Jack Haddad

Amylin's Pullback Is Unjustified

DocJones, I still do not understand your anger? What's so upsetting about the contents of this article. Why don't you provide me a link to show evidence of how these two molecules have the same mechanism of action.

Furthermore, you have to understand that Liraglutide got denied based on a weak "methodology and design" clinical trial. The safety and efficacy of the the agent could have been demonstrated and presented in a much improved manner to the FDA.


On Apr 10 10:24 PM Doc Jones wrote:

> I am truly upset about this article, there is a lot of speculation
> here not based on facts. I am a Endo that participated in the the
> original byetta studies and just recently the liraglutide Lead-3
> and Lead-6. It should be noted that Liraglutide and Byetta have the
> exact same mechanism of action. Liraglutide is 97% homologous to
> endogenous GLP-1 and Byetta is 57% homologous. Both molecules are
> albumin bound and resist the action of DPP-4. The question about
> the c-cell tumors came about when a few instances were seen and mice
> and rats. It is important to note that rats develop c-cell tumors
> on their own and the mice and rats that developed c-cell tumors on
> Liraglutide had 36 times the normal human dose. When doses 60 times
> the normal human dose were used in primates there was no traceable
> action on calcitonin levels. All 5000+ patients that took also had
> no change in calcitonin levels. Novo Nordisk knew there could be
> a link and decided to monitor calcitonin levels unlike Byetta trials.
>
> As for the FDA advisory committee, the major concern was cardiovascular
> risk and Liraglutide passed with an 8 to 5 vote based on the favorable
> lipid profile and blood pressure data up to 1 year (Lead-3). The
> question asked about the c-cell tumors was can the occurrence in
> animals be linked to humans and the first vote was 12 to 1 and after
> the thyroid expert explained c-cell tumor occurrence and overall
> physiology the panel voted 6 to 6 with 1 vote abstained. The fact
> of the matter is there could be a link but in order to study this
> link studies would have to be done in excess of 10 years due to nature
> of these type of tumors. If the FDA does accept the NDA for Liraglutide
> it will likely require more safety data. I have clinical experience
> with Liraglutide and have seen the benefits and feel that it is a
> needed drug in diabetology. I suggest you write an article based
> on facts rather than opinions and fore-drawn conclusions.
> Doc Jones MD

Amylin's Pullback Is Unjustified

Nova, having Carl Ichan as "activist investor is a blessing. We need him to keep riding the executive board until good change is done. I'm very optimistic.

I will re-enter AMLN this coming Monday; the May strike 10 calls at 1.10 and more are a great premium and a hedge against a downside.


On Apr 09 10:54 PM nova wrote:

> Jack,
>
> You are correct. Byetta and liraglutide are distinct molecules even
> they do belong to the same "class."
>
> FDA Scientific Advisory Committee concluded that Liraglutide (a diabetes
> drug made by Novo Nordisk (seekingalpha.com/symbo...)) posed
> a significant risk in causing thyroid tumors in humans. The vote
> was 12:1 to support such conclusion.
>
> Unfortunately many people on Wall-Street have no clue about a degree
> of devastation cancer can bring to people and their families. In
> a case if the FDA give a "green light" to Liraglutide, it will be
> an incredible travesty to our health care exposing a great number
> of patients to cancer devastation and consequences.
>
> Assuming that, at best for Liraglutide, it approval will be delayed
> by at least a few years, Byetta with it superior to other diabetic
> drugs efficacy profile will be able to substantially penetrate the
> huge diabetic market.
>
> The major problem with AMLN is its management: highly incompetent,
> highly greedy and corrupt. It is of interest that Amylin reminds
> me ImClone. As soon as ImClone got rid off its old Board and CEO,
> the company, in spite of Wall-Street insinuations and lies, was able
> to move forward successfully and be sold later to LLY at a very substantial
> premium.
>
> In my opinion, as soon as Amylin will get a new management and LAR
> Byetta approved, it can be sold in two years at ~$6B+ or for $50+
> per share. The present AMLN price below $10 is just ridiculous.