Latest / BioSpace / Lilly tees off with Novo at ADA, GSK’s $10.6B deal, FDA reform continues in Makary’s absence
Transcript
- Jef: All right. I can hear okay. I heard Annalise shuffling away. All right, well let's get to our show. Heather, why don't you start us off with introductions today? Heather: ⁓ sure. ⁓ I my name is Heather, ⁓ and I am a senior editor at Biospace in charge of Clinica Space, which hits your inboxes every Monday. Jef: Thank you. And Annalise? Annalee Armstrong: I am Annalie Armstrong, senior editor, and I do the Biofarm Executive newsletter, which goes out Wednesday mornings. Jef: And last but not least, our newest team member, Gabby. gabby: And Thanks, Jeff. I'm Gabrielle Mason, and I put together our daily newsletter, Gene Poole, plus the weekly manufacturing brief. Jef: You're you're very quiet. gabby: Is it be is it better when I'm closer? Okay. Okay. I'll start over. Yeah. I'm Gabrielle Mason and I put together our ⁓ sorry. Jef: Yeah, yeah, yeah. C give your intro again. Yeah. gabby: I'm Gabrielle Mason and I put together our weekly manufacturing brief and our daily newsletter called Gene Pool. Jef: And I'm Jeff Axt, managing editor, and I just hang out with these fine folks every day. So, as I said, ⁓ one of our big headlines this week was ⁓ many of our big headlines this week, we're all coming out of ADA or the American Diabetes Association. This is their annual conference. It was in New Orleans this past weekend. And although it has diabetes in the name, it has become basically the weight loss conference. So we have our two leading rivals, Eli Lilly and Novo Nordisk. They all had Tons of presentations and data to share. Everything's coming up roses for Eli Lilly. They boasted positive results for their new pill found found, as well as the next gen acid retatrotide, across not just weight loss, but other obesity related indications. This included sleep apnea, knee pain, and menopause. So we'll get to some of those results. And then, like I said, rival Novo Nordisk is also ⁓ at ADA, huge presence there, and is also looking to expand beyond a weight loss to other and beyond diabetes, I should say, as well. They both have approvals in diabetes and weight loss and are looking to expand beyond that. We have a couple of additional indications, but these companies are really going after more. In Novo's case, they're looking at asthma related adverse events, blood pressure, liver disease, and this is specifically for their semaglutide products. ⁓ so Novo presented lots of data supporting these expansions at the meeting and then they had executives sit down with analysts over dinner and the word we heard coming out of that dinner was pretty positive. The analysts seem to think that maybe the company is turning a corner after a couple of really rough years, ⁓ and the successful launch of a Govi pill would be contributing to a step in the right direction for Novo. So Biospace was all over these updates. We're gonna dive into each of these in a little bit more detail now. Annaline Heather, you were all over these. What can you tell us? Annalee Armstrong: Yeah, so I think the biggest story was probably Lily's triple G retatide data. ⁓ that was kind of on the I believe that was on Monday that that came out. ⁓ the drug elicited what BMO capital markets called impressive weight loss, with patients losing 30.3% body weight at 104 weeks. This topped their previous data that showed 28.3% at 80 weeks. William Blair said that this broke a new record in the quote Weight loss Olympics, so really shows you the stakes here. Heather: Yeah, that one, weight loss Olympics, that's gonna stick. ⁓ I I actually said it in an email to somebody yesterday. ⁓ but yeah, the this is absolutely crazy. I mean, this is in the realm of bariatric surgery, which I think they even in their press release, ⁓ when they first announced these data ⁓ said. And you know, this is this is achieving that kind of weight loss, which is really important ⁓ for a number of people for you know for health reasons and without surgery. So it's pretty impressive. Annalee Armstrong: Mm-hmm. Yeah, and just a reminder that this drug, they are not necessarily suggesting that this is something that everybody should use. This is something that Lily is raising up as something that can be used for very severe cases of obesity. So this is maybe not gonna be what everyday people use all the time, ⁓ just given the ⁓ weight loss that is pr ⁓ possible with this. However, analysts have said that maybe there could be some fine-tuning because lower doses are also yielding pretty impressive weight loss. So Heather: Yeah. Annalee Armstrong: a pretty interesting product that I think is going to change things once it reaches reaches the market. ⁓ So that was great. You know, very exciting to see Lily achieve more weight loss. But what I actually thought was the coolest ⁓ readout ⁓ from Lily was some data that they showed in menopause. so they ⁓ showed that patients who were peri and post-menopause lost weight at similar rates. ⁓ and this was on ⁓ FoundAo I believe. Wait, I need to check that. Sorry guys. Heather: It was fair. Yeah. Okay. Annalee Armstrong: Okay, okay, cool. I'm just gonna say that again. So this was for Lily's Foundaleo, which is their approved ⁓ oral option. ⁓ it's a GLP one. and this is really a key, I think, because women, when they go through menopause, can gain weight due to hormonal changes, and it can be really hard to overcome that. So they were able to show that their drug does work ⁓ in this condition. And I think it's always positive to see women's health highlighted. It's so rare to see, especially a major company, ⁓ really highlighting women's health. So I thought that was some of the better ⁓ one of the cooler readouts that ⁓ happened at the conference. Heather: For sure, yeah. And Novo Novo presented a lot of ⁓ of data on their kind of obesity related indications that they're targeting too. So, you know, liver disease, kidney disease. But you know, what I thought was the most interesting, as Jeff said, was the the added confidence that ⁓ the analysts seemed to have with with ⁓ Novo. So they they hosted a little soiree and ⁓ and Bemo analysts were impressed with ⁓ the strategy that CEO Mazier might. Do star and CFO Karsten Monk Nudson ⁓ shared ⁓ at that dinner. So according to Bemo, ⁓ they acknowledged that the company's recent challenges, you know, had happened, but they also provided confidence that change is afoot. ⁓ so that's ⁓ that's good news. And that was kind of just the kind of a idea I've been getting around Novo lately is that things are looking up. Annalee Armstrong: Yeah, and I don't think it's standard protocol for a CEO to attend a meeting like ADA. I certainly don't think L Lily's Eli Ricks was there. Or Eli Ricks. Heather: Yeah. Annalee Armstrong: I certainly don't think that Eli Lilly's David Ricks was there. ⁓ I guess it just kind of shows the full court press that Novo is doing right now to regain that ground. Heather: Yeah, they're doing a good job too. They seem to be getting organized on the media front as well. ⁓ they have a new guy who seems pretty on top of it. Jef: Yeah, I was gonna say I was gonna say that just we've been waiting for that turnaround since there were the major changes at Novo, changing out the CEO, changing up the board. There's been a lot of restructuring and so this is exactly what analysts in the industry have been have been waiting for. Heather: But they are? Yeah. I think something else that's helping a lot is how the Wagobi pill launch is going. ⁓ so Novo announced this weekend that ⁓ that that pill has crossed the three million prescription threshold and that's just since January. ⁓ because they were approved in ⁓ late December and launched ⁓ the product in in January and three million prescriptions already. Jef: I think that's a huge part of it. You know, they had first to market advantage with the injectables, but then they lost that lead over time to Lily. I think they with this shorter four month lead on the oral front, they were, you know, full court press to get that out there and take advantage and kind of saturate the market. Of course now we do have Foundayo and Lily's getting plenty of prescriptions as well, but Novo seems to be doing just fine. Annalee Armstrong: Right. And I actually just talked to Kylira's ⁓ CCO who led the ⁓ launch of Zepp Bound at Eli Lilly and you know, she told me that that launch just like absolutely defied everything they thought. And it seems like these pills are going to do that all over again. Jef: Yeah. Well now we should pivot briefly to diabetes. Like I said at the top, this is a diabetes conference and we actually did get a pretty interesting diabetes result out of it in a head to head of Lily versus Novo and drum roll, you can guess who won. gabby: Yeah, kind of unsurprising at this point. Lily did come out on top. ⁓ so that was also for Foundeo. ⁓ and it found in a late stage phase three program that Foundaio reduced blood sugar more than novosemaglutide and also more than other available treatments for type two diabetes. So BMO Capital Markets wrote that Foundia has shown a consistently competitive profile in the indication, and Lily now plans on filing for approval. Yeah. Jef: Yeah, really interesting that both Zeppound and Wagovi came out f you know, f well, they weren't called that, but they came out first for diabetes and then made it into weight loss. And now with these oral options it was straight to