other countries.
Jeff Cranmer (32:56):
and of course, uh, our podcast listeners, uh,
should, tune into our sisterpodcast, BioCentury Show where.
Steve and Simone, and, andsometimes, me sits down with
a key opinion leader, likeFritz and, uh, discusses,
uh, key issues such as this.
(33:17):
And, uh, another key issuethat we are watching quite
closely here at BioCenturyis the Biosecure Act.
Steve, uh, I know youasked Fritz about it.
what did you learn?
Steve Usdin (33:26):
So there's a new version, kind of a modified
version of last year'sBiosecure Act, that, is being
introduced in the Senate.
there's an effort to try to getit, as an amendment to, um,
the Defense Appropriations Act.
and I asked him whetherBIO endorses it.
They did endorse theBiosecure Act, um, last year.
he said that, BIO didn't havea position yet, on it, but
(33:49):
it sounded to me like it'slikely that BIO at a minimum
won't, um, won't oppose it.
The key differences betweenthis one and what was rejected
last year is that instead ofnaming specific companies, the
amendment sets up a process foridentifying companies that would
be national security concerns.
Like last year's bill.
(34:09):
Uh, then it has about a fiveyear grandfathering, period for
companies that have, contractswith those, companies that
are identified as nationalsecurity concerns to, define
alternative service providers.
and it imposes, a ban onU.S. contracting and, grant
making to entities that.
Rely on companies that areidentified as, uh, biotechnology
(34:31):
companies of concern after thatgrandfathering period is over.
Jeff Cranmer (34:35):
Okay, Steve.
Uh, another important.
Voice in the policy world.
former FDA CommissionerScott Gottlieb, he's on
Pfizer's, board, I believea couple of others, and he
is also a partner at NEA.
he warned on Friday thatrestrictions on in-licensing
(34:57):
medicines from China couldtrigger, what he's calling an
international IP arms race.
one that would undermine U.S.
industry and public health.
Steve, what promptedhis warning?
Steve Usdin (35:11):
Scott was speaking at the USC
Schaeffer Center's DC Campus.
It was a meeting about a report,um, that the Schafer Center
has put out about ideas forreforming FDA, which by the way,
is a very interesting report andhas a lot of good ideas in it.
He said that, FDA reformsare needed to make the U.S.
competitive with China.
As an aside, Janet Woodcockwas in the audience.
(35:33):
Um, she was on a later paneland she kind of spoke up
and she pushed back and shesaid to Scott, well, your
ideas are good, but, FDAreforms should be separated
from discussions of China.
The two really aren't, um,linked either on a policy
level or intellectually.
and Scott, it was really funny,he said to everybody know, he
said, well, now you see whatmy morning staff meetings used
to be like when I was at FDA.
(35:54):
so Scott's, one of his pointswas to warn against imposing
restrictions on in-licensingdrugs from China, and he said
that he could provoke, as yousaid, an arms race, an IP arms
race, in which other companies.
Would imposerestrictions on U.S. IP.
And he mentioned that, ofcourse, the United States,
uh, US-based companies sellan awful lot of IP or license
(36:14):
an awful lot of IP, around theworld, and, would be hurt by,
restrictions on, on doing so.
He also noted that somereally important drugs have
been and are being developedin China, and that it would
harm American patients to bedenied access and he cited.
legends CAR T for multiplemyeloma, which J&J, acquired
(36:35):
in which, he said, youknow, is stupendous.
for patients.
Simone Fishburn (36:39):
Okay, so Gottlieb's being
pretty outspoken aboutthe IP situation.
What are we hearing otherpeople say and you know, what
do you think are the chancesthat this kind of policies
actually gonna, you know,stick that it's gonna stay?
Do you think?
Do you think they'llroll it back?
Steve Usdin (36:55):
So the origins for a lot of the, uh, concern on
this issue are, are a New YorkTimes story from a, a week or
two ago where they got a hold ofa draft executive order that's
been floating around the WhiteHouse, which calls for, creating
a system, uh, for intensifyingscrutiny of, in-licensing
(37:16):
of medicines from China.
Perhaps subjecting them to somekind of a process like the CFIUS
process that's used to, um,scrutinize it in some cases,
prohibit Chinese investmentsin the United States.
I don't doubt that the draftexecutive order that the.
The Times reportedabout is real.
I, I haven't seen it.
I've tried and I haven't beenable get a copy of it as far
(37:37):
as I know nobody else has.
But, it's most likely thatthat draft was created.
I think there's a lot of draftexecutive orders on a lot
of topics that are floatingaround the White House,
and a lot of them aren'tgonna see the light of day.
The Times reporting said thatPeter Thiel and the company
associated, with Kushner,are, Pushing this idea.
Um, they're saying thatcompetition from China,
(37:59):
threatens to, to harmAmerican, biotech companies.
And this is a way to kindof level playing field.
Simone Fishburn (38:05):
let me go back to what I said about the U.K.
Because what was rare thereis, I mean, we know there's a
lot of people walking aroundgovernment who really just don't
understand the ecosystem, and itseems to me that those arguments
indicate a lack in, certainlywith respect to this ecosystem
and you know, how much purchasedoes people like Scott Gottlieb
(38:26):
and those kind of voices, howmuch influence do they have?
Steve Usdin (38:29):
He, he's quite influential.
but there's also.
A tremendous amount ofagreement, bipartisan agreement,
Democrats and Republicans,that the US should take
steps to protect Americanindustry from China there.
So, you know, protectionismis, is, popular concept
in Washington right now.
there's a, great deal ofinterest in disengaging or
(38:53):
disentangling, us, technologycompanies, from China.
I think that there's a spilloverfrom the national security
debates around, semiconductorsand AI technology in China.
One of the things that I thinkhappens in Washington a lot is
that policymakers who understandone area very well, or at least
(39:13):
believe that they understand itvery well, like semiconductors
or ai, assume that what theyknow about those areas apply to
other areas that are adjacent.
That happens a lot withbiotech policy because
there aren't a lot of peoplein Congress who really
understand biotech policy.
There are a few, butthere aren't very many.
there aren't very many peoplein the White House who do, and
(39:35):
they're kind of drowned out by,um, some of these other voices.
That's where I thinkthat somebody like Scott
Gottlieb, speaking out.
Very publicly.
And by the way, there'sa, um, an op-ed that he
has in the WashingtonPost, today about this.
I think that, that, itdoes have influence.
It raises these issuesand it makes people
start asking questions.
Jeff Cranmer (39:57):
All right, and you can find Steve's story.
On BioCentury.com, there'llbe a link in the show notes.
And let's see.
Hey, let's, uh, let'shead to the clinic.
Singapore hosted the WorldSleep Congress and Lauren
had the opportunity to diginto some cool data that's
(40:18):
coming out for narcolepsy.
Uh, the two leadingcompanies, Takeda.
And Alkermes, uh, Lauren gotto speak with the Ageless
Richard Pops, as well as akey member of Takeda's team.
Takeda, the company that crackedthe code on Orexin, agonist.
Lauren.
Do I have that right?
Lauren Martz (40:39):
That's right.
Yeah.
Jeff Cranmer (40:40):
Excellent.
