November 3, 2025 • 27 mins
Novo Nordisk’s unsolicited $8.5 billion bid for Metsera has thrown a wrench into Pfizer’s plans to return to the obesity race via its acquisition of the New York-based start-up. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the details of the competing bids and what’s at stake for the pair of suitors.
The analysts also assess the reasons behind the abrupt departure of Center for Drug Evaluation and Research Director George Tidmarsh from FDA and a surge in activity on the Hong Kong stock exchange. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.
View full story: https://www.biocentury.com/article/657475
#Biotech #PharmaDeals #ObesityDrugs #MergersAndAcquisitions #FDA #LifeSciences #GlobalBiotech #HongKongMarket
00:01 - Sponsor Message: Voyager Therapeutics
01:53 - Metsera M&A
15:23 - Tidmarsh Ouster
25:12 - Hong Kong IPOs
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 you
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Jeff Cranmer (00:49):
5 weeks after it appeared that Pfizer
was getting back into theobesity game via its proposed
acquisition of Metserafor more than $7 billion.
Those ambitions could becurtailed by an unsolicited
bid from Novo Nordisk, which isoffering 8.5 billion to acquire.
(01:15):
The obesity startup.
We will discuss the latestM&A intrigue on this week's
BioCentury this week podcastand intrigue at FDA as
well, Tidmarsh is out.
We'll also touch on thelatest from the Hong
Kong Stock Exchange.
(01:35):
I'm Jeff Cranmer,executive editor.
Here at BioCentury's andjoining me today are my
colleagues, editor-in-Chief,Simone Fishburne, Washington,
editor Steve Usdin, and ourman in the U.K. Stephen Hansen.
Stephen, you've beenfollowing the obesity
(01:56):
space for some time now.
Metsera, Pfizer, Novo.
What do you makeof what's going on?
Stephen Hansen (02:01):
Yeah.
Thanks Jeff.
yeah, we've got, uh, we'vegot a little bit of drama now.
you know, as you said, backSeptember 22nd, Pfizer
had announced that it wasacquiring Metsera for about,
call it 4.9 billion upfront.
And then there was a 22 anda half dollars per share, CVR
attached to that, which broughtit to about 7.3 to 7.4 billion.
five weeks later, as yousay, Novo comes public
(02:24):
with an unsolicited offer.
And as, kind of turned out,They were one of the parties
that had been, negotiatingwith Metsera for quite some
time, uh, basically backsince the start of the year.
and had kind of been one of thefinal two bidders for Metsera.
so they've come publicnow, upped the ante.
And you know, we weretalking about this on Friday.
(02:44):
You know, there werekind of three directions
that this could go.
Either Pfizer could stepup and increase their bid.
They could let Novo win, youknow, and walk away with it.
Or Pfizer could go the litigatorroute and basically sue
Metsera for breach of contract.
And as we kind of learnedout over the weekend and
today, it looks like Pfizer'schosen door number three.
(03:05):
so they filed the one suiton Friday, which was for
breach of contract againstMetsera, and then they filed
a second suit today, whichwas a federal antitrust claim.
Against Metsera, theirshareholders, and Novo,
basically claiming thatNovo was, illegally looking
to acquire the companyto suppress competition,
destroy a, you know, startup,these sorts of things.
(03:29):
Metsera, I believe
Jeff Cranmer (03:30):
That was really remarkable, Stephen,
the way that press releasewas written, wasn't it?
Simone Fishburn (03:35):
yeah.
let's just get into ita little bit, Stephen,
because, there's so manythreads here to separate out.
First of all, Metsera sort ofeven engaged in this by defining
the Novo bid as a quote unquotesuperior company proposal.
And that was a sort ofclause, let's say, in the
(03:55):
agreement with Pfizer.
Now, Pfizer is questioningthat, that questioning whether
this qualifies, I think
Stephen Hansen (04:02):
Right.
They're
Simone Fishburn (04:03):
superior company pro, and that's
the claim for the breach of
Stephen Hansen (04:06):
exactly.
They're claiming that NovoNordisk's bid, which is
about a billion dollars morethan Pfizer's bid, does not
constitute a superior companyproposal, largely on the
grounds that there is a highamount of regulatory risk in
getting that deal completed.
They're contending that theyalready essentially have the
(04:28):
early termination granted by theFTC for the antitrust, waiting
period, and that they basicallyhave a, clear route through
to getting the deal done.
And so they're basically sayingit's not a superior bid despite
the billion dollar differencein the financials involved here.
Simone Fishburn (04:45):
Okay, so hang, hang on one sec. I'm not.
You know, as I said, I justplay a lawyer on tv, I'm
not arguing whether there'smerit or not in their cases.
I'm just saying that we do knowthat in this, dance beforehand
where there were many parties,but you know, Novo was party
number one or whatever theycalled.
there was a perceptionby Metsera, or Metsera's
(05:06):
board of regulatory risk,so it's not completely
out of the blue..
Stephen Hansen (05:10):
That is.
And so that's part, that'spart of the, sort of the palace
intrigue here, is the factthat in the runup privately,
when they were having thesenegotiations, in the, uh, in
the proxy statement that was,you know, subsequently published
by Metsera, they essentially,you know, said that their board
went with the Pfizer offer,because while it was inferior
(05:31):
from a, you know, fiduciary,you know, financial perspective.
It was believed to be the betteroffer overall because there
was a clearer site to beingable to get the deal done.
now the, the other bitof intrigue in this is
the structure of theproposal from Novo.
So what they are proposingis, six and a half billion
equity value upfront.
(05:52):
So $56 and 50 cents per share.
And that is gonna be structuredin such a way that they would
effectively be buying 50% of,the outstanding equity stake
in Metsera, via the issuance ofnew preferred non-voting shares.
And then that upfrontpayment would immediately
(06:14):
be paid and then paid out toshareholders as a dividend.
Prior to any regulatoryreview, any of that stuff.
So effectively shareholderswould be getting all of that
upfront money straight away.
that also basically meansthat Novo is effectively
taking a massive termination,fee risk here, because
effectively all that moneyis then out the door before
(06:37):
there's any regulatory review.
So, if they were togo with the Novo deal.
