Gilead’s Ouro Buy, J&J/Protagonist’s Approval, Aurinia’s Revamp, ACIP Confusion, More

[Music] Hello and welcome to Biospaces the Weekly. Gilead continues its deal-making spree, following oral medicines for around $2 billion. With its lead asset targeting autoimmune diseases, its the latest headline and the sizzling hot space of I and I. Other news in this space this week includes J&J and partner protagonists, Newsuriasis approval, and Santa Fe's licensing deal with Cali. We'll also discuss a business update from Arinia Pharmaceuticals, the company at the heart of the drama surrounding former Cedar director George Tidmarsha's exit from the FDA. Meanwhile, the FDA is keeping us busy with new policies. This week we breakdown draft guidance put out on the use of alternatives to animal models. We'll also touch on the confusion about the relatively new commissioners National Priority Fetcher program, as well as the most recent dramas surrounding the CDC's faxie and advisory committee. Let's dive in. [Music] Hello my one and only team member this week. [Laughter] Yes it's a quiet week. Well quiet in the biospace virtual office. Not so quiet on the drug development front, although today was kind of managed boat, which is nice. I do feel like the world is giving us a little bit of a quieter week this week so we can survive without Annelys. She is off on her spring break with her family. So I appreciate you for talking to me for you. Yes. Well yeah it's so it's yeah it's been a little bit of a quiet week but the week has a theme which is the inflammation and immunology space. Or is it immunology and inflammation? I can never remember which eye goes first. I think it's immunology and inflammation but you know what it's all that stuff. It's a little better. It's a little immune and all those you know that really this basically has picked up in recent years. I think the the theme last year was all about the movement of CAR-T over to this space. Right and and that still was touched on in in a couple of these a couple of notes I saw around some of these that some of these deals and investments but we will we will get to that. So just so the rest of you know who we are. I am Heather McKenzie, senior editor at BioSpace and I'm Jeff Axe, managing editor. So we will take you through all the I and I news as well as some other other fun stuff this week. But see up let's let's start there. Well we woke up this morning to a deal that had been percolating since last night. I like the percolating of coffee person. Yes. That would and this would be Gilead's acquisition of oral medicines for just over two billion dollars. Yeah that's right. So they're going to put down 1.675 billion up front but then there's up to 500 million in milestones, so payments. Gilead is hoping to share that cost with its long time partner Galapagos. It said on Monday when it announced this news about the oral acquisition that it was also nearing an agreement that would see Galapagos soldering 50% of that up front and milestone payments. For those of you who don't remember Gilead and Galapagos have been in a relationship. Since 2019 there has been a bit of drama around Galapagos. Last year they announced they were going to have a spin up company and split off their cell therapies and then they've made in those plans. So there's a lot going on with Galapagos. We've been following it closely. So I'll be curious to see how this potential deal with Gilead to collaborate on the oral pipeline works out. But back to oral. The lead candidate is a T cell engageder that's currently in an early stage basket study for autoimmune diseases. Gilead CMO Deepmar Berger said that the pipeline that they're getting from oral really compliments Gilead's existing inflammatory inflammation pipeline. I just say inflammatory pipeline. We can sound like it's a inflammatory pipeline. And this deal really fits right in with what CEO Daniel Day had called a proactive and disciplined strategy to business development. So this follows on the $7.8 billion acquisition just last month of Arsalix. And that's bringing Carties back into this discussion. So Gilead's gobbled up Arsalix last month and now is adding Oro to the mix as well. Yeah, I really like these deals when two or when three or more companies work together and it seems like this is what's happening here. It's it really seemed from a lot of the from the press releases for one thing from the companies as well as the analyst notes that I read this morning. It really seemed like people are assuming this thing between that Gilead and Galapagos are is a dumb deal. So we'll we'll have to see when that's finalized. Yeah, it seems like I work out and then I'll be curious like I said to see how that might stabilize things that Galapagos there was a lot of question about what this new CEO would do. You know, Paul Stoffel's left last year and there's been a lot of question about how the company will move forward. So maybe this