Ep. 357 - Deal-O-rama, Gilead and Tallon's U.K. vision

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<v Jeff Cranmer>Deal O Rama the past week has seen a flurry of biotech deals, headline by Merck, proposing to Buy Terns for 6.7 billion for a chronic leukemia therapy, and Gilead proposing to buy Ouro with partner Galapagos.

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<v Jeff Cranmer>The latter deal proposal comes as Gilead is looking to defend its position in HIV while resetting an eye and growing oncology.

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<v Jeff Cranmer>And across the Atlantic new clinical trial regulations are on tap for the U.K. Do they mark the start of a new era for the UK's life science sector.

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<v Jeff Cranmer>We speak with the head of MHRA, Lawrence Tallon to find out.

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<v Jeff Cranmer>I'm Jeff Cranmer and this is the BioCentury This Week podcast.

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<v Jeff Cranmer>Joining me today are my colleagues.

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<v Simone Fishburn>Simone Fishburn, Editor in Chief.

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<v Paul Bonanos>Paul Bonanos, Director of Biopharma Intelligence.

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<v Lauren Martz>And Lauren Martz, Executive Director of Biopharma Intelligence.

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<v Jeff Cranmer>Okay, Paul, you have been doing double duty, you're our daily news editor keeping us in line with everything that's happened in the biotech industry, but you're also our lead deals writer, and you had a bit of a busy week last week.

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<v Jeff Cranmer>Paul where do you wanna start?

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<v Paul Bonanos>Oh, let's see.

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<v Paul Bonanos>Yeah, you're right.

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<v Paul Bonanos>There have been a lot of deals lately.

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<v Paul Bonanos>I did have to write a few deal stories and it's really been kind of all month.

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<v Paul Bonanos>I mean, it's.

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<v Paul Bonanos>It's still March.

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<v Paul Bonanos>We saw Servier by Day One.

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<v Paul Bonanos>This month.

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<v Paul Bonanos>That was early in the month.

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<v Paul Bonanos>Things went relatively quiet for a bit.

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<v Paul Bonanos>Our colleague called it Spring Break.

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<v Paul Bonanos>But then since two Fridays ago, three big transactions, you all talked about Synnovation last week, selling the PI3Kα  program to Novartis.

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<v Paul Bonanos>And since then, as you said, we have Gilead buying a private bispecifics developer called Ouro, on Wednesday for 1.7 billion upfront.

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<v Paul Bonanos>And then Merck taking out the oncology company Terns for 6.7 billion on Thursday.

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<v Paul Bonanos>There were also a couple smaller deals on Friday, and it looks like it's carrying over into this week.

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<v Paul Bonanos>Do you wanna talk about the Merck one first?

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<v Jeff Cranmer>Yeah, let's start there Paul.

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<v Jeff Cranmer>That was certainly the biggest of the week.

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<v Paul Bonanos>Yes, Merck buying Terns, so it's 6.7 billion Terns.

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<v Paul Bonanos>They've been around since 2017.

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<v Paul Bonanos>Went public in 2021, and it's a little bit of a comeback story.

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<v Paul Bonanos>They had been pushing.

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<v Paul Bonanos>Pushing harder in metabolic disease for a while.

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<v Paul Bonanos>they had an oral GLP-1, a couple other metabolic programs, but they pulled the plug on that last year, stopped investing in that area, which made their lead program a program for chronic myelogenous leukemia, CML, called TERN-701.

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<v Paul Bonanos>It's in the same class broadly as Gleevec, which is decades old targeting BCR-ABL.

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<v Paul Bonanos>There some newer ones in that class as well.

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<v Paul Bonanos>Novartis, notably has Scemblix, which unlike Gleevec, works via an allosteric mechanism rather than an active site mechanism.

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<v Paul Bonanos>Scemblix does have some warnings on its label, pancreatic toxicity, some blood pressure changes, food effects, and TERN-701 is designed to avoid all of that.

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<v Paul Bonanos>Ideally, it can drive remissions where patients go off therapy for a while and maybe even have some curative potential.

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<v Paul Bonanos>TERN-701 has some Phase I/II data, looks like a clear efficacy signal with a good safety profile.

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<v Paul Bonanos>And Merck, of course, has been doing M&A to fill the Keytruda gap when it goes off patent in a couple of years since, since about the middle of last year, Merck has bought a COPD company Verona, and an infectious disease play Cidara, it's close to $20 billion for those two.

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<v Paul Bonanos>Terns is 6.7 billion.

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<v Paul Bonanos>And they're adding that into the mix.

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<v Paul Bonanos>Keytruda is a really big thing that's hard to replace.