Under this structurethat they've proposed.
it's a big financialrisk for Novo.
Simone Fishburn (06:45):
Well, let's come back to that in a minute
because I, I just wanna coverthere's so much landscape to
cover before we analyze, Who,who's got more risk, whatever.
there's also a Big America firstpart of the Pfizer response,
right?
Steve, I don't knowif you wanna weigh in.
You've used the wordperfidious Danes, and I
wanna see if I can get youto use it on the podcast.
Steve Usdin (07:06):
Yes.
So I haven't, yes, I havebeen saying that, Pfizer's
gonna be claiming that theperfidious Danes are, trying to
beat out an American company.
Look, the fact that, um, AlbertBourla, stood, arm in arm with
Donald Trump in the White House.
and was the first companyto announce the most favored
nation, agreement, with theWhite House, you know, isn't
lost on anybody in Washington.
(07:27):
And I think that they aregoing to basically try, you
know, to try to leveragethat, to their advantage, with
the administration, with thecourts and, um, with the, with
the court of public opinion.
You're
Stephen Hansen (07:39):
right.
I mean, and that was quiteclear in their, in the statement
that they put out, in responseto the publication of Novo's,
um, unsolicited proposal.
and then that language sortof continued even in, in
their press releases aboutthe litigation being filed.
I mean, you know,they reference.
Novo Taking an anti-competitiveaction to protect its dominant
market position and to kill anascent American competitor,
(08:03):
before it gained the support ofPfizer, one of America's leading
Simone Fishburn (08:07):
wait.
wait.
Pfizer's not na.
So I hope they're notsaying Pfizer's nascent.
Stephen Hansen (08:11):
No, it's Pfizer's not nascent,
but you know, the, themulti-billion dollar
Metsera is nascent in this
Simone Fishburn (08:17):
So, so Stephen, here's how I've
been thinking about it.
And tell me, I may be way off,but tell me what you think.
So for me, I feel like.
You know, Novo has had alot of trouble recently.
It's now got a new CEO,who's coming in, let's
say Guns are blazing.
Like let's try whatever we can.
If it doesn't pan out,I don't know that Novo
(08:40):
walks away looking.
Particularly badthey tried something.
'cause it feels like Pfizer,if they got outbid on this
and, and Nova won and in, inlight of the fact also that
this is, what did you call it?
Jeff, there, I, I forget whatnumber attempt you said for them
to get back into the obesityrace,
Stephen Hansen (08:58):
I think it's their third.
Simone Fishburn (08:59):
It the third attempt to do that.
So, I don't know.
It feels like Pfizer, couldtake some sort of ego bruising
over this if they lost out.
Stephen Hansen (09:09):
Yeah.
No, I, I think that's right.
I mean, so from the NovoNordisk perspective.
I think in some ways, tome this reads as if it
shows their maybe lack ofconfidence in the commercial
potential of CagriSema.
I mean, there's some issuesaround, so it's, it's got,
has some formulation issues.
You know, obviously itdidn't show the efficacy
that investors were wanting.
I think there's some questionaround how much that can
(09:30):
challenge, you know, is Zepboundin Lilly with CagriSema.
The follow on to that isamycretin, but that's basically
at the same position thatthe Metsera programs are at.
I mean, it's juststarting Phase III now.
So, I think this is anattempt by them to sort of
try and broaden out theirmore near term competitive,
portfolio in obesity.
but you're right, I don't thinkthey have a lot to lose on it
(09:52):
other than money at this point.
how I see this happening.
I mean, this is, I think this isMetsera is effectively trying to
play, you know, they're tryingto play them off each other.
They're basically trying toget Pfizer to pay an extra
billion dollars, up the ante.
and Pfizer has basically said,no, we're not gonna up the ante.
We're gonna sue you.
And that's effectivelywhat Metsera said in their
(10:13):
response is it basically said.
that Pfizer's trying to litigatetheir way into paying not
the fair price for Metsera.
Simone Fishburn (10:21):
Pfizer's saying we'd rather pay the
lawyers than you, is what I'munderstanding from you.
Jeff Cranmer (10:24):
yeah.
Pfizer's, Pfizer's basicallytrying to play the uh, Marcellus
card and say there's somethingrotten in the state of Denmark.
But, but Stephen,uh, you know, met,
Simone Fishburn (10:37):
to go there.
You had to go there.
Yeah.
Jeff Cranmer (10:39):
you know, warming up the Shakespeare is
always, good, uh, especiallywhen you have a high school
student getting ready to startreading his first Shakespeare.
but Stephen, I, I thinkyou're underselling Metsera's
press release because.
Pfizer's press release was, uh,if you haven't read it, dear
listener, I urge you to read it.
It, it's really, quite differentthan other press releases
(11:02):
that Pfizer's Crack team ofcommunications people puts out.
But Metsera's waspretty good too.
You know, they said, uh.
Pfizer is trying to litigateits way into buying Metsera
for a lower price, and thenthey said, Pfizer's litigation
arguments are nonsense.
Steven, final word beforewe, move on to some other
Stephen Hansen (11:24):
I mean, the other thing that struck me
about this when we were talkingabout the potential ways
this could go is when we weretalking about the what ifs of
the, the litigation route is.
The thing that just didn'tmake sense to me is You know,
these are assets that Pfizerreally needs, and one of
the most attractive, aspectsabout them is the fact that
they're heading into Phase III.
They're trying to playcatch up, and so they really
(11:45):
need these assets to bedeveloped as quickly and
as optimally as possible.
And I just question whethertying Metsera's team up in
litigation is the best wayto put these assets to, for,
I mean, these are the assetsthat they want to buy, and
are you then potentiallyhandicapping or you know,
inhibiting their ability tooptimize that development path?
(12:07):
kind of feels like you're.
Maybe shooting yourself in thefoot if your Pfizer here by
taking the litigation route,rather than just spending an
extra billion dollars to, youknow, to equal up the bid.
But
Jeff Cranmer (12:17):
Yeah.
What's, what's a billion dollarshere?
Stephen Hansen (12:19):
what's a billion dollars between?
Between friends, right?
Simone Fishburn (12:22):
well they spent more than that on, a
lot more than that on Seagenand various other things.