Uh, there's a good piece.
Lauren.
Uh, what did you learn?
Lauren Martz (40:44):
Thanks Jeff.
so I learned that this isreally a milestone year for
narcolepsy because of howthis class has advanced.
So, at the meeting, which was,uh, over a week ago now, we
learned that Takeda's therapy,at the primary endpoints and
the secondary endpoints ina pair of Phase III studies.
(41:04):
And we also have PhaseII data from Alkermes.
I think overall this just helpsprovide validation for this
idea that you can agonize theorexin 2 receptor and have an
impact on, not just wakefulness,but on some other, you know,
symptoms that come along,with narcolepsy, type one.
the reason that this wasparticularly interesting is
(41:25):
that this is a disease thathas had approved therapies.
But they don't really getat the underlying biology
in the same way as targetingthe orexin 2 receptor does.
So patients with narcolepsytype one are lacking the
neurons that produce theorexin neurotransmitter.
And we can't just addback that neurotransmitter
(41:48):
in a therapeutic form forseveral reasons, you know?
it's a large protein.
It needs to cross theblood brain barrier.
Um, and then design an agonisthas been challenging, because of
some of the same, same problemsand also the fact that you
need to kind of replicate Therise and fall of levels of this
neurotransmitter in a patient'sbrain to help them, you know,
(42:09):
have a normal sleep wake cycle.
so Takeda was the firstcompany to sort of have
a, a breakthrough in thisclass after, many ups and
downs in some failures.
Uh, so I think this isa, a big moment for, that
program in particular.
and I think there are a lot ofeyes on this field because it's
not just these two that have,have had some clinical success.
(42:31):
There are, um, severalothers that have moved
into the clinic as well.
right now I think thereare questions about which
one of these might endup being best in class.
So Takeda is ahead.
It's looking toward regulatorysubmissions this year.
There are questions, youknow, there are side effect
profiles that are common toboth therapies in this class
and, and potentially the otherones that that come forward too.
(42:54):
Um, there arequestions about dosing.
So, Takeda's therapyis dosed twice a day.
Alkermes so far in the PhaseII trial was dosed once a day,
which may be more convenient forpatients, but Takeda is arguing
that twice daily dosing is.
Potentially a path tobetter efficacy because
of the way that you want.
Orexin not just continue to risethroughout the day before you
(43:17):
reach, uh, time to sleep whenit should fall off quickly.
Jeff Cranmer (43:21):
Lauren, you spoke to Sarah Sheikh, uh, head of
Global Development and SVP ofthe Neuroscience Therapeutic.
Area, unit at Takeda.
and on that point, I, Ithought it was kind of
cool what she was saying.
It was like the, the patientcould almost like figure
out what works best forthem based on what they're
doing on a certain day.
(43:41):
Like, you know, if, you know youhave a big meeting or whatever,
you can kind of plan, um, whenyou take that second dose.
Lauren Martz (43:48):
Exactly.
So you can control the interviewinterval between your two doses
based on, you know, how longyou wanna stay awake for that,
or how long you wanna, havefull wakefulness for that day
and, and what you have laterin the evening, for example.
So I think that, youknow, it makes sense.
Jeff Cranmer (44:03):
What else?
Uh, you, you also wrotethat they're exploring
other indications.
Uh, what, what other indicationsare they digging into for these?
Lauren Martz (44:11):
Sure.
So narcolepsy type one isthe indication where there
actually is a loss of orexin.
There is another type ofnarcolepsy where orexin
is present, but we stillhave the same, issues,
uh, symptoms with sleep.
So.
that's another area whereboth of these companies
and some others are testingorexin 2 receptor agonists.
(44:33):
In some cases it's, differentagonists that, may act on
the receptor in differentways because orexin is
present in these patients.
It's just, not working,potentially not working
as it should be.
there are also some othersleep uh, disorders where
modulating this pathway couldhave a therapeutic effect.
And then there are a lotof thoughts about, other
(44:56):
conditions where wakefulness,cognition, mood, the types of
symptoms that are associatedwith narcolepsy that,
you know, orexin, uh, tworeceptor pathway activity.
Not sort of the, the primarysymptom associated with
that disorder, but areproblematic for patients.
So, you know, I think, A DHD forexample, was, was proposed as a
(45:19):
potential indication where thisclass of drugs could have sort
of more of a, symptomatic effectfor patients and something
that they're exploring.
Jeff Cranmer (45:28):
interesting stuff.
Lauren, Pops and Sheikh bothvery optimistic that there's
an opportunity to build.
really build franchisesaround orexin assets.
So we will be, uh,keeping an eye out.
I know Takeda has, um,other assets in the clinic,
uh, preclinical as well.
we'll be, uh, continuingto watch this space.
(45:50):
Some other stuff tocheck out on our website.
Uh, Stealth finally got itsapproval for Barth Syndrome.
Uh, it's been a rollercoaster 10 year journey.
Steve and I collaborated on apiece, that published Friday we
also, uh, have our colleaguePaul Bono's story on Lizard's
(46:10):
M&A survey that they did with,uh, top biopharma executives.
And, um, as I mentionedearlier, check out.
Steve's conversation with FritzBittenbender of Genentech,
who is the chair of BIO.
And keep an eye outfor two more podcasts.
This week we'll have, therecording of Stephen Hansen, and
(46:32):
Simone, on stage in Cambridge.
wrapping up the GrandRounds conference.
um, so joining, uh, Simoneand Stephen James Sabry, of
course, the prolific deal maker.
At Genentech Roche, nowBioMarin and Michelle
Jones, Simone, good stuff?
Simone Fishburn (46:51):
Always good stuff, Jeff.
I recommend people listento it if they wanna get
the, get the skinny.
Jeff Cranmer (46:56):
And we'll also be doing a podcast, uh, Lauren
and I, uh, and Selina, uh, onceshe gets off the plane from the
U.K. we'll be sitting down with.
An AI expert frompodcast sponsor, IQVIA.
So look out for thosetwo podcasts this week.
Thank you for tuning in.
If you like what you're hearing,please, like and subscribe.
(47:20):
and a special thanks toKendall Square Orchestra.
Which provides the musicfor BioCentury this week
and the BioCentury Show.
Uh, tickets are now on salefor the group's eighth season,
so if you're in the greaterBoston, area, go check it
out and, uh, enjoy a relaxingevening of wonderful music.
Eric Pierce (47:45):
BioCentury would like to thank IQVIA
Biotech for supporting theBioCentury This Week podcast.
Learn why IQVIA Biotech isproud to be the go-to CRO
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Visit IQVIABiotech.com.
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Jeff Cranmer (00:49):
After years of falling behind in the obesity
race, Pfizer is back in the gamewith a $5 billion acquisition
of obesity startup Metsera.
We'll take a look at the dealand what it does for Pfizer's.
Chances to catch up to EliLilly and Novo Nordisk.
(01:11):
Also on the latest by Centurythis week podcast, U.K. Science
Minister Patrick Valance agreesthat U.K. drug pricing needs a
fix, but he's confident industrycan come back to the table.
We'll discuss why.
And Donald Trump's deadline fornearly 20 biopharma companies
(01:32):
to make drug pricing concessionsis rapidly approaching.