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<v Paul Bonanos>It's like, uh,  what Michael Lewis wrote in Moneyball, where you can't replace Jason Giambi, you can just replace him in parts.

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<v Paul Bonanos>You can't buy a $32 billion drug.

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<v Paul Bonanos>Right?

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<v Paul Bonanos>this is one of the pieces that will hopefully fill in the gap when they lose patent protection.

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<v Simone Fishburn>do we know how far they are to filling that gap with different pieces?

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<v Paul Bonanos>I haven't totted it up yet, but   obviously they, if they put almost 20 billion out for COPD and infectious disease, they have high hopes for many billions in sales from those at peak.

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<v Paul Bonanos>And it sounds like Terns is a multi-billion dollar drug opportunity too.

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<v Jeff Cranmer>Certainly worth ting up.

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<v Jeff Cranmer>I imagine Merck will continue to hunt for more deals.

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<v Jeff Cranmer>Let's talk about Gilead.

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<v Jeff Cranmer>Lauren had been   digging into a Gilead story, and then all of a sudden  they propose quite an interesting deal leveraging their relationship with Galapagos.

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<v Jeff Cranmer>Paul what,  what's going on here and is this a done deal or is it still coming together?

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<v Paul Bonanos>it's partly done, let's put it that way.

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<v Paul Bonanos>I mean, there, there are a lot of moving parts and one of them is still moving.

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<v Paul Bonanos>That's another way to put it.

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<v Paul Bonanos>Let's start with the Ouro piece, right?

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<v Paul Bonanos>Ouro is what we've been calling a NewCo.

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<v Paul Bonanos>I think our definition is it's innovation from Asia combined with Western VC money to form a global developer of the asset or assets from Asia.

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<v Paul Bonanos>Yes.

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<v Paul Bonanos>A startup company that's going to.

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<v Paul Bonanos>Globalize a, an innovative bit from Asia.

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<v Paul Bonanos>So that's what Ouro was.

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<v Paul Bonanos>It was a program from Keymed Chinese company and it was backed by a syndicate with founding investor Monograph Capital plus TPG Life Sciences, NEA, and Norwest among others.

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<v Paul Bonanos>The program is a T cell engager that targets CD3 and BCMA, and it's in development for some immunological conditions, some anemias, cytopenias, Sjogren's syndrome, bullous pemphigoid.

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<v Paul Bonanos>It's in Phase I/II testing now apparently with some clinical data, but Ouro hasn't said much about that so far.

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<v Paul Bonanos>So Gilead is looking to buy them or has, proposed to buy them for 1.7 billion.

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<v Paul Bonanos>we don't say it's done until it's done, but that deal has been, has been cinched.

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<v Paul Bonanos>And here's where it gets interesting.

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<v Paul Bonanos>So Gilead, as you mentioned, had a deal with the Belgian company Galapagos dating back to 2019.

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<v Paul Bonanos>Gilead paid more than $5 billion in cash and equity for access to Galapagos pipeline.

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<v Paul Bonanos>And so far it has not amounted to very much.

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<v Paul Bonanos>Galapagos has been through a lot.

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<v Paul Bonanos>It doesn't really resemble its former self, it's been through a whole era with Paul s Stoffels, as CEO tried to bring in some cell therapies, tried to separate the cell therapy business from the not cell therapy business that didn't happen.

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<v Paul Bonanos>Stoffels is gone.

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<v Paul Bonanos>New CEO came in last year.

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<v Paul Bonanos>Long story short, Galapagos still has a lot of cash, a very thin pipeline, and the idea has been that it would in-license something of value worth pursuing.

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<v Paul Bonanos>And Gilead still owns, about a quarter of Galapagos has two board seats.

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<v Paul Bonanos>They have some influence over what Galapagos does, and so the solution that Gilead and Galapagos are apparently working out it's not final yet, but both have signaled their intent is to integrate Ouros employees into Galapagos, split some of the development costs of the T cell engager, and then Galapagos would share in the economics if things work out and the T cell engager reaches the market.

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<v Paul Bonanos>Does that all make sense?

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<v Paul Bonanos>I mean, it's a, a naughty little arrangement, right?

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<v Paul Bonanos>But it's a chance for Gilead to put Galapagos Cash to work for a worthwhile program that could set up both companies for a good outcome.

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<v Paul Bonanos>It's obviously very early, but I think Ouro's program has some promise and it's a chance for Galapagos to reshape itself.

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<v Paul Bonanos>They've been on the ropes for a long time and,

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<v Simone Fishburn>It sounds to me, and Lauren, I think you're gonna talk a little bit more about Gilead.