So we could talk about that andwe probably will do again,
Jeff Cranmer (12:29):
I, I say, you know, JPMs around the corner,
let's just, set up that icerink in, Union Square as like
a steel cage match rla and,who's the new CEO of, of Novo?
Stephen Hansen (12:42):
Mike Doustdar
Jeff Cranmer (12:43):
Steven, they can.
They, they can just, youknow, let's, get real.
Let's let them just, dukeit out in Union Square
Stephen Hansen (12:49):
in an ice rink?
Do you to a figure skating matchor what are you, what are you
yeah.
Well, yeah.
That would actually be, thatwould actually be better.
That would sort be like, uh,zoo, well, Zoolander, right?
Or what, what's that guy?
Simone Fishb (13:03):
I, I'd be a judge.
I'd sit there putting up my,you know, 6.0.
Anyway, let's move on.
Jeff Cranmer (13:09):
Alright.
All right, well, we're gonnatake a quick break Stephen,
thanks for joining us.
I know it's, your dayoff, but, uh, y you, you
couldn't resist joining us.
So, uh, have a lovely evening,sir, and I'll take a quick
break and we will come backto, FDA, what can I say?
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Jeff Cranmer (14:13):
Attention to all our Boston peeps.
The BioCentury's Thisweek podcast will be on
the road November 6th inthe Boston Cambridge area
for K-Blockbuster Night.
Simone will be there and ourcolleague Josh Berlin will be
there and you can join them atVenture Café Cambridge to watch
(14:37):
a live recording of our podcastwith special guests joining
Simone and Josh to discussKorea Biotech, register for
free at venturecafecambridge.orgor send Josh a note, our me a
note on LinkedIn to learn more.
(14:57):
And speaking ofKorea, that's what the
K-Blockbusters all about.
BioCentury goes on theroad again and will be
in Seoul in March forour 5th East-West Summit.
I am currently recruiting,presenting companies.
And you can take advantageof early bird rates right
(15:18):
now to register as adelegate or apply to present.
Okay, Steve, you've had abusy weekend once again.
tell us what's going on at FDA.
Steve Usdin (15:31):
Oh, I wish I knew.
Okay.
There's a lot ofthings going on at FDA.
Here's a few of them.
So George Tid the directorof CDER, was put on
administrative leave Sunday.
They're conflicting reportsabout whether he's resigned, but
one thing's completely clear,he's not gonna do a Prasad.
He's not returning to FDA.
He has burned his bridges.
He said in media interviewsthat he was pushed out
(15:52):
because he objected to theway FDA Commissioner Makary
was trying to approve drugsunder the commissioner's
National Priority Voucherprogram, without due process
and diligence that are typicalin FDA reviews and, subject
to political interference.
But his ouster came as theHHS Inspector General was
investigating allegationsof ethics violations and
(16:14):
Aurinia Pharmaceuticals fileda lawsuit against Tidmarsh.
Personally, I thinktwo things can be true.
Tidmarsh could haveexpressed reservations
about the approvals process.
And the administration couldbe taking the concerns Aurinia
raised very seriously andthey are serious allegations
that he use his officialposition to pursue a vendetta
against Kevin Tang, Aurinia'sChairman, and that he initiated
(16:38):
regulatory action againstanother company affiliated
with Tang that makes API fordesiccated thyroid products,
and then tried to extort abribe to make it go away.
The truth of the allegations isgonna be decided by the courts.
It's certain that Tidmarshposted comments on LinkedIn
and then deleted them.
They were aimed at Auriniawhen he deleted them.
(16:59):
He wrote that theywere his personal views
and not FDA's or HHS'.
I wrote a commentary inSeptember when this happened,
saying he should be fired,and that was before all these
other allegations surfaced.
Adding to the turmoil FDAstaff report that Vinay
Prasad, director of CBERand FDA's, Chief Medical
and Scientific Officer.
Has created a toxicwork environment.
(17:21):
Some of his top staff haveasked for transfers to CDER,
but Prasad has blocked them.
FDA staff have told me thatPrasad is rarely in Washington,
that he calls on the cell phoneand intimidates junior staff
cutting out their supervisors.
he claimed in a webcastrecently that OCE Director,
Richard Pazdur was responsiblefor a controversial.
(17:41):
Complete response letter, thatwas issued to Replimune, but
in fact, it was Prasad thatsigned, all the documentation.
It was Prasad's call to issue,that complete response letter.
And that's created a lotof, ill will around, FDA.
Simone Fishburn (17:56):
Steve, I just wanna make a
couple of points here.
first of all, I think it'svery clear that this huge
amount of instability atFDA is really just not good
generally, I think that you'vepointed out that Tidmarsh made
some, Statements or claimsthat actually have merit, um,
regarding questions about thecommissioner's, voucher program
(18:17):
at the same time, there'sreally a lot of questionable
activity allegedly, right?
If you, believe that all thethings that have come out
in the Wall Street Journaland so on, uh, are correct.
and to me it really, to behonest, seems like there's just
very little due diligence goingon behind these appointments.
so I think that that ongoinginstability is not great
(18:37):
for the agency and, andtherefore for drug developers.
I do wanna make one morepoint though, because I think
this gets lost in a lot ofthese really big headlines,
which are very alarming.
And I was speaking toA CEO over the weekend.
There are a lot of reallygood people at FDA still
working really hard, andthese are the levels below.
And a lot of companies areactually having engagements
(18:59):
with the career people atFDA who have to navigate
through all of this.
And so there's sortof a sense that.
They're kind of maybe gettinglost in the narrative somewhere.
Those people who are stayingat FDA, doing their best
and just trying to get drugdevelopment moving along.
And for many companiesit is moving along.
And then for others, weknow, we've seen the uniQure
(19:20):
data, information today,which you might elaborate on.
There's a lot of uncertaintyand a lot of other companies,
for example, in cell andgene therapies and their
investors just don't know.
How to think about thestability, the predictability of
the things that FDA is saying.
What do you think Steve?
Steve Usdin (19:39):
So, yeah, of course the fact that there's
a great deal of instability,that there's turmoil at FDA
doesn't mean that everythingis going, down the toilet.
