Ep. 331 - Metsera M&A Melee & Tidmarsh Ouster

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<v Eric Pierce>BioCentury This Week is brought to you by Voyager Therapeutics.

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<v Jeff Cranmer>5 weeks after it appeared that Pfizer was getting back into the obesity game via its proposed acquisition of Metsera for more than $7 billion.

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<v Jeff Cranmer>Those ambitions could be curtailed by an unsolicited bid from Novo Nordisk, which is offering 8.5 billion to acquire.

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<v Jeff Cranmer>The obesity startup.

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<v Jeff Cranmer>We will discuss the latest M&A intrigue on this week's BioCentury this week podcast and intrigue at FDA as well, Tidmarsh is out.

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<v Jeff Cranmer>We'll also touch on the latest from the Hong Kong Stock Exchange.

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<v Jeff Cranmer>I'm Jeff Cranmer, executive editor.

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<v Jeff Cranmer>Here at BioCentury's and joining me today are my colleagues, editor-in-Chief, Simone Fishburne, Washington, editor Steve Usdin, and our man in the U.K. Stephen Hansen.

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<v Jeff Cranmer>Stephen, you've been following the obesity space for some time now.

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<v Jeff Cranmer>Metsera, Pfizer, Novo.

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<v Jeff Cranmer>What do you make of what's going on?

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<v Stephen Hansen>Yeah.

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<v Stephen Hansen>Thanks Jeff.

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<v Stephen Hansen>yeah, we've got, uh, we've got a little bit of drama now.

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<v Stephen Hansen>you know, as you said,  back September 22nd, Pfizer had announced that it was acquiring Metsera for about, call it 4.9 billion upfront.

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<v Stephen Hansen>And then there was a 22 and a half dollars per share, CVR attached to that, which brought it to about 7.3 to 7.4 billion.

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<v Stephen Hansen>five weeks later, as you say, Novo comes public with an unsolicited offer.

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<v Stephen Hansen>And as, kind of turned out, They were one of the parties that had been, negotiating with Metsera for quite some time, uh, basically back since the start of the year.

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<v Stephen Hansen>and had kind of been one of the final two bidders for Metsera.

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<v Stephen Hansen>so they've come public now, upped the ante.

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<v Stephen Hansen>And you know, we were talking about this on Friday.

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<v Stephen Hansen>You know, there were kind of three directions that this could go.

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<v Stephen Hansen>Either Pfizer could step up and increase their bid.

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<v Stephen Hansen>They could let Novo win, you know, and walk away with it.

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<v Stephen Hansen>Or Pfizer could go the litigator route and basically sue Metsera for breach of contract.

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<v Stephen Hansen>And as we kind of learned out over the weekend and today, it looks like Pfizer's chosen door number three.

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<v Stephen Hansen>so they filed the one suit on Friday, which was for breach of contract against Metsera, and then they filed a second suit today, which was a federal antitrust claim.

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<v Stephen Hansen>Against Metsera, their shareholders, and Novo, basically claiming that Novo was, illegally looking to acquire the company to suppress competition, destroy a, you know, startup, these sorts of things.

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<v Stephen Hansen>Metsera, I believe

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<v Jeff Cranmer>That was really remarkable, Stephen, the way that press release was written, wasn't it?

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<v Simone Fishburn>yeah.

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<v Simone Fishburn>let's just get into it a little bit, Stephen, because, there's so many threads here to separate out.

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<v Simone Fishburn>First of all, Metsera sort of even engaged in this by defining the Novo bid as a quote unquote superior company proposal.

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<v Simone Fishburn>And that was a sort of clause, let's say, in the agreement with Pfizer.

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<v Simone Fishburn>Now, Pfizer is questioning that, that questioning whether this qualifies, I think

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<v Stephen Hansen>Right.

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<v Stephen Hansen>They're

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<v Simone Fishburn>superior company pro, and that's the claim for the breach of

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<v Stephen Hansen>exactly.

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<v Stephen Hansen>They're claiming that Novo Nordisk's bid, which is about a billion dollars more than Pfizer's bid, does not constitute a superior company proposal, largely on the grounds that there is a high amount of regulatory risk in getting that deal completed.

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<v Stephen Hansen>They're contending that they already essentially have the early termination granted by the FTC for the antitrust, waiting period, and that they basically have a, clear route through to getting the deal done.