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<v Simone Fishburn>But from where I'm sitting, I mean maybe it's a great deal and I hope so.

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<v Simone Fishburn>But it is a little bit, like you said, there seem to be two companies that are a bit struggling.

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<v Simone Fishburn>Both Galapagos was a high flyer.

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<v Simone Fishburn>I think at some point we talked about it being a bellwether in Europe.

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<v Simone Fishburn>It's certainly not at that kind of trajectory right now.

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<v Simone Fishburn>Maybe this can help it turn around and at the same time.

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<v Simone Fishburn>Lauren, help me out here.

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<v Simone Fishburn>I mean, Gilead, it seems to me that since the heyday of being fantastic in infectious disease, and maybe they're still in fantastic in infectious disease.

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<v Simone Fishburn>They bought Kite.

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<v Simone Fishburn>They've been trying to establish a really solid footprint in cancer, and then INI and their story hasn't yet caught fire in my mind.

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<v Simone Fishburn>Tell me how you're looking at this, because I think you did a bit of a deeper dive on Gilead.

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<v Lauren Martz>I think that's, fair.

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<v Lauren Martz>Except for, I don't think they're necessarily struggling in the infectious disease area from, you

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<v Simone Fishburn>No, I

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<v Lauren Martz>HIV franchise is, is, you know, a leader, leader in that space.

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<v Lauren Martz>But yes.

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<v Simone Fishburn>I just wanna clarify.

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<v Simone Fishburn>Totally agree.

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<v Simone Fishburn>Infectious disease, that that story is very solid.

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<v Lauren Martz>Yeah.

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<v Lauren Martz>The super solid story in HIV that follows on from the HCV success, which is great.

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<v Lauren Martz>I think.

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<v Lauren Martz>it hasn't necessarily been the same story in INI and cancer, although there are a couple really successful cancer programs.

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<v Lauren Martz>That, that Gilead has.

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<v Lauren Martz>But within the INI space a lot of those misses as Paul sort of alluded to date, back to the original Gilead deals.

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<v Lauren Martz>And even before the Galapagos deals, and even before the really broad 2019 Galapagos deal there was a 2015 collaboration that was, I think$750 million deal for Filgotinib.

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<v Lauren Martz>Which did not pan out.

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<v Lauren Martz>And after that, there were several programs through that broader deal that also didn't work out within the INI space.

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<v Lauren Martz>When I spoke with Dietmar Berger, CMO of Gilead a couple of weeks ago he did talk about prioritizing INI building internally.

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<v Lauren Martz>This obviously is going externally as well.

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<v Lauren Martz>But this is the first T cell engager within this INI space for the company that I'm aware of.

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<v Lauren Martz>So it does give them a new modality and a new way to go after the sort of this hot area of B-cell depletion, whether that's through CAR Ts or T cell engagers, or even the more standard MABs.

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<v Lauren Martz>So they are working within the CAR T cell space to try to accomplish something similar with a bicistronic CAR T, um, again, CD19 and CD20.

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<v Lauren Martz>This just gives them another avenue into those kind of B-cell depletion amenable diseases.

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<v . Simone Fishburn>Thanks Lauren.

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<v . Simone Fishburn>So tell us about the rest in INI and then, you know, maybe move to cancer.

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<v . Simone Fishburn>How's that kite deal worked out for them and more?

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<v Lauren Martz>Sure.

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<v Lauren Martz>So within INI something I found interesting in their pipeline is that they have two Phase II programs, for IBD, for ulcerative colitis and Crohn's disease.

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<v Lauren Martz>And these are really innovative new mechanisms there and a and a third in Phase I. So it seems like that's sort of becoming an area of focus, which has been historically a really difficult disease to to treat with some of the other inflammatory disease mechanisms.

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<v Lauren Martz>In 2024, there was also a $4.3 billion acquisition of CymaBay Therapeutics, which gave the company Livdelzi, which is a primary biliary cholangitis therapy, which Dietmar Berger suggested is the anchor for this rebuilding of the INI pipeline at Gilead.

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<v Lauren Martz>And then you also asked about cancer, which is the third pillar that the company has.

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<v Lauren Martz>So he mentioned that as Gilead has done historically looking externally for oncology assets is something that they'll continue to do.

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<v Lauren Martz>So a lot of the M&A that Gilead has done over the past five, 10 years has been cancer focused, and there's definitely been some mixed success there.

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<v Lauren Martz>But the Kite acquisition,  I think we can consider that a success.

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<v Lauren Martz>So, Yescarta came out of that.