It doesn't mean that nothingis working as it should.
There are things that areadvancing, and in fact, there
are positive things that, FDA isdoing from a policy standpoint.
You know, when I was thinkingabout this podcast last
week, I thought we would be.
(19:59):
talking about remarks thatTidmarsh made at a patient
meeting last Tuesday.
all that seems moot now,but it really isn't.
So at that meeting, he saidthat CDER was undertaking a
review of endpoints used tosupport accelerated approval
of cancer drugs, that overallsurvival should be the basis
for confirmatory trials, andthat companies should resist
pressure from clinicians andpatients to allow crossover
(20:21):
from standard of care toinvestigational therapies
and confirmatory trials.
There was a furiousresponse from cancer patient
advocates and clinicians tothat, to those statements.
obviously with Tidmarsh, out thedoor, those issues are probably
at least pushed into thefuture, if not, out the door.
But Tidmarsh also outlinedsteps that FDA's taking to
(20:42):
speed first in human trialsto reduce delays in improving
and advancing clinical trials.
and other things that arereally, top priorities
of, of industry.
So yeah, it's kindof a, a mixed bag.
you mentioned about, um,due diligence, in recruiting
Tidmarsh for the job.
And it's interesting becauseat that same meeting, he told
a story, John Crowley, who wasmoderating the, fireside chat.
(21:04):
he asked Tidmarsh, he said,you know, basically, how was it
that you, that you got the job?
And what Tidmarsh said wasthat he got to know Jay
Bhattacharya, who's the NIHdirector, back when they
were both at, um, Stanford.
And they were both engaged in atremendous amount of controversy
involving, COVID policies.
after the, election.
(21:24):
what Tidmarsh said is that,he had, dinner with, Jay
Bhattacharya with Makary thatJay Bhattacharya was staying,
at Makary's house, that they're,close friends and, that he
basically offered to help.
Makary, help him out atFDA, that McCarry started
calling him on the phoneand asking him for advice.
And then after one of thosecalls Tidmarsh's wife turned
(21:46):
to him and said, really, youknow, Makary needs help, you
should offer to help him,Tidmarsh said, oh yeah, okay.
he called up, uh, Makaryand said, you know, is
there any way I could help?
And Makary said, yeah, actually,I need somebody to run CDER.
six weeks later,he was at a job.
He was the, director of CDER.
none of that really sounds likethere was a tremendous amount of
diligence as, as you mentioned.
Jeff Cranmer (22:06):
he, said that on stage.
Steve Usdin (22:08):
Yeah, yeah.
He described allof this on stage.
Jeff Cranmer (22:10):
Wow.
Okay.
FDA, well, Simone said, Reallyglad to hear, that there's
still some people working hardin the trenches to keep, drug
developers in the U.S. andelsewhere in the world on track.
But, it's a littledisheartening, frankly, to hear
what you just said there, Steve.
uniQure came up at, sortof the beginning of this,
(22:33):
what's going on there?
Steve Usdin (22:34):
We don't know exactly what's going on there,
but this is an example of thekind of turmoil that's happening
at FDA and in particular atCBER under, Vinay Prasad So
uniQure was aligned with FDA ona submission for a gene therapy
for a Huntington's disease.
and um, actually they wereeven talking, as recently
(22:54):
as last month about theirplans for commercialization
of this product.
And it comes out today, now,and we find out that actually,
FDA has completely reversed itsposition that it had before.
They're not, on boardwith uniQure's submission.
and that apparently the, themain problem was that they'd
used, a natural historystudy as their, external
(23:16):
control for the trial.
And CBER is no longerwilling to accept that as
the control for the trial.
This is really problematic.
It's really problematic,especially for
Huntington's patients.
Look, this is auniformly fatal disease.
it affects I think, about 6,000Americans a year, and this
(23:36):
was the first thing that'scome along that actually
could help patients withHuntington's live longer.
It was the firsthope that they had.
and apparently FDA is pullingthe rug out from under them
if they actually require aplacebo controlled trial.
First, what, Huntington'spatient would agree
(23:56):
to be in that trial?
and second.
It's probably gonna takethree years to complete it.
it's not clear whether itactually could be done at, all.
but the ethical and thecommercial implications of that
are really, very troubling.
And it also sends a messageto other companies that
are developing trialsfor rare progressive
(24:17):
diseases that are based onnatural history studies.
that's been kind of anassumption, and FDA's
explicitly agreed in many casesthat they would, allow that.
and now apparently they'rer eversing position on it.
It's not clear if it'sjust for Huntington's or is
that gonna be read through,to other conditions, but
it's a major uncertainty.
Jeff Cranmer (24:39):
it's remarkable and I, I haven't looked at.
stocks for similar rare diseasecompanies who are late stage.
But I can tell youuniQure is down 42% today.
They're now, under $2billion in market cap.
This is a, substantialcompany that's been on the
forefront of developingdrugs for rare diseases.
(25:02):
they know what they'redoing and, what a setback.
It's just remarkable.
Alright.
It's enough enough doomand gloom for today.
Let's, uh.
Let's turn to a partof the world where
things are happening.
Hong Kong, the Hong KongStock Exchange, has been
receiving most new listingsquite warmly, five offerings
(25:24):
have at least doubled in valueduring the first trading day.
And last week, four moreBiopharmas entered the
Hong Kong queue, for eitheran IPO or a dual listing,
BrightGene, NovaBridge, Alebundand let's see, uh, Lupeng,
(25:45):
and then turning stateside,MapLight Therapeutics met
its goal to go public.
It, priced its IPO earlylast week raising nearly $300
million, in a public offeringand concurrent private placement
with Goldman Sachs, Thecompany, uh, briefly traded
(26:05):
above $20, gave back its gains.
to finish a little bit belowits $17 public offering price.
you can check out all thelatest on public financings
in our weekly finance report.
crafted by our, sometime podcastcontributor Paul Bonanos, along
(26:27):
with the newest BioCentury'sLindsay Martin, well, I,
I think that's, uh, wherewe'll leave things this week.
Steve is going tocontinue monitoring
what's happening at FDA.