will help clarify some of that. I really hope they stick around in some form because I love that name. I just love saying Galapagos Galapagos gobbles. You know, just a couple of. Right. Well, Gilead was just part for the course this week, which seemed to be as we have mentioned all about I and I. Right. So the other one I wanted to talk about was a protagonist in partnership with J and J. These two companies have been developing a treatment for plaque psoriasis that reached the finish line this past week. So the drug will be marketed as I I go tied. Does that sound right to you Heather? That's how I look for Gilead's it. It's an IL-23 receptor blocker and it is approved to treat plaque psoriasis. The approval came early and with a clean label. So analysts were thrilled with this. It's just another drug for J and J, but it's a first for a protagonist right off the bat protagonist will receive a $50 million payment as a result of the approval and they will now enjoy royalty royalties from these sales as the drug hits the market. So pretty exciting for a protagonist and for the plaque psoriasis community in general. Yeah definitely. I like to see these milestones for companies. You know, you know, you're right. It is just another drug for J and J, which has I don't even know how many hundreds or something, but but yeah definitely very good for psoriasis patients as well. Well, and that transition. Right and that transition to a commercial stage company for protagonist. Those are always fun transitions to watch. Yeah. Well another deal. Santa Fe put down 180 million upfront two flights and some trisacific T-celling gauger from California based Cali, which I'm only assuming was named after the state. Cali therapeutic studies. Viasa has the potential to treat a broad range of B-cell mediated autoimmune diseases and that's according to Cali. And Santa Fe has, Santa Fe has been very active in the immunology space lately. They struck a deal with C-NO bio pharmaceutical earlier this month and Dren bio and EVO and EVO Q. EVO? Maybe. Yeah. EVO. EVO therapeutic last year. So yeah, they're definitely very active in this space. They really are. Like I said, I, you know, maybe it's a little bit of that observer bias with that bias, or once you see something you just see it all the time, but I feel like I and I is in our news circle cycle every week now, whereas before it wasn't this active and you know, certainly not, you know, before 2024, 2025, at least to my awareness. I think it's echo chamber. Is that maybe when you keep getting all the same news because you read certain news and you then you get the same news, but that sounds worse than it is, but especially now with all these AI algorithms feeding us what we want to read, right? So I feel like there is a bit of an echo chamber there. Building our echo chambers that they're trapping us in. Well, even even the drama this week had to do with the I and I space. Yes, I'm excited to talk about this one. So, Arinia Pharmaceuticals, for those of you who don't remember, let's take a little bit of refresher on the background here. Last fall, George Tidmarsh, who was then the Cedar director, called out Arinia's approved loopist treatment, loop kidneys. He said that the active ingredient had "significant toxicity" and he also said that it "had not been shown to provide a direct clinical benefit for patients." So, basically posted a link to the saying that this was one that the FDA maybe shouldn't have approved. This company has a very important player, Kevin Tang. He's the president of Tang Capital Management and very well known in the bioforma space. This is an investment group that has made a name on offering an exit route to troubled biotechs. But he is directly connected to Arinia. He's been on the board of directors there since 2024. So, when George Tidmarsh posted this inflammatory post, no pun intended there with the inflammation about Arinia, Arinia sued, but Tang himself complained to the FDA about this conduct. The FDA passed that off to the office of the inspector general and Tidmarsh ended up under investigation for his personal conduct. And amid that investigation, he did exit the FDA. So, it was, you know, fit with this theme of FDA senior leadership turnover, but this one was a little bit different because there was a specific company involved and there was Kevin Tang involved and it was all this drama. That was all last fall. Now, the new news this week is that Kevin Tang is taking over a CEO of Arinia and he's appointed several of his associates from Tang capital management to other key positions in the C-suite and several members of the C-suite are now exiting the company. So, I don't know if it's directly related to the drama. that the company saw last year. But Tang, like I said, he's, you know, got a name in this space. And I'm very curious what his intention is taking over fully. This is absolutely one. Annelie, I'm sure, would have more thoughts