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<v Lauren Martz>That's the top selling CAR T cell therapy, it's a, a CD19 CAR T and Gilead's working on a few other CAR Ts.

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<v Lauren Martz>We've seen some in vivo CAR T cell deals that have followed that one.

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<v Lauren Martz>that is sort of one of the anchors of the company's oncology portfolio and pipeline.

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<v Lauren Martz>And then they also have Trodelvy, which came from the Immunomedics deal, which I think is also considered a success.

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<v Lauren Martz>I mean, that was a, a huge acquisition and maybe got some criticism for the purchase price.

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<v Lauren Martz>But the company's moving this, this antibody drug conjugate into the early lines of treatment for breast cancer for triple negative breast cancer, which could really expand the market and I think help it reach kind of the peak sales potential that Gilead was thinking about when it did that deal.

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<v Simone Fishburn>So Lauren, I just wanted to ask you, you know, I think about the Kite deal that in that day, that was a very edgy technology.

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<v Simone Fishburn>I mean, it's still an edgy technology actually, but you know, it was one of the first deals they really did stick their neck out there.

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<v Simone Fishburn>I think the Trodelvy deal, even then when they did that, that was quite a new technology.

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<v Simone Fishburn>And I think what I'm asking you is whether,  for my criticisms earlier where Gilead is right now, maybe, you know, do you see that they have quite an appetite for very forward thinking, next generation science and technologies that they're not playing it safe with me toos or eighth in class?

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<v Simone Fishburn>Is that a fair assessment?

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<v Lauren Martz>I think that.

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<v Lauren Martz>I think they're certainly sticking, sticking with building out where they have been successful in the past, other than those examples which are reaching into new spaces.

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<v Lauren Martz>But since then, we've seen a lot of, you know, as I mentioned, building on the CAR T success with In Vivo CAR Ts and other adjacent technologies.

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<v Lauren Martz>I haven't seen a ton of ADC activity after the tro delvy deal, but I, I think that's, I think that's probably fair.

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<v Simone Fishburn>I guess I'm thinking of our audience out there who might be thinking, would Gilead be interested in my asset?

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<v Simone Fishburn>And, what's it gonna take for somebody to get interest from Gilead?

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<v Lauren Martz>And I think that, you know, he did mention that they are always on the lookout for oncology deals.

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<v Lauren Martz>So I think it's probably a fair assumption that innovative oncology is kind of on the table.

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<v Lauren Martz>you know, We did just see the bispecific for INI deal, which.

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<v Lauren Martz>I think we can still say that's at the cutting edge.

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<v Lauren Martz>It's an incredibly crowded space.

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<v Lauren Martz>I think we're all trying to understand which of the bispecific T cell engagers against BCMA or CD19 is going to end up successful and how they will differentiate and how, how activity and like the profile of the therapy for INI differs with what you would wanna see in oncology.

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<v Lauren Martz>It's certainly an innovative space.

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<v Lauren Martz>It's a crowded space and I think we'll all see how that plays out.

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<v Jeff Cranmer>All right, and you can read Lauren's story and uh, Paul's story on both of the deals that we just discussed, up on BioCentury.com, or you can click on the link in the show notes.

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<v Jeff Cranmer>We did tease that it was a big couple of weeks for deals.

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<v Jeff Cranmer>What else you got Paul?

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<v Paul Bonanos>I, it's just worth mentioning there were a couple smaller ones on Friday that I thought were, worth noting and somewhat interesting.

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<v Paul Bonanos>So Excellergy a venture backed company with an INI program.

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<v Paul Bonanos>Its got and promise an allergy, food allergy, hives, maybe a couple more things that had just entered the clinic.

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<v Paul Bonanos>Went to Novartis for an undisclosed amount upfront, but the total deal value is 2 billion, including milestones.

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<v Paul Bonanos>It looks like a strong exit for some VCs.

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<v Paul Bonanos>The startup was spun out of Stanford and RedTree was the seed investor, RedTree has close ties to Stanford and other West Coast institutions they had done a series A with Samsara and Decheng joining RedTree.

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<v Paul Bonanos>So good for them.

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<v Paul Bonanos>And then Transcend a neuropsychiatric company with a PTSD product in the clinic was acquired by Otsuka for 700 million upfront.

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<v Paul Bonanos>They're also 525 million in milestones in that deal.

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<v Paul Bonanos>So from Wednesday to Friday, four substantial deals, probably somewhere around 10 billion upfront in total.

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<v Paul Bonanos>And then the last one this morning, it's much smaller, but uh, Kezar life sciences acquired by Aurinia.