And Stephen, will stay ontop of the Metsera deal
and we'll keep bringing itto you at BioCentury.com.
(26:48):
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[AI-generated transcript.]
Eric Pierce (00:02):
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Jeff Cranmer (00:49):
5 weeks after it appeared that Pfizer
was getting back into theobesity game via its proposed
acquisition of Metserafor more than $7 billion.
Those ambitions could becurtailed by an unsolicited
bid from Novo Nordisk, which isoffering 8.5 billion to acquire.
(01:15):
The obesity startup.
We will discuss the latestM&A intrigue on this week's
BioCentury this week podcastand intrigue at FDA as
well, Tidmarsh is out.
We'll also touch on thelatest from the Hong
Kong Stock Exchange.
(01:35):
I'm Jeff Cranmer,executive editor.
Here at BioCentury's andjoining me today are my
colleagues, editor-in-Chief,Simone Fishburne, Washington,
editor Steve Usdin, and ourman in the U.K. Stephen Hansen.
Stephen, you've beenfollowing the obesity
(01:56):
space for some time now.
Metsera, Pfizer, Novo.
What do you makeof what's going on?
Stephen Hansen (02:01):
Yeah.
Thanks Jeff.
yeah, we've got, uh, we'vegot a little bit of drama now.
you know, as you said, backSeptember 22nd, Pfizer
had announced that it wasacquiring Metsera for about,
call it 4.9 billion upfront.
And then there was a 22 anda half dollars per share, CVR
attached to that, which broughtit to about 7.3 to 7.4 billion.
five weeks later, as yousay, Novo comes public
(02:24):
with an unsolicited offer.
And as, kind of turned out,They were one of the parties
that had been, negotiatingwith Metsera for quite some
time, uh, basically backsince the start of the year.
and had kind of been one of thefinal two bidders for Metsera.
so they've come publicnow, upped the ante.
And you know, we weretalking about this on Friday.
(02:44):
You know, there werekind of three directions
that this could go.
Either Pfizer could stepup and increase their bid.
They could let Novo win, youknow, and walk away with it.
Or Pfizer could go the litigatorroute and basically sue
Metsera for breach of contract.
And as we kind of learnedout over the weekend and
today, it looks like Pfizer'schosen door number three.
(03:05):
so they filed the one suiton Friday, which was for
breach of contract againstMetsera, and then they filed
a second suit today, whichwas a federal antitrust claim.
Against Metsera, theirshareholders, and Novo,
basically claiming thatNovo was, illegally looking
to acquire the companyto suppress competition,
destroy a, you know, startup,these sorts of things.
(03:29):
Metsera, I believe
Jeff Cranmer (03:30):
That was really remarkable, Stephen,
the way that press releasewas written, wasn't it?
Simone Fishburn (03:35):
yeah.
let's just get into ita little bit, Stephen,
because, there's so manythreads here to separate out.
First of all, Metsera sort ofeven engaged in this by defining
the Novo bid as a quote unquotesuperior company proposal.
And that was a sort ofclause, let's say, in the
(03:55):
agreement with Pfizer.
Now, Pfizer is questioningthat, that questioning whether
this qualifies, I think
Stephen Hansen (04:02):
Right.
They're
Simone Fishburn (04:03):
superior company pro, and that's
the claim for the breach of
Stephen Hansen (04:06):
exactly.
They're claiming that NovoNordisk's bid, which is
about a billion dollars morethan Pfizer's bid, does not
constitute a superior companyproposal, largely on the
grounds that there is a highamount of regulatory risk in
getting that deal completed.
They're contending that theyalready essentially have the
(04:28):
early termination granted by theFTC for the antitrust, waiting
period, and that they basicallyhave a, clear route through
to getting the deal done.
And so they're basically sayingit's not a superior bid despite
the billion dollar differencein the financials involved here.
Simone Fishburn (04:45):
Okay, so hang, hang on one sec. I'm not.
You know, as I said, I justplay a lawyer on tv, I'm
not arguing whether there'smerit or not in their cases.
I'm just saying that we do knowthat in this, dance beforehand
where there were many parties,but you know, Novo was party
number one or whatever theycalled.
there was a perceptionby Metsera, or Metsera's
(05:06):
board of regulatory risk,so it's not completely
out of the blue..
Stephen Hansen (05:10):
That is.
And so that's part, that'spart of the, sort of the palace
intrigue here, is the factthat in the runup privately,
when they were having thesenegotiations, in the, uh, in
the proxy statement that was,you know, subsequently published
by Metsera, they essentially,you know, said that their board
went with the Pfizer offer,because while it was inferior
(05:31):
from a, you know, fiduciary,you know, financial perspective.
It was believed to be the betteroffer overall because there
was a clearer site to beingable to get the deal done.
now the, the other bitof intrigue in this is
the structure of theproposal from Novo.
So what they are proposingis, six and a half billion
equity value upfront.
(05:52):
So $56 and 50 cents per share.
And that is gonna be structuredin such a way that they would
effectively be buying 50% of,the outstanding equity stake
in Metsera, via the issuance ofnew preferred non-voting shares.
And then that upfrontpayment would immediately
(06:14):
be paid and then paid out toshareholders as a dividend.
Prior to any regulatoryreview, any of that stuff.
So effectively shareholderswould be getting all of that
upfront money straight away.
that also basically meansthat Novo is effectively
taking a massive termination,fee risk here, because
effectively all that moneyis then out the door before
(06:37):
there's any regulatory review.
So, if they were togo with the Novo deal.
Under this structurethat they've proposed.
it's a big financialrisk for Novo.
Simone Fishburn (06:45):
Well, let's come back to that in a minute
because I, I just wanna coverthere's so much landscape to
cover before we analyze, Who,who's got more risk, whatever.
there's also a Big America firstpart of the Pfizer response,
right?
Steve, I don't knowif you wanna weigh in.
You've used the wordperfidious Danes, and I
wanna see if I can get youto use it on the podcast.
Steve Usdin (07:06):
Yes.
So I haven't, yes, I havebeen saying that, Pfizer's
gonna be claiming that theperfidious Danes are, trying to
beat out an American company.