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<v Stephen Hansen>And so they're basically saying it's not a superior bid despite the billion dollar difference in the financials involved here.

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<v Simone Fishburn>Okay, so hang, hang on one sec. I'm not.

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<v Simone Fishburn>You know, as I said, I just play a lawyer on tv, I'm not arguing whether there's merit or not in their cases.

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<v Simone Fishburn>I'm just saying that we do know that in this, dance beforehand where there were many parties, but you know,  Novo was party number one or whatever they called.

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<v Simone Fishburn>there was a perception by Metsera, or Metsera's board of regulatory risk, so it's not completely out of the blue..

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<v Stephen Hansen>That is.

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<v Stephen Hansen>And so that's part, that's part of the, sort of the palace intrigue here, is the fact that in the runup privately, when they were having these negotiations, 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 from a, you know, fiduciary, you know, financial perspective.

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<v Stephen Hansen>It was believed to be the better offer overall because there was a clearer site to being able to get the deal done.

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<v Stephen Hansen>now the, the other bit of intrigue in this is the structure of the proposal from Novo.

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<v Stephen Hansen>So what they are proposing is, six and a half billion equity value upfront.

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<v Stephen Hansen>So $56 and 50 cents per share.

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<v Stephen Hansen>And that is gonna be structured in such a way that they would effectively be buying 50% of, the outstanding equity stake in Metsera, via the issuance of new preferred non-voting shares.

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<v Stephen Hansen>And then that upfront payment would immediately be paid and then paid out to shareholders as a dividend.

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<v Stephen Hansen>Prior to any regulatory review, any of that stuff.

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<v Stephen Hansen>So effectively shareholders would be getting all of that upfront money straight away.

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<v Stephen Hansen>that also basically means that Novo is effectively taking a massive termination, fee risk here, because effectively all that money is then out the door before there's any regulatory review.

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<v Stephen Hansen>So, if they were to go with the Novo deal.

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<v Stephen Hansen>Under this structure that they've proposed.

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<v Stephen Hansen>it's a big financial risk for Novo.

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<v Simone Fishburn>Well, let's come back to that in a minute because I, I just wanna cover there's so much landscape to cover before we analyze, Who, who's got more risk, whatever.

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<v Simone Fishburn>there's also a Big America first part of the Pfizer response, right?

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<v Simone Fishburn>Steve, I don't know if you wanna weigh in.

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<v Simone Fishburn>You've used the word perfidious Danes, and I wanna see if I can get you to use it on the podcast.

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<v Steve Usdin>Yes.

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<v Steve Usdin>So I haven't, yes, I have been saying that, Pfizer's gonna be claiming that the perfidious Danes are, trying to beat out an American company.

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<v Steve Usdin>Look, the fact that, um, Albert Bourla, stood, arm in arm with Donald Trump in the White House.

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<v Steve Usdin>and was the first company to announce the most favored nation, agreement, with the White House, you know, isn't lost on anybody in Washington.

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<v Steve Usdin>And I think that they are going to basically try, you know, to try to leverage that, to their advantage, with the administration, with the courts and, um, with the, with the court of public opinion.

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<v Steve Usdin>You're

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<v Stephen Hansen>right.

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<v Stephen Hansen>I mean, and that was quite clear in their, in the statement that they put out, in response to the publication of Novo's, um, unsolicited proposal.

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<v Stephen Hansen>and then that language sort of continued even in, in their press releases about the litigation being filed.

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<v Stephen Hansen>I mean, you know, they reference.

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<v Stephen Hansen>Novo Taking an anti-competitive action to protect its dominant market position and to kill a nascent American competitor, before it gained the support of Pfizer, one of America's leading

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<v Simone Fishburn>wait.

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<v Simone Fishburn>wait.

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<v Simone Fishburn>Pfizer's not na.

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<v Simone Fishburn>So I hope they're not saying Pfizer's nascent.

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<v Stephen Hansen>No, it's Pfizer's not nascent, but you know, the, the multi-billion dollar Metsera is nascent in this

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<v Simone Fishburn>So, so Stephen, here's how I've been thinking about it.

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<v Simone Fishburn>And tell me, I may be way off, but tell me what you think.

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<v Simone Fishburn>So for me, I feel like.

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<v Simone Fishburn>You know, Novo has had a lot of trouble recently.

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<v Simone Fishburn>It's now got a new CEO, who's coming in, let's say Guns are blazing.