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<v Paul Bonanos>Hard to say whether they're actually going to keep advancing the asset or whether this was a deal for a company trading below cash.

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<v Paul Bonanos>Aurinia is now being steered by a new management team from Tang Capital, and Tang has Concentra that often does these sort of buy and shut down deals.

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<v Paul Bonanos>So it's not clear exactly what the future of Kezar is, but that's one more M&A deal today.

00:16:17.976 --> 00:16:23.749
<v Jeff Cranmer>Yeah, Tang's been  quite active with these deals, Paul, are they keeping any companies alive or are they just shutting 'em all down?

00:16:24.450 --> 00:16:27.686
<v Paul Bonanos>all of the deals, nearly all of them anyway, have a CVR.

00:16:27.720 --> 00:16:30.889
<v Paul Bonanos>Should someone want to acquire the asset and advance it?

00:16:31.356 --> 00:16:32.591
<v Paul Bonanos>Or should there be.

00:16:33.325 --> 00:16:39.230
<v Paul Bonanos>More of a positive outcome, but to my knowledge, no, no deals have happened, and I don't think Concentra advances the assets.

00:16:39.230 --> 00:16:41.432
<v Paul Bonanos>They tend to buy and keep the cash.

00:16:42.533 --> 00:16:43.201
<v Jeff Cranmer>Right on.

00:16:43.201 --> 00:16:49.008
<v Jeff Cranmer>And you mentioned, that Ouro was set up as a a NewCo under the NewCo model.

00:16:49.008 --> 00:16:52.977
<v Jeff Cranmer>I just wanted to drop Keymeds name in there.

00:16:52.977 --> 00:16:59.183
<v Jeff Cranmer>Keymed is one of the most active China-based companies behind the NewCo Deals.

00:16:59.451 --> 00:17:06.424
<v Jeff Cranmer>it's uh, kind of a double win for keymed,   first, getting the deal for Ouro and then getting this takeout as well.

00:17:06.657 --> 00:17:23.307
<v Jeff Cranmer>So Keymed, along with  Jiangsu Hengrui two of the companies to really watch really deep pipelines Hengrui had its, uh, earnings last week and I think they've said they have a hundred innovative molecules in their pipeline.

00:17:23.307 --> 00:17:27.179
<v Jeff Cranmer>So expect more movement from both of those companies.

00:17:27.179 --> 00:17:27.546
<v Jeff Cranmer>All right.

00:17:27.779 --> 00:17:38.490
<v Jeff Cranmer>We are gonna take a uh, quick break and then we're gonna come back and hear about Simone's conversation with Lawrence Tallon, CEO of MHRA.

00:17:39.191 --> 00:17:44.430
<v Voice Talent>BioCentury This Week is brought to you by the 26th Bio€quity Europe in Prague, Czech Republic.

00:17:46.030 --> 00:17:51.103
<v Voice Talent>Innovators everywhere are seeing speed as the driver of investment, partnering in success.

00:17:51.537 --> 00:17:52.637
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<v Voice Talent>The question for European biotechs is clear: How do you compete in this arena facing new momentum from Asia, and an unpredictable landscape in the U.S.?

00:18:07.318 --> 00:18:08.554
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00:18:09.188 --> 00:18:11.256
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00:18:12.124 --> 00:18:14.026
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00:18:14.792 --> 00:18:16.394
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00:18:17.061 --> 00:18:31.442
<v Voice Talent>In its 26th edition, Bio€quity Europe travels to central and Eastern Europe for the first time — to explore emerging opportunities in the region and debate how European biotech can accelerate to compete — and lead — in today's world.

00:18:32.009 --> 00:18:37.615
<v Voice Talent>Join us in Prague, May 4 to 6 for this destination event for investors and biopharma leaders.

00:18:38.182 --> 00:18:42.086
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00:18:42.820 --> 00:18:44.423
<v Voice Talent>Where Europe accelerates to compete.

00:18:46.357 --> 00:19:00.538
<v Jeff Cranmer>Okay, and Bio€quity Europe, first time in Central and Eastern Europe for the event now in its 26th year we have some limited spaces remaining for presenting companies.

00:19:00.939 --> 00:19:08.680
<v Jeff Cranmer>You can reach out to me if you have interest in uh, nominating a company or nominating yourself   to present.

00:19:08.713 --> 00:19:12.217
<v Jeff Cranmer>Uh, advanced rates end this week.

00:19:12.651 --> 00:19:17.455
<v Jeff Cranmer>So rates will be going up, so it's a good time to jump in.

00:19:18.289 --> 00:19:19.157
<v Jeff Cranmer>Simone.

