Jef Akst: Hello, my one and only team member this week. ⁓

Heather: Hi. ⁓ Yes. ⁓ Yes, a, yeah, a, it's a quiet week. ⁓ Well, quiet in the virtual office. ⁓ Not so quiet on the drug development front, although. Today was kind of manageable, which was nice.

Jef Akst: I do feel like the world is giving us ⁓ a little bit of a quieter week this week so we can survive without Annalise. She is off on her spring break with her family. So I appreciate that. Thank you, Universe.

Heather: Hear me knock on wood for you, Jeff. ⁓ Well, 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.

Jef Akst: That's right. think it's immunology and inflammation, but you know what, it's all that stuff. Autoimmune and all those, know, really, the space really has picked up in recent years. I think the theme last year was all about the movement of CAR T over to this space.

Heather: Yeah, sounds a little better. Right, and that still was touched on in a couple of these, a couple of notes I saw around some of these deals and investments, but we will get to that. So just so the rest of you know who we are, I am Heather McKenzie, Senior Editor at Biospace.

Jef Akst: and I'm Jeff Axe, Managing Editor.

Heather: So we will take you through all the I &I news as well as some other fun stuff this week. ⁓ But 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. ⁓ This would be Gilead's acquisition of oral medicines for just over $2 billion.

Jef Akst: Yes. That's right. So they're going to put down 1.675 billion upfront, but then there is up to 500 million in milestone payments. Gilead is hoping to share that cost with its longtime partner, Galapagos. It said on Monday when it announced this news about the Oro acquisition that it was also nearing an agreement that would see Galapagos shouldering 50 % of that upfront 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 gonna have a spin-up company and split off their cell therapies and then they made 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 Oro pipeline works out. But back to Oro, the lead candidate is a T cell engager that's currently in an early stage basket study for autoimmune diseases.

Heather: Thank Thank

Jef Akst: Gilead CMO Dietmar Berger said that the pipeline that they're getting from Oro really complements Gilead's existing inflammation pipeline. should I say inflammatory pipeline? Make it sound like it's an angry pipeline. And this deal really fits right in with what CEO Daniel O'Dea had called a proactive and disciplined strategy to business development. So this follows on the $7.8 billion acquisition just last month.

Heather: It's inflammatory. .

Jef Akst: of Arcelics and that's bringing Cartes back into this discussion. So Gilead's gobbled up Arcelics last month and now is adding Oro to the mix as well.

Heather: 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 Gilead and Galapagos is a dumb deal. So we'll, we'll have to see when that's finalized.

Jef Akst: Yeah, it seems like it work out. And then I'll be curious, like I said, to see how that might stabilize things at Galapagos. There was a lot of question about what this new CEO would do. know, Paul Stauffles 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.

Heather: I really hope they stick around in some form because I love that name. just love saying Galapagos, Galapagos gobbles, know, it just up. Well, Gilead was just par for the course this week, which seemed to be, as we have mentioned, all about I and I.

Jef Akst: Yeah. Right. Right, so the other one I wanted to talk about was Protagonist in partnership with J &J, these two companies have been developing a treatment for Plaxoriasis that reached the finish line this past week. the drug will be ⁓ marketed as Icotide. Does that sound right to you Heather, Icotide? It's an IL-23 receptor blocker and it is approved to treat...

Heather: Sounds... that's how I would pronounce it.

Jef Akst: Plaxoriasis, the approval came early and with a clean label. So analysts were thrilled with this. It's just another drug for J &J, but it's a first for a protagonist. Right off the bat, protagonists will receive a $50 million payment as a result of the approval and they will now enjoy royalties from these sales as the drug hits the market. So pretty exciting for a protagonist and for the Plaxoriasis community in general.

Heather: Thank Yeah, definitely. I like to see these milestones for companies. It's the first, you know, you're right. It is just another drug for J &J, which has, I don't even know how many hundreds or something, but, but yeah, definitely very good for, for psoriasis patients as well. Well, another, yeah. Oh, yeah. Well, another deal, Sanofi put down 180 million upfront.

