"Needham & Company Reiterates a 'Buy' on Aegerion Pharmaceuticals (AEGR); Now (Enhanced Mgmt Team, Robust Phase 3 Primary Endpoint Data) and Then (Phase 3 56-week follow-up 2Q11, FDA submission likely . . ."
This, according to StreetInsider.com
Yahoo gremlins are preventing me from posting the full reply I intended. However, the gist of same is the following:
If I gave the impression that I disagree with you, then I apologize.
Even when you do get approved the FDA often times wants more info:
First New Lupus Drug in a Half-Century Approved
The FDA has approved belimumab (Benlysta) to treat patients with systemic lupus
erythematosus who are already receiving standard treatment. Belimumab, a fully human
monoclonal antibody that targets the B-lymphocyte stimulator protein, is the first
new lupus therapy in over 50 years.
In two trials comprising some 1700 patients with lupus, those treated with belimumab
plus standard therapy had less disease activity than patients who receive placebo
plus standard therapy. The belimumab group may have had fewer severe flares, but the
studies were not conclusive. Patients taking belimumab had a higher rate of death
and serious infection than the placebo group.
In these studies, the treatment did not seem effective in people of African or
African American heritage, but the study populations weren't large enough to make
definitive conclusions. The FDA has asked the manufacturer to undertake another
trial in this subgroup.
Of course having money come if you get approved for something makes it easier to take, but this company has some major proving to do. t
MTP's lower HDL and still haven't addressed possible negative sequeulas from intestinal fat accumulation. I don't know Bio, I think the FDA is going to want to see more data, like at least another, probable two year's data. T
Bio, inclusive with the intestinal fat build-up should be studies evaluating malabsorption syndromes brought on by the MTP. For example, what are the levels of all fat soluble vitamins in the blood and in body stores after 3 mos, 6mos, a year etc. Would a severly low Vit D level cause secondary hyperparathyroidism? I would also suspect any type of GI problem that is pre-existing will eliminate its use and some occult GI problems will be exposed with the MTP inhibitors use. The most valuable asset the company has is the CEO's salesmanship and I assume that will be most valuable to him only in the long. t
Bio, the most troubling issues for me besides the CEO of AEGR's cavalier attitude is the decrease in HDL and more importantly what happens to the form of that decreased HDL? Is it more useful or not? I don't know myself, but am trying to learn. Also, that fatty accumulation in the intestines. That organ/iatrogenic organ dysfunction has not been addressed in any of their CC's and I think the CEO is mistaken to think that the "new" FDA isn't going to pay attention to that detail. Also, of importance is the fact that there are only 23 patients remaining from their original 29. These patients are under a strict 20 gm per day fat diet. How many people are going to make that target as an outpatient? I suspect not too many will succeed. If you use Xenical as your model, the drug we call the policeman for fat, I don't think the MTP-inhibitor will fare too well with long term use. Xenical came out over 10 years ago with great fanfare. Once people found out what it really was all about it's all but disappeared. I saw one lady who almost threw the bottle at me and said the med didn't work and it made her sick. I ask her what she had for supper last night and she told me "spare ribs." I noted to her that spare ribs was a very fatty food and she shouldn't have that if she wanted to take Xenical with any chance for success. She then replied, "I only ate two, I usually eat three." I think that will give you some idea about what you're dealing with in regards to the American public and their being used to "having it your way." t
I'm pretty sure the Needham analyst is Mark Monane. He asks a lot of questions on many of the biotech ccs I listen to, including ISIS. (I think he is an MD.)
Given that Crooke made it a point of contrasting Mipo's clinical studies with Lomitapide's, one might have thought that an analyst might have followed up and asked AEGR's management to reply to Crooke's contention. No such luck.
Oh well, zzzzzzzzzzzzzzz. (Sorry. I couldn't resist.)