00:19:19.157 --> 00:19:19.857
<v Jeff Cranmer>All right.

00:19:20.125 --> 00:19:21.894
<v Jeff Cranmer>Let's head to the motherland.

00:19:21.960 --> 00:19:26.298
<v Jeff Cranmer>You got to sit down with Lawrence Tallon virtually.

00:19:26.531 --> 00:19:33.271
<v Jeff Cranmer>on the eve of a major overhaul of new clinical trial regulations.

00:19:33.471 --> 00:19:33.971
<v Jeff Cranmer>What did you learn?

00:19:35.173 --> 00:19:37.375
<v Simone Fishburn>Oh, it was a really interesting conversation.

00:19:38.376 --> 00:19:41.646
<v Simone Fishburn>I gotta tell you, it was like more interesting live.

00:19:41.646 --> 00:19:50.955
<v Simone Fishburn>I wish we'd recorded it, but uh,  we will have an opportunity actually at Grand Grounds in Amsterdam, we will have both Lawrence Tallon and Emer Cooke.

00:19:50.989 --> 00:19:53.458
<v Simone Fishburn>So, uh, Opportunity to hear him live.

00:19:53.491 --> 00:19:57.461
<v Simone Fishburn>But yeah, it's an interesting and exciting time.

00:19:57.695 --> 00:20:13.744
<v Simone Fishburn>Potentially let's do this whole potentially thing in the U.K. The government is bringing in a series of clinical trial reforms that in fact predate in their genesis, they predate Lawrence Tallon being CEO of MHRA.

00:20:14.179 --> 00:20:16.682
<v Simone Fishburn>It's gonna be his job to make sure they all work.

00:20:16.682 --> 00:20:19.284
<v Simone Fishburn>And he's bringing a lot of other ideas to the table.

00:20:19.617 --> 00:20:28.026
<v Simone Fishburn>So the clinical trials reform, which Jeff, I don't know, I'm not gonna say that whole title and name of that law that is, is in there.

00:20:28.527 --> 00:20:28.894
<v Simone Fishburn>But

00:20:28.993 --> 00:20:30.962
<v Jeff Cranmer>There's quite, quite a few parentheses

00:20:31.096 --> 00:20:32.931
<v Simone Fishburn>a lot of parentheses going on there.

00:20:32.931 --> 00:20:34.566
<v Simone Fishburn>I don't know what the British are doing in that.

00:20:34.799 --> 00:20:44.843
<v Simone Fishburn>But anyway it passed last year and it comes into force on April the eighth, and they're calling it the biggest overhaul in 20 years for clinical trials in the U.K.

00:20:45.210 --> 00:20:50.015
<v Simone Fishburn>Skeptics among, you will say the bar was low, but I think that's a little cruel.

00:20:50.315 --> 00:20:53.785
<v Simone Fishburn>Um, it's certainly, you know, there's a lot of new things in here.

00:20:54.152 --> 00:21:11.970
<v Simone Fishburn>And I think that an important context to this is something that we've been talking about and we'll be talking about all year, which is this global race to improve the speed at which first in human data are generated and generally to improve clinical trial efficiencies for sponsors.

00:21:12.471 --> 00:21:16.540
<v Simone Fishburn>So,  Lawrence Tallon talked about,  I'll tell you two or three of the highlights.

00:21:17.108 --> 00:21:22.247
<v Simone Fishburn>One is there's gonna be a guaranteed 14 day first assessment of Phase I clinical trials.

00:21:22.480 --> 00:21:26.718
<v Simone Fishburn>So 14 days to get a turnaround to get a response from MHRA.

00:21:27.219 --> 00:21:36.694
<v Simone Fishburn>The second, which they call the other end of the spectrum, they call the low, lower risk end of the spectrum is a notifiable scheme, right?

00:21:36.694 --> 00:21:49.708
<v Simone Fishburn>So what that means is that if these are fairly, low risk trials and they've already got thorough regulatory approval in sort of a reference regulator like the US or EU, or Australia.

00:21:50.308 --> 00:21:59.451
<v Simone Fishburn>Then in the U.K. instead of having to work for full clinical trial approval basically within 14 days, if you haven't heard from them, if you haven't been given a reason to amend it, you can just go ahead.

00:22:00.218 --> 00:22:04.122
<v Simone Fishburn>So that is like a, removing unnecessary hurdles.

00:22:04.122 --> 00:22:09.560
<v Simone Fishburn>And they think that about a fifth of clinical trial volume will be in these notifiable schemes.

00:22:09.961 --> 00:22:12.663
<v Simone Fishburn>And then, you know, they're still working towards this.