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<v Simone Fishburn>Like let's try whatever we can.

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<v Simone Fishburn>If it doesn't pan out, I don't know that Novo walks away looking.

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<v Simone Fishburn>Particularly bad they tried something.

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<v Simone Fishburn>'cause it feels like Pfizer, if they got outbid on this and, and Nova won  and in, in light of the fact also that this is, what did you call it?

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<v Simone Fishburn>Jeff, there, I, I forget what number attempt you said for them to get back into the obesity race,

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<v Stephen Hansen>I think it's their third.

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<v Simone Fishburn>It the third attempt to do that.

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<v Simone Fishburn>So, I don't know.

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<v Simone Fishburn>It feels like Pfizer, could take some sort of ego bruising over this if they lost out.

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<v Stephen Hansen>Yeah.

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<v Stephen Hansen>No, I, I think that's right.

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<v Stephen Hansen>I mean, so from the Novo Nordisk perspective.

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<v Stephen Hansen>I think in some ways, to me this reads as if it shows their maybe lack of confidence in the commercial potential of CagriSema.

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<v Stephen Hansen>I mean, there's some issues around, so it's, it's got, has some formulation issues.

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<v Stephen Hansen>You know, obviously it didn't show the efficacy that investors were wanting.

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<v Stephen Hansen>I think there's some question around how much that can challenge, you know, is Zepbound in Lilly with CagriSema.

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<v Stephen Hansen>The follow on to that is amycretin, but that's basically at the same position that the Metsera programs are at.

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<v Stephen Hansen>I mean, it's just starting Phase III now.

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<v Stephen Hansen>So, I think this is an attempt by them to sort of try and broaden out their more near term competitive, portfolio in obesity.

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<v Stephen Hansen>but you're right, I don't think they have a lot to lose on it other than money at this point.

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<v Stephen Hansen>how I see this happening.

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<v Stephen Hansen>I mean, this is, I think this is Metsera is effectively trying to play, you know, they're trying to play them off each other.

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<v Stephen Hansen>They're basically trying to get Pfizer to pay an extra billion dollars, up the ante.

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<v Stephen Hansen>and Pfizer has basically said, no, we're not gonna up the ante.

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<v Stephen Hansen>We're gonna sue you.

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<v Stephen Hansen>And that's effectively what Metsera said in their response is it basically said.

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<v Stephen Hansen>that Pfizer's trying to litigate their way into paying not the fair price for Metsera.

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<v Simone Fishburn>Pfizer's saying we'd rather pay the lawyers than you, is what I'm understanding from you.

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<v Jeff Cranmer>yeah.

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<v Jeff Cranmer>Pfizer's, Pfizer's basically trying to play the uh, Marcellus card and say there's something rotten in the state of Denmark.

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<v Jeff Cranmer>But, but Stephen, uh, you know, met,

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<v Simone Fishburn>to go there.

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<v Simone Fishburn>You had to go there.

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<v Simone Fishburn>Yeah.

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<v Jeff Cranmer>you know, warming up the Shakespeare is always, good, uh, especially when you have a high school student getting ready to start reading his first Shakespeare.

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<v Jeff Cranmer>but Stephen, I, I think you're underselling Metsera's press release because.

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<v Jeff Cranmer>Pfizer's press release was, uh, if you haven't read it,  dear listener, I urge you to read it.

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<v Jeff Cranmer>It, it's really, quite different than other press releases that Pfizer's Crack team of communications people  puts out.

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<v Jeff Cranmer>But Metsera's was pretty good too.

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<v Jeff Cranmer>You know, they said, uh.

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<v Jeff Cranmer>Pfizer is trying to litigate its way into buying Metsera for a lower price, and then they said, Pfizer's litigation arguments are nonsense.

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<v Jeff Cranmer>Steven, final word before we, move on to some other

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<v Stephen Hansen>I mean, the other thing that struck me about this when we were talking about the potential ways this could go is when we were talking about the what ifs of the, the litigation route is.

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<v Stephen Hansen>The thing that just didn't make sense to me is You know, these are assets that Pfizer really needs, and one of the most attractive, aspects about them is the fact that they're heading into Phase III.

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<v Stephen Hansen>They're trying to play catch up, and so they really need these assets to be developed as quickly and as optimally as possible.

