You have not listened to anything I've said and argued with me with AEGR way over a $100 and you are doing the same without doing any homework. ISIS will be going for two orphan indications for their ApoC III inhibitor. One is for FCS, and the second is for partial lipodystrophy. The reason why partial lipodystrophy is because there is no one else going for that indication. But once approved look for them to go after lipodystrophy in the area that AEGR is in as well as acquired lipodystrophy. If you really followed the physiology behind the disease you might understand. Keep your strong buy recommendation on AEGR just as you have since it was over a hundred. t
Aegerion is certainly a poorly managed company, but ISIS beats them easily. One maketed drug, Kynamro, with less than 100 users only in the US. Now this idea of anti apo CIII for lipodystrophy. Plain delusion: why should a drug as they state "robustly reducing triglycerides" have any effect on lipodystrophy?
Aegerion is certainly a badly managed company, but ISIS beats them easily! One one marketed drug, KYNAMRO, used by less than 100 patients, only in the US. Now this idea of anti apo CIII for lipodystrophy: plain delusion. Why, as they state, should a drug "robustly reducing triglycerides" improve lipodystrphy? Their CEO's last name (Crooke) is most appropriate.
Sentiment: Strong Buy
ISIS is going for an indication for their ApoCIII inhibitor for orphan drug status for PARTIAL lipodystrophy. They are going for this indication first as there is no other drugs available for this. Once they get that indication they will be going for treatment for full lipodystrophy. It will cost less than AEGR's drug, will treat the disease more directly and will be notable safer. Also, will probably really lower CV risk compared to the AEGR drug. t
Unfortunately unfortunately there are very few undiscovered homozygotes to be found. Today's new low expresses the market seems to agree with that sentiment. t
Juxtipid will work in severe HoF where PCSK9 inhibitors won't, but in real truth there aren't that many HoF patients out there and no matter how many times Mr. Beer wants to do another study looking for more they won't be found in any new huge quantities. Also, if you are a practitioner you should know how insurance companies work. A patient no matter what will have to show a failure on a $1000 dollar per month drug before they will be able to use a drug that costs $33, 000 per month. t
At the Atherosclerosis Congress in Amsterdam dr Raal presented one year data on homozygotes treated with evolocumab (a major PCSK9 inhibitor). Rather disappointing. Mean LDL-C reduction little more than 20%, vs 45-50% with lomitapide (also my own experience). Lomitapide, if properly handled, is also well tolerated.
Sentiment: Strong Buy
I don't disagree, but the fact is that IMO about 70% of the patients in the US have already been flushed out. And with the newer agents some patients that would have qualified for juxapid will not now, or they will have to fail on the much cheaper PCSK9 inhibitors:
Alirocumab treatment effect on non-HDL-C: Pooled analyses of 10 phase 3 trials in the ODYSSEY program
Journal of Clinical Lipidology, 06/16/2015
Bays HE, et al.
To assess the treatment effect of alirocumab on non-high-density lipoprotein cholesterol (non-HDL-C) across 10 studies in patients with heterozygous familial hypercholesterolemia, high cardiovascular (CV) risk, and/or statin intolerance. Researchers determined that alirocumab significantly and consistently reduced non–HDL–C levels, and a highly significant percentage of patients achieved their non–HDL–C goals.
In this analysis of 10 diverse alirocumab clinical trials, two trials (n = 2,416) compared alirocumab 150 mg every 2 weeks (Q2W) versus placebo.
Eight trials (n = 2,499) evaluated alirocumab 75 mg Q2W, increasing to 150 mg Q2W at week 12 if low-density lipoprotein cholesterol (LDL-C) goals were not achieved at week 8.
In five trials, the comparator was ezetimibe; in the other five, it was placebo.
Patients received stable background statin +/- other lipid-lowering therapies (LLTs), except in two trials (conducted without statin).
Non-HDL-C may be a stronger predictor of atherosclerotic cardiovascular disease (ASCVD) risk than LDL-C.