00:22:12.998 --> 00:22:13.731
<v Simone Fishburn>Here's what's interesting.

00:22:13.731 --> 00:22:22.106
<v Simone Fishburn>They're working towards this 150 day goal between when you first apply and when the first patient is dosed.

00:22:22.641 --> 00:22:27.778
<v Simone Fishburn>Now within that there's a 60 day part of that, which is under MHRA.

00:22:28.012 --> 00:22:29.513
<v Simone Fishburn>They've already met that goal.

00:22:29.948 --> 00:22:39.357
<v Simone Fishburn>I think they've actually even beaten that goal, but the remaining part of it is not entirely under Lawrence Tallon's responsibility.

00:22:39.357 --> 00:22:41.359
<v Simone Fishburn>There are other players as well.

00:22:41.692 --> 00:22:47.798
<v Simone Fishburn>And so this is where it gets interesting because there's NICE and there's the NHS.

00:22:48.400 --> 00:22:54.338
<v Simone Fishburn>And so,  they have um,  ILAP scheme and they have an aligned pathway, but generally.

00:22:55.207 --> 00:23:02.847
<v Simone Fishburn>The integrated system of the U.K. is something that Lawrence Tallon and his colleagues are trying to turn to their advantage.

00:23:03.048 --> 00:23:12.391
<v Simone Fishburn>So instead of a lack of coordination between these bodies being something that slows things down, what they're trying to do is get them better aligned.

00:23:12.391 --> 00:23:14.925
<v Simone Fishburn>And they say the government have given them incentives for that.

00:23:15.394 --> 00:23:17.962
<v Simone Fishburn>And so actually make it more efficient

00:23:18.829 --> 00:23:28.606
<v Lauren Martz>Simone, did he talk at all about how the different as the different government organizations,  are gonna work together or the other ways that they're gonna make this process more efficient?

00:23:29.907 --> 00:23:30.174
<v Simone Fishburn>Right?

00:23:30.174 --> 00:23:31.343
<v Simone Fishburn>Yes, he absolutely did.

00:23:31.343 --> 00:23:51.863
<v Simone Fishburn>So the first thing is he outlined a few specifics, the U.K. has an advantage, he says, of a single payer health system, so that allows them to create a single national contract, with terms and conditions so that you know you don't have to have multiple different contracts every time you go to a different site.

00:23:52.096 --> 00:23:53.531
<v Simone Fishburn>And so there's one template.

00:23:53.531 --> 00:24:03.040
<v Simone Fishburn>He did say that it would be a template that's adaptable to the local environment, but generally one of the things that can take people sponsors a long time is back and forth over the contract.

00:24:03.741 --> 00:24:25.363
<v Simone Fishburn>So this would be like a template and because it's a single payer health system, it can be used, throughout the U.K. The other is he said that they're gonna actually make data more available so that trial sponsors can know what sites are recruiting quickly and which are not doing so well, and so they can choose their trial sites.

00:24:25.596 --> 00:24:28.732
<v Simone Fishburn>And then, you know, they also wanna make incentives flow to the right sites.

00:24:29.334 --> 00:24:32.269
<v Simone Fishburn>And another thing which is that they're gonna use this NHS app.

00:24:32.269 --> 00:24:36.607
<v Simone Fishburn>So we've talked about this from  Patrick Vallance before the Minister for Science.

00:24:37.041 --> 00:24:49.253
<v Simone Fishburn>The point being that the U.K. has something that just about every place has that not only is recruitment slow, but so many patients who would be eligible for trials just don't get into them.

00:24:49.253 --> 00:24:59.130
<v Simone Fishburn>And so the idea of this app, which most people have, is that it would actually make it a lot easier for many patients who are eligible to get into these trials.

00:24:59.798 --> 00:25:05.103
<v Jeff Cranmer>Simone, one thing uh, that caught my eye when I was, editing the piece was the aligned pathway.

00:25:05.103 --> 00:25:09.307
<v Jeff Cranmer>Can you, uh, I, I love a good pathway with a regulatory, uh, organization.

00:25:09.307 --> 00:25:11.542
<v Jeff Cranmer>Can you, uh, break down what that's all about?

00:25:13.077 --> 00:25:23.121
<v Simone Fishburn>the aligned pathway is  new system whereby NICE, which is the sort of HTA for NHS approves whether a drug is gonna be covered by NHS.

00:25:23.454 --> 00:25:32.963
<v Simone Fishburn>So where the  NICE approval process and the MHRA, which is the regulatory approval process don't happen in sequence but in parallel.