We'll get the take of the newchair of BIO on the scramble to
avoid international referencepricing, And former FDA
Commissioner Scott Gottliebwarns against restricting
in-licensing drugs from China.
Finally, what'snext for narcolepsy?
(01:54):
We look at the datafrom the World Sleep
Congress in Singapore.
I'm Jeff Cranmer, oneof the executive editors
here at BioCentury, andtoday I am joined by.
Simone Fishburn (02:07):
Simone Fishburn, editor in chief.
Steve Usdin (02:10):
Steve Usdin, Washington editor.
Lauren Martz (02:12):
Lauren Martz, executive Director of
Biopharma Intelligence.
Stephen Hansen (02:15):
And Stephen Hansen, director
of Biopharma Intelligence.
Jeff Cranmer (02:19):
All right.
We have a, uh, packedpodcast for you and,
uh, it's good to have.
The team back.
We had a lot of folks, over atGrand Rounds, our, debut grand
rounds on European soil, uh,over in the U.K. and Cambridge.
But, uh, first if you couldredesign FDA from the ground
(02:42):
up, what would it look like?
That's the fundamentalquestion underlying the 2025.
BioCentury's Back toSchool Essay authored by
our very own Steve Usdin.
Our Washington editor.
Steve has been a leading voiceon regulation and policy,
for nearly three decades now.
(03:04):
if you're interested inreading back to school, visit
BioCenturybacktoschool.comfor immediate access.
To the eight part series.
That's if you're a subscriber.
Uh, if you're not yet asubscriber but are interested,
a complimentary trial toBioCentury awaits, it's
available via the same link,BioCenturybacktoschool.com.
(03:28):
And that will grant you accessto the in-depth data and
analysis, which is essentialfor navigating today's
rapidly evolving sector.
You'll get the back toschool report and, a lot of
other cool stuff, includingwhat we're about to talk
about on this podcast.
And that is Pfizer makingits comeback in obesity.
(03:51):
Stephen you wrote that Pfizer'skind of been in the game before,
but kind of fell out of it.
what happened and, and whyis Metsera This 3-year-old
startup, the thing that's gonnaput Pfizer back on the map.
Stephen Hansen (04:05):
Thanks, Jeff.
So you're right, Pfizer was,so, they were at one point
one of the leading companiesin obesity with respect to,
uh, the small molecule race.
So small moleculesfor A GLP-1 agonist.
they had been developing aprogram called danuglipron.
but uh, they ran intosome, uh, tolerability
(04:25):
issues with that program.
And it was also, at thetime, it was formulated
as a twice a day pill.
which I think theyfinally realized was not
really a commerciallycompetitive profile.
so they ditched thatfor a follow-up program.
but then that oneran into issues.
So that one ran into someliver toxicity issues as
we, uh, sometimes know fromthese small molecule, assets.
(04:46):
And so then they moved backto danuglipron, uh, this time
looking to reformulate it as aonce a day pill, which they did.
They moved thatinto phase three.
but then earlier this yearin April, they announced
that they were discontinuingthat program, also due to,
uh, liver toxicity issues.
So, they've had multiplegoes at it in the small
molecule side, but theydidn't really get into the
(05:08):
injectable, you know, peptideside of the obesity, sort of
competitive race as of yet.
but clearly, obviously, despitethe setbacks that they saw with
their oral GLP-1's, this isa pretty big move to try and,
uh, sort of catch them up andget them back into the race.
Jeff Cranmer (05:24):
Yeah.
Deal terms I think 4.9billion in enterpirse value
and then there's, uh, somecontingent value rights.
Stephen, is that correct thatif those all hit, and that's
not always the case if you'vebeen following the CVR space,
but if they do, I think, um, thedeal would be over $7 billion.
(05:45):
Am I correct in that Stephen?
Yeah, no, that's
Stephen Hansen (05:46):
about right.
It's um, you know, it's.
4.9 billion upfront.
So that's what everyone'sgonna be getting straight away.
And then you're right, basedon sort of if there's a Phase
III trial start, I believefor the combination plus,
if they hit on a couple ofapprovals, yeah, it could be
another more than 2 billionon top of that for the CVR.
So it's a pretty hefty,option on top of that.
(06:07):
But sort of getting backto your question about
sort of why Metsera.
I mean, I think, you know,obviously it's, it's early, but
the data that we have seen have,have been pretty impressive.
So they have kind oftwo lead injectable
programs, um, MET-097,which is a GLP-1R agonist
but the early data we havefor that, so they have,
(06:27):
12 week data out from thatprogram that showed 11.3%
placebo adjusted weightloss, which is pretty good
for three months, especiallyfor a GLP-1, only agonist.
And then they also havean amylin agonist, uh,
MET-233 which showed 8.4%placebo adjusted weight
loss after just five weeks.
(06:49):
which, you know, if, if thatwere to continue to trend down,
you know, that's potentially abest in class, uh, amylin asset.
So you have those two, uh,you know, showing pretty
strong efficacy, efficacyearly, plus the way that
the programs are formulated.
Um, they're getting pretty long,half lives, so they're looking
at potentially moving to oncemonthly dosing, you know, which
(07:12):
would be pretty strong so far interms of a, commercial profile.
Then on top of that, theyhave other follow on programs.
So they have a pro drugof the GLP-1 that they're
saying could be even longerthan once a monthly dosing.
and then they have anoral program as well.
you know, we've talked on thispodcast quite a bit about some
of the challenges with theoral peptides and obesity.
(07:34):
a lot of that revolvesaround the fact that.
If they're once daily oralpeptides and they come at pretty
high doses, and so there aresome real questions around
how scalable those are from acommercial standpoint in terms
of whether you could reallymanufacture enough API to
supply a market like obesity.
When you're talking about50 or a hundred milligrams
(07:57):
per day of a peptide.
But what Metsera at leastpre-clinically, thinks, kind
of sets their oral programapart is that it has sort of
a higher, much higher potency,better bioavailability and
sort of an enhanced uptake,technology that they think kind
of combined, you know, at leastaccording to their modeling.
You know, they think theycan get sort of a 92% lower
(08:18):
dose as compared to like,for instance, 50 milligram
oral semaglutide, which Novohad tested in Phase III, but
decided not to bring forwardto the regulators because they
just thought it was too highof a dose to be able to, you
know, be able to manufacture.
so Metsera thinks thatit has an oral platform.
Despite being a peptide, theythink could be, commercially
(08:41):
viable just from a manufacturingscalability perspective.
So I think that's prettyintriguing because, you know,
I I, if people would've pickedup on, I've been pretty,
uh, skeptical, let's sayof the, uh, chances for an
oral peptide in, in obesity.
But if the data they haveholds, uh, it could, could be
a pretty interesting story.
Jeff Cranmer (09:02):
And, where is this one in the clinic, Stephen?
Stephen Hansen (09:04):
Yeah, so the, uh, the most advanced
program is the MET-097 Soit's the GLP-1 agonist, uh,
they're supposed to be havingthey had before this deal.
Metsera was expecting toannounce Phase IIb data this
month, with more phase two Bdata coming early next year.
