AbbVie&#x27;s $10.9 billion deal to acquire Apogee will expand its immunology pipeline by delivering assets for atopic dermatitis and asthma. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the takeout and the assets AbbVie gains. The analysts then discuss moves by FDA to reverse controversial setbacks that occurred under the agency’s former leadership and assess Acting CDER Director Michael Davis’ memo outlining how his predecessor repeatedly overruled career staff to quash a drug approval. The analysts also discuss continuing signs of political involvement at FDA. Finally, they discuss China NMPA’s first-ever approval of a CAR T for solid tumors, satricabtagene autoleucel (satri-cel) from Carsgen. View full story: https://www.biocentury.com/article/659864 #BiotechMA #Immunology #FDA #CART #ChinaBiotech 00:59 - AbbVie Buys Apogee 05:20 - uniQure U-turn 09:02 - FDA Reversals 12:32 - Tzield Memo 20:53 - Solid Tumor CAR T Approval To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com. Reach us by sending a text

Ep. 373 - AbbVie M&A, FDA reversals, a CAR T first

BioCentury This Week

# Full Transcript

**Podcast:** BioCentury This Week

## Participants

- **Jeff Cranmer** (BioCentury)
- **Selina Koch** (BioCentury)
- **Steve Usdin** (BioCentury)
- **Lauren Martz** (BioCentury)
- **Paul Bananos** (BioCentury)

## Transcript

AbbVie is buying Apogee for $10 billion to bolster its immunology and respiratory portfolio. We'll dig into the deal on this week's BioCentury This Week podcast. Plus, a reversal at FDA for Unicure puts natural history controls back in play for rare neuro. We'll discuss that and other recent reversals of FDA decisions.

And we'll also discuss the world's first CAR T-cell therapy product approved for solid tumors. I'm Jeff Cranmer, host of the BioCentury This Week podcast. And joining me today, my fellow executive editor, Selina Koch, Washington editor, Steve Usdin, executive director of Biopharma Intelligence, Lauren Martz, and our news editor, Paul Bananos.

Paul, let's bring you in right away. Let's hear about this big deal by AbbVie. Sure, yeah. It was the big news out of the gate Monday morning, wasn't it? Rumored over the weekend and then the announcement came early today. It's the latest large deal for AbbVie. You may remember that the company had two big deals in late 2023. We had Immunogen, buying Immunogen and cancer, and Cerevel in neuroscience. They've done a few smaller deals since then, a couple in the 10-figure range.

You may remember Capstan last year. And now here's an 11-digit takeout, actually even a little bigger than Immunogen or Cerevel. It's $10.9 billion. And it's in immunology, which is AbbVie's biggest therapeutic area in terms of revenue right now. So the company they're buying is Apogee, as you said, formed in 2022. It's a very quick turnaround. Apogee specializes in optimized biologics. The targets are usually familiar.

They're engineered with half-life extension technology to enable less frequent dosing. And some patients will prefer that. Their pipeline has a few programs. The most advanced is in atopic dermatitis. It's called Zumiloki Bart. AbbVie said that, you know, that's where most of the value is in this deal. um Zumi, we'll stick with that name, had some phase two data recently suggesting it can be competitive with other drugs in atopic dermatitis.

Most directly within the IL-13 class, it would compete with Ebglis. That's Lebrichizumab from Lilly. There's also the big one in this area is Dupixent, different target IL-4 from Sanofi and Regeneron. That's now a blockbuster many times over. And Ebglis and Dupixent are generally administered every two to four weeks. Apogee's is more like every three months.

So there's a dosing advantage that usually leads to patient preferences, adherence advantages, that sort of thing. And I mentioned, uh, AbbVie's historical strength in immunology. It's, it's the biggest therapeutic area for that company. People probably know Humira is the big one historically. It now has biosimilar competition, but it was one of the best selling drugs...

Ep. 373 - AbbVie M&A, FDA reversals, a CAR T first

Transcript

Built for investment professionals

Every day you wait, your competitors are finding
edge in conversations you're not hearing.

Ep. 373 - AbbVie M&A, FDA reversals, a CAR T first

Transcript

Built for investment professionals

Every day you wait, your competitors are findingedge in conversations you're not hearing.

Every day you wait, your competitors are finding
edge in conversations you're not hearing.