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<v Stephen Hansen>And I just  question whether tying Metsera's team up in litigation is the best way to put these assets to, for, I mean, these are the assets that they want to buy, and are you then potentially handicapping or you know, inhibiting their ability to optimize that development path?

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<v Stephen Hansen>kind of feels like you're.

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<v Stephen Hansen>Maybe shooting yourself in the foot if your Pfizer here by taking the litigation route, rather than just spending an extra billion dollars to, you know, to equal up the bid.

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<v Stephen Hansen>But

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<v Jeff Cranmer>Yeah.

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<v Jeff Cranmer>What's, what's a billion dollars here?

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<v Stephen Hansen>what's a billion dollars between?

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<v Stephen Hansen>Between friends, right?

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<v Simone Fishburn>well they spent more than that on, a lot more than that on Seagen and various other things.

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<v Simone Fishburn>So we could talk about that and we probably will do again,

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<v Jeff Cranmer>I, I say, you know, JPMs around the corner, let's just, set up that ice rink in, Union Square as like a steel cage match rla and, who's the new CEO of, of Novo?

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<v Stephen Hansen>Mike Doustdar

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<v Jeff Cranmer>Steven, they can.

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<v Jeff Cranmer>They, they can just, you know, let's, get real.

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<v Jeff Cranmer>Let's let them just, duke it out in Union Square

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<v Stephen Hansen>in an ice rink?

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<v Stephen Hansen>Do you to a figure skating match or what are you, what are you yeah.

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<v Stephen Hansen>Well, yeah.

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<v Stephen Hansen>That would actually be, that would actually be better.

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<v Stephen Hansen>That would sort be like, uh, zoo, well, Zoolander, right?

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<v Stephen Hansen>Or what, what's that guy?

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<v Simone Fishburn>I, I'd be a judge.

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<v Simone Fishburn>I'd sit there putting up my, you know, 6.0.

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<v Simone Fishburn>Anyway, let's move on.

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<v Jeff Cranmer>Alright.

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<v Jeff Cranmer>All right, well, we're gonna take a quick break Stephen, thanks for joining us.

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<v Jeff Cranmer>I know it's,  your day off, but, uh, y you, you couldn't resist joining us.

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<v Jeff Cranmer>So, uh, have a lovely evening, sir, and I'll take a quick break and we will come back to, FDA, what can I say?

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<v Jeff Cranmer>Okay, Steve, you've had a busy weekend once again.

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<v Jeff Cranmer>tell us what's going on at FDA.

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<v Steve Usdin>Oh, I wish I knew.

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<v Steve Usdin>Okay.

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<v Steve Usdin>There's a lot of things going on at FDA.

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<v Steve Usdin>Here's a few of them.

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<v Steve Usdin>So George Tid the director of CDER, was put on administrative leave Sunday.

00:15:41.840 --> 00:15:47.278
<v Steve Usdin>They're conflicting reports about whether he's resigned, but one thing's completely clear, he's not gonna do a Prasad.

00:15:47.446 --> 00:15:48.947
<v Steve Usdin>He's not returning to FDA.

00:15:48.947 --> 00:15:50.316
<v Steve Usdin>He has burned his bridges.

00:15:50.682 --> 00:16:06.966
<v Steve Usdin>He said in media interviews that he was pushed out because he objected to the way FDA Commissioner Makary was trying to approve drugs under the commissioner's National Priority Voucher program, without due process and diligence that are typical in FDA reviews and, subject to political interference.

00:16:07.131 --> 00:16:17.676
<v Steve Usdin>But his ouster came as the HHS Inspector General was investigating allegations of ethics violations and Aurinia Pharmaceuticals filed a lawsuit against Tidmarsh.

00:16:17.743 --> 00:16:20.546
<v Steve Usdin>Personally, I think two things can be true.

00:16:20.846 --> 00:16:24.249
<v Steve Usdin>Tidmarsh could have expressed reservations about the approvals process.

00:16:24.917 --> 00:16:48.273
<v Steve Usdin>And the administration could be taking the concerns Aurinia raised very seriously and they are serious allegations that he use his official position to pursue a vendetta against Kevin Tang, Aurinia's Chairman, and that he initiated regulatory action against another company affiliated with Tang that makes API for desiccated thyroid products, and then tried to extort a bribe to make it go away.

00:16:48.807 --> 00:16:51.876
<v Steve Usdin>The truth of the allegations is gonna be decided by the courts.