weight loss and now they're like, ⁓ let's add diabetes as well. gabby: Yeah, it's the reverse. Jef: Mm-hmm. All right. Well, moving on from the front runners now. Everyone, of course, wants a piece of this pie in the rapidly expanding weight loss space. So another big pharma looking to enter the market is Roche in partnership with Zeeland Pharma. Annaly and Heather, you guys teamed up to cover this update. What can you tell us? Heather: Yeah, I always like covering the the kind of so-called underdogs. ⁓ and and Roche and Zealand would would count here. ⁓ so phase two data from petrolinotide, which ⁓ the two are partnered on, ⁓ only listed nine percent placebo adjusted weight loss after 42 weeks. And that data was ⁓ reported back in March. So this didn't exactly wow investors. But last week ⁓ Annalie and I spoke with executives from the companies. And they defended these results. ⁓ Manu Chakravarthy, he's the ⁓ the global head of cardiovascular, renal and metabolism product development. What title? ⁓ he he told me that this isn't the point of petrolinotide. So so you know, excessive weight loss is not the point. ⁓ the idea is that it could become a more tolerable first line option ⁓ for obesity. And this kind of goes right back to what Annalise was saying in terms of not everyone wanna take ⁓ what I call RETA. ⁓ they'll you know, i it's it's it's really looking I've I've noticed at ADA that there's a lot more segmentation happening or starting to happen. Annalee Armstrong: Right, and I talked to Zealand's CEO, Adam Steensberg, and he said that in the medium to long term, people are really gonna want some of these easier assets, things that they can stay on, ⁓ and things that they can adhere to. I think that this was you know good sentiment from both of them. However, this is a really competitive space. I do see a patient segment, those who can't tolerate the other drugs that are already out there, but like I just wonder how big that market is. Patients have really shown that they will what they will do to access these drugs and what they're willing to accommodate or or deal with ⁓ to achieve that weight loss. So I think it's gonna be tough for some of these other companies that are achieving lower weight loss. there's probably room in the kind of long-term maintenance market where like people start with the higher power drugs and then taper off and change to something else. ⁓ I think it'll really we gotta wait until these drugs get on the market to see how patients are gonna react. ⁓ but it's it's a it's kind of a tough call right now to see how some of these, as you call them, the underdogs are gonna do. Jef: Right. And there's so many of them. Like there's way more results from ADA than we can cover here. But, you know, Roche and Zeelin is just one of those many quote unquote underdogs, one of the many that are trailing Lo Novo and Lily trying to get into this market with differentiated products, either due to their tolerability profile or otherwise. ⁓ just to to preview a couple here, we also caught up with Kylera Therapeutics ⁓ after its record setting IPO. Pfizer had some data on a key asset from its big Met Sarah by and there were others. Like I said, there's way more than we can cover here. Definitely check out the Biospace website for all of our ADA coverage. And with that, ⁓ let's move on from ADA for a minute. ⁓ the biggest news of this past week, actually outside of ADA, actually came just on Tuesday as we're recording this, as GSK struck the biggest traditional biotech pharma MA of the year so far. It bought out new New Valent Bio and its oncology pipeline for $10.6 billion. This deal is second only to ⁓ slightly less traditional deal with ⁓ a generics company, Sun Pharma buying Organon for eleven point seven five billion. Outside of that, this was, like I said, the biggest traditional big pharma buyout of a biotech. And then we also had a smaller deal on Monday, J and J notched a buyout of Firefly Bio for a billion. ⁓ much less in value there. But these deals do add to the continued uptick that we've seen in MA in biopharma just this year. And of course much of that momentum is being driven by Eli Lilly and its GLP one cash. Annalee Armstrong: Yes, super thanks to JJ and GSK. I had to update my analysis that I have in the works. ⁓ so you can see that story. ⁓ it's in Biofarm Executive ⁓ today as you listen to this. But basically what I found, Lily has signed 10 deals this year, which is like an unprecedented pace. ⁓ I took a look at their deal history for and the history of the top 10 pharma's by revenue over the past 10 years. Lily has now signed 30 total MA transactions. Which easily overtook Novartis, which has done 26. it's just what I think is really interesting is deal count