Which would likely set thatprogram up, you know, if
(09:25):
everything was positive,to move into Phase III,
uh, sometime next year.
And then they've got, theamylin program is also in
Phase I/II, and a coupleothers that are moving as well.
So I think there arefour clinical programs
in all in total.
That are being tested right now.
So, should those phase two Bsread out quite well, I mean,
gets Pfizer right back intophase three pretty quickly.
(09:46):
Um, which I think, youknow, is a, is is a pretty
intriguing opportunity for them.
Jeff Cranmer (09:50):
Yeah, and this is one of those companies
that gets you excited about.
Biotech founded in 2022based in New York City.
the company had announcedtwo private fundings
totaling, over 500 million,uh, that was last year.
Went public in January, and,you know, it, it hasn't been,
(10:11):
uh, easy sailing for, uh.
For IPOs this year,but they've done well.
they priced at 18.
Uh, share price went upas high as, 47 40 and
who'd we have in this?
Was it Arch, Stephen?
Stephen Hansen (10:26):
Yeah, this was, this was one of a Arch company,
uh, launched it, and I thinkthere was others, like, um,
Population Health Partners wasin there as well as, Fidelity.
But yeah, as you say, the, uh,the takeout price is about.
10 cents higher than their,their all time high that
they traded out this year.
so it, it basically, getsa takeout at what happened
their all time high basically.
Plus then you have theCVR as sort of the,
(10:48):
uh, sort of the upside.
frankly, I was a bit bitsurprised, you know, given
that Metsera was really oneof the stronger, I think,
obesity companies out there.
But, um, maybe they justgot a deal where they,
they just thought thiswas too good to be true.
Jeff Cranmer (11:00):
well, you know, it's gotta be tough for these
independents to go toe to toecommercially with Lily and Novo.
Stephen Hansen (11:06):
No, I think that's a good point, Jeff.
I think that's something elseis, you know, the, the amount of
money that needs to be investedin these companies, not only
to run the Phase IIIs, but thento invest in the manufacturing,
especially if you're biotechor the amount of money that you
would have to spend trying to,you know, get access to a CDMO.
And I know that's alreadya pretty competitive space
trying to buy up CDMO spaces,uh, in peptide manufacturing.
(11:28):
So.
It might've been just asituation where, um, Metsera
just looked at it and said,you know, given the amount of
money that we would need toinvest to be competitive, maybe
we're better off, you know,taking this deal with Pfizer
and having Pfizer make thoseinvestments where there's, you
know, maybe they have a betterchance of, uh, of really being
commercially competitive Here.
Jeff Cranmer (11:47):
Stephen, who else, uh, should, should folks be
watching among the independents?
I know we have Zealand.
They have that bigdeal with Roche.
anyone else out there?
Stephen Hansen (11:56):
Right.
Yeah.
I mean, I think if we'rethinking strictly on M&A, might
take them off the board justbecause as you mentioned, they
had that $1.6 billion upfrontdeal with, uh, with Roche,
uh, for their amylin program.
similarly, Gubra hada deal with, AbbVie,
pretty sizable deal.
but others to note, Imean, I think, you know,
there's obviously stilla lot of attention on
(12:17):
Viking Therapeutics.
and then after that, coupleother privates to, you
know, consider there'sVerdiva, which is doing,
injectable and oral therapies.
There's Kailera Therapeutics,which also raised I
think over $400 millionin their launch as well.
And then, you know, maybe alittle more if you're thinking
of companies working in obesity.
(12:39):
That aren't just obesitycompanies, but that might
be, you know, looking at the,uh, muscle sparing, areas.
You could think of a companylike Scholar Rock, uh, which
looks like they're on theverge of probably having a,
commercial product for SMA, butthen also, you know, look like
they're moving towards, uh,late stage testing for a, uh,
myostatin inhibitor for obesity.
So, just a couple other namesto, uh, keep your eye on.
Jeff Cranm (13:02):
Sounds good, Steven.
Thanks.
For that.
And, uh, I know a quickshout out to, uh, our
colleague Paul Bonanos, whocontributed to the piece.
we're gonna go to a quick breakand then we will be back, to
bring in Simone to talk aboutwhat's going on in the U.K.
Alanna Farro (13:19):
BioCentury This Week is brought to
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(13:40):
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To get a firsthand lookat China's dynamic life
sciences ecosystem,register and learn more at
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Jeff Cranmer (13:56):
We are back and partnering opens this week
for our 12th China HealthcareSummit in Shanghai, scheduled
for October 22nd of 24th.
Register now at BioCenturyChina summit.com and start
scheduling your meetings soyou have a full dance card
when you arrive in Shanghai.
(14:17):
you can send me a messageon LinkedIn if you want
to apply to present, asa presenting company.
We have a great class.
Uh, Sobi will bethere Hua Medicine.
Quite a few other fromthe West and from China.
can also send a message to,uh, me or my colleague Josh
Berlin on LinkedIn If you'reinterested in joining the
(14:39):
China Summit tour of Shanghai'sZhangjiang, it is quite a site
to behold, and, uh, we hope tosee you in Shanghai or you can
register for Digital Pass ifyou can't make it out this year.
And We are gonnaturn to the U.K. now.
Simone, you just cameback from the motherland.
(14:59):
Um, our grand rounds, ourthird grand rounds meeting,
happened at your oldstomping grounds, Cambridge.
And how did the meeting go?
And, uh, give us a few ofthe highlights before we
dive into what, uh, thescience minister is saying.
Simone Fishburn (15:18):
Thank you Jeff.
Um, I will certainly go ina little depth in a couple
of minutes to what PatrickValance, who is the Minister
for Science, spoke about ina, very good fireside chat
with Kate Bingham of SV HealthInvestors and former chair of
the COVID Vaccine Task Force.
(15:38):
other highlights.
We had a great, openingkeynote by Steve Jackson,
who is of course a pioneerin the DNA damage response.
And, you know, I have totell you, it was followed
by a really good debate.
The debate was with SteveBates and Jérôme Van Biervliet.
And it was on the topic that I'mgonna talk about in a moment,
which is, can the U.K. isthis the UK's biotech moment?
(16:01):
And obviously there wassome news in the week
before that really put alot of that into doubt.
Lots of really good energy.
What I wanted to say isthat the U.K. got some sort
of body blows in terms of.
Announcements, Merckdeciding to pull back on a
billion dollar R&D facility.
(16:21):
It had, I think,broken ground on now.
Not gonna build that in London.
AstraZeneca and Lilly followingthat with announcements saying
they're also reconsidering theirinvestments in the country and
Sanofi piled in there as well.
So, you know, when wetalk to people, that was
kind of, certainly a, avery big blow, but on the
(16:42):
other hand you wouldn'tknow it from the energy.
Like there's justtremendous energy.
People really talking alot about their science.
There's really a very.
high level of engagementbetween scientists,
between investors, farmers.
I mean, the, the meetingwas focused on translational
bottlenecks, and once we weren'ttalking about the policy issues,
(17:05):
it was incredible actually.
So people are not walkinground with long faces at all.
Actually.
They were pretty optimisticabout their science and
their potential to actuallytranslate that science.
