Friday, April 7, 2023

T1D Research News (Quick Bits from April)

This blog covers three pieces of news which do not apply directly to cure focused research, but which I found interesting anyway.

  • Tight Honeymoon Control Does Not Improve Long Term Insulin Production
  • Insulin Price Drops
  • Sanofi Buys Provention

Tight Honeymoon Control Does Not Improve Long Term Insulin Production

For many decades, there has been a theory that sugar itself was toxic to beta cells, and that tight blood glucose control during the honeymoon phase would result in longer beta cell survival, more natural insulin production, and therefore better long term results.  I don't think this was ever the majority belief, but some people definitely did believe it, and they advocated for very tight controls in recently diagnosed people.

The study reported on below compared C-peptide production in people who used a hybrid closed loop at diagnosis to those who did not.  Those with the hybrid closed loop were in range 14% more than those who did not, showing better control.  However, this did not affect C-peptide production.

https://jamanetwork.com/journals/jama/fullarticle/2801975

Insulin Price Drops

The retail cost of insulin has been going up for decades, even as the manufacturing cost has been dropping (relative to inflation).  However, that is ending as Sanofi, Eli Lilly, and Novo Nordisk have all announced huge price cuts in the United States.   See https://www.cnn.com/2023/03/16/health/sanofi-insulin-price-reduction/index.html (and many other news sites) for details. 

Why Is This Happening?  

This is happening now because these companies are about to face a new competitor, who they have never faced before.  In March 2022, JDRF announced that they would work with a non-profit, Civica to manufacture low cost insulin.  In June, California announced that it would manufacture low cost insulin.  Finally, in March 2023 California  announced that they had signed a contract with Civica to manufacture insulin which would be distributed by CalRx for $30.  During this same time, the US Senate passed a law capping insulin copays at $35/month for medicare patients, and several states also passed laws limiting insulin costs in various ways.

So the three commercial insulin manufacturers had little choice and dropped their prices by 90%. 

Discussion

A full discussion of this will take much more space than I have here. However, the very quick summary is that we have seen a huge "market distortion" for decades in the price of insulin. The insulins available have not changed in decades, their manufacturing has not changed, and yet their price (adjusted for inflation) has gone up very steeply and steadily. This is the exact opposite of what a market economy should do.  If you look at the price changes (shown below) it is pretty clear that the companies involved have realized that they can make more money by raising prices when their "competition" does, rather than actually competing with them. 

But now we have a non-profit, with seed funding from the state of California, and the support of JDRF, competing with the three existing corporate insulin manufacturers.  Just a few months after this competition was announced, all three of the corporate manufacturers have announced huge price cuts.  My guess is that California (as a state) will end up cash positive before they even start distributing their insulin.  The citizens of California will already have saved more money on insulin than California used to fund Civica.  JDRF will be in even better shape, since their "cost" was only in publicity, lobbying, and coordinating, but (again) their membership will save real money every month.

For me, this is an interesting experiment.  The last few decades have shown very clearly that the free market does not work for life-saving products when there are only a small number of manufacturers.  Even economists understand that the free market does not work when there is a monopoly, but it is clear from the price of insulin, that it does not work for 3 companies, either.  With 3 manufacturers, they learn that they can make a lot more money by not competing, than by competing.  So that is what they do.  As we move forward, we will see if 3 for-profit manufacturers and 1 non-profit/public-good manufacturer create a better market for society as a whole.

The big insulin manufacturers themselves claim that their profits motivate new breakthroughs and better products.  This is obviously untrue for insulin.  No actual improvements in insulin have been marketed in over a decade.  Lantus was approved in 2000; Levemir in 2005, Humalog in 1996, and  Novolog in 2000.  




From California:
https://www.healthcaredive.com/news/California-manufacture-insulin/626916/
https://www.gov.ca.gov/2023/03/18/governor-newsom-announces-30-insulin-through-calrx/
From JDRF:
https://www.jdrf.org/press-releases/jdrf-announces-support-of-civica-to-manufacture-and-distribute-low-cost-insulin/

Sanofi Buys Provention (And Other Tzield News)  

Provention is the company that just got FDA marketing approval for Teplizumab / Tzield for people at risk of T1D.  The new news is that Sanofi is buying Provention. Obviously, Sanofi is a very large "big pharma" company, and Provention is a small "boutique" drug development company.  I'll leave it to the business analysts to comment on this, but it is very common for big pharma companies to buy boutique drug developers when they have a successful product, so this should not surprise anyone.  I would not expect anything to change for Teplizumab, but only time will tell with certainty.  

In the long term I think this is good for T1D cure creation in general.  Sanofi is paying good money for Provention, and that will motivate future investors and future executives to try to find disease modifying treatments for T1D.  These guys made a huge pot of money doing exactly that.  The stock price went up about 350%.  That should motivate people!

One comment I've often heard in the years since I started the blog, is that companies that make a lot of money off of T1D are not going to invest in cures.  This is not exactly that, but it is pretty close.  Sanofi makes a lot of money off of insulin (see above), and Tzield should delay the start of that revenue stream in people who use it, and yet they still were willing to put a lot of money in Provention.  And if they now kill it, that will be pretty obvious and very public.   Sure they could do it, but not in secret.

Put another way, over the last 6 years, about 1/2 billion dollars have been invested in Provention, and it is now worth about 3 billion.  That is great return on investment!  Those investors will want to do that again, if they get the opportunity.

News coverage: https://www.reuters.com/markets/deals/frances-sanofi-acquire-us-based-provention-bio-29-bln-2023-03-13/

Other Provention/Tzield News

I've learned a few more things about Tzield:

  • A few people have gotten the Tzield in the Sacromento area, and a few people are about to get it in the San Francisco area.  In all cases, the treatment was covered by their insurance.
  • About half the people who get it get "flu like" symptoms, which last a few weeks.
  • Because it requires an infusion every day for 14 days, and these are done in clinics, you need to have access to a clinic which is open 7 days a week, and you need the time and transportation to get there. 
Joshua Levy
http://cureresearch4type1diabetes.blogspot.com
publicjoshualevy at gmail dot com
All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.