00:25:33.265 --> 00:25:35.366
<v Simone Fishburn>And so that's actually gonna be the default.

00:25:35.366 --> 00:25:43.173
<v Simone Fishburn>So they have very clear incentives for MHRA and NICE to work together, which has not been the case in the previous few years.

00:25:43.441 --> 00:25:49.314
<v Simone Fishburn>But they've this new system has created incentives for them to do that, and they actually want that to be the default.

00:25:49.314 --> 00:26:01.926
<v Simone Fishburn>So it's not that you have to have an agreement with NICE in order to get a drug approved by MHRA, but they feel that if you have that early on and they are aligned, then your path to market and to selling in the U.K.

00:26:01.926 --> 00:26:02.861
<v Simone Fishburn>will be much easier.

00:26:03.595 --> 00:26:19.810
<v Simone Fishburn>And just one last thing about that because Steve Usdin also talked to Lawrence Tallon, and he raised this, several months ago when he spoke, where there's always this question of pricing in the U.K. But even beyond that, there's still this point that the U.K. is only a small part of the market, right?

00:26:19.810 --> 00:26:21.880
<v Simone Fishburn>Like, I think Tallon puts it at 3%.

00:26:22.314 --> 00:26:36.161
<v Simone Fishburn>So I think that his goal is to have approvals in the U.K. be a gateway to approvals in other jurisdictions so that, he could have alliances with these other regulatory authorities, whereby if it's approved in the U.K.

00:26:36.161 --> 00:26:39.698
<v Simone Fishburn>it might automatically appro approved in other certain other countries.

00:26:40.131 --> 00:26:45.336
<v Simone Fishburn>And then that would mean that actually you are opening up a much bigger market by getting MHRA approval.

00:26:45.537 --> 00:26:49.540
<v Simone Fishburn>So I think he's got some interesting ideas about how to make the U.K. a destination.

00:26:49.907 --> 00:26:51.276
<v Simone Fishburn>And we'll see.

00:26:51.942 --> 00:26:53.811
<v Jeff Cranmer>Certainly something we're gonna be watching.

00:26:53.845 --> 00:26:58.650
<v Jeff Cranmer>Uh, read the interview on BioCentury.com Click the link in the show notes.

00:26:59.284 --> 00:27:06.391
<v Jeff Cranmer>And while you're there, you can like us, subscribe to us and this indeed is a topic we're gonna stay with.

00:27:06.391 --> 00:27:09.094
<v Jeff Cranmer>Lauren, you have a couple of stories coming up.

00:27:09.426 --> 00:27:10.862
<v Jeff Cranmer>Anything to tease for us?

00:27:11.663 --> 00:27:14.065
<v Lauren Martz>I'll be speaking with a few other regulators from the U.K.

00:27:14.265 --> 00:27:21.138
<v Lauren Martz>to get more details on the clinical trial reforms and learn a bit about how they're approaching rare diseases under the,  the new regulations.

00:27:21.806 --> 00:27:22.574
<v Jeff Cranmer>Excellent.

00:27:22.773 --> 00:27:38.022
<v Jeff Cranmer>Elsewhere in biotech, the Critical Path Institute's new One to Millions initiative is looking to build the shared infrastructure needed to operationalize FDA's plausible mechanism framework.

00:27:38.623 --> 00:27:44.895
<v Jeff Cranmer>Our colleague Steve Usdin, wrote a piece on that after speaking with the head of C-Path.

00:27:45.529 --> 00:27:51.635
<v Jeff Cranmer>Shreehas Tambe has been named CEO of Biocon.

00:27:51.935 --> 00:28:03.114
<v Jeff Cranmer>He's an insider tap to lead the Indian biotech bellwether as it restructures to  sort of create one Biocon.

00:28:03.548 --> 00:28:17.362
<v Jeff Cranmer>And Kodiak's VEGF conjugate has finally found its footing in diabetic retinopathy can read our colleague Tierney Baums, piece in BioCentury.com.

00:28:17.362 --> 00:28:19.463
<v Jeff Cranmer>Thanks for tuning in.

00:28:19.730 --> 00:28:26.237
<v Jeff Cranmer>We'll be back next week with our Second Quarter Public Markets preview.

00:28:26.336 --> 00:28:28.272
<v Jeff Cranmer>Stephen Hansen will be joining us.

00:28:28.940 --> 00:28:34.645
<v Jeff Cranmer>And a special thanks to Kendall Square Orchestra, which provides the music for BioCentury this week.

00:28:34.846 --> 00:28:35.646
<v Jeff Cranmer>Thanks for tuning in.