Look, the fact that, um, AlbertBourla, stood, arm in arm with
Donald Trump in the White House.
and was the first companyto announce the most favored
nation, agreement, with theWhite House, you know, isn't
lost on anybody in Washington.
(07:27):
And I think that they aregoing to basically try, you
know, to try to leveragethat, to their advantage, with
the administration, with thecourts and, um, with the, with
the court of public opinion.
You're
Stephen Hansen (07:39):
right.
I mean, and that was quiteclear in their, in the statement
that they put out, in responseto the publication of Novo's,
um, unsolicited proposal.
and then that language sortof continued even in, in
their press releases aboutthe litigation being filed.
I mean, you know,they reference.
Novo Taking an anti-competitiveaction to protect its dominant
market position and to kill anascent American competitor,
(08:03):
before it gained the support ofPfizer, one of America's leading
Simone Fishburn (08:07):
wait.
wait.
Pfizer's not na.
So I hope they're notsaying Pfizer's nascent.
Stephen Hansen (08:11):
No, it's Pfizer's not nascent,
but you know, the, themulti-billion dollar
Metsera is nascent in this
Simone Fishburn (08:17):
So, so Stephen, here's how I've
been thinking about it.
And tell me, I may be way off,but tell me what you think.
So for me, I feel like.
You know, Novo has had alot of trouble recently.
It's now got a new CEO,who's coming in, let's
say Guns are blazing.
Like let's try whatever we can.
If it doesn't pan out,I don't know that Novo
(08:40):
walks away looking.
Particularly badthey tried something.
'cause it feels like Pfizer,if they got outbid on this
and, and Nova won and in, inlight of the fact also that
this is, what did you call it?
Jeff, there, I, I forget whatnumber attempt you said for them
to get back into the obesityrace,
Stephen Hansen (08:58):
I think it's their third.
Simone Fishburn (08:59):
It the third attempt to do that.
So, I don't know.
It feels like Pfizer, couldtake some sort of ego bruising
over this if they lost out.
Stephen Hansen (09:09):
Yeah.
No, I, I think that's right.
I mean, so from the NovoNordisk perspective.
I think in some ways, tome this reads as if it
shows their maybe lack ofconfidence in the commercial
potential of CagriSema.
I mean, there's some issuesaround, so it's, it's got,
has some formulation issues.
You know, obviously itdidn't show the efficacy
that investors were wanting.
I think there's some questionaround how much that can
(09:30):
challenge, you know, is Zepboundin Lilly with CagriSema.
The follow on to that isamycretin, but that's basically
at the same position thatthe Metsera programs are at.
I mean, it's juststarting Phase III now.
So, I think this is anattempt by them to sort of
try and broaden out theirmore near term competitive,
portfolio in obesity.
but you're right, I don't thinkthey have a lot to lose on it
(09:52):
other than money at this point.
how I see this happening.
I mean, this is, I think this isMetsera is effectively trying to
play, you know, they're tryingto play them off each other.
They're basically trying toget Pfizer to pay an extra
billion dollars, up the ante.
and Pfizer has basically said,no, we're not gonna up the ante.
We're gonna sue you.
And that's effectivelywhat Metsera said in their
(10:13):
response is it basically said.
that Pfizer's trying to litigatetheir way into paying not
the fair price for Metsera.
Simone Fishburn (10:21):
Pfizer's saying we'd rather pay the
lawyers than you, is what I'munderstanding from you.
Jeff Cranmer (10:24):
yeah.
Pfizer's, Pfizer's basicallytrying to play the uh, Marcellus
card and say there's somethingrotten in the state of Denmark.
But, but Stephen,uh, you know, met,
Simone Fishburn (10:37):
to go there.
You had to go there.
Yeah.
Jeff Cranmer (10:39):
you know, warming up the Shakespeare is
always, good, uh, especiallywhen you have a high school
student getting ready to startreading his first Shakespeare.
but Stephen, I, I thinkyou're underselling Metsera's
press release because.
Pfizer's press release was, uh,if you haven't read it, dear
listener, I urge you to read it.
It, it's really, quite differentthan other press releases
(11:02):
that Pfizer's Crack team ofcommunications people puts out.
But Metsera's waspretty good too.
You know, they said, uh.
Pfizer is trying to litigateits way into buying Metsera
for a lower price, and thenthey said, Pfizer's litigation
arguments are nonsense.
Steven, final word beforewe, move on to some other
Stephen Hansen (11:24):
I mean, the other thing that struck me
about this when we were talkingabout the potential ways
this could go is when we weretalking about the what ifs of
the, the litigation route is.
The thing that just didn'tmake sense to me is You know,
these are assets that Pfizerreally needs, and one of
the most attractive, aspectsabout them is the fact that
they're heading into Phase III.
They're trying to playcatch up, and so they really
(11:45):
need these assets to bedeveloped as quickly and
as optimally as possible.
And I just question whethertying Metsera's team up in
litigation is the best wayto put these assets to, for,
I mean, these are the assetsthat they want to buy, and
are you then potentiallyhandicapping or you know,
inhibiting their ability tooptimize that development path?
(12:07):
kind of feels like you're.
Maybe shooting yourself in thefoot if your Pfizer here by
taking the litigation route,rather than just spending an
extra billion dollars to, youknow, to equal up the bid.
But
Jeff Cranmer (12:17):
Yeah.
What's, what's a billion dollarshere?
Stephen Hansen (12:19):
what's a billion dollars between?
Between friends, right?
Simone Fishburn (12:22):
well they spent more than that on, a
lot more than that on Seagenand various other things.
So we could talk about that andwe probably will do again,
Jeff Cranmer (12:29):
I, I say, you know, JPMs around the corner,
let's just, set up that icerink in, Union Square as like
a steel cage match rla and,who's the new CEO of, of Novo?
Stephen Hansen (12:42):
Mike Doustdar
Jeff Cranmer (12:43):
Steven, they can.
They, they can just, youknow, let's, get real.
Let's let them just, dukeit out in Union Square
Stephen Hansen (12:49):
in an ice rink?
Do you to a figure skating matchor what are you, what are you
yeah.
Well, yeah.
That would actually be, thatwould actually be better.
That would sort be like, uh,zoo, well, Zoolander, right?
