Arguably the most important takeaway from the following is that although the Public Citizens' search discovered 26 cases of thyroid cancer associated with Victoza it also discovered 20 cases of thyroid cancer associated with Byetta.
Anybody considering making a buyout offer will doubtless factor in potential repercussions from the Public Citizens' initiative. Even if the FDA ignores it, the publicity would hardly be helpful to anybody looking to reverse the three-year decline in use of exenatide.
And the ongoing proceedings in the Los Angeles Superior Court seem likely to result in a finding that exenatide therapy is either innocent or guilty. Either way one would expect label changes to follow - affecting the value of the exenatide asset.
From an article on the Public Citizens' initiative -
"Data generated by Public Citizen's Health Research Group
We found 26 cases of thyroid cancer associated with liraglutide treatment by analyzing the FDA's AERS database from February 2010 through September 2011. We used MedDRA terms and found for "thyroid cancer" (n=10), "thyroid neoplasm" (n=12), "thyroid adenoma" (n=1), and "thyroid cancer metastatic" (n=3). Using a similar search, we found no thyroid cancers reported to the FDA for the diabetes drugs nateglinide, repaglinide, glipizide, or sitagliptin.
There were two cases reported for rosiglitazone (thyroid adenoma and thyroid neoplasm), but twenty for exenatide, the other FDA-approved GLP-1 agonist. Thus, it appears that the two FDA-approved GLP-1 agonists (liraglutide and exenatide) share the property of increasing thyroid cancer risk.
Elashoff et al, using the FDA's AERS database, found "pancreatitis more than six-fold more likely to be reported in association with sitagliptin or exenatide than other drugs for type 2 diabetes" (both work through the GLP-1 receptor, as does liraglutide). The rate of pancreatitis for exenatide itself was increased more than 10-fold compared to the rate for control diabetes drugs."
From the Butler Report (Elashoff et al) -
"It will be important to establish whether PanIN lesions and pancreatic duct glands express GLP-1 receptors and, if so, undergo proliferation in response to GLP-1 mimetic therapy. Such an effect could explain the relatively early signal for pancreatic cancer observed here.
Because of thyroid tumors in mice treated with liraglutide reported to the FDA by Novo Nordisk, we also examined the FDA AERS database for thyroid cancer in association with exenatide or sitagliptin therapy.
There was an increase in reported thyroid cancer as an adverse event related to exenatide or sitagliptin therapy (data combined) compared to other therapies, this increase was statistically significant for exenatide. GLP-1 therapy has been shown to lead to C-cell hyperplasia in rats, but it is unknown what, if any, effects GLP-1 therapy has on the human thyroid gland. The adverse reporting in the FDA database is not sufficiently sophisticated to robustly distinguish between thyroid cancer subtypes.
It is perhaps of concern that this signal has appeared in the relatively short duration the drugs have been available when there was little a priori concern that would be expected to bias reporting. The findings for pancreatic and thyroid cancer reported here imply that more detailed studies of the actions of GLP-1 on the thyroid gland and exocrine pancreas in humans are warranted."
Check out the "Legal Actions" link in the following post for extracts from Lilly and Amylin SEC filings regarding the thousand-plus law suits alleging injury or wrongful death as a result of using Byetta -
Perhaps whoever had the bright idea yesterday of hiding the link to this thread can now come up with a way of hiding the thread itself?
I'm guessing you've already used up your multiple ids in allocating one-star ratings?
"You present yourself as someone in the know, when actually your understanding of the significance and benefit:risk ratio of this revolutionary GLP-1 technology is considerably lacking."
You're as cheap as they come, aren't you? Wish I had a penny for every time somebody like you has tried to further his personal financial agenda in these forums by trying to influence others to focus upon my credibility rather than upon the information I provide.
Yep, good solid evidence to back my theory that Victoza decline is a major part of the valuation in pricing AMLN. Thanks Fud. Although I was more inclined to Victoza negative news regarding required ongoing studies for panccreatitis and the skipped cardio, chalk another one up Victoza - thyroid.
Thanks - I wasn't expecting anybody here to have the honesty to confirm that they believe the evidence of an increased risk of thyroid cancer with GLP-1 therapy will be a factor in any buyout valuation of Amylin -
"Using a similar search, we found no thyroid cancers reported to the FDA for the diabetes drugs nateglinide, repaglinide, glipizide, or sitagliptin.
There were two cases reported for rosiglitazone (thyroid adenoma and thyroid neoplasm), but twenty for exenatide, the other FDA-approved GLP-1 agonist. Thus, it appears that the two FDA-approved GLP-1 agonists (liraglutide and exenatide) share the property of increasing thyroid cancer risk."
But how do you see this working to Amylin's advantage? Using the more easily recognisable brand names, the Public Citizens' search discovered the following incidence of thyroid cancer -
Why do you think the FDA might withdraw approval of Victoza on the grounds of safety, yet take no action in respect of the other GLP-1 therapies Byetta and Bydureon which, allowing for the lesser use in comparison to Victoza, appear to carry the same risk of thyroid cancer?
Does anybody here see the Public Citizens' initiative as being a factor in any buyout valuation of Amylin?
Many posters here seemed to be optimistic that Public Citizens might be able to leverage their finding of an increased rate of thyroid cancer in diabetics who took Victoza to force the FDA to withdraw approval of the main competitor to exenatide therapy.
But the search also discovered a rate of thyroid cancer in diabetics who took Byetta which seemed to be proportionate to its use - and the conclusion was that an increased risk of thyroid cancer was common to GLP-1 therapy, as no cases were discovered in diabetics who took Januvia.
Surely anybody contemplating making an offer to buy the Company must be aware of the possibility of an FDA withdrawal of Byetta and Bydureon - and must be wondering if there are far safer biotech acquisitions available on which to spend $6 billion or more?
I'm guessing that this individual has lost interest in our discussion. Does anybody else here have any thoughts on the buyer perception of the risk that the FDA could withdraw approval of Byetta and Bydureon on the grounds of protecting public health?
After all, there are other competitive therapies - Januvia for one - which don't seem to carry the same risk of thyroid cancer.
I believe the net effect of your influence, if anyone took you seriously, was to deter them from buying an equity which would have been a windfall to their portfolio. I personally am up well over 100% profit in my common shares and up over 380% in my January 2013 calls.
What you have done is diminish the quality of life of those who took you seriously and did not invest in this company and taken food off of their tables. You present yourself as someone in the know, when actually your understanding of the significance and benefit:risk ratio of this revolutionary GLP-1 technology is considerably lacking. Why don't you just go away and stop harming the readers of this board further. You've done enough damage here.