Psychedelics, peptides and GLP-1s

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Eli Lilly Psychedelic Drugs

0:30Today is Friday, July 31st, and you're listening to The Topline, brought to you by Fierce Pharma and Fierce Biotech. I'm your host, Ayla Ellison.

0:55Peptides, psychedelics, and GLP-1s. Oh my. This week on The Topline, we are covering three very different stories from across the biopharma industry. First, Eli Lilly is making a multi-billion dollar bet on psychedelic drugs, adding new momentum to a field that has spent years trying to move into the medical mainstream. Then, we turn to peptides, a loosely regulated category of products that became the focus of a politically charged FDA advisory committee meeting.

1:30And finally, Novo Nordisk is taking Eli Lilly to court over ads claiming Zetbound produces significantly more weight loss than Wake Ovi, escalating the rivalry between the two biggest players in the obesity drug market. Fierce Pharma marketing staff writer Zoe Becker is joined by Fierce Biotech's Will Maddox and Fierce Pharma's Kevin Dunleavy to break down what happened and why these stories matter. Welcome to Let's Talk About It, the Topline's recently launched news review show where our editors talk about some of the most interesting and impactful stories from this week.

2:20I'm Fierce Pharma marketing staff writer Zoe Becker. And I'm Will Maddox, staff writer at Fierce Biotech. And I'm Kevin Dunleavy, staff writer for Fierce Pharma. Thank you both for joining me today. We are coming at you with a news roundup of some of the hottest recent stories across pharma biotech and pharma marketing. So let's start with you, Will.

Psychedelic Drug Space

2:42You and Darren recently worked on a big story about Eli Lilly's recent $2.8 billion play into the psychedelic drug space. Super trippy stuff there, of course. The question is, will this spark more movement in the psychedelic drug area? What did you find out about that? Yeah, thanks, Zoe. Interesting story. Yeah, big, big acquisition for Eli Beckley. And they have a drug that's sort of a DMT compound, which is the same active ingredient in ayahuasca.

3:13Folks may have heard or tried that. Not sure what you guys do on the weekend, but this comes from a plant. It's also, this compound is also secreted by a Sonoran toad, a desert toad for defense. So that's always fun for me to look into where these things come from in nature. So it's this big deal. And the question was, given other activity in the space, what are we likely to see? There's kind of an interesting story. There had been talk for years about sort of some of these psychedelic drugs that are maybe, you know, illegal or controlled substances in some forms becoming approved medicine.

3:49Things took a bump. Like in 2024, there was a MDMA-related drug from a company called Lycos that got rejected. Took a big chunk out of the business and the momentum. Over the last couple of years, things had been building. We have companies like AbbVie and Otsuka making other big acquisitions. Political climate changing as well. We have some endorsement from some high-level political figures. We have candidates receiving priority review vouchers this year from the FDA under the Trump administration.

4:22So we have a lot of this momentum kind of building. And I think that really was reflected from a lot of the analysts and folks that I saw were just kind of talked to were discussing basically that this momentum is just going to keep going. And the fact that a company like Lilly with all of its size and success is hopping in is a great sign for things. Another piece that was interesting is sort of the launch of Spravato by Johnson & Johnson, which is sort of a chemical equivalent or similarity to ketamine, which has had blockbuster sales.

4:57It's taken through a nasal spray and it's for patients with depression as well. So that kind of also set the tone that, hey, this is a really commercially viable situation. There are all these clinics that got built out that are sort of built for these experiences, which can't have sort of trips or hallucinogenic properties. And so the infrastructure is there and now the approvals perhaps are coming and the funding is flowing. So it does seem that the quote on the story was sort of it was a rising tide moment that sort of everybody's going to benefit from some of these changes.

5:31I had one analyst had a funny description of it being a like the positive version of the group project. We've all probably been on the group project where we do all the work and everyone gets the credit. But this analyst sort of framed it as the ideal group project where everyone is sort of doing their work in their own little area. We have LSD. We have a psilocybin drug moving forward. We have this DMT drug moving forward and that each one kind of builds on the next one. So I thought that was a nice way to think about it. And yeah, I think the analysts, you know, agreed.

6:03And we also talked a little about future kind of M&A targets. And I think folks were looking at companies with phase two, phase three data that are showing good readouts for some of these drugs. And those could be potential targets for future M&A. I had one analyst point out an Irish company called GH Research that has an inhaled DMT product. That's, again, the ayahuasca drug that's in phase two right now for treatment-resistant depression as a company that's sort of on the edge there and a potential topic.