Or what, what's that guy?
Simone Fishb (13:03):
I, I'd be a judge.
I'd sit there putting up my,you know, 6.0.
Anyway, let's move on.
Jeff Cranmer (13:09):
Alright.
All right, well, we're gonnatake a quick break Stephen,
thanks for joining us.
I know it's, your dayoff, but, uh, y you, you
couldn't resist joining us.
So, uh, have a lovely evening,sir, and I'll take a quick
break and we will come backto, FDA, what can I say?
Alanna Farro (13:25):
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Jeff Cranmer (14:13):
Attention to all our Boston peeps.
The BioCentury's Thisweek podcast will be on
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Simone will be there and ourcolleague Josh Berlin will be
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(14:37):
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Simone and Josh to discussKorea Biotech, register for
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(14:57):
And speaking ofKorea, that's what the
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BioCentury goes on theroad again and will be
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I am currently recruiting,presenting companies.
And you can take advantageof early bird rates right
(15:18):
now to register as adelegate or apply to present.
Okay, Steve, you've had abusy weekend once again.
tell us what's going on at FDA.
Steve Usdin (15:31):
Oh, I wish I knew.
Okay.
There's a lot ofthings going on at FDA.
Here's a few of them.
So George Tid the directorof CDER, was put on
administrative leave Sunday.
They're conflicting reportsabout whether he's resigned, but
one thing's completely clear,he's not gonna do a Prasad.
He's not returning to FDA.
He has burned his bridges.
He said in media interviewsthat he was pushed out
(15:52):
because he objected to theway FDA Commissioner Makary
was trying to approve drugsunder the commissioner's
National Priority Voucherprogram, without due process
and diligence that are typicalin FDA reviews and, subject
to political interference.
But his ouster came as theHHS Inspector General was
investigating allegationsof ethics violations and
(16:14):
Aurinia Pharmaceuticals fileda lawsuit against Tidmarsh.
Personally, I thinktwo things can be true.
Tidmarsh could haveexpressed reservations
about the approvals process.
And the administration couldbe taking the concerns Aurinia
raised very seriously andthey are serious allegations
that he use his officialposition to pursue a vendetta
against Kevin Tang, Aurinia'sChairman, and that he initiated
(16:38):
regulatory action againstanother company affiliated
with Tang that makes API fordesiccated thyroid products,
and then tried to extort abribe to make it go away.
The truth of the allegations isgonna be decided by the courts.
It's certain that Tidmarshposted comments on LinkedIn
and then deleted them.
They were aimed at Auriniawhen he deleted them.
(16:59):
He wrote that theywere his personal views
and not FDA's or HHS'.
I wrote a commentary inSeptember when this happened,
saying he should be fired,and that was before all these
other allegations surfaced.
Adding to the turmoil FDAstaff report that Vinay
Prasad, director of CBERand FDA's, Chief Medical
and Scientific Officer.
Has created a toxicwork environment.
(17:21):
Some of his top staff haveasked for transfers to CDER,
but Prasad has blocked them.
FDA staff have told me thatPrasad is rarely in Washington,
that he calls on the cell phoneand intimidates junior staff
cutting out their supervisors.
he claimed in a webcastrecently that OCE Director,
Richard Pazdur was responsiblefor a controversial.
(17:41):
Complete response letter, thatwas issued to Replimune, but
in fact, it was Prasad thatsigned, all the documentation.
It was Prasad's call to issue,that complete response letter.
And that's created a lotof, ill will around, FDA.
Simone Fishburn (17:56):
Steve, I just wanna make a
couple of points here.
first of all, I think it'svery clear that this huge
amount of instability atFDA is really just not good
generally, I think that you'vepointed out that Tidmarsh made
some, Statements or claimsthat actually have merit, um,
regarding questions about thecommissioner's, voucher program
(18:17):
at the same time, there'sreally a lot of questionable
activity allegedly, right?
If you, believe that all thethings that have come out
in the Wall Street Journaland so on, uh, are correct.
and to me it really, to behonest, seems like there's just
very little due diligence goingon behind these appointments.
so I think that that ongoinginstability is not great
(18:37):
for the agency and, andtherefore for drug developers.
I do wanna make one morepoint though, because I think
this gets lost in a lot ofthese really big headlines,
which are very alarming.
And I was speaking toA CEO over the weekend.
There are a lot of reallygood people at FDA still
working really hard, andthese are the levels below.
And a lot of companies areactually having engagements
(18:59):
with the career people atFDA who have to navigate
through all of this.
And so there's sortof a sense that.
They're kind of maybe gettinglost in the narrative somewhere.
Those people who are stayingat FDA, doing their best
and just trying to get drugdevelopment moving along.
And for many companiesit is moving along.
And then for others, weknow, we've seen the uniQure
(19:20):
data, information today,which you might elaborate on.
There's a lot of uncertaintyand a lot of other companies,
for example, in cell andgene therapies and their
investors just don't know.
How to think about thestability, the predictability of
the things that FDA is saying.
What do you think Steve?
Steve Usdin (19:39):
So, yeah, of course the fact that there's
a great deal of instability,that there's turmoil at FDA
doesn't mean that everythingis going, down the toilet.
It doesn't mean that nothingis working as it should.
There are things that areadvancing, and in fact, there
are positive things that, FDA isdoing from a policy standpoint.
You know, when I was thinkingabout this podcast last
week, I thought we would be.
(19:59):
talking about remarks thatTidmarsh made at a patient
meeting last Tuesday.
all that seems moot now,but it really isn't.
So at that meeting, he saidthat CDER was undertaking a
review of endpoints used tosupport accelerated approval
of cancer drugs, that overallsurvival should be the basis
for confirmatory trials, andthat companies should resist
pressure from clinicians andpatients to allow crossover
(20:21):
from standard of care toinvestigational therapies
and confirmatory trials.
There was a furiousresponse from cancer patient
advocates and clinicians tothat, to those statements.
obviously with Tidmarsh, out thedoor, those issues are probably
at least pushed into thefuture, if not, out the door.
But Tidmarsh also outlinedsteps that FDA's taking to
(20:42):
speed first in human trialsto reduce delays in improving
and advancing clinical trials.
and other things that arereally, top priorities
of, of industry.