00:16:52.543 --> 00:16:56.815
<v Steve Usdin>It's certain that Tidmarsh posted comments on LinkedIn and then deleted them.

00:16:57.015 --> 00:16:59.585
<v Steve Usdin>They were aimed at Aurinia when he deleted them.

00:16:59.817 --> 00:17:03.822
<v Steve Usdin>He wrote that they were his personal views and not FDA's or HHS'.

00:17:04.088 --> 00:17:10.561
<v Steve Usdin>I wrote a commentary in September when this happened, saying he should be fired, and that was before all these other allegations surfaced.

00:17:10.796 --> 00:17:18.569
<v Steve Usdin>Adding to the turmoil FDA staff report that Vinay Prasad, director of CBER and FDA's, Chief Medical and Scientific Officer.

00:17:19.137 --> 00:17:21.105
<v Steve Usdin>Has created a toxic work environment.

00:17:21.240 --> 00:17:25.877
<v Steve Usdin>Some of his top staff have asked for transfers to CDER, but Prasad has blocked them.

00:17:26.045 --> 00:17:35.186
<v Steve Usdin>FDA staff have told me that Prasad is rarely in Washington, that he calls on the cell phone and intimidates junior staff cutting out their supervisors.

00:17:35.487 --> 00:17:41.692
<v Steve Usdin>he claimed in a webcast recently that OCE Director, Richard Pazdur was responsible for a controversial.

00:17:41.926 --> 00:17:48.800
<v Steve Usdin>Complete response letter, that was issued to Replimune, but in fact, it was Prasad that signed, all the documentation.

00:17:48.800 --> 00:17:52.471
<v Steve Usdin>It was Prasad's call to issue, that complete response letter.

00:17:52.538 --> 00:17:55.406
<v Steve Usdin>And that's created a lot of, ill will around, FDA.

00:17:56.208 --> 00:17:58.576
<v Simone Fishburn>Steve, I just wanna make a couple of points here.

00:17:58.710 --> 00:18:22.334
<v Simone Fishburn>first of all, I think it's very clear that this huge amount of instability at FDA is really just not good generally, I think that you've pointed out that Tidmarsh made some, Statements or claims that actually have merit, um, regarding questions about the commissioner's, voucher program at the same time, there's really a lot of questionable activity allegedly, right?

00:18:22.334 --> 00:18:27.372
<v Simone Fishburn>If you, believe that all the things that have come out in the Wall Street Journal and so on, uh, are correct.

00:18:27.806 --> 00:18:33.444
<v Simone Fishburn>and to me it really, to be honest, seems like there's just very little due diligence going on behind these appointments.

00:18:34.278 --> 00:18:40.219
<v Simone Fishburn>so I think that that ongoing instability is not great for the agency and, and therefore for drug developers.

00:18:40.952 --> 00:18:47.593
<v Simone Fishburn>I do wanna make one more point though, because I think this gets lost in a lot of these really big headlines, which are very alarming.

00:18:47.593 --> 00:18:49.728
<v Simone Fishburn>And I was speaking to A CEO over the weekend.

00:18:50.162 --> 00:18:56.468
<v Simone Fishburn>There are a lot of really good people at FDA still working really hard, and these are the levels below.

00:18:56.468 --> 00:19:04.809
<v Simone Fishburn>And a lot of companies are actually having engagements with the career people at FDA who have to navigate through all of this.

00:19:05.109 --> 00:19:07.412
<v Simone Fishburn>And so there's sort of a sense that.

00:19:07.712 --> 00:19:10.982
<v Simone Fishburn>They're kind of maybe getting lost in the narrative somewhere.

00:19:11.016 --> 00:19:16.054
<v Simone Fishburn>Those people who are staying at FDA, doing their best and just trying to get drug development moving along.

00:19:16.387 --> 00:19:18.457
<v Simone Fishburn>And for many companies it is moving along.

00:19:18.723 --> 00:19:23.929
<v Simone Fishburn>And then for others, we know, we've seen the uniQure data, information today, which you might elaborate on.

00:19:24.328 --> 00:19:32.171
<v Simone Fishburn>There's a lot of uncertainty and a lot of other companies, for example, in cell and gene therapies and their investors just don't know.

00:19:32.403 --> 00:19:38.076
<v Simone Fishburn>How to think about the stability, the predictability of the things that FDA is saying.

