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
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...
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
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.
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
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 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
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
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
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
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
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
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?
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 Pharma downgraded to Sell from Neutral at Guggenheim (18.59)
About VolanesorsenVolanesorsen (ISIS-APOCIIIRx) is an antisense drug in
development intended to treat patients with severely high triglycerides either
as a single agent or in combination with other triglyceride-lowering agents.
Volanesorsen is designed to target apoC-III, a protein produced in the liver
that plays a central role in the regulation of serum triglycerides.2 Humans who
do not produce apoC-III have lower levels of triglycerides and lower instances
of cardiovascular disease.3 Humans with elevated levels of apoC-III have high
triglycerides associated with multiple metabolic abnormalities, such as insulin
resistance and/or metabolic syndrome.4 In addition, the prevalence of type 2
diabetes is increased in patients with elevated triglycerides.5 Humans with
severely elevated levels of triglycerides are at risk of many serious health
conditions, including pancreatitis,4 which can be life-threatening and require
hospitalization. Volanesorsen is currently being evaluated in a Phase 3 study
in patients with FCS. A second Phase 3 study of volanesorsen is planned to
begin later this year in patients with Familial Partial Lipodystrophy, another
severe and rare lipid disorder.
It is a big joke, based only on some old genetic data. ISIS is always unreliable