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Sanofi Sells Two Portfolios of Established Products for CNS Disorders, Pain and Vascular Diseases to Neuraxpharm
The deal - encompassing 17 molecules - will more than likely strengthen Neuraxpharm’s position in the CNS market in Europe and completely makes sense in terms of strategy.
I am personally a big fan of Paul Hudson and I think trimming the fat is the right thing to do to keep Sanofi competitive on the long term.
And trim he did. Over the last 24 months Sanofi has been offloading its least strategic assets - both in Rx and consumer health - to a variety of buyers. The trimming also includes royalties, the API business and an upcoming 6,000-strong round of layoffs.
The direction Hudson is taking Sanofi in is a refreshing one, especially when compared to the slow Brandicourt years that were marked - for better and for worse - by Sanofi’s exit from the diabetes space, the dengue vaccine Dengvaxia fiasco, and the strategic asset swap (animal health for consumer health) with Boehringer Ingelheim.
Hudson’s vision for a new and leaner Sanofi can also be illustrated by its complete rebranding announced in early 2022.
Hudson wants to focus the company’s resource on first-in-class/best-in-class assets like Dupixent. Dupixent has tremendous commercial potential - especially given the breadth of its current and potential indications - but is facing intense competition from AbbVie’s Rinvoq. Rinvoq did better than Dupixent in a pivotal eczema trial in terms of efficacy but safety is a generally a concern with JAK-inhibitors like Rinvoq. Very recently, AbbVie started ramping up its ad spend for Rinvoq while Sanofi had started spending less on its Dupixent ads. Now with more cash on hand, Sanofi should be able to defend its mindshare and market share in the long run.
Other examples of first-in-class/best-in-class plays are the recent European approvals of enzyme replacement therapies Xenpoxyme and Nexviadyme.
One other area where Sanofi is strategically investing in is AI-based drug discovery and development - especially in oncology and immunology - through partnerships with Exscientia, Yseop, Owkin and other players.
And last but not least: the COVID-19 vaccine program in collaboration with GSK. I must say that I was extremely surprised that an entity with such a vaccine-rich history such as Sanofi (Pasteur) was not one of the first players to enter the COVID-19 vaccine market, but better late than never, right? The data shows that the vaccine candidate potentially provides more protection against omicron variants when compared to approved jabs but I am ambivalent in terms of its commercial potential given how crowded this space is.
An important factor that is not often mentioned is that Sanofi is not necessarily in a bad position when it comes to patent cliffs, especially when compared to other large pharmas such as BMS or Pfizer. I think this is giving Sanofi the time to carefully craft its long-term strategy without having to worry about replenishing its pipeline as soon as possible.
Intercept Announces Positive Data in Fibrosis due to NASH from a New Analysis of its Phase 3 REGENERATE Study of Obeticholic Acid (OCA)
I will start by saying that NASH is an absolutely brutal space with an incredibly high rate of failure in terms of clinical trials - it’s actually so high that there is a paper called “Why do so many NASH trials fail?” (a highly recommended read if you’re into that space).
So it wasn’t really a surprise seeing Intercept getting slapped with a CRL in 2020 for its obeticholic acid for the treatment of fibrosis due to NASH.
Now they are re-analyzing the data from the pivotal REGENERATE trial again, but this time instead of relying on individual pathologists to study the biopsy samples, they are using “consensus panels” of three pathologists to reduce bias - in-line with FDA guidance.
Now, let’s take a second to think about the fact that Intercept’s management was “surprised” by the FDA being less than happy with the idea of having only individual pathologists examine the sample. Did management really need the FDA to tell them that having only one set of eyes for each sample is a relatively important methodological flaw? I was - still am - really surprised that no one advised management that this could be a liability and a huge source of bias when the trial was being designed.
This makes me skeptical of Intercept’s management. Don’t they have KOLs for that?
In any case, the new analysis yielded the same conclusions as the initial one in terms of efficacy:
The 10 mg dosage hit none of the 2 endpoints
The 25 mg one only hit 1 endpoint of the 2: “At least one stage of fibrosis improvement with no worsening of NASH”
So the 10 mg dosage is not “approvable” due to the lack of efficacy, while the 25 mg dosage has good efficacy (only one endpoint needs to be hit).
But the problem with the 25 mg formulation - and obeticholic acid in general - is the safety profile.
Ocaliva is approved for primary biliary cholangitis and has a black box warning capping the dose at 10 mg due to the risk of serious liver injury. This is in addition to other reported safety concerns such as pruritus as well as gallbladder and LDL levels issues. Intercept management might think that these safety signals are “monitorable and manageable” but I wouldn’t be that sure.
I don’t see the 25 mg formulation getting approved - at least based on the currently available data - due to its safety profile. I would need to see more safety data to change my mind.
I also don’t trust Intercept management to come up with any sort of viable risk-mitigation program when push comes to shove.
It is worth noting that if approved, Ocaliva would be the first treatment for fibrosis due to NASH. But Intercept is not the only player with their eyes on the NASH space: GSK, Gilead, Novo Nordisk and a bunch of other biotechs have their own NASH programs.
DISCLAIMER: This is for informational purposes only, you should not construe any such information or other material as legal, tax, investment, financial, or other advice.
DISCLOSURE: I am long $SNY, $PFE, $ABBV, $BMY, $GSK, $NVO and $GILD. I have no business relationships with any company that is mentioned in this article.