00:19:38.442 --> 00:19:39.144
<v Simone Fishburn>What do you think Steve?

00:19:39.545 --> 00:19:47.419
<v Steve Usdin>So, yeah, of course the fact that there's a great deal of instability, that there's turmoil at FDA doesn't mean that everything is going, down the toilet.

00:19:47.419 --> 00:19:49.988
<v Steve Usdin>It doesn't mean that nothing is working as it should.

00:19:49.988 --> 00:19:56.194
<v Steve Usdin>There are things that are advancing, and in fact, there are positive things that, FDA is doing from a policy standpoint.

00:19:56.627 --> 00:19:59.364
<v Steve Usdin>You know, when I was thinking about this podcast last week, I thought we would be.

00:19:59.865 --> 00:20:03.501
<v Steve Usdin>talking about remarks that Tidmarsh made at a patient meeting last Tuesday.

00:20:03.669 --> 00:20:06.337
<v Steve Usdin>all that seems moot now, but it really isn't.

00:20:06.605 --> 00:20:25.089
<v Steve Usdin>So at that meeting, he said that CDER was undertaking a review of endpoints used to support accelerated approval of cancer drugs, that overall survival should be the basis for confirmatory trials, and that companies should resist pressure from clinicians and patients to allow crossover from standard of care to investigational therapies and confirmatory trials.

00:20:25.958 --> 00:20:31.395
<v Steve Usdin>There was a furious response from cancer patient advocates and clinicians to that, to those statements.

00:20:31.630 --> 00:20:39.171
<v Steve Usdin>obviously with Tidmarsh, out the door, those issues are probably at least pushed into the future, if not, out the door.

00:20:39.671 --> 00:20:47.179
<v Steve Usdin>But Tidmarsh also outlined steps that FDA's taking to speed first in human trials to reduce delays in improving and advancing clinical trials.

00:20:47.712 --> 00:20:50.715
<v Steve Usdin>and other things that are really, top priorities of, of industry.

00:20:50.715 --> 00:20:53.518
<v Steve Usdin>So yeah, it's kind of a, a mixed bag.

00:20:53.884 --> 00:20:57.689
<v Steve Usdin>you mentioned about, um, due diligence, in recruiting Tidmarsh for the job.

00:20:57.689 --> 00:21:04.328
<v Steve Usdin>And it's interesting because at that same meeting, he told a story,  John Crowley, who was moderating the, fireside chat.

00:21:04.462 --> 00:21:09.134
<v Steve Usdin>he asked Tidmarsh, he said, you know, basically, how was it that you, that you got the job?

00:21:09.401 --> 00:21:17.608
<v Steve Usdin>And what Tidmarsh said was that he got to know Jay Bhattacharya, who's the NIH director, back when they were both at, um, Stanford.

00:21:17.608 --> 00:21:22.213
<v Steve Usdin>And they were both engaged in a tremendous amount of controversy involving, COVID policies.

00:21:22.446 --> 00:21:24.148
<v Steve Usdin>after the, election.

00:21:24.482 --> 00:21:36.228
<v Steve Usdin>what Tidmarsh said is that, he had,  dinner with, Jay Bhattacharya with Makary that Jay Bhattacharya was staying, at Makary's house, that they're, close friends and, that he basically offered to help.

00:21:36.228 --> 00:21:43.535
<v Steve Usdin>Makary,  help him out at FDA, that McCarry started calling him on the phone and asking him for advice.

00:21:43.535 --> 00:21:52.076
<v Steve Usdin>And then after one of those calls Tidmarsh's wife turned to him and said, really, you know, Makary needs help, you should offer to help him, Tidmarsh said, oh yeah, okay.

00:21:52.144 --> 00:21:54.945
<v Steve Usdin>he called up, uh, Makary and said, you know, is there any way I could help?

00:21:54.945 --> 00:21:57.715
<v Steve Usdin>And Makary said, yeah, actually, I need somebody to run CDER.

00:21:57.883 --> 00:21:59.851
<v Steve Usdin>six weeks later, he was at a job.

00:21:59.851 --> 00:22:01.987
<v Steve Usdin>He was the, director of CDER.

00:22:02.186 --> 00:22:06.525
<v Steve Usdin>none of that really sounds like there was a tremendous amount of diligence as, as you mentioned.