Jef Akst: Right, that transition to a commercial stage company for protagonists, those are always fun transitions to watch.

Heather: to license a trispecific T-cell engager from California-based Cali, which I'm only assuming is named after the state. ⁓ Cali Therapeutics, that is. The asset has the potential to treat a broad range of B-cell-mediated autoimmune diseases, and that's according to Cali. And Sanofi has been very active in the immunology space lately. They struck a deal with CINO Biopharmaceutical earlier this month and Drenbio and EVOQ Therapeutics last year. ⁓ So yeah, they're definitely very active in this space.

Jef Akst: Evac, maybe? Yeah. They really are. Like I said, maybe it's a little bit of that observer bias. What's that bias where once you see something, you just see it all the time. But I feel like I and I is in our news cycle every week now, whereas before it wasn't this active and certainly not before 2024, 2025, at least to my awareness.

Heather: Yeah I think it's echo chamber. that, know, when you, 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, yeah. Yeah. Yeah. They are 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.

Jef Akst: Maybe. That sounds right. 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. Yes, I'm excited to talk about this one. So, Orinia pharmaceuticals. For those of you who don't remember, let's take a little bit refresher on the background here. Last fall, George Tidmarsh, who was then the Cedar Director, called out Orinia's approved lupus treatment. Lup-kid-ness? He said that the active ingredient had, quote, significant toxicity. And he also said that it, quote, had not been shown to provide a direct clinical benefit for patients. So, basically posted to LinkedIn 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 biopharma 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 Orinia. 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 urinia, urinia 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 as CEO of Orinia 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 got a name in this space and I'm very curious what his intention is taking over fully. This is absolutely one Annali I'm sure would have more thoughts on if she were to hear, she follows him very closely. But 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 Orinia. So back in September, 2024, a year and a half ago,

Heather: You

Jef Akst: It was about 5 % and then by late last month, it was up to almost 10%, 9.2%. 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 an arena, a lot going on there.

Heather: Yeah, our staff writer, Tristan Menalek, even said when this news came out, said, ⁓ Anna Lee will be all over this. And we all wanted to write it. ⁓ But time is of the essence. But yeah, it follows another trend as well, which is, well, 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

Jef Akst: That's right, that's right. Mm-hmm.

Heather: with Commissioner Marty McCary and ⁓ Unicure when everyone assumed that he was talking about Unicure a few weeks ago. Well, ⁓ continuing with the drama, last

Jef Akst: Right. Right.

Heather: Thursday, ⁓ Robert Malone, who is the vice chair of the CDC's advisory committee on immunization practices, he posted on social media on X ⁓ that the committee was being disbanded.

Jef Akst: Yeah, that was a surprise to see that.

Heather: Yeah, I mean, five hours later, he walked it back. 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 dissolving and reforming remains one of the options being considered after a after a legal decision came down. ⁓ regarding the committee's work a couple of weeks ago.

Jef Akst: 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 Minera's former CDC director was, she said Kennedy had asked her to pre-approve the ACIP recommendations. And that was kind of at the heart of why she left the CDC. And as a reminder, she was the only Senate 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 ACIP. But this particular turn of events really shocked me. I mean, if it's gonna be dismantled, okay, that would be a surprise, especially since it's got a lot of folks that Robert F. 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 followup from HHS, ⁓ Andrew Nixon, spokesperson who often corresponds with us, he wrote to us and he said, quote, unless 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,

Heather: you

Jef Akst: There's a communication problem here to be sure.

Heather: think there's a real identity question there. Who is us exactly? ⁓ well, this week Clinica Space, I looked at ⁓ another key policy the FDA has come out with in the past year, ⁓ and that is Commissioner's National Priority Venture Program. ⁓ And last week, actually announced that there will be a public meeting on June 12 to ⁓ commission feedback from this.

Jef Akst: Yeah, good question.

Heather: for this almost program from stakeholders, ⁓ which is excellent because they have a lot of feedback. So far there have been four approvals and one rejection under the program, which unfortunately for disc medicine belongs to them. But the program has been criticized for a lack of transparency. Last month, Democratic representative Jake Ockenclause, I I was gonna mess that one up. ⁓ said that the program is 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 the selections. 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.

