Life Science Today 036 – PRA + ICON, J&J + FDA, Oncopeptides, Roivant, Merck

Originally Published as The Niche Podcast

PRA acquired by Icon, Johnson & Johnson’s vaccine approved, Oncopeptides’ earns FDA approval, Roivant acquires Silicone Therapeutics, and Merck acquires Pandion.


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Story References
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Music by Luke Goodson
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Life Science Today is your source for stories, insights, and trends across the life science industry. Expect weekly highlights about new technologies, pharmaceutical mergers and acquisitions, news about the moves of venture capital and private equity, and how the stock market responds to biotech IPOs. Life Science Today also explores trends around clinical research, including the evolving patterns that determine how drugs and therapies are developed and approved. It’s news, with a dash of perspective, focused on the life science industry.

Transcript

Introduction

Welcome to The Niche Podcast – Your weekly rundown of the biotech, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, PRA acquired by Icon, Johnson & Johnson’s vaccine approved, Oncopeptides’ earns FDA approval, Roivant acquires Silicone Therapeutics, and Merck acquires Pandion.


PRA Health Sciences Acquired by Icon for $12B

Icon has entered into a definitive agreement to acquire PRA Health Sciences in a $12B stock and cash deal partially financed through Citi. The merged companies will be consolidated in Q3 2021, and headquartered out of Dublin, Ireland. The combined clinical research organization (CRO) will be one of the largest in the world. According to their statement this will put them as the number 1 or number 2 CRO in a variety of key categories. By my back of the napkin math, this turns two top 10 CROs into a top 5 CRO.

This kind of massive merger creates a lot of questions in a market that has seen a fair amount of consolidation in that last few years. We’ve seen InVintiv Health and Inc Research merge into Syneos, Covance get scooped up by LabCorp, and IMS plus Quintiles turn into IQVIA. Now PRA and Icon make up the newest top 5 organization. These deals are massive and complex and there are real questions about how much they may or may not help the market. On the one hand, with more and more complicated and rare disease drugs on the horizon, enormous global networks can be integral to successful recruitment and execution of clinical trials. There are also clear changes in how things like AI and machine learning will impact decentralized clinical trial design and execution moving forward. Large companies with massive infrastructure are better positioned for capital investments in these pipelines. It’s not always clear that they are better positioned for institutional implementation.

What is evident is that the clinical research space is growing. That makes room for more small, mid, and large CROs. In 2020, the market was around $44B globally, estimates put growth at between 5.7% and 9% across the next decade. While deals between top 10 players like this may not happen every quarter, we’ve highlighted several examples of smaller organizations making similar moves to expand reach. Conversely there are no examples of divestments like we see so frequently in pharmaceutical counterparts. Because of the changing needs in the market, especially with the alterations in how technology is impacting clinical trial design and implementation, I think we are more likely to see increased consolidation, not decreases, at least for a few years. But more often than $12B deals like this one, they will be companies like IQVIA or Syneos scooping up some small to mid-sized company with a captive audience or a technological innovation. This could be the biggest move in CROs in 2021, but we will definitely keep our eyes on the market as the year progresses.


Johnson & Johnson Vaccine Approved by FDA

The FDA has approved the third COVID19 vaccine for use in the United States. Based on the safety and efficacy data available from Johnson & Johnson’s clinical trials this is not a surprise (Check out episode 32 for more). Millions of doses will be distributed in the comings weeks. The benefits of a single dose vaccine without the same cold-chain requirements of the mRNA vaccines should help increase access and speed the rate at which a majority of the population is vaccinated. Counting vaccines from China and Russia this brings the total approved COVID19 vaccine count to 12 globally.


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FDA Approved Pepaxto + Dexamethasone for 5th Line Therapy

Oncopeptides first in class anti-cancer peptide-drug conjugate has been approved by the FDA for the treatment of refractory multiple myeloma. The approval allows the therapy, sold as Pepaxto, to be given along with dexamethasone as a 5th line treatment. While nothing like a blockbuster approval, the breakthrough gets a first in class treatment on the market and provides some novel hope for those facing persistent and likely deadly multiple myeloma. The treatment connects an active drug to a peptide that aids drug absorption into myeloma cells. Once absorbed, the cell hydrolyzes the peptide bonds and the trapped drug is released to do significant damage that cascades to programmed cell death. Oncopeptides has a number of clinical trials ongoing for Pepaxto so there is significant potential that they will see further approvals through 2021 and 2022.


Roivant Acquires Silicone Therapeutics in $450M Deal

Roivant is on a mission to change the way drugs are discovered and developed. Their most recent acquisition stays squarely in this milieu. They have acquired Silicone Therapeutics in a deal valued at $450M. Silicone Therapeutics has built a computational physics platform to analyze and optimize small drug targets. The combination of their computational platform with a specialized super-computer cluster allows them to may accurate simulations of all atoms in a biologically meaningful analysis. Basically, they can see how a specific small molecule might behave in a specific biological context. Combined with Riovants VantAI protein degradation tracker, this gives them a distinctive suite of tools for developing a variety of novel therapeutics. Roivant’s holdings currently have a few phase III and at least 10 therapies in phase II trials. This means that rubber will meet the road in the next three years on whether Roivants silicone valley approach will prove profitable or not.


Merck Acquires Pandion Therapeutics

Merck (MSD outside US) has inked a $1.85B deal to acquire Pandion Therapeutics. The deal is relatively typical of these acquisitions. Pandion has several promising drugs in their clinical pipeline, but they also have a key pipeline tool, called TALON. In theory, TALON allows for the targeted design of both systemic and tissue specific candidates to provided targeted drug delivery. Their lead candidate is in phase I trials for ulcerative colitis and systemic lupus, but I suspect Merck may also be interested in their PD-1 agonists. Their (Merck’s) current cash cow is Keytruda, a PD-1 inhibiting monoclonal antibody. From the outside it’s always hard to know if Merck wants to get the TALON pipelines, thinks the PD-1 antagonists from Pandion or a threat or boon, or sees their other therapeutics as aligning well with Merck’s strategic goals. It’s probably some calculated amalgam between these forces. There is no immediate output from this deal. Instead, the TALON platform and Pandion’s pipeline will come under Merck’s control moving forward. We can expect some targeted phase II trials in the back half of 2021. Otherwise, the results of these deal may take some time to see realized. 


Closing Credits

Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, clinical trials, and life science industries. You can learn more at thenichepod.com or find us on your favorite podcast app. Like, comment, subscribe, and most of all share with your friends. If you like what you hear, please rate and review, it really helps us. Once again, I’m Dr. Noah Goodson, I’ll see you next week.