My letter to Sanofi-aventis re: HIP

Dear Dr. Maas, Diabetes Research and Development at Sanofi and

Mr Christopher Vienbacher CEO:



I am a vigilant mother of a 10 year old boy with diabetes since age 2.

The struggles he faces to get through the day are heart breaking.

The tools (i.e. pumps, cgms, insulin…) we have thus far to manage his diabetes are just band aides.

I believe, as many others do in the diabetes community, that HIP is our answer.



Human Islet Peptide is part of the Reg3a gene that makes new islets

from pancreatic progenitor cells. This is known in the type 1

diabetes community. Sanofi-Aventis is being unfair to millions of people with diabetes,

whom they have committed to be an innovative leader in the field.

For the company to give up its islet neogenisis program with a human peptide, before it starts is unjust.



Please move this project forward. Sanofi-Aventis giving up on this

before human trials will set back diabetes for decades.







Sincerely,



Patrice Cocco



CC: Manny Hernandez, Founder TuDiabetes

As someone who writes about “the business of diabetes” the reality isn’t necessarily pretty. Sanofi makes BILLIONS selling insulin, specifically it’s blockbuster Lantus which alone is projected to grow to an astounding $6 billion in sales by 2014 when the patent expires, as well as Apridra. In Germany, Austria and Switzerland, which is arguably Sanofi’s home market (the roots of the insulin business come from the company once known as Hoechst AG), in addition to Lantus and Apidra, Sanofi also sells the Insuman® Brand of Human Insulin varieties. The reality is that an investment made in Human Islet Peptide may or may not pan out, but would almost certainly destroy a certain successful business: insulin as it exists today. However, regeneration by itself will not cure type 1 diabetes, something else to address the autoimmmunity problem and create immune tolerance to islets is also required. This, incidentally, is not the first time Sanofi (or it’s predecessor companies, notably Aventis); back in the late 1990s, the company dumped a product now being developed by an Israel-based company named Andromeda for an autoimmunity treatment known as Diapep 277. Whether these products make it to commercialization remains to be seen, but it would appear that Sanofi sees more money is keeping patients chronically ill than curing them.

I should add that it is highly likely that CureDM, Inc., as a biotech startup, has some right to terminate their contract in the event that the partner (in this case, Sanofi), is not acting in good faith to commercialize the molecule. I am not trying to rain on anyone’s parade here, only making sure that we have all the facts before presuming the worst!

Scott – I don’t understand why you are so against us trying to get Sanofi’s attention. Of course we understand that they may be abandoning the product. That’s precisely why we are urging some kind of action. I know the co-founder of CureDM and know that termination is not an option. Hence the campaign. I understand you do not want to participate and that you think the effort is futile. But your posts could impede what others really want to try. I don’t think that is really your intent. But I’m heavy hearted in the fear that may be the result.

This is Sanofi’s form letter response to us all!

Sanofi strives to help people manage the complex challenges of diabetes by delivering innovative, integrated and personalized solutions. Our vision is to serve as a valued partner to the diabetes community which we hope to accomplish by listening and engaging in a dialogue directly with people living with diabetes and we appreciate hearing from you. We believe your feedback and community engagement will help us to identify gaps to improve our existing offerings, identify new opportunities and forge new relationships to provide solutions that are truly relevant.

In all our activities, we always keep in mind the genuine interest of people with diabetes. We evaluate all our projects engaging internal and external experts and ensure that our development efforts are devoted to solutions providing benefit to patients. We can’t comment on this particular project you referred to for proprietary reasons; but we can reassure you that all projects which can bring real benefits to patients are a priority at Sanofi, and we remain committed to discovering breakthrough treatments for diabetes including a focus on beta cell function recovery. We look forward to providing updates to you when we have information available to share.

Sanofi Diabetes Team

This is my Response to Sanofi’s form letter:

Is Sanofi interested in diabetes or just selling insulin?–Beta Recovery is not Islet Recovery

Dear Laura:
Please be informed that Beta Recovery is not Islet Recovery. If Sanofi doesn’t know the difference between an islet and beta cell, I’m not comfortable using your insulin. Beta Cell Recovery is not associated with a cure for diabetes, whereas, Islet Neogenesis is. Does Sanofi-Aventis expect to be taken seriously as a diabetes company? I’m not a scientist, but I know the difference between beta cells and islets. Does Sanofi-Aventis know this?

At the very least, as person with diabetes, please tell your company that beta recovery is not the same as islet neogenesis. As the article explains, beta cells are not islets and islets are not beta cells. Please share this simple paragraph with Dr. Maas and Mr. Viehbacher. Mayber it will mean more coming from you as an employee of Sanofi. Thank you. Patrice.

From the Journal of Diabetes 2(2010) 76–84
The terms islet and beta cell are often used interchangeably, yet islets are highly complex multicellular organelles that contain the insulin-producing beta cell and four other cells types, all of which, play a role in maintaining glucose homeostasis within a very narrow range. While the formation of new islets in adults is rare, occurring primarily in response to pancreatic injury and major stress to the pancreas, beta cell replication from existing cells occurs throughout adulthood. Understanding of regulatory factors controlling pancreatic development has more clearly defined the differences between new islet formation from progenitor cells located throughout the adult pancreas and beta cell replication occurring within existing islets. This review sets forth to more clearly distinguish the differences between the postnatal pathways of islet neogenesis and beta cell replication with a discussion of the potential implications for reversal of type 1 and 2 patients utilizing islet neogenesis agents that are now in development. For type 1 patients, an immune tolerance agent in conjunction with an islet neogenesis agent may allow achievement of adequate islet mass, perhaps with subsequent potential to withdraw medications. For type 2 patients, lifestyle changes and/or medications may sustain production of new islets and limit the accelerated beta cell apoptosis characteristic of the condition.

what came of this?