00:22:06.825 --> 00:22:08.460
<v Jeff Cranmer>he, said that on stage.

00:22:08.559 --> 00:22:08.859
<v Steve Usdin>Yeah, yeah.

00:22:08.859 --> 00:22:10.461
<v Steve Usdin>He described all of this on stage.

00:22:10.729 --> 00:22:11.028
<v Jeff Cranmer>Wow.

00:22:11.195 --> 00:22:11.630
<v Jeff Cranmer>Okay.

00:22:11.896 --> 00:22:24.576
<v Jeff Cranmer>FDA, well, Simone said, Really glad to hear, that there's still some people working hard in the trenches to keep, drug developers in the U.S. and elsewhere in the world on track.

00:22:24.576 --> 00:22:29.948
<v Jeff Cranmer>But, it's a little disheartening, frankly, to hear what you just said there, Steve.

00:22:30.015 --> 00:22:33.684
<v Jeff Cranmer>uniQure came up at, sort of the beginning of this, what's going on there?

00:22:34.519 --> 00:22:50.836
<v Steve Usdin>We don't know exactly what's going on there, but this is an example of the kind of turmoil that's happening at FDA and in particular at CBER under, Vinay Prasad So uniQure was aligned with FDA on a submission for a gene therapy for a Huntington's disease.

00:22:51.202 --> 00:22:59.076
<v Steve Usdin>and um, actually they were even talking, as recently as last month about their plans for commercialization of this product.

00:22:59.377 --> 00:23:06.351
<v Steve Usdin>And it comes out today, now, and we find out that actually, FDA has completely reversed its position that it had before.

00:23:06.518 --> 00:23:10.221
<v Steve Usdin>They're not, on board with uniQure's submission.

00:23:10.555 --> 00:23:17.863
<v Steve Usdin>and that apparently the, the main problem was that they'd used, a natural history study as their, external control for the trial.

00:23:18.096 --> 00:23:22.800
<v Steve Usdin>And CBER is no longer willing to accept that as the control for the trial.

00:23:23.034 --> 00:23:24.068
<v Steve Usdin>This is really problematic.

00:23:24.068 --> 00:23:27.638
<v Steve Usdin>It's really problematic, especially for Huntington's patients.

00:23:27.638 --> 00:23:32.210
<v Steve Usdin>Look, this is a uniformly fatal disease.

00:23:32.443 --> 00:23:43.922
<v Steve Usdin>it affects I think, about 6,000 Americans a year, and this was the first thing that's come along that actually could help patients with Huntington's live longer.

00:23:43.922 --> 00:23:46.258
<v Steve Usdin>It was the first hope that they had.

00:23:46.424 --> 00:23:53.964
<v Steve Usdin>and apparently FDA is pulling the rug out from under them if they actually require a placebo controlled trial.

00:23:54.231 --> 00:23:57.701
<v Steve Usdin>First, what, Huntington's patient would agree to be in that trial?

00:23:58.303 --> 00:23:58.903
<v Steve Usdin>and second.

00:23:59.237 --> 00:24:02.374
<v Steve Usdin>It's probably gonna take three years to complete it.

00:24:02.707 --> 00:24:05.644
<v Steve Usdin>it's not clear whether it actually could be done at, all.

00:24:05.810 --> 00:24:11.383
<v Steve Usdin>but the ethical and the commercial implications of that are really, very troubling.

00:24:11.883 --> 00:24:20.692
<v Steve Usdin>And it also sends a message to other companies that are developing trials for rare progressive diseases that are based on natural history studies.

00:24:20.925 --> 00:24:27.499
<v Steve Usdin>that's been kind of an assumption,  and FDA's explicitly agreed in many cases that they would, allow that.

00:24:27.598 --> 00:24:30.902
<v Steve Usdin>and now apparently they're r eversing position on it.

00:24:31.001 --> 00:24:38.676
<v Steve Usdin>It's not clear if it's just for Huntington's or is that gonna be read through, to other conditions, but it's a major uncertainty.

00:24:39.144 --> 00:24:41.546
<v Jeff Cranmer>it's remarkable and I, I haven't looked at.

00:24:42.113 --> 00:24:47.318
<v Jeff Cranmer>stocks for similar rare disease companies who are late stage.

00:24:47.318 --> 00:24:52.390
<v Jeff Cranmer>But I can tell you uniQure is down 42% today.

