Aegerion Pharmaceuticals Expected To Take A Hit [View article]
There is an interesting article in BioCentury this week comparing the two drugs. There are a couple of key points that I'd like to point out. According the thy Kynamro label, "The use of KYNAMRO as an adjunct to LDL apheresis is not recommended." Hence, those patients currently on apheresis are not targets for this drug. As lipidologist Gilbert Thompson says in an interview for the artilce, "If Kynamro is not recommended with apheresis, then from the point of view of any clinician who is treating hoFH, I think they would go for Juxtapid.” With respect to pricing, it doesn't make difference to the prescribing physician - they want to use the best drug, which is Juxtapid. Lipidologist Eliot Brinton states, "the $59,000-$119,000 price difference would not be a driving factor in his choice of treatment." There may be some patients that docs put on Kynamro (women of child-bearing potential, patients with gastrointestinal disorders or those on concomitant therapies that have interactions with Juxtapid), but the drug of choice is unambiguously Juxtapid for the majority of patients - this is the conclusion of every piece of market research and stands in to reason from the data.
Aegerion Pharmaceuticals Expected To Take A Hit [View article]
This is one of the most ill-informed articles I have read in a long time on Seeking Alpha. You state, "Kynamro has not displayed any potential serious damage to the liver." Have you even looked at the drug's label???? Here is the link to it in case you can't find it: http://www.kynamro.com~/media/Files/Kynamro/... Notice the black box warning for hepatotoxicity. You may be the one person on the planet who is interested in these stocks and the HoFH market that can't identify this important feature of the label. Furthermore, every analyst that I've seen who has done a comparison of Juxtapid and Kynamro, has concluded that that Juxtapid is the superior product on efficacy, safety, and tolerability. I do, however, see ill-informed speculators, such as yourself, who are backing Kynamro for some inexplicable reason. The overall superiority was even evident in the FDA panel that was held prior to approval of both products. I'm 99% sure you were not paying attention to the panel or you have no ability to interpret drug data. In addition, we have conducted a survey of lipidologists that showed Juxtapid was preferred 2:1 over Kynamro (http://bit.ly/nEORWJ). At the very minimum, you should make an attempt to get the facts straight.
At the end of the day, the vote was close for mipo (9/6), the vote for lomitapide was not (13/2). My survey indicated that lipidologists prefer the profile of lomitapide, which is consistent with the AdCom panel voting. I'm not sure how anyone can look favorably at mipo over lomitapide, which has superior safety, tolerability, and efficacy.
Physician Survey Results On Lomitapide And Mipomersen Support Our Thesis [View article]
I have not talked to any cardiologists, but my gut feeling is these incredibly severe patients are seeing a relatively small number of experts (lipidologists). I expect the company to need a very small sales force and for them to have a very attractive P&L, much like Alexion. Awareness of the product is already high and the company has stated that they are identifying candidates for therapy now. My expectation is the stock runs into a panel/PDUFA and if approved goes up 2-3x from where it is now.
Physician Survey Results On Lomitapide And Mipomersen Support Our Thesis [View article]
That is not the conclusion. The conclusion is docs prefer lomitapide over mipo. A QD oral is better than an weekly SC injection. Efficacy and tolerability are both better for lomitapide - hence the physician preference. Its not a stretch by any means.
Aegerion Pharmaceuticals: We Are Bullish On The Lomitapide Story [View article]
I fully expected them to finance, which I noted. While I wish I had sold before this deal, I have not and have bought more today. Now that the financing overhang is gone. I fully expect the stock to run into panel/approval. I'm not playing this stock to make a buck or two. I'm playing it to make over 100%
Aegerion Pharmaceuticals: We Are Bullish On The Lomitapide Story [View article]
I would urge you and others to compare the efficacy and safety/tolerability for the two products and make an investment decision based on an analysis of the data. I also think the track record of management is an important factor in making an investment decision. The scenario by which both products get approved with similar labels and warnings is possible (versus only one product getting approved). Should they both get approved, I think Aegerion's product is going to be the commercially dominant product - again, this is just based on my interpretation of the data that I've seen. My interpretation of FDA's request for a larger data set for mipo is that they have concerns about the product. Again, this is just a subjective viewpoint. Your points do not argue for a "rapid approval." If you recall, GENZ/ISIS submitted their NDA in March 2012 and have a January 2013 PDUFA date - this is a standard 10 month review. Neither company got a Priority Review - what do you make of that?
Aegerion Pharmaceuticals Expected To Take A Hit [View article]
Aegerion Pharmaceuticals Expected To Take A Hit [View article]
http://www.kynamro.com~/media/Files/Kynamro/...
Notice the black box warning for hepatotoxicity. You may be the one person on the planet who is interested in these stocks and the HoFH market that can't identify this important feature of the label.
Furthermore, every analyst that I've seen who has done a comparison of Juxtapid and Kynamro, has concluded that that Juxtapid is the superior product on efficacy, safety, and tolerability. I do, however, see ill-informed speculators, such as yourself, who are backing Kynamro for some inexplicable reason. The overall superiority was even evident in the FDA panel that was held prior to approval of both products. I'm 99% sure you were not paying attention to the panel or you have no ability to interpret drug data. In addition, we have conducted a survey of lipidologists that showed Juxtapid was preferred 2:1 over Kynamro (http://bit.ly/nEORWJ). At the very minimum, you should make an attempt to get the facts straight.
Aegerion's Lomitapide - FDA Approval, Strong Launch, Stock Price Increase Anticipated [View article]
Aegerion's Lomitapide - FDA Approval, Strong Launch, Stock Price Increase Anticipated [View article]
Aegerion's Lomitapide - FDA Approval, Strong Launch, Stock Price Increase Anticipated [View article]
Aegerion's Lomitapide - FDA Approval, Strong Launch, Stock Price Increase Anticipated [View article]
Aegerion's Lomitapide - FDA Approval, Strong Launch, Stock Price Increase Anticipated [View article]
Physician Survey Results On Lomitapide And Mipomersen Support Our Thesis [View article]
Physician Survey Results On Lomitapide And Mipomersen Support Our Thesis [View article]
Physician Survey Results On Lomitapide And Mipomersen Support Our Thesis [View article]
Physician Survey Results On Lomitapide And Mipomersen Support Our Thesis [View article]
Aegerion Pharmaceuticals: We Are Bullish On The Lomitapide Story [View article]
Aegerion Pharmaceuticals: We Are Bullish On The Lomitapide Story [View article]
Aegerion Pharmaceuticals: We Are Bullish On The Lomitapide Story [View article]
Aegerion Pharmaceuticals: We Are Bullish On The Lomitapide Story [View article]