6:37So, yeah, folks I talked to just said there's a lot untreated depression and treatment-resistant depression are huge indications and only growing. And so I think there's just a lot of room in the market for different versions. Also, within versions, people want to have different kinds of experiences. Some people wouldn't mind having a little hallucinogenic trip. Other people would probably rather avoid it. Some people are fine taking four or six hours to sort of experience things. And others would like to be in and out of the clinic in a couple hours or as little time as possible.

7:09So there's a lot of sort of patient choice and desire, I think, that will come into this one as the different drugs get approved and the different ways that they are being taken and that sort of thing. So I think it sounds like there's a lot of positivity and momentum in this space and a lot of room for different versions of depression treatments. So, yeah, super interesting story, definitely something that we're continually following and, yeah, as this industry kind of grows.

7:40Yeah, there's so much buzz around this now. And I did a story a couple of months ago about a company called Optimi who does manufacturing. And they credited a lot of the buzz to a Joe Rogan podcast that got people excited about it. And then soon after that, Trump signed his executive order. So it just sort of that kind of fueled some of the buzz that was already happening. We knew about it for a few years here, but it really seems to be heating up now. When you make the world's or the country world's most popular podcast, things start to move.

8:14A lot of power in the Rogan airwaves for sure. I mean, we're up and coming too. He could be our competitor. That's true. That's crazy. I did not know Ayahuasca was involved. Yeah, well, yeah, it's a similar compound that indigenous people had sort of extracted from these plants and used to have visions and connect sort of in a spiritual experience. And so that was one other thing is that so many of these drugs are actually built upon these indigenous traditions, whether it's psilocybin, sort of the DMT, Ayahuasca route, LSD, MDMA.

8:51A lot of these drugs occur in nature and have been used both for healing and for sort of spiritual ceremonies or practices for thousands of years, which I think makes a lot of these treatments really unique kind of in the pharma biotech world. Yeah, I'm curious about the manufacturing of that, what that's going to look like. Very interesting.

Peptides and FDA Advisory Committee

9:15Speaking of Joe Rogan, he is also a big known advocate for something else we've been covering lately, which are peptides. So, Kevin, you reported on this advisory committee meeting that they had last week where they were voting and discussing on some peptides that had been restricted from the 503A bulk drug substances list. Kevin, tell us about peptides. What is happening here? What was the ultimate outcome of the committee and the vote? Yeah, it's not something we've covered much recently.

9:46Yeah, thanks, Zoe. It was something that was new to me as well. I learned a lot about peptide drugs, which is that I don't know much about about them at all because they're really unregulated. They're they're kind of in a gray area. They're supported by Robert F. Kennedy Jr. And that's how a lot of people have come to know them. But they've been they've been floating around on the on this gray market for more than a decade. We think of them as gym bros using them. People that want to get an advantage and weekend athletes who want to get an advantage.

10:18Well, as far as the meeting went, Zoe, it was interesting. There were six drugs that were approved, six of the seven that were up for a decision. Six were approved and one was not. And this basically means they'll be recommended that compounders can make them now legally. The one drug that was rejected, it is a drug for it's called emidilatide. It's for opioid withdrawal and narcolepsy. But anyway, in these meetings, it was interesting because there was controversy heading in that Robert F. Kennedy Jr.

10:51had stacked the deck on this committee wanting to get these peptides approved. He added several new members in April and was criticized because they were almost all industry people. And it turned out that all these people that were added in April voted yes to approve these peptides. Six of these people were added in April and two were added in May. And all the votes were the same, eight to six to one on the first day of this peptide vote. And all the same members voted the exact same way.

11:21So there was very little as far as any suspense with these votes. And it kind of each of the votes took on the same sort of process where you had industry people and patients kind of in unison saying how good these products were. And then the FDA weighing in with their objections and warnings about each of these drugs. The votes were interesting in this round on Thursday because they were all the same. They were all eight to six to one with the committee members voting yes, eight yes, six no, and one abstention.

11:57And in each case, all of the votes came in. The same people voted the same way. So it was really sort of a kangaroo court, if you will, with the voting because there was no suspense. It just seemed like it was already predestined, regardless of what the arguments for the drugs were. So I was kind of surprised on the following day that one of the drugs was rejected. Yeah, that is surprising. And to me, it's an example of this like a larger political issue of people's minds being made up,

12:27even though their job is to sit and listen to the facts about a topic or a case or whatever. And yet all their votes are completely predictable and consistent with what was known about them going into that moment. You know, it seems to play out here. Like you said, the votes just being the same for everyone and the industry people voting exactly how they were predicted. All of RFK's people voting exactly how one might think they would. So that's another example of sort of just the malleability of what people believe is science or what people believe is fact is not exactly as objective as maybe we would hope.