on it. She was here. She follows him very closely. But it will, it is interesting to note that this is not completely out of the blue. This follows a year and a half of Tang capital growing at stake in Arinia. So back in September 2024, a year and a half ago, it was about five percent. And then by late last month, it was up to almost 10 percent, 9.2 percent. So maybe he's been planning something here. And again, I need to do a little bit more diving into this. But that's the update on Arinia, a lot going on there. Yeah, our staff writer Tristan Manalek even said when this news came out, he said, "Oh, Annelie, it would be all over this." That's right. That's right. And we all wanted to write it. But time is at the essence. But yeah, it follows another trend as well, which is, well, I mean, the history follows another trend, which is FDA leaders speaking out on social media and alluding to companies. The same thing obviously happened with with Commissioner Marty McCarrie and and Unicure when everyone assumed that he was talking about Unicure a few weeks ago. Right. Well, just continuing with the drama, last Thursday, Robert Malone, who is the vice chair of the CDC's Advisory Committee on Immunization Practices, was he posted on social media on acts that the committee was being disbanded. Yeah, that was a surprise to see that. Yeah, I mean, five hours later, he walked it back, however, so it's an FDA official quickly refuted this claim. And, and, and yeah, and then Malone kind of posted again saying, "Well, it was miscommunication," and quote, "disvolving and reforming remains one of the options being considered after a legal decision came down regarding the committee's work a couple of weeks ago." Yeah, so by way of background, this is the committee that Robert F. Kennedy, Jr., the Secretary of the Health and Human Services Department, had totally revamped last year. We had a lot of coverage on this. And there have been a lot of questionable decisions coming out of this committee. This was also the committee that Susan Mnera's former CDC director was, she said, Kennedy had asked her to pre-approved the ASTIP recommendations. And that was kind of the, at the heart of why she left the CDC. And as a reminder, she was the only appointed CDC director in the past year. And we still don't have a permanent director there. So, drama is the word here. Lots of drama around ASTIP. But this, this particular turn of events really shocked me. I mean, if it's going to be dismanted, okay, that would be a surprise, especially since it's, you know, got a lot of folks that Robert F. Kennedy himself has put in position. But to me, the most surprising part here was that the vice chair, Robert Malone, himself, was the one putting out this news and granted it was just by social media. But a lot of official news has come by social media in the past year. So, what's to say that this wasn't official news? In the follow-up from HHS, Andrew Nixon, the spokesperson who often corresponds with us, he wrote to us and he said, quote, "In less officially announced by us, any assertions about what we are doing next is baseless speculation." End quote. That shocks me that it has to come directly from HHS and not the people working for HHS. So, again, there's a communication problem here to be sure. I think there's a real identity question there. Who is us exactly? Yeah, good question. Well, this week in Cunicus Basel, I looked at another key policy that the FDA has come out with in the past year. And that is the Commissioner's National Priority Vetcher Program. And last week, they actually announced that there will be a public meeting on June 12 to commission feedback from this, for this, on this program from stakeholders, which is excellent because they have a lot of feedback. So, so far, there have been four approvals and one rejection under the program, which, unfortunately, for disc medicine, belongs to them. But the panel has been, but the, sorry, the program has been criticized for a lack of transparency. Last month, Democratic Representative Jake Aachenklaus, if you know it's going to mess that one up, said that the program is shrouded, quote, shrouded in secrecy. And I spoke with other experts a few weeks ago, actually, who told me that selection criteria for the program is not as standardized as they would like. And they also want to know who is making this elections. Well, the FDA, earlier this year in January, did put out a staff guide elucidating who the decision makers are and their roles. But clearly, these experts, regulatory experts and industry folks would still like to see more detail. Yeah, we definitely need more clarity around this program. This is the one that we've talked about in the past, you know, experts have told us as, you know, a company as an executive in the industry. Do you even want one? Should you even apply? These are questions that companies are asking themselves. So with that a little bit more