Jeff Cranmer (17:18):
Uh, that sounds brilliant.
Simone.
Uh, I've, been hearing ravereviews from, some of the
folks that, helped connect uswith some of the presenting
companies who were there.
And, I appreciated yousending me pictures of the
buttery and other cool spotswhere we held the meeting.
But tell me a bit aboutthis fireside chat
you had with, PatrickValance and Kate Bingham.
Simone Fishburn (17:42):
Right.
Well, they call him LordValance over there, but we
don't do that at BioCenturyand she's Dame Bingham.
We don't do that either.
just to make it clear, KateBingham knows Patrick Valance
very well, and so it wasreally a very frank, she did
not hold back from askinghim the difficult questions,
but it was a, a very frank,he was, he was very open.
He was, very articulateabout their policy and.
(18:05):
He has a background from GSK.
He worked there for like over adecade and for about six years
or so, he was head of R&D.
So he really understands theissues the issues are as such,
and I know Steve agrees withme on this, these farmers
who are saying that pullingback Investment because
there's not enough investmentin U.K. life sciences and
(18:27):
listing a panoply of reasons.
Steve, I think we agree.
This is all aboutdrug pricing, right?
Steve Usdin (18:32):
it is obviously, I mean, the other things
are important, but I alwayssay when people say it's,
uh, it's not the money, it'sthe principle of the thing.
It's the money
Simone Fishburn (18:39):
Yeah.
Steve Usdin (18:40):
and, and that, and that, that's
what it is here, you know?
So as I wanna cut to the chase,you know, Patrick Valens said
that, he agreed that somethinghas to be done in the U.K.
so that NHS spendsmore on drugs.
the other way to look at itis so, so they claw back less.
The question I have is,does he have the power
to make that happen?
(19:01):
He's the, he is thescience minister.
He is not, uh, thefinance ministry, he
is not the head of NHS.
Simone Fishburn (19:06):
So he obviously doesn't have the
power to make that happen,but what is clear to me from
conversations with variouspeople who were in attendance,
there is at least that thegovernment has taken notice.
So I was hearing that RachelReeves, who's the chancellor,
(19:26):
was sending messages saying sortof explain this to me and so on.
So this is, this is notsomething that has only gone
as far as Patrick Valance.
Okay.
This is certainly going allthe way to the top in terms of
understanding its importance.
you know, it was all overthe papers that, I will say
though, that in the days thatI spent with my family and
(19:47):
friends who are not in ourecosystem, they had no idea.
So I'm not sure that the Joepublic really knows, but you
know, I think the main pointis that Patrick Valance said.
He is on the phone to Pascal.
That's Pascal Soriot, of course,who's CEO of AstraZeneca.
that there are a lot ofbackroom conversations
(20:07):
going on right now.
He categorically said thathe can, you know, he thinks
they can bring industryback to the table on this.
I don't think anybody thinksthat Merck is gonna restart,
digging its billion dollarfacility that it pulled back on.
And that's, you know, as we'vetalked about partly on Merck.
the real question, Steve,I mean, it's not just that
Patrick balance doesn't havethe power, it's really where
(20:31):
is the money gonna come from ifthey've got, the money's gotta
come from somewhere, if they'regonna spend more on drugs And
industry's contention, whichis correct and true, is that
NHS spend has gone down to 9%of its spend being on drugs.
Where it used to be 14or 15%, and that's what
peer countries are at.
And so they're like, it'scompletely unacceptable
(20:52):
that this is your levelof spend and why would we
carry on investing there?
so the question is how arethey change the V bag scheme?
Steve Usdin (21:00):
And that, and, and I would interrupt and say it's
not just a matter of amountof revenues that pharma and,
and, big biotech companiesare making in the U.K. It's
also patient access to drugs.
I think patient accessto drugs and, in the U.K.
arguably, is worse than itis in, in pure countries.
Certainly worse than it is in.
the United States.
And the other thing I thinkthat's important that Patrick
(21:21):
Valance said in, in theinterview, and we've got the
story, everybody should, shouldread it, that he acknowledged
that there also, that thereare geopolitical concerns
that are, affecting the U.K.
in particular the demandsfrom the Trump administration.
The companies invest more in theUnited States, and that they,
demonstrate their commitment tothe United States by investing
in manufacturing, investingin R&D in the United States.
(21:43):
And you know, like I said in thelast time that we talked about
this, it's a zero sum game.
If companies are investingmore in the United States,
unless their, global marketsare increasing, and global
revenue's increasing, whichfor many of these companies
certainly isn't the case.
they're gonna have tocut back somewhere.
So for the U.K. to becompetitive, to get a piece
of that action is gonnabecome increasingly difficult.
(22:04):
And they're gonna have to makeit worth it, to these companies.
Simone Fishburn (22:07):
Right.
And so, and you know, youwrote about that previously,
like Merck at the same time aspulling back in the U.K. has
invested a certain amount in theU.S. but to your other points.
Okay.
this is an area where I actuallydo think Valance can have
some influence and that istalking about clinical care,
talking about patient access.
He was quite articulate aboutgetting community hospitals
(22:31):
and more patients into clinicaltrials, and that being a key
and core parameter for the NHS.
he talked a lot about dataand how they're going to be
creating a 600 million pound.
health data research service,which is sort of gonna be
run as a government company,but is actually independent
(22:51):
from government in the wayit, you know, it operates.
It'll have its ownCEO and everything.
but it's sort of a nonprofit,so the money will get sent back
to the NHS and It's going tobe used to enable hospitals
throughout the NHS to getaccess to appropriate levels
of anonymized data and forpeople in the NHS themselves
(23:12):
to be closer to the innovationenterprise and actually
enter innovating themselves.
And he talked about two AIbased research computing
resources that they've opened.
There's a lot of thingsgoing on beyond this question
of the negotiations overthe drug pricing, so.
Steve Usdin (23:30):
And there's also, yeah.
Then there's also the thingsthat I spoke with Lawrence
Tallon about, that we talkedabout MHRA trying to, expand.
Its.
Its reach globally tryingto be more innovative.
it's interesting, we're gonnatalk about this later, in the
podcast because Scott Gottlieb,the former FDA commissioner,
was trying to position, theargument for reforming FDA.
(23:53):
As being something that'sgoing to make the United States
more competitive, in terms ofthe competition with China.
it sounds like in theU.K. they're trying to
make a similar argument.
They're saying, you know, wecan do regulatory reforms,
and regulatory in the U.K.
means both, approvals or,or reviews of, medicines.
But also the, the pricing.
'cause the, yeah, the pricingis part of the regulatory
scheme there, so that they're,they're saying that they can
(24:15):
make themselves more competitiveand attract companies there.
it's really a, uh, a debatableproposition as to whether,
countries are going to be ableto innovate themselves out of.
the problem that they have, interms of competition from China.
I think that, the Chinese,have got certain structural
advantages and certain,competitive advantages.
(24:37):
and they're not gonnalet go of those.
I'm not sure that the thingsthat are being done in the west
are of a magnitude, that they'regoing to, to offset them.
I would also say thatmy contention is that.