13:06Yeah, there was one weight loss peptide mostly used for weight loss. And there were a lot of questions even from the members who were approving, widely approving these drugs. And they seemed to have a lot of questions about it. And yet they still provided or at the end had the same vote. So it seemed like it was all set up to begin with. But it is hard to understand when this environment, which is so unregulated, that what really the efficacy and the safety is of these drugs, because they've never really been tested. And the makers of these drugs don't really seem to have any interest in testing them or trying to get them approved through the FDA.

13:40So just a lot of questions about these things. Hmm. I feel like I did a peptide story once and there was something about how some peptide users like prefer it to be purchased on the black market or however they're currently purchasing it because it's less regulated. So that should also be something very interesting to look out for. I mean, I heard some people are using these peptides for like tanning. Is that true? Yeah. What happened to the sun? I think it's part of the bodybuilding. It goes along with the gym hole thing that people are concerned with.

14:15It seems to be widely used by younger people, weightlifting people that are concerned with body image and that sort of thing. Yes. All the tan without the cancer. I mean, it is a whole new world out here. We're reporting on peptides and psychedelics. What is next? Crazy.

Novo Nordisk vs Eli Lilly Lawsuit

14:31But back to regulated weight loss drugs, currently regulated weight loss drugs over in the pharma marketing world right now. Now, there is a big case unfolding, a lawsuit that Novu Nordisk filed last week against its obesity rival, Eli Lilly. So in this suit, Novu is accusing Lilly of running ad campaigns that are containing deliberately false messages comparing their two products between Novu Nordisk's Ozempic for diabetes and Wagovi for obesity and Lilly's Monjaro for diabetes.

15:09And it's Zep bound for obesity. Lots of drug names in here. But they're basically saying that this false and misleading advertising causes us irreparable harm. And they want Lilly to conduct a corrective advertising campaign to basically tell consumers that its earlier ads conveyed a deceptive comparison of their medicines. And it all goes back to these two head-to-head studies that Lilly did in, I want to say, 2024 and 2021, comparing its Monjaro to Ozempic and Zep bound to Wagovi.

15:41And at the time, these studies used Tessa Lilly's drug against the highest dose of Novu's drugs. But the problem is a year after the Ozempic study, Novu's higher dose Ozempic got approved. And then I think more recently, its higher dose Wagovi got approved. So basically, Novu's saying, like, these studies are no longer accurate because we have the higher dose out now. They said that Lilly was saying that its Zep bound produces significantly more weight loss than Wagovi and that its Monjaro reduces A1C significantly more than Ozempic.

16:14So since these higher dose versions has come out, Lilly did recently put on, like, a little footnote to its ads just saying that the higher dose Wagovi is out now. But Novu is still saying that footnote is ambiguous, confusing, and wholly inadequate. It does not communicate that the new higher dose of Wagovi is substantially more effective than the doses included in the study. And therefore, the ads message claiming dramatic superiority of Zep bound is not supportable. That's what it said in its lawsuit. Lilly, meanwhile, is saying they're saying that these head-to-head trials are the strongest evidence we had for comparing medicine.

16:50Novu wants to stop Lilly from sharing our results, but Novu has never tested its highest doses of its medicine against Lilly's medicines. Instead, it's using a lawsuit to advance comparisons it has never put to the test. That's what a spokesperson told at Pierce Pharma Marketing. And Novu is saying we welcome competition, but competition that's grounded in honest, up-to-date science. We can't stand by, as these advertisements are deceiving patients, is essentially what a spokesperson, their general counsel, told us. And they also cited in their lawsuit consumer survey evidence that more than 30% of people who saw the Zep bound ad came away with the message that Zep bound produces significantly more weight loss than Wagovi.

17:32And that Lilly's ads have generated about 7 million impressions since April. Novu did send Lilly a cease and desist letter about this ad and its trial comparison in April. And Lilly did spread its advertising to social media channels after that, which was included in the lawsuit as well. So two days after filing that lawsuit, Novu went back to the courts and basically filed a notice that it's going to be seeking a preliminary injunction against Lilly's ads on August 17th, which would prevent Lilly from disseminating these allegedly false and misleading direct-to-consumer ads.

18:08So it's definitely an interesting case here. I mean, of course, we've reported on it a lot on the pharma side, but Novu and Lilly have had interesting history with their obesity drugs. I feel like at first they were kind of like coming together to at least carve out the obesity market and normalize it being a condition being treated with therapeutic intervention. And then after that, they were both together going after the compounders who made compounded or fake versions of their drugs.

18:40And now that compounding is no longer allowed, I feel like now is when we're really seeing them go at each other and try to differentiate their brands more than before. Novu was first to market with, I believe, both of their products. Definitely would go be in the obesity market, but Lilly has since caught up and at least in the last quarter, it overtook Novu's sales on that. And the next one we're looking at is the oral obesity market with their respective GLP-1 pills. So lots to come from that.