So yeah, it's kindof a, a mixed bag.
you mentioned about, um,due diligence, in recruiting
Tidmarsh for the job.
And it's interesting becauseat that same meeting, he told
a story, John Crowley, who wasmoderating the, fireside chat.
(21:04):
he asked Tidmarsh, he said,you know, basically, how was it
that you, that you got the job?
And what Tidmarsh said wasthat he got to know Jay
Bhattacharya, who's the NIHdirector, back when they
were both at, um, Stanford.
And they were both engaged in atremendous amount of controversy
involving, COVID policies.
after the, election.
(21:24):
what Tidmarsh said is that,he had, dinner with, Jay
Bhattacharya with Makary thatJay Bhattacharya was staying,
at Makary's house, that they're,close friends and, that he
basically offered to help.
Makary, help him out atFDA, that McCarry started
calling him on the phoneand asking him for advice.
And then after one of thosecalls Tidmarsh's wife turned
(21:46):
to him and said, really, youknow, Makary needs help, you
should offer to help him,Tidmarsh said, oh yeah, okay.
he called up, uh, Makaryand said, you know, is
there any way I could help?
And Makary said, yeah, actually,I need somebody to run CDER.
six weeks later,he was at a job.
He was the, director of CDER.
none of that really sounds likethere was a tremendous amount of
diligence as, as you mentioned.
Jeff Cranmer (22:06):
he, said that on stage.
Steve Usdin (22:08):
Yeah, yeah.
He described allof this on stage.
Jeff Cranmer (22:10):
Wow.
Okay.
FDA, well, Simone said, Reallyglad to hear, that there's
still some people working hardin the trenches to keep, drug
developers in the U.S. andelsewhere in the world on track.
But, it's a littledisheartening, frankly, to hear
what you just said there, Steve.
uniQure came up at, sortof the beginning of this,
(22:33):
what's going on there?
Steve Usdin (22:34):
We don't know exactly what's going on there,
but this is an example of thekind of turmoil that's happening
at FDA and in particular atCBER under, Vinay Prasad So
uniQure was aligned with FDA ona submission for a gene therapy
for a Huntington's disease.
and um, actually they wereeven talking, as recently
(22:54):
as last month about theirplans for commercialization
of this product.
And it comes out today, now,and we find out that actually,
FDA has completely reversed itsposition that it had before.
They're not, on boardwith uniQure's submission.
and that apparently the, themain problem was that they'd
used, a natural historystudy as their, external
(23:16):
control for the trial.
And CBER is no longerwilling to accept that as
the control for the trial.
This is really problematic.
It's really problematic,especially for
Huntington's patients.
Look, this is auniformly fatal disease.
it affects I think, about 6,000Americans a year, and this
(23:36):
was the first thing that'scome along that actually
could help patients withHuntington's live longer.
It was the firsthope that they had.
and apparently FDA is pullingthe rug out from under them
if they actually require aplacebo controlled trial.
First, what, Huntington'spatient would agree
(23:56):
to be in that trial?
and second.
It's probably gonna takethree years to complete it.
it's not clear whether itactually could be done at, all.
but the ethical and thecommercial implications of that
are really, very troubling.
And it also sends a messageto other companies that
are developing trialsfor rare progressive
(24:17):
diseases that are based onnatural history studies.
that's been kind of anassumption, and FDA's
explicitly agreed in many casesthat they would, allow that.
and now apparently they'rer eversing position on it.
It's not clear if it'sjust for Huntington's or is
that gonna be read through,to other conditions, but
it's a major uncertainty.
Jeff Cranmer (24:39):
it's remarkable and I, I haven't looked at.
stocks for similar rare diseasecompanies who are late stage.
But I can tell youuniQure is down 42% today.
They're now, under $2billion in market cap.
This is a, substantialcompany that's been on the
forefront of developingdrugs for rare diseases.
(25:02):
they know what they'redoing and, what a setback.
It's just remarkable.
Alright.
It's enough enough doomand gloom for today.
Let's, uh.
Let's turn to a partof the world where
things are happening.
Hong Kong, the Hong KongStock Exchange, has been
receiving most new listingsquite warmly, five offerings
(25:24):
have at least doubled in valueduring the first trading day.
And last week, four moreBiopharmas entered the
Hong Kong queue, for eitheran IPO or a dual listing,
BrightGene, NovaBridge, Alebundand let's see, uh, Lupeng,
(25:45):
and then turning stateside,MapLight Therapeutics met
its goal to go public.
It, priced its IPO earlylast week raising nearly $300
million, in a public offeringand concurrent private placement
with Goldman Sachs, Thecompany, uh, briefly traded
(26:05):
above $20, gave back its gains.
to finish a little bit belowits $17 public offering price.
you can check out all thelatest on public financings
in our weekly finance report.
crafted by our, sometime podcastcontributor Paul Bonanos, along
(26:27):
with the newest BioCentury'sLindsay Martin, well, I,
I think that's, uh, wherewe'll leave things this week.
Steve is going tocontinue monitoring
what's happening at FDA.
And Stephen, will stay ontop of the Metsera deal
and we'll keep bringing itto you at BioCentury.com.
(26:48):
If you like what you'rehearing, like us, subscribe
to us, ask us a question.
we appreciate youlistening to us.
that's it for this week'sBioCentury's This Week podcast.
We are grateful to KendallSquare Orchestra for providing
the music for our podcasts.
And don't forget if you're inBoston, on Thursday night.
(27:11):
Josh Berlin and Editorin Chief Simone.
we'll be bringing theBioCentury's this week
podcast to you at theVenture Café Cambridge, it.
Is free to register.
You can go toventurecafecambridge.org
or you can send me a, uh,message on LinkedIn or
(27:32):
at jeff@BioCentury.comor, hit Josh up.
We will catch you, next week.
Thanks for tuning in.
Eric Pierce (27:41):
BioCentury would like to thank Voyager
Therapeutics for supporting theBioCentury This Week podcast.
To learn more aboutVoyager's programs advancing
transformative medicines forneurological diseases, visit
voyagertherapeutics.com.
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