Pfizer + ReViral, Novartis, Charles River + Explora Labs

Viral therapies, rare disease approvals, and lab space premiums

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Story References
Pfizer + ReViral
Novartis
Charles River + Explora Labs

About the Show
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 Life Science Today, your source for stories, insights, and trends across the life science industry. I’m your host, Dr. Noah Goodson. This week, viral therapies, rare disease approvals, and lab space premiums.

Disclaimer

The views expressed on Life Science Today are those of the host and guests. They do not necessarily reflect the opinions of any organizations with which they are affiliated. 

Flush With Cash Pfizer Starts to Acquire

There are few guarantees in drug development, but one sure thing is that Pfizer will acquire and build a lot in the next two years. Their dedication to leading in COVID19 vaccines and therapies and their bets on the right horses have resulted in absolutely stunning corporate cash piles. This all means you’ve got to build more, because shareholders love when you say you’ve increased revenue 92% over last year. But the very next question is ‘what’s next? 

In one small corner of ‘what’s next,’ Pfizer has made the $525M acquisition of ReViral. The details of cost + milestones are not public. What we do know is that the privately held company, ReViral has been steadily developing a fusion inhibitor to RSV that can be orally administer and is currently being tested in infants as well as adults. Pfizer notably earned FDA fast-track designation for their potential vaccine against the same condition. Whether this is a market dominance move or competition squashing isn’t clear. Their approach to COVID suggests to me they currently like the vaccine + therapy approach with a hope that both prove effective in clinical trials. 

With RSV killing 160,000 annually and zero targeted therapeutics, there is certainly opportunity for improved effective care. 

Novartis Earns Rare Disease Approval

Novartis has earned FDA approval to treat patients experiencing PROS with Vijoice. That statement might sound like every other approval we talk about on this show. But the more we dig in, the more interesting it becomes. The first part isn’t actually that interesting, and it’s that PROS stands for PIK3CA-Related Overgrowth Spectrum. What is interested about that is that PROS is actually a cluster of multiple rare diseases all related to this one gene. We’ve talked about this before on the show but rare diseases are defined by prevalence in the population and some are quite rare indeed. While they may have unique sub-diagnosis, there are instances where clinically rare diseases are clustered together for the ease of things like treatment, care, and medical billing. Changes in a single gene can have wildly different diseases because genes are complicated. PROS itself represents a spectrum of disorders, but is clinically characterized by several factors including overgrown blood vessels and other abnormal body growths. 

And that brings us to the second reason this study is interesting. Studying a condition like PROS is hard. It’s a complex spectrum of multiple rare diseases and identifying sub-populations of sub-populations and then generating clinical meaningful data is incredibly technically challenging and not consistent since the spectrum of conditions are not consistent.  

Even if you take money out of the equation, it’s not an easy proposition. The study that lead to FDA approval for Vijoice used a unique approach. Rather than a typical approval for a more common illness that might have phases determine safety and efficacy, a single-arm study was leveraged through compassionate use to test Novartis therapy. The data generated were analyzed more like Real-World Data and showed that in at least some of the participants their life-threatening lesions decreased >20% after treatment. Collectively the data pointed to potential viability and as this is life-threatening with no other therapeutic options the FDA granted approval. 

On the surface, this is a small approval for a rare disease cluster, but under the hood there are a lot of specialized considerations that mark this as unique from the disease state, to the use of real world clinical data as RWE. Novartis will continue additional studies to understand what specific subpopulations of PROS patients can benefit most, and to ensure the results are replicated when studied in a larger population. 

Charles River Laboratories Acquisition 

Charles River Laboratories continued their pattern of growth through acquisition last week bringing Explora BioLabs into the fold. This should be a minor purchase right? A couple of turnkey vivarium facilities in Boston and Southern California with around 100 staff. But it’s not a small buy. It’s a $295M deal that ropes Explora into Charles River’s larger developmental lab wing. 

This acquisition underpins one of the important market trends. Rather than Biotech’s and other companies building their own space for expensive projects, numerous pieces of the overall developmental pipeline are being outsourced. From development to preclinical contract research support, all the way through to heavy late stage biomanufacturing. The challenge is that each of these steps often requires expensive and extensive built infrastructure plus highly talented and hard to come by individuals. It’s usually theoretically more affordable to run these service inhouse – but when you tack on delays in construction to all the other demands on a biotech it becomes far more fiscally viable to identify external partners. Sure, they’ll cost more in immediate cash but compare that to the burn rate of delays! Plus, when you go with an external partner who is certified, who can say they are fully accredited, now you’ve got a validated mechanisms of risk mitigation. All of this means big growth in demand for these services – and Charles River knows it well, seeing a ~21% increase in revenue from their similar services last year. 

It should be noted that Explora only saw $38M in revenue last year, and 7.8x revenue for a total sale price of $295M is a premium. Charles seems to be betting on larger market dominance as a mechanism of growth. It will be interesting to see if brand recognition and facility control continues to be a profit center going forward. 

Closing Credits                                                            

Thanks for joining me for Life Science Today, your source for stories, insights, and trends across the life science industry. Learn more at LifeScienceTodayPodcast.com. If you like what you hear, please tell a friend. Once again, I’m Dr. Noah Goodson, I’ll see you next week.