Alirocumab reduced non-HDL-C levels by up to 53.2% at week 12 and was consistent at week 24; it also reduced LDL-C, ApoB and fasting triglyceride levels.
A substantially higher percentage of patients who received alirocumab achieved their non-HDL-C goals of
Some patients will not respond to PCSK9's. Just a fact that all do not respond to treatment. These patients will be identified for Juxtapid patients.... There is value in Juxtapid but not as much as we everyone hoped for....
I agree with you CJ. What a disaster purchase. It did allow AZN to pick up two excellent respiratory drugs from ACT for like half off thanks to Mr. Beer. t
the only reason the drug was acquired was to take the attention off the failed launch of juxtapid and to quiet growth concerns to delusional shareholders after the miserable Q4 2014 ER report. I sold after that CC because it became clear that this co was doomed and it was essentially an hour long apology by all of mgmt following the sex scandal, horrible numbers, and an admittedly FLAWED model that they said was far too optimistic on sales growth and underestimated reimbursement issues. This drug just let the mgmt draw another 2 years of salary and eventually this co gets sold for pennies.
Myalept has some pretty scary side-effects to be used in NASH. Couple that with the cost per patient and it isn't feasible to be a drug for that indication. I still can't believe that Mr. Beer paid that much for that drug. He should really get out of biotech altogether IMO. t
Myalept is where the value for AEGR is. They will explore an indication for NASH patients as well as other indications. Juxtapid will be overdone this year and expect a big big drop off in revenues. Maybe they can sell the company finally......he paid over 300 m for myalept which was a lot at the time given minimal sales and peak estimates of 250m or so...
I trust AMGEN and Regeron will do a better job at helping patients than BEER who enriched himself while other will surely lose their investments. There is nothing left to AEGR but an empty shell led by a narcissistic sleaze bag.
WASHINGTON, June 10 (Reuters) - An advisory panel to the U.S. Food and Drug Administration recommended approval of Amgen Inc's cholesterol-lowering drug Repatha but said it should be only used in patients at high risk of cardiovascular disease.
The panel voted unanimously to approve the drug, known also as evolocumab, for patients with homozygous familial hypercholesterolemia (HoFH), a hereditary disorder that causes high LDL and can cause heart attacks in very young people, including children.
They voted 11-4 to approve Repatha in patients with high cholesterol who are at high risk of cardiovascular disease whose cholesterol cannot be lowered sufficiently using statins or other drugs.
The FDA is not obliged to follow the advice of its advisory panels but typically does so
Sentiment: Strong Sell
The scary thing is that about 70-75% of all patients are on only 5 to 10 mg and the cost is already $350K. There will be more resistance around the globe to foot a higher than what is already a very high price for a drug that is now about 25 years old. Just like what happened when GILD got too greedy and the real price in India for their HepC drug is $900 for a full course instead of $84K something like that will happen to juxapid in many places around the world. t
They have to do this because of sales not being able to meet those lofty goals. I hope Mr. Beer doesn't bragging again that they had to do this to meet increased demand. This latest movement could explain the reason for the exodus of MF the CFO. t
You are hoping for magic and you might want to think about what you are saying. You are saying that juxtapid that isn't making enough money right now will/could cut their prices and "wipe out" Mipo. If anything they are going to have to increase the price or hold where they are. They will undoubtedly have to cut their price to other countries and I think they have made that very plain. But they have earnings short-falls as it is and a price cut would just hurt them further. Also, keep in mind that as cheap as juxta is to make, it only costs about 40 cents for dose of Mipo in regards to the actual ingredients. Your other dream is that the new CFO is going to do all of this magic, get more patients on the drug, cut the costs, and get more people out there to sell this when they already have over 100 reps for an orphan drug. At the same time they have a study going on in Japan, and they are planning to do pediatric studies.....with almost no money since Mr. Beer bought the lipodystrophy drug. I don't know where you are coming from, but if you are really a small investor and you believe everything you've said with outdated data.....I wish you the best. If you are a hired gun then I expect to see the same. t