19:10Of note, ZepBound ad spending is consistently on our top 10 lists of the top 10 drug ad spenders per month and per quarter. Last quarter, ZepBound was fourth amongst brands in estimated national linear television ad spending. Lilly spent $67.8 million on their ZepBound ads last quarter, according to iSpot. Novu was not on that list, so I don't know what that says, but definitely interesting stuff, especially as we're in an age where there's been a lot more scrutiny on DTC ads.

19:42The FDA has been cracking down on it. They've sent out a lot of untitled letters recently, basically going after companies for everything from not listing other side effects out to the way they write out their indications to even eye-catching graphics was one. And of course, the DTC ad world is only this way in the U.S. I mean, there was a petition recently to have the FDA ban DTC ads altogether, which is how it is in other countries. So, I don't know. Very interesting.

20:13What do you guys think of that? Are you Team Lilly or Team Novu? Because I can see both sides, I think. I'm a little surprised that Lilly would do this. They seem to be winning the war. And to claim significant weight loss advantage seems kind of an extreme way of describing that, just knowing what we know about the trials. So, it seems like overkill to me. I was struck by the details in the story about the original study. And, you know, I don't know these drugs as probably well as you two guys do. But just in terms of comparing the dosage between like ZepBound of, I think it was 10 milligrams and 15 milligrams against Wagovia at 1.7 and 2.4.

20:53Like you said, those were the highest approved versions. So, I guess they could do what they could do. But it did seem like, I mean, that's a lot more medicine right off the bat. So, it does seem like, of course, there'd be more weight loss. And if you have a higher dose, you're going to have the impact. So, that was one thing that stuck out to me. Another was just sort of thinking, like you mentioned sort of the Lilly versus Novo visibility. And being a European company where these commercials are illegal probably has something to do with it. Whereas Lilly's sort of born and bred at the land of drug commercials and have money and know what to do with it.

21:28So, I think there's probably a different mindset coming out of each company. But, you know, Novo's clearly mad about it at this point. Good point. Yeah. I mean, it seems like Novo's the underdog here, which is really not something I thought I would be saying back when It's Wagovi was first approved. And they were kind of both first to the obesity market. Well, Novo was before Lilly. But interesting stuff for sure. I have one more question just before we get along. You might not know the answer to this, but I'm curious about just like these commercials that list just pure pounds of weight lost.

22:04To me seems a weird way to measure it because, I mean, you have people of different sizes and different, you know, you have men, women and tall and short. Or, I don't know, is that just kind of how it goes with these types of measures? Like someone who's 500 pounds and loses 30 versus 50, maybe it doesn't make a big difference versus, you know what I'm saying? I just sound like they're talking to people's different sizes seems like a weird way to compare and advertise.

22:35I think they're trying to just talk to the average Joe. When you throw out percentages, you have to stop and think, what would that mean as far as how many pounds I would lose? And even though that's so simplified of what they're saying, I think that's the only way that they can really sort of quantify that in a way that's really digestible. As I read your story, I was just thinking about, oh, that's just a very sort of interesting way, but maybe I'm not the audience. No, that's true. That's a good point. I feel like BMI, I feel like they used to talk about BMI more than I'm seeing it recently, but I don't know.

23:12But that is a more confusing measure. I would agree. Our average Joe, you see two numbers. I mean, I'm sure that's what they leaned into. Yeah. And I'm sure consumers probably would want to see an ad that says, hey, this one is better than this one. In this case, we'll see how this cracks out, but I don't know. It'll be interesting to set a precedent against sort of using us picking the exact moment in time where your drug and the other drug, like what's the best moment in time to compare these two drugs, right?

23:45Before your competitor comes out with a new one, let's run a trial now. Let's run a study now where we have this advantage and we can use this data point as long as we need to in all of our commercials to show our advantage, even though it might be an outdated version of what's available to the public. So I think that looks like it was a strategy here. And depending on how this lawsuit goes, could be an interesting advertising world strategy moving forward for people to time it right and have their own version of this for other drugs or whatever.

24:18So true, especially because it's not in like a big immunology market or some of those other big markets. It's like these are the main two obesity products that everyone they're very mainstream in the general public, too, which I know was another thing with their branding that they wanted to differentiate between because some people just say Ozempic and to them that means all of the drugs. But obviously, we know there's more nuances there, but it is an interesting thing because these drugs have gone so mainstream and compounding, of course, didn't help that back then.

24:51But yeah, very interesting stuff. Well, thank you both for joining me today and talking the news of the week.

25:03That's it for The Top Line. I'm your host, Ayla Ellison. You can find out more about this topic in our show notes at fiercepharma.com. Look for podcasts. And that's The Bottom Line from The Top Line.