Jef Akst: Yeah, we definitely need more clarity around this program. This is the one that we've talked about in the past. 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 without 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...

Heather: Thank

Jef Akst: Maybe we'll have a more solid program that will have more support from the industry after this.

Heather: Yeah, because the people I spoke with, they even said, you know, upfront, well, this is fantastic. know, getting drugs to the market faster can only be a good thing. It's just kind of all the, you know, how the soft just gets made essentially. Yeah. Well, speaking of guidance, the FDA also released draft guidance on animal testing alternatives last week. And this guidance is intended to help drug developers ⁓ at sponsors validate new approach methodologies or more commonly called NAMs, or NAMs, ⁓ that have the potential to replace in vivo or animal testing. so experts 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, Sartara's Kevin Snyder, suggested that a good use for NAMs right off the bat would be to explain the results of animal tests.

Jef Akst: What does he mean by that?

Heather: 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.

Jef Akst: Yes, I've heard this before that NAMs aren't going to immediately replace animal testing, but rather ⁓ supplement it.

Heather: Yeah. And this is, ⁓ this is a consistent viewpoint too, to other experts as well. yeah. ⁓ well looking at, ⁓ so, the newsletter that I curate, ⁓ clinical space, clinical space came out, ⁓ on Monday and there was a lot of good stuff in this one. I really liked this, ⁓ this edition. ⁓ Bernie Ziprich who lives with ALS and has founded a research effort to help accelerate R and D.

Jef Akst: Yeah.

Heather: 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.

Jef Akst: Yeah, anything to help this patient population. I know you have a personal interest in this, Heather, I do as well. I wrote a book on ALS years ago that I was just really interested in. 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 build that gap, that would be amazing.

Heather: Yeah. Yeah, I mean they need options so much. The patients in your book, which by the way is excellent, check it out everyone, we're trying to do it themselves.

Jef Akst: Yeah, absolutely.

Heather: Well, another excellent feature this week looked at the increasing interest from companies like Lilly and Regeneron in ⁓ using gene therapy to treat hearing loss. And it also looked at how those learnings and the momentum that this is creating can extend to other indications.

Jef Akst: Yes, that one was a good one too. Definitely check that one out. This is another space we've been following closely, Regeneron in particular, with the big splashy news that I think was at ASGCD a couple years ago. I still remember when that dropped. So I'm glad to have an update on what's going on here.

Heather: Thank Yeah. Yeah, it's really cool. ⁓ Well, Jeff, maybe you can sub in for Annalee on the Biocharm exec front this week.

Jef Akst: 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 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. That's kind an interesting trend. Check out the story to learn a little bit more there. And then I just wanted to throw out, and in case you missed it, from last week's BE, because it's just gone gangbusters on our site. It's getting a lot of traffic. And that's about the top company's 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 &J still reigns, but no surprise, Lilly has jumped up the list this year thanks to its GLP-1 offerings. Those are two great overviews of what big pharma is doing in terms of spending and earning.

Heather: Definitely. Check another in case you missed it, ⁓ Biospace dropped annual salary report this week. And among its many findings, our 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. Hello and welcome to Biospaces the Weekly. Gilead continues its deal-making spree, swallowing oral medicines for around $2 billion. With its lead asset targeting autoimmune diseases, it's the latest headline in the sizzling hot space of I &I. Other news in the space this week includes J &J and partner Protagonist's new psoriasis approval and Sanofi's licensing deal with Cali. We'll also discuss a business update from Arrhenia Pharmaceuticals. the company at the heart of the drama surrounding former Cedar director George Tidmarsh's exit from the FDA. Meanwhile, the FDA is keeping us busy with new policies. This week we break down put out on the use of alternatives to animal models. We'll also touch on the confusion about the relatively new commissioners national priority voucher program. as well as the most recent drama surrounding the CDC's Vaccine Advisory Committee. Let's dive in.