information on the program, they're a little bit, you know, that's a hard question to answer. But hopefully this public meeting coming up will give some answers. Hopefully the FDA will take into account some of the feedback that they're getting and maybe we'll have a more solid program that will have more support from the industry after this. Yeah, because the people I spoke with, they even said, you know, upfront, well, this is fantastic. You know, getting drugs to the market faster can only be a good thing. It's just kind of all the, you know, how the software gets made essentially. Right. Well, speaking of guidance, the FDA also released draft guidance on animal testing alternative last week. And this guidance is intended to help drug developers, sponsors, validate new approach methodologies or more commonly called NAMS, that have the potential to replace in vivo or animal testing. And so experts on that biospace spoke with in the past week have emphasized the FDA's recommendation around defining the regulatory purpose of these NAMS. So defining how to use them in the regulatory process. And one source, that CERTERA's Kevin Snyder suggested that a good use for NAMS right off the bat would be to explain the results of animal tests. What does he mean by that? Yeah, well, he said that companies could use these models to demonstrate that a safety signal seen in animal studies is specific to that species. And then that could overcome the FDA's concerns that that would translate to humans. Yes, I've heard this before that NAMS aren't going to immediately replace animal testing, but rather supplemented. Yeah. And this is a consistent view point to other experts as well. So yeah. Well, looking at the news letter that I curate clinical space, clinical space came out on Monday. And there was a lot of good stuff in this one. I really like this edition. Bernie Ziprich, who lives with ALS and has founded a research effort to help accelerate R&D, he argues that what we really need in this disease space is a basket of targeted or precision drugs. So in the emerging area of precision medicine, he said this becomes more difficult due to the funding gap between early research and drug development at the industry level. And he's arguing for congressional intervention. Yeah, anything to help this patient population. I know you have a personal interest in this, how their eye do as well. I wrote a book on ALS a years ago that I was just really interested. And I got to know a lot of the patients in this space and they desperately need options. This has been like so many neurodiseases, but I feel like this one in particular really stalled in terms of progress. So if Congress can help, if Congress can provide that funding to help fill that gap, that would be amazing. Yeah, I mean, they need options so much of the patients in your book, which by the way is excellent. Check it out everyone. We're trying to do it themselves. Yeah, absolutely. Well, another excellent feature this week was looked at the increasing interest from companies like Lily and Regeneron in using gene therapy to treat her hearing loss. And it also looked at how those learnings and the momentum that this is creating can extend to other indications. Yes, that one was a good one to definitely check that one out. This is another space we've been following closely. Regeneron in particular with the the big splashing news that I think was at ASGCD a couple of years ago, I still remember when that dropped. So I'm glad to have an update on what's going on here. Yeah, it's really cool. Well, Jeff, maybe you can sub in for Analy on the bioform exec front this week. I sure can. Yeah, there's a lot in there. I won't go over it all. So definitely check it out. But the one the the lead story this week is pretty interesting. It's about big pharma R&D spending. So the top 16 largest pharmaceutical companies spent almost $160 billion on research and development in 2025. But that's actually a 3.6% drop compared to the prior year where they spent 165 billion. So that's kind of an interesting trend. Check out the story to learn a little bit more there. And then I just wanted to throw out an encase you missed it from last weeks, BE because it's just gone gangbusters on our sites, getting a lot of traffic. And that's about the top companies revenue. Right. So how much are they spending is this week? But last week we took a look at how much they were making. And J and J still reigns, but no surprise Lily has jumped the list this year thanks to its GLP-1 offerings. So those are two great overviews of what big pharma is doing in terms of spending and earning. Definitely. Check that one out. In case you missed it, BioSpace dropped our annual salary report this week. And among its many findings are data show what most employers fear. Raises, especially those higher than 5%, are easier to come by if staffers switch companies. So check that out and we'll see you all next week.