If they don't need to,that, there's room in the
world for innovation, nomatter where it comes from.
and that, probably the bestpolicies are gonna be those
that, promote, innovation,wherever it comes from,
(25:00):
and, promote access forpatients to that innovation.
Simone Fishburn (25:04):
Right.
So Steve, you know, IIIactually wanted to say this.
There's, for the U.K.
there's three names thatpeople should remember.
One is Patrick Valent,the other is Steve Bates.
The other is Lawrence Tallon.
Sorry, everybody, three guys.
But still, so having PatrickValance, I mean the, everybody
I spoke to was very enthusiasticfeeling that somebody in this
(25:26):
position of influence reallyunderstands the industry.
I mean, this is a laborgovernment, which is not a
particularly pharma friendlygovernment, but it's got
probably the best advocate theycould have in that position.
the second one is SteveBates, who is moving into
the office for Life sciences.
Where again, these arevery difficult things.
I don't know if anybody cando it, but if anybody can,
(25:49):
Steve's the person just tounderstand how you pick up
the phone to person A andperson C and person E, and
understand that those peopleneed to understand certain
issues in order to move themfrom one position to another.
Again, Steve reallyunderstands the ecosystem
and the third person willsee what he can achieve.
Again, Lawrence Tallon, whomyou interviewed, people have
(26:12):
a very positive impressionof him heading up MHRA.
So there's no lackof good ideas.
And your points about Chinais exactly what Valance says.
He's like, we don't need tocompete with him on everything.
We need to figure out whatwe're really good at and compete
on that and deliver on that.
innovation can come fromeverywhere we need to work out.
(26:32):
He's put in more aggressivegoals, actually, I mean.
MHRA, they've talkedabout under 50 days.
Valance says he doesn't thinkthat's actually fast enough.
Right.
So, you know,hopefully that's just a
starting point.
Steve Usdin (26:45):
That's forgetting trials.
Start forgetting
Simone Fishburn (26:46):
for getting trials started, and we all know
that one of China's biggest,biggest advantages is the
speed at which you can start.
People can start trials there.
So understanding that,understanding that
the NHS is kind of.
Very broken, but at thesame time a potential
jewel in the crown.
So again, I do think thathaving smart people who
understand the ecosystem,let me put it like this, it's
(27:09):
the best chance they've got.
Doesn't mean they can doit, but the better, better
off than, than withoutthose people in place.
So I'm interested tosee how that unfolds.
Steve Usdin (27:18):
No, I, I think it's fascinating.
And also just to add on to whatyou said, one, one thing, which
what you're saying basically isthat there're, there's, they're
kind of hyper networked, right?
Everybody in the U.K.
who's involved in, doingscience and promoting
innovation and creatingpublic policy around this.
They all know each other.
They all, um, understand eachother, and now they're trying
(27:40):
to work on the same page topromote something that's gonna,
make life sciences a pillar oftheir, um, of their economy.
Simone Fishburn (27:48):
And they're doing it with a very good
substrate where they reallyhave a, a lot of biotechs
and a lot of innovation.
So let's see, we'llsee where it goes.
I don't think it's easy, butI, uh, do think it's exciting.
Jeff Cranmer (28:00):
Well, and, uh, good news for our listeners if
they wanna tuck into this more.
We have a two part q and a thatwe'll begin publishing today.
That's Monday.
Uh, as we record this, uh, parttwo will come out, soon after.
and it is the q and awith Patrick Valance
and Kate Bingham.
and it is good stuff.
(28:20):
Alright, let's stay withthe policy and head over to
Washington, Steve, uh, biopharmacompanies are under pressure
from a September 29th deadline.
That's next Monday to proposeconcessions to the White House.
(28:41):
In hopes of avoiding, uh,what is being called most
favored nation price controls.
Steve, you sat down withthe new Chair of BIO.
what did you learn?
Steve Usdin (28:54):
So, yeah, so I spoke with, uh,
Fritz Bitten Bender.
who, as I said in my,uh, introduction to the
interview, he's reallywired into Washington's life
sciences public policy scene.
He's the senior VP for PublicAffairs and Access at Genentech,
and he's chair of BIO.
Before joining Genentechabout nine years ago, he was
the executive Vice presidentof Public Affairs at BIO.
(29:15):
So this has really beenhis life for a long time.
First thing he said, industrybelieves that President
Trump's September 29 deadlinefor companies to come
up with voluntary steps.
To comply with his request forMFN pricing is a real deadline.
Fritz gave some insight intohow Roche and Genentech are
approaching this, and heconfirmed my reporting that the
administration has refused tonegotiate with BIO or PhRMA.
(29:39):
So Roche is making proposals fora more competitive Medicare part
B market, which is interestingbecause of course Genentech's a
big part B company is a companythat has a lot of biologics.
They're also making proposalsfor reforming Part D in
ways that narrow the gapbetween list and net prices.
And they're presenting otherideas that Fritz said will
create savings for patientsand taxpayers, but he can
(30:00):
see that they aren't MFN.
I'm hearing that othercompanies, are taking
a similar approach.
I'm also hearing concernsfrom some of the companies
that one or more of theirpeers, there are 17 companies
that are speaking with theadministration, uh, and by the
way, by the administration.
I mean, pretty much, MehmetOz uh, the head of, CMS who's
heading up these negotiations.
So anyway, there's a concernthat one of these companies
(30:23):
is gonna break ranksand offer to comply with
administration's MFN demands.
If that happened, the WhiteHouse could use it as pressure,
on the other companies.
Even if it doesn't, it'spretty smart policy for the
administration to request.
Negotiations separately witheach one of these companies.
They can't coordinatewith each other because
of antitrust concerns.
(30:43):
The administration can takesomething that one company
has offered, a concession,another concession that
another company has offered.
It can aggregate these and say,okay, well, we'll, we'll put
them all into a big packageand um, we'll try to apply
them to the entire industry.
That could be whathappens, if there isn't
some kind of an agreement.
what, uh, Fritz Bittenbendersaid, and what I'm hearing is
(31:06):
that the most likely responsefrom the Trump administration
will include, some kind ofso-called demonstration project,
which would be mandatory fromthe Center for Medicare and
Medicaid Innovation at CMS.
Um, that could be for PartD, that could be for Part
B, or it could be for both.
it could be some, furtherattempt by the administration to
(31:27):
impose MFN pricing on Medicaid.
and, Commerce Secretary HowardLutnick has said that tariffs
could play into this somehow.
Um, as a way to get MFN pricingpolicies imposed in the United
States should also say that.
One of the other thingsthat's gonna come out of this,
and, and I we're seeing someannouncements already, is
that companies are gonna startannouncing that their European
(31:49):
pricing is gonna be closelyaligned, with their US pricing.
It's gonna be really interestingto see how that plays out.
you know, are those, realprices or are those gonna be.
List prices and the companiesand the, the countries that
they're, um, negotiatingwith, will have some kind of,
undisclosed, discounting orreating or something like that.
(32:09):
We don't know howthat's gonna work.
that's gonna be really aninteresting thing, kind
of summing it all up.
You know, look, we'vegot another week.
Um, I expect that some ofthese deadlines, sometimes
when we hear these deadlinesfrom the Trump administration,
they're not real.