really has no correlation to deal amount. You look at Bristol Meyer Squibb bought ⁓ Selgene in a deal that was almost a hundred billion dollars ⁓ after all was said and done. ⁓ so I kind of took a look at those different metrics. So you could see that in Biofarm Exec this week. ⁓ I also talk about Lily's licensing deals, ⁓ which are also a key part to how they're gonna build out their their next gen pipeline. Jef: Definitely check that one out. We all know Annalie is a whiz with her data journalism, but this is one of the coolest charts she has ever made. You can click through the different years and just visually see who was the biggest buyer that year. And like you said, Annalie, it surprised me that in some of those years, you know, one ⁓ pharma would be by far the biggest ⁓ piece of the pie with a single mega buyout. Whereas this year, Eli Lilly clearly has the biggest piece of the pie, but no single blockbuster deal. It's just a ton of these boltons that it keeps doing. Annalee Armstrong: Yeah. And we did a we all tried to guess who was gonna be who was going to have spent the most and we were all wrong. So Jef: Yep, check it out. Try to make your own guesses and then test yourself with Annalise chart. Okay, pivoting yet again. ⁓ FDA, still front and center in our coverage. We ⁓ are still lacking a commissioner at this point. Acting commissioner Kyle Diamante seems to have the respect of FDA's staff and has made some moves to try to re-establish public and industry trust. We'll we'll touch a little bit more on those later. But first, there has been a report, ⁓ the first report we've seen of a possible. permanent replacement for Marty McCarey as the next leader of the agency. gabby: Yeah, so the White House is reportedly considering Norman Sharpless for the post of FDA Commissioner, ⁓ according to CNN. So Sharpless, who previously led the National Cancer Institute, has been a pretty vocal critic of HHS Secretary Kennedy's vaccine policies. Maybe this is the White House kind of trying to send a message that walks back some of RFK's prior vaccine sentiment, though HHS hasn't publicly confirmed Sharpless's candidacy with the press. Jef: Yeah, this is just a report at this point. ⁓ so we will definitely watch that. Very eager to see who it will be and when this will actually happen. We've had so much turnover at FDA leadership this year that everyone is eager to get stable ⁓ leadership back in place. But as we wait to see how the commissioner role shakes out, ⁓ we do want to understand a little bit more about how Marty McCarry's programs, initiatives that he started during his tenure, will play out. One in particular that has caused some drama is the commissioner's national priority voucher program. McCarey started this with his CIBR director, Fanaye Prasad, ⁓ first announced it last year and and then had a couple of different ⁓ iterations of recipients of these vouchers. Basically, it's a program to expedite review of products that fit certain on certain national priorities. But from the beginning, as we've reported a ton, there have been questions and concerns surrounding this initiative to the point that Sonofi actually requested its drug T Zield or Zield, I'm not sure how to pronounce that one. okay. Heather: ⁓ teasil, teasy old I usually call it, yeah. Jef: ⁓ be removed from the CNPV program. So that was pretty dramatic. You know, this seems like a a good thing, shorten review times, but there's been just so many questions about it and so much involvement of FDA leadership in the reviews that Senofi actually wanted out. So the new update here is last week the FDA held a listening session to get some feedback on that program. And they actually ended up getting multiple calls, calls to pause the program ⁓ at this point. So Heather, what more can you tell us about this? Heather: Yeah, I I kind of wonder if FDA had, you know, expected that or not expected that, that kind of decisive request for action. ⁓ but yeah, CMPV program has been kind of this Pandora's box from the beginning. and during this listening meeting, ⁓ patient representatives, industry and trade groups ⁓ all expressed concerns with the limited transparency ⁓ with which the program was launched and has been implemented. ⁓ as well as the vagueness of criteria by which the awards are given out. ⁓ both of these topics are ones that ⁓ I and we have reported on extensively in the past few months. Representative ⁓ Jake Auckingcloss of Massachusetts has also raised concerns around the transparency of the program, ⁓ just basically ⁓ requests from Congress for information that weren't ⁓ heeded and And yeah, so it's been a bit of a bit of a can of worms to use another ⁓ another idiom. Jef: So outside of just the lack of clarity on the