Originally Published as The Niche Podcast
Device acquisitions, rare disease approvals, COVID success stories, and clinical research ups and downs.
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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, pharma, clinical research, and life science industries. I’m your host, Dr. Noah Goodson. This week, device acquisitions, rare disease approvals, COVID success stories, and clinical research ups and downs.
Disclaimer
The views expressed on The Niche Podcast are those of the host and guests. They do not necessarily reflect the opinions of any organizations or companies with which they are affiliated.
Medtronic Acquires Intersect ENT for $1.1B
Medtronic has announced the $1.1B acquisition of Intersect ENT. The cash deal will expand on Medtronic’s position in the ear nose throat space. Intersect’s core assets, Propel and Sinuva, are sinus implants that improve localized drug release. Medtronic’s ENT catalogue contains dozens of devices and solutions within the space. This latest acquisition gives them a well developed in patient and out-patient drug delivery platform. They may simply use this to scale out sales, but I can certainly imagine them working to integrate Intersect’s underlying technology across Medtronic’s business. Biodegradable drug delivery platforms are certainly right up their alley.
New Treatment for Pompe Disease
Late onset Pompe Disease (LOPD) is a debilitating and deadly muscular dystrophy. Pompe Disease may show symptoms as early as birth, but LOPD may have symptoms appear well into adulthood and often has a more rapid progression. A genetic mutation in the GAA gene which produces a protein called acid alpha-glucosidase can cause a build up of glycogen, primarily in human muscle tissue. This build-up will cause permanent damage and lead to loss of the ability to move and breath.
A new enzyme replacement therapy from Sanofi, nexviazyme, has been approved by the FDA. In a phase III clinical trial nexviazyme showed significant improvement in walking and breathing ability while causing less adverse events than the current leading treatment alglucosidase alfa. The therapy was developed by Sanofi and may provide significant life extension and improved quality of life to individuals suffering from LOPD. This is not a cure, or a gene therapy. Enzyme replacement therapy works by infusing functional human GAA into the body every two weeks so that tissues can better regulate glycogen build up and thus mitigate damage. It should be noted that Sanofi is not competing with other companies here but actually expanding on their own treatments for both infant and late onset Pompe Disease. The new formulation of avalglucosidase alfa-ngpt has beat Sanofi’s own therapy sold as Lumizyme since 2014. The new formulation will likely be similar in cost to Sanofi’s current Pompe disease therapies. This might sound like a pretty decent price structure for a novel treatment, but averaging $300K/year this is no discount drug.
Adagio’s Successful IPO
Adagio Therapeutics went public last week, raising $309M at $17.00/share. Share prices quickly shot up, but eventually settled down to $20.88 at closing on Friday, a 21% gain. Adagio’s launch is based on early success of ADG20, an antibody therapy being studies for the treatment and prevention of COVID19. With COVID19 once again on the rise in the US, and vaccine hesitancy expediting the spread of the disease, expect plenty of opportunities for Adagio to make a run at emergency use authorization for their therapy later this year. With this significant capital infusion, I’d expect them to attempt to build out their pipeline as well as move ADG20 through late-phase trials as rapidly as possible.
Moderna’s Pivot and Growth
Speaking of COVID19 winners. There is none bigger than Moderna. A relatively minor biotech who now has a market cap of $166B and a $2.2B profit from Q2. It’s possible, and even likely, that Moderna is over-valued. But they are still extremely valuable and cash flush right now. But I’ve thought that before and was wrong. So maybe don’t ask me. So what’s next for the burgeoning giant?
What I do know is all that money is flying into a massive R&D pipeline. How big? Well they’ve got 23 mRNA products in a pipeline with a full 15 in clinical trials. And they aren’t being slow about pivoting. Their oncology product mRNA-2416 was cut in favor of mRNA-2752, same focus different product. And their vaccine business is also rolling. On the back of the technological success of their COVID19 vaccine, new products for Flu, seasonal boosters, and a Respiratory Syncytial Virus (RSV) vaccine are all on the way. Modern a, it seems, is here to stay.
WCG Clinical Punts on IPO
The clinical research support organization, WCG clinical has been busy. In May they acquired Avoca Group to expand their consulting wing. Then in July they acquired Intrinsic Imaging to build out their clinical trial support and imaging solutions and VeraSci to build out CNS clinical trial offerings. Their last fiscal year pulled in about $0.5B in revenue. With all this in hand they were heading for an $720M IPO at a $6.1B valuation. But right before launch on Thursday, they pulled the plug. The understated announcement sights market forces.
This is a critical move at this moment for a variety of reasons. First, it represents a shift in the confidence in the booming biotech and clinical research market. Most companies have been blasting through IPOs and acquisitions at an outstanding rate over the last 2 years. This pull back suggests maybe WCG wants to get their organization a restructured and aligned after all this acquisition activity before going public in this current climate. Whatever the reason, it certainly represents a distinct contrast to trends in the industry as a whole.
Acquisitions Across Clinical Research
How hot is the clinical research market? Well there were a number of acquisitions this last week ranging from preclinical work through site networks.
The pre-clinical contract research organization Inotiv Inc announced they are acquiring Gateway Pharmaceutical Laboratories to expand their drug metabolism and pharmacokinetics (DMPK) capabilities. Inotiv holds a market cap of about $430M, supporting the non-clinical portions of drug development. The acquisition should see them build out further lab offerings to their partners across the biotech and pharma industries.
The CRO NAMSA is entirely focused on medical device studies and registries. This specialization is integrated into their business and sales model. In 2020, the private equity group Archimed acquired the majority interest stake in NAMSA. It’s no surprise to see them lay down a series of acquisitions to build out their offerings this year. First they acquired Syntactx in January to expand their electronic data capture capacity. In March, they scoped up American Preclinical Services to enhance their early pipeline capacity. Now, they’ve announced the acquisition of Clinlogix. This merger will build on NAMSA’s global footprint and continue their strong focus on medical devices. I’m not sure where Archimed want’s them to go, but I’d expect a period of consolidation, especially after this latest acquisition.
CenExel is a clinical research site network with expertise built into specific centers within their site network. Each site is a different arm of the larger organization, though some sites share therapeutic focus for broader reach. They’ve added a new Tampa location, CenExel FCR, through the acquisition of ForCare Clinical Research. This principal investigator led network has expertise in Dermatology, Immunology, Inflammatory diseases, and other areas relevant to CenExel’s model. CenExel is owned by Webster Equity Partners and has only been around for about 3 years. Whether this is a small side acquisition or if the PE backers want to build out the network isn’t clear at this time. What is definitive is that the role of site networks is evolving in clinical research. We can expect plenty of shifts and shuffles in this segment of the clinical research landscape over the next 5 years.
Closing Credits
Thanks for joining me on The Niche Podcast; your weekly summary of top news in the biotech, pharma clinical research, 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.