They kind of get blown offand, things happen a little bit
later than has been promised.
That may be the case here.
But, what I'm hearing is,at least from the company
side, they believe that,this deadline next, um,
(32:32):
Monday is a, is a real one.
And that we should hear probablyone from the companies, um,
what it is that they've,what kind of concessions
they're willing to make.
And, two, from the, uh, Trumpadministration, whether they're
willing to accept those.
or whether they're going toimpose, um, some other kind of
measures that are intended tolower the prices of drugs in
the United States, and perhapsto increase the prices that
(32:54):
are paid in other countries.
Jeff Cranmer (32:56):
and of course, uh, our podcast listeners, uh,
should, tune into our sisterpodcast, BioCentury Show where.
Steve and Simone, and, andsometimes, me sits down with
a key opinion leader, likeFritz and, uh, discusses,
uh, key issues such as this.
(33:17):
And, uh, another key issuethat we are watching quite
closely here at BioCenturyis the Biosecure Act.
Steve, uh, I know youasked Fritz about it.
what did you learn?
Steve Usdin (33:26):
So there's a new version, kind of a modified
version of last year'sBiosecure Act, that, is being
introduced in the Senate.
there's an effort to try to getit, as an amendment to, um,
the Defense Appropriations Act.
and I asked him whetherBIO endorses it.
They did endorse theBiosecure Act, um, last year.
he said that, BIO didn't havea position yet, on it, but
(33:49):
it sounded to me like it'slikely that BIO at a minimum
won't, um, won't oppose it.
The key differences betweenthis one and what was rejected
last year is that instead ofnaming specific companies, the
amendment sets up a process foridentifying companies that would
be national security concerns.
Like last year's bill.
(34:09):
Uh, then it has about a fiveyear grandfathering, period for
companies that have, contractswith those, companies that
are identified as nationalsecurity concerns to, define
alternative service providers.
and it imposes, a ban onU.S. contracting and, grant
making to entities that.
Rely on companies that areidentified as, uh, biotechnology
(34:31):
companies of concern after thatgrandfathering period is over.
Jeff Cranmer (34:35):
Okay, Steve.
Uh, another important.
Voice in the policy world.
former FDA CommissionerScott Gottlieb, he's on
Pfizer's, board, I believea couple of others, and he
is also a partner at NEA.
he warned on Friday thatrestrictions on in-licensing
(34:57):
medicines from China couldtrigger, what he's calling an
international IP arms race.
one that would undermine U.S.
industry and public health.
Steve, what promptedhis warning?
Steve Usdin (35:11):
Scott was speaking at the USC
Schaeffer Center's DC Campus.
It was a meeting about a report,um, that the Schafer Center
has put out about ideas forreforming FDA, which by the way,
is a very interesting report andhas a lot of good ideas in it.
He said that, FDA reformsare needed to make the U.S.
competitive with China.
As an aside, Janet Woodcockwas in the audience.
(35:33):
Um, she was on a later paneland she kind of spoke up
and she pushed back and shesaid to Scott, well, your
ideas are good, but, FDAreforms should be separated
from discussions of China.
The two really aren't, um,linked either on a policy
level or intellectually.
and Scott, it was really funny,he said to everybody know, he
said, well, now you see whatmy morning staff meetings used
to be like when I was at FDA.
(35:54):
so Scott's, one of his pointswas to warn against imposing
restrictions on in-licensingdrugs from China, and he said
that he could provoke, as yousaid, an arms race, an IP arms
race, in which other companies.
Would imposerestrictions on U.S. IP.
And he mentioned that, ofcourse, the United States,
uh, US-based companies sellan awful lot of IP or license
(36:14):
an awful lot of IP, around theworld, and, would be hurt by,
restrictions on, on doing so.
He also noted that somereally important drugs have
been and are being developedin China, and that it would
harm American patients to bedenied access and he cited.
legends CAR T for multiplemyeloma, which J&J, acquired
(36:35):
in which, he said, youknow, is stupendous.
for patients.
Simone Fishburn (36:39):
Okay, so Gottlieb's being
pretty outspoken aboutthe IP situation.
What are we hearing otherpeople say and you know, what
do you think are the chancesthat this kind of policies
actually gonna, you know,stick that it's gonna stay?
Do you think?
Do you think they'llroll it back?
Steve Usdin (36:55):
So the origins for a lot of the, uh, concern on
this issue are, are a New YorkTimes story from a, a week or
two ago where they got a hold ofa draft executive order that's
been floating around the WhiteHouse, which calls for, creating
a system, uh, for intensifyingscrutiny of, in-licensing
(37:16):
of medicines from China.
Perhaps subjecting them to somekind of a process like the CFIUS
process that's used to, um,scrutinize it in some cases,
prohibit Chinese investmentsin the United States.
I don't doubt that the draftexecutive order that the.
The Times reportedabout is real.
I, I haven't seen it.
I've tried and I haven't beenable get a copy of it as far
(37:37):
as I know nobody else has.
But, it's most likely thatthat draft was created.
I think there's a lot of draftexecutive orders on a lot
of topics that are floatingaround the White House,
and a lot of them aren'tgonna see the light of day.
The Times reporting said thatPeter Thiel and the company
associated, with Kushner,are, Pushing this idea.
Um, they're saying thatcompetition from China,
(37:59):
threatens to, to harmAmerican, biotech companies.
And this is a way to kindof level playing field.
Simone Fishburn (38:05):
let me go back to what I said about the U.K.
Because what was rare thereis, I mean, we know there's a
lot of people walking aroundgovernment who really just don't
understand the ecosystem, and itseems to me that those arguments
indicate a lack in, certainlywith respect to this ecosystem
and you know, how much purchasedoes people like Scott Gottlieb
(38:26):
and those kind of voices, howmuch influence do they have?
Steve Usdin (38:29):
He, he's quite influential.
but there's also.
A tremendous amount ofagreement, bipartisan agreement,
Democrats and Republicans,that the US should take
steps to protect Americanindustry from China there.
So, you know, protectionismis, is, popular concept
in Washington right now.
there's a, great deal ofinterest in disengaging or
(38:53):
disentangling, us, technologycompanies, from China.
I think that there's a spilloverfrom the national security
debates around, semiconductorsand AI technology in China.
One of the things that I thinkhappens in Washington a lot is
that policymakers who understandone area very well, or at least
(39:13):
believe that they understand itvery well, like semiconductors
or ai, assume that what theyknow about those areas apply to
other areas that are adjacent.
That happens a lot withbiotech policy because
there aren't a lot of peoplein Congress who really
understand biotech policy.
There are a few, butthere aren't very many.
there aren't very many peoplein the White House who do, and
(39:35):
they're kind of drowned out by,um, some of these other voices.
That's where I thinkthat somebody like Scott
Gottlieb, speaking out.
Very publicly.
And by the way, there'sa, um, an op-ed that he
has in the WashingtonPost, today about this.
I think that, that, itdoes have influence.
It raises these issuesand it makes people
start asking questions.
Jeff Cranmer (39:57):
All right, and you can find Steve's story.
On BioCentury.com, there'llbe a link in the show notes.
And let's see.
Hey, let's, uh, let'shead to the clinic.