00:24:52.557 --> 00:24:55.826
<v Jeff Cranmer>They're now, under $2 billion in market cap.

00:24:55.826 --> 00:25:02.133
<v Jeff Cranmer>This is a, substantial company that's been on the forefront of developing drugs for rare diseases.

00:25:02.366 --> 00:25:06.003
<v Jeff Cranmer>they know what they're doing and, what a setback.

00:25:06.003 --> 00:25:07.471
<v Jeff Cranmer>It's just remarkable.

00:25:07.905 --> 00:25:08.405
<v Jeff Cranmer>Alright.

00:25:08.405 --> 00:25:11.276
<v Jeff Cranmer>It's enough enough doom and gloom for today.

00:25:11.276 --> 00:25:12.042
<v Jeff Cranmer>Let's, uh.

00:25:12.376 --> 00:25:15.247
<v Jeff Cranmer>Let's turn to a part of the world where things are happening.

00:25:15.446 --> 00:25:26.892
<v Jeff Cranmer>Hong Kong, the Hong Kong Stock Exchange, has been receiving most new listings quite warmly, five offerings have at least doubled in value during the first trading day.

00:25:27.659 --> 00:25:51.249
<v Jeff Cranmer>And last week, four more Biopharmas entered the Hong Kong queue, for either an IPO or a dual listing, BrightGene, NovaBridge, Alebund and let's see, uh, Lupeng, and then turning stateside, MapLight Therapeutics met its goal to go public.

00:25:51.249 --> 00:26:08.432
<v Jeff Cranmer>It, priced its IPO early last week raising nearly $300 million, in a public offering and concurrent private placement with Goldman Sachs,  The company, uh, briefly traded above $20, gave back its gains.

00:26:08.700 --> 00:26:13.837
<v Jeff Cranmer>to finish a little bit below its $17 public offering price.

00:26:13.971 --> 00:26:22.113
<v Jeff Cranmer>you can check out all the latest on public financings in our weekly finance report.

00:26:22.279 --> 00:26:34.593
<v Jeff Cranmer>crafted by our, sometime podcast contributor Paul Bonanos, along with the newest BioCentury's Lindsay Martin,  well, I, I think that's, uh, where we'll leave things this week.

00:26:34.759 --> 00:26:38.762
<v Jeff Cranmer>Steve is going to continue monitoring what's happening at FDA.

00:26:39.029 --> 00:26:48.073
<v Jeff Cranmer>And Stephen, will stay on top of the Metsera deal and we'll keep bringing it to you at BioCentury.com.

00:26:48.306 --> 00:26:52.978
<v Jeff Cranmer>If you like what you're hearing, like us, subscribe to us, ask us a question.

00:26:53.278 --> 00:26:55.279
<v Jeff Cranmer>we appreciate you listening to us.

00:26:55.614 --> 00:26:58.983
<v Jeff Cranmer>that's it for this week's BioCentury's This Week podcast.

00:26:59.150 --> 00:27:06.657
<v Jeff Cranmer>We are grateful to Kendall Square Orchestra for providing the music for our podcasts.

00:27:07.057 --> 00:27:11.229
<v Jeff Cranmer>And don't forget if you're in Boston,  on Thursday night.

00:27:11.296 --> 00:27:14.732
<v Jeff Cranmer>Josh Berlin and Editor in Chief Simone.

00:27:14.965 --> 00:27:23.642
<v Jeff Cranmer>we'll be bringing the BioCentury's this week podcast to you at  the Venture Café Cambridge, it.

00:27:24.009 --> 00:27:25.977
<v Jeff Cranmer>Is free to register.

00:27:25.977 --> 00:27:36.755
<v Jeff Cranmer>You can go to venturecafecambridge.org or you can send me a, uh, message on LinkedIn or at jeff@BioCentury.com or, hit Josh up.

00:27:36.788 --> 00:27:39.124
<v Jeff Cranmer>We will catch you, next week.

00:27:39.257 --> 00:27:40.057
<v Jeff Cranmer>Thanks for tuning in.

00:27:41.192 --> 00:27:46.530
<v Eric Pierce>BioCentury would like to thank Voyager Therapeutics for supporting the BioCentury This Week podcast.

00:27:46.830 --> 00:27:54.739
<v Eric Pierce>To learn more about Voyager's programs advancing transformative medicines for neurological diseases, visit voyagertherapeutics.com.