Originally Published as The Niche Podcast
A new MS therapeutic, Fujifilm picks CDMO facility site, consolidation in medical services, and a new oncology startup.
Sponsors
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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.
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, a new MS therapeutic, Fujifilm picks CDMO facility site, consolidation in medical services, and a new oncology startup.
Janssen Receives FDA Approval for Ponvory
Janssen Pharmaceuticals, the Johnson & Johnson subsidiary is on a role. First, they rapidly developed and are now deploying one of the leading COVID19 vaccines. On Friday, they received approval for a new therapy, Ponvory, to treat relapsing Multiple Sclerosis (MS). Ponvory outperformed Sanofi’s Aubagio in a head-to-head clinical trial, reducing relapse rates by 30.5%. Not only were the rates of relapse decreased, but 10% more patients had zero relapsed on Ponvory. Overall this represents a solid addition to the space for those suffering from MS. Of course, it’s not a cure. But it does appear to significantly aid in slowing the progress, at least in many cases of relapsing MS.
Does this mean Aubagio is off the market? Probably not. The drug has almost a decade of clinical applications and may still be a better option for certain individuals. One of the added advantages of Ponvory is that it only lingers in the blood stream for a short period of time. This could allow some individuals to take it, and then get off it within just a couple of weeks if they need to try and alternative therapeutic, or make a lifestyle change, for example in family planning. In the last couple of decades, therapeutics have dramatically changed the expectations for many of those diagnosed with MS. Hopefully, Ponvory will be another step in allowing those to live long and full lives.
Fujifilms $2B CDMO Facility
Back in November we highlighted the announcement by Fujifilm that they were investing $2B into a contract development and manufacturing facility in the United States. We mentioned at the time that NC would probably be one of the top three choice. I am happy to announce that this facility is coming to Holly Springs, North Carolina. While you may not have heard of Holly Springs, it is just south of the Research Triangle Park and in easy shot of Raleigh and Durham. The facility will provide massive bioreactors, starting with 8x 20,000L units and include everything needed for clients to commercially scale products end to end. This addition will continue to center this region as a major national and interactional biotech and biopharma destination. Massive CMDO developments like this are part of the broader picture of how therapeutic development is changing going forward. The need for end-to-end product pipeline security becomes increasingly important as biopharma outputs are increasingly complex. In the coming decade, more and more start ups will be concerned that their sophisticated gene therapy or monoclonal antibody will be packageable and distributable early on in the development process. CMDO facilities may play an increasing role in these decentralized developmental pipelines. Many companies will want to envision their product fully actualized in the market and have partnerships in place to follow that journey, before even moving into the clinic. I can absolutely imagine the collaborative manufacturing that’s occurred around COVID19 vaccines opening up broader possibilities for the way drugs are delivered end-to-end going forward.
Sponsor
Developing a new product in the biopharma space is incredibly challenging. There are design barriers, capital to raise, and regulatory hurdles. The Scope Method provides consultative solutions to navigate industry specific challenges. We’ve helped companies pivot into new therapeutic spaces, change trajectory through clinical insights, and empowered CEOs with tools that turns their data into stories that raise capital. The Scope Method will help you develop data driven strategic processes. Find out more at thescopemethod.com.
Medical Supply Consolidation
Agiliti has acquired Northfield Medical, Inc. in a $475M deal that consolidates the companies under the Agiliti brand in the medical supply and repair space. Both companies primary service area is in providing contracts to repair and manage medical devices. Last year, Agiliti logged $773M in revenue while Northfield was definitely pretty far south of this number (internet numbers put in the $100M range). Agiliti also filed with the SEC to go public back in November, and then listed a potential initial $100M IPO at the beginning of march. Based on the revenue and acquisition, my guess is the IPO is a very small percentage of total stock, or was just a preliminary filing, set to be dramatically increased in the next couple of weeks. The combined companies should have revenue close to $900M/year. These are the kind of companies that generally read to me as unexciting great additions to a solid portfolio. They provide a critical service. They grow steadily. They are needed in healthy and unhealthy markets, and repairs and medical supplies tend to have increased demand in challenging markets. Now, that being said, it’s very hard to find detailed backend financial information on a company that’s been private forever. I would definitely keep an eye of for numbers and documents if they proceed with an IPO. The addition of Northfield should readily consolidate into their multi-facility service model regardless of what happens with the IPO.
Aktis Oncology Jumps Onto Scene with $72M Series A
Aktis Oncology launched with a massive $72M Series A this week. The company is in the targeted oncology space, but unlike many similar startups, it’s not a cell therapy or monoclonal antibody company. Instead, they are using radiopharmaceuticals to treat solid tumors. The basic synopsis is that their alpha radiotherapy will rapidly penetrate tumors while clearing readily from other tissues. There is enough faith in their platform to get names like Bristol Myers Squibb on board. Their approach in theory could provide significant imaging capabilities as well. Based on the early round bid, imaging value is probably secondary to therapeutic hopes, but as Aktis builds out their team and solutions we will learn a lot more.
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.