Singapore hosted the WorldSleep Congress and Lauren
had the opportunity to diginto some cool data that's
(40:18):
coming out for narcolepsy.
Uh, the two leadingcompanies, Takeda.
And Alkermes, uh, Lauren gotto speak with the Ageless
Richard Pops, as well as akey member of Takeda's team.
Takeda, the company that crackedthe code on Orexin, agonist.
Lauren.
Do I have that right?
Lauren Martz (40:39):
That's right.
Yeah.
Jeff Cranmer (40:40):
Excellent.
Uh, there's a good piece.
Lauren.
Uh, what did you learn?
Lauren Martz (40:44):
Thanks Jeff.
so I learned that this isreally a milestone year for
narcolepsy because of howthis class has advanced.
So, at the meeting, which was,uh, over a week ago now, we
learned that Takeda's therapy,at the primary endpoints and
the secondary endpoints ina pair of Phase III studies.
(41:04):
And we also have PhaseII data from Alkermes.
I think overall this just helpsprovide validation for this
idea that you can agonize theorexin 2 receptor and have an
impact on, not just wakefulness,but on some other, you know,
symptoms that come along,with narcolepsy, type one.
the reason that this wasparticularly interesting is
(41:25):
that this is a disease thathas had approved therapies.
But they don't really getat the underlying biology
in the same way as targetingthe orexin 2 receptor does.
So patients with narcolepsytype one are lacking the
neurons that produce theorexin neurotransmitter.
And we can't just addback that neurotransmitter
(41:48):
in a therapeutic form forseveral reasons, you know?
it's a large protein.
It needs to cross theblood brain barrier.
Um, and then design an agonisthas been challenging, because of
some of the same, same problemsand also the fact that you
need to kind of replicate Therise and fall of levels of this
neurotransmitter in a patient'sbrain to help them, you know,
(42:09):
have a normal sleep wake cycle.
so Takeda was the firstcompany to sort of have
a, a breakthrough in thisclass after, many ups and
downs in some failures.
Uh, so I think this isa, a big moment for, that
program in particular.
and I think there are a lot ofeyes on this field because it's
not just these two that have,have had some clinical success.
(42:31):
There are, um, severalothers that have moved
into the clinic as well.
right now I think thereare questions about which
one of these might endup being best in class.
So Takeda is ahead.
It's looking toward regulatorysubmissions this year.
There are questions, youknow, there are side effect
profiles that are common toboth therapies in this class
and, and potentially the otherones that that come forward too.
(42:54):
Um, there arequestions about dosing.
So, Takeda's therapyis dosed twice a day.
Alkermes so far in the PhaseII trial was dosed once a day,
which may be more convenient forpatients, but Takeda is arguing
that twice daily dosing is.
Potentially a path tobetter efficacy because
of the way that you want.
Orexin not just continue to risethroughout the day before you
(43:17):
reach, uh, time to sleep whenit should fall off quickly.
Jeff Cranmer (43:21):
Lauren, you spoke to Sarah Sheikh, uh, head of
Global Development and SVP ofthe Neuroscience Therapeutic.
Area, unit at Takeda.
and on that point, I, Ithought it was kind of
cool what she was saying.
It was like the, the patientcould almost like figure
out what works best forthem based on what they're
doing on a certain day.
(43:41):
Like, you know, if, you know youhave a big meeting or whatever,
you can kind of plan, um, whenyou take that second dose.
Lauren Martz (43:48):
Exactly.
So you can control the interviewinterval between your two doses
based on, you know, how longyou wanna stay awake for that,
or how long you wanna, havefull wakefulness for that day
and, and what you have laterin the evening, for example.
So I think that, youknow, it makes sense.
Jeff Cranmer (44:03):
What else?
Uh, you, you also wrotethat they're exploring
other indications.
Uh, what, what other indicationsare they digging into for these?
Lauren Martz (44:11):
Sure.
So narcolepsy type one isthe indication where there
actually is a loss of orexin.
There is another type ofnarcolepsy where orexin
is present, but we stillhave the same, issues,
uh, symptoms with sleep.
So.
that's another area whereboth of these companies
and some others are testingorexin 2 receptor agonists.
(44:33):
In some cases it's, differentagonists that, may act on
the receptor in differentways because orexin is
present in these patients.
It's just, not working,potentially not working
as it should be.
there are also some othersleep uh, disorders where
modulating this pathway couldhave a therapeutic effect.
And then there are a lotof thoughts about, other
(44:56):
conditions where wakefulness,cognition, mood, the types of
symptoms that are associatedwith narcolepsy that,
you know, orexin, uh, tworeceptor pathway activity.
Not sort of the, the primarysymptom associated with
that disorder, but areproblematic for patients.
So, you know, I think, A DHD forexample, was, was proposed as a
(45:19):
potential indication where thisclass of drugs could have sort
of more of a, symptomatic effectfor patients and something
that they're exploring.
Jeff Cranmer (45:28):
interesting stuff.
Lauren, Pops and Sheikh bothvery optimistic that there's
an opportunity to build.
really build franchisesaround orexin assets.
So we will be, uh,keeping an eye out.
I know Takeda has, um,other assets in the clinic,
uh, preclinical as well.
we'll be, uh, continuingto watch this space.
(45:50):
Some other stuff tocheck out on our website.
Uh, Stealth finally got itsapproval for Barth Syndrome.
Uh, it's been a rollercoaster 10 year journey.
Steve and I collaborated on apiece, that published Friday we
also, uh, have our colleaguePaul Bono's story on Lizard's
(46:10):
M&A survey that they did with,uh, top biopharma executives.
And, um, as I mentionedearlier, check out.
Steve's conversation with FritzBittenbender of Genentech,
who is the chair of BIO.
And keep an eye outfor two more podcasts.
This week we'll have, therecording of Stephen Hansen, and
(46:32):
Simone, on stage in Cambridge.
wrapping up the GrandRounds conference.
um, so joining, uh, Simoneand Stephen James Sabry, of
course, the prolific deal maker.
At Genentech Roche, nowBioMarin and Michelle
Jones, Simone, good stuff?
Simone Fishburn (46:51):
Always good stuff, Jeff.
I recommend people listento it if they wanna get
the, get the skinny.
Jeff Cranmer (46:56):
And we'll also be doing a podcast, uh, Lauren
and I, uh, and Selina, uh, onceshe gets off the plane from the
U.K. we'll be sitting down with.
An AI expert frompodcast sponsor, IQVIA.
So look out for thosetwo podcasts this week.
Thank you for tuning in.
If you like what you're hearing,please, like and subscribe.
(47:20):
and a special thanks toKendall Square Orchestra.
Which provides the musicfor BioCentury this week
and the BioCentury Show.
Uh, tickets are now on salefor the group's eighth season,
so if you're in the greaterBoston, area, go check it
out and, uh, enjoy a relaxingevening of wonderful music.
Eric Pierce (47:45):
BioCentury would like to thank IQVIA
Biotech for supporting theBioCentury This Week podcast.
Learn why IQVIA Biotech isproud to be the go-to CRO
supporting biotechs frominnovation to patient impact.
Visit IQVIABiotech.com.
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