program, have you heard any other specific concerns? Heather: ⁓ yeah, I mean, experts I've talked to have mentioned the the criteria, the selection criteria as being a big one. ⁓ the second round of vouchers last fall included mostly approved products. ⁓ the only one on the November list, that was the the second group, that wasn't ⁓ approved yet was Lily's Foundo, ⁓ which ⁓ is obviously a weight loss pill. and the first nine vouchers were or more in line with what you typically think of as a Priority indications, ⁓ ones for rare diseases and ones with ⁓ high, you know, high unmet need cancers. But this isn't necessarily the focus that they'd intended, right? I mean, so some of these national priorities, like you were saying, Jeff, is you know, are addressing a public health crisis, ⁓ increasing affordability, ⁓ both of which found A would match, as well as onshoring drug development is another one. ⁓ but A lot of people are are just confused about a lot of the new rare desi rare disease pathways as well. Yeah, we we've ⁓ we've had a few of them, the ⁓ the plausible mechanism pathway, ⁓ the the R REDP rare ⁓ rare disease evidence principles, ⁓ just because there are so many of them. ⁓ so in clinical space this week we put out an explainer ⁓ detailing each one, and you know, hopefully that's helpful for people. Jef: Yeah, there are so many. There's the new ones and the old ones, and understanding how they all fit together and what are the evidence, what is the the bars for evidence what is the word I'm looking for here? But what are the criteria that are needed for approval or even to be accepted into the program for priority review or whatever it is. So yeah, that is a really helpful explainer to try to differentiate between all these programs. But there's a limit to what we can provide given the open questions that nobody seems to have answers to. Heather: Yeah, and there's an a lot of open questions with the plausible mechanism framework. It's now called a framework ⁓ as well. So there was another meeting last month ⁓ held by CEDAR and Sieber. where FGA leaders clarified that this program should be looked at as a framework instead of an approval pathway. ⁓ so that was good clarity. But people are still confused, ⁓ mainly with how broadly it can be implemented. ⁓ so is it, you know, is this framework just for N of one diseases, just for examples like KJ, ⁓ baby KJ, who ⁓ had a a personalized CRISPR treatment ⁓ developed just for him and he's doing really well. But the thing is that not a lot of biopharma companies are creating N of one ⁓ therapies because it just doesn't fit the biotech mold, ⁓ you know, the economic mold. ⁓ so yeah, so that's a question a lot of people have. And As well, the the plausible mechanism along with other new rare pathways and guidance also include a lot about external controls and real world evidence. And these, as we well know, have tripped up a number of companies, including Biohaven and ⁓ and Unicare recently. Jef: Yeah, that actually relates to another FD announcement this past week. It did encourage the use of prior knowledge to speed up development timelines for cell and gene therapies. Again, a welcome development, external controls, real world evidence. But this speaks to this very concern and confusion in the industry with a handful of rare disease drug develop developers getting those surprise rejections or otherwise being turned away from the FDA. I mean, you mentioned Biohaven and Unicure. I can also think of Repli Moon and Capricor. We've covered all of these where There was some use of external control and the FDA was not on board with the application. So it's I think there just needs to be more clarity here. FDA has, with this new guidance, doubled down on the fact that they are encouraging of the use of prior knowledge or external controls to help expedite approvals of these therapies, but there needs to be better communication between FDA and industry on the nature of those controls and what they will accept. All right, well with that we will s sign off for today. Please join us back next week where we have plenty more updates from the world of biopharma. Hi, welcome to Biospaces the Weekly. Today we'll catch you up on all the results coming out of ADA this past weekend in New Orleans. We'll also touch on MA activity in biopharma so far this year. It has definitely been picking up with GSK making headlines just this week with a $10.6 billion acquisition. And the FDA is still front and center in our coverage as we await news of who will replace Marty McCary as the next commissioner. Let's get it let's dig in. Heather: That's good, very casual. Yeah. Yeah. Jef: tried to make it I I really didn't like the very scripted tone I had last week so I tried it