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William Haynes

 
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  • FDA Delays Decision On Orexigen Anti-Obesity Drug - What This Means To The Stock [View article]
    If the delay is for a post-marketing obligation as they say then there are a few options:

    1. Preliminary data from the LIGHT study looks bad (point estimate for CV risk is above 1.0) but the 95% confidence interval is below 1.8 so the FDA has to approve the drug based on the SPA. They have the suspicion that OREX will dump the study as soon as they get approval and then there will be a potentially unsafe drug on the market with no definitive data on safety. So the FDA is trying to get OREX to agree to agree to fund and continue the LIGHT study as a post-marketing obligation.

    2. The FDA wants REMS or a black box around the BP and HR increases which OREX does not want (would kill the drug)
    Jun 11 03:56 PM | 2 Likes Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    I am an MD and direct a lipid clinic. There is no evidence that treating TG levels under 500 either reduces CV events or prevents pancreatitis. If TGs are above 500, then it appears that treatment prevents pancreatitis.

    The reason the FDA and AdCom went they way they did is likely due to a combination of the trials they referenced plus the torcetrapib fiasco (when Pfizer almost managed to railroad the FDA into approving an unsafe lipid drug), PLUS the Zetia controversy. In fact Zetia is closest to the situation with Vascepa. A drug that is not unsafe, but which gets a lot of prescriptions and marketing, but then is found to not protect from CV events. The FDA did not want another Zetia controversy, simple as that.

    Finally, it seems that a lot of the longs here swallowed the Amarin management line (LDL effects are substantial and important), rather than look at the data independently. In truth, the LDL effect of Vascepa is minor. And the drug is less effective at reducing TG than Lovaza.
    Oct 18 09:21 AM | 1 Like Like |Link to Comment
  • Amarin Will Receive A Positive Vote By The Advisory Committee [View article]
    SPA are guidelines only. The SPA was developed in 2008. There have been major changes in data since 2008. It is delusional to imagine the FDA will ignore the multiple studies since 2008 showing no benefit of non-statin drugs on CV outcomes.
    Oct 16 11:32 PM | Likes Like |Link to Comment
  • Amarin - Still Not Worried By A Generic Lovaza And An Update On Vascepa [View article]
    My only problem with talking about 'efficacy' is that Vascepa is LESS effective than Lovaza at the job it is hired to do. What is that job? Reduce triglycerides. Lovaza reduces TG by about 50%. Vascepa by 35%. LDL is a secondary target in such patients, has other drugs that can control it better, and is inaccurately measured and less prognostically important when TG is above 400. Non-HDL cholesterol is more accurate and important in such patients, and the differences here between Vascepa and Lovaza are less.

    So, when I see a patient in my lipid clinic (that I have run for 18 years), with triglycerides of 1000, and at risk of acute pancreatitis from that, what drug do I recommend? The one that lowers TG the most (Lovaza). If the non-HDL cholesterol is above target after I give that patient Lovaza, then I may add a statin or ezetimibe. But my primary target is triglycerides and I will use the drug that lowers that best. If the insurance won't cover Lovaza then I recommend over the counter fish oil (i.e. Super-EPA or similar).

    I have no position in Amarin or GSK or any other pharma company.
    Sep 17 09:22 AM | 1 Like Like |Link to Comment
  • New Competition Could Drive Novartis Shares Down [View article]
    Stock is now at 73.65. Your analysis was deeply flawed.
    Jul 13 12:40 PM | Likes Like |Link to Comment
  • Amarin's Anchor Will Hold As Vascepa's Sails Unfurl [View article]
    I don't understand these two contradictory paragraphs. Are Lovaza sales increasing or decreasing?

    'Lovaza works but it raises bad cholesterol. There's no wonder prescriptions for Lovaza declined from the 3rd quarter of 2012 through the first quarter of 2013. If a patient's bad cholesterol numbers are rising while his or her triglycerides are falling, that's not necessarily an acceptable trade-off. Doctors have noticed this and they're evaluating the risk-reward of prescribing it.'

    Compared to:

    'Notably, Lovaza revenues climbed in the first quarter of 2013 to a record $267.9mm while the previous two quarters were records as well. This seems to contradict the idea that doctors are some how disenchanted with "fish oil" as some would have you believe.'
    Jun 21 07:07 PM | Likes Like |Link to Comment
  • The Future Of Omega-3 Based Lipid Management: All Eyes On Amarin [View article]
    Citation on events only had 43 patients and is an unreviewed abstract. Huge number of scandals in Japan recently due to investigators there making up data. I do not think this work can be used as any kind of supportive evidence for benefit of EPA. Need to wait for REDUCE-IT.
    Jun 1 06:58 PM | Likes Like |Link to Comment
  • The Future Of Omega-3 Based Lipid Management: All Eyes On Amarin [View article]
    I am an MD and Lipidologist. The Science Daily story cited quotes one (1) scientist from Oregon State University who is way more enthusiastic about fish oils than warranted by high quality studies. Also, be aware of this below that story:

    'Story Source: The above story is reprinted from materials provided by Oregon State University.'

    High dose EPA and/or DHA are good for triglycerides. However, I and most physicians now have doubts that fish oil reduces cardiovascular events. The recent trials shoing no benefit of fish oil were exceedingly well performed, lasted several years, and had 1000's of patients. See this story in theheart.org:

    http://bit.ly/10QfQLJ

    Quote of the story:

    'Dr Eric Topol (Scripps Clinic, La Jolla, CA), editor in chief of theheart.org, posted a video blog on the site, noting that the dose of n-3 fatty acids used in the study was the same dose used in the GISSI and GISSI-HF trials, two studies that showed a benefit with regard to reducing sudden cardiac death, presumably through the ability to suppress ventricular arrhythmias. "I have an awful lot of patients that come to me on fish oil, and I implore them to stop taking it," said Topol.'

    The ANCHOR and MARINE studies were well conducted but do not prove that Vascepa has any CV benefit other than on triglycerides and non-HDL cholesterol. While the changes in LDL are in the right direction, they are small compared to what can be achieved with a dose increase of a statin. And the price of using Vascepa is that triglyceride control is worse (look at the the TG changes in the labels of Vascepa versus Lovaza). If I am prescribing a drug for triglycerides, I choose the one that works best on TG (currently Lovaza or OTC equivalents; Costco has a great deal on high potency fish oil)

    I am 100% sure that I will be flamed for this post. But be aware that I have been running a lipid clinic for 17 years and using fish oil to treat triglycerides for much longer than Lovaza let alone Vascepa existed.
    Jun 1 06:46 PM | 1 Like Like |Link to Comment
  • Intel Wins Samsung's Galaxy Tab [View article]
    Does Android even work on an Intel Atom?
    May 20 12:59 AM | Likes Like |Link to Comment
  • It Can Happen Here: The Confiscation Scheme Planned For U.S. And U.K. Depositors [View article]
    Worst article ever. You seem to have missed multiple instances where the paper makes it clear that 'insured depositors' are different from 'unsecured debtors'. For example:

    'In order to achieve this, the authorities recognize the need for effective communication to depositors, making it clear that their deposits will be protected.'
    Mar 28 12:38 PM | 27 Likes Like |Link to Comment
  • Aegerion's Lomitapide - FDA Approval, Strong Launch, Stock Price Increase Anticipated [View article]
    Lipidologist here - working in an academic medical center. I reviewed the data extensively. My view is that loimitapide is more effective and can be given orally, but has more GI side effects and causes far more hepatic fat accumulation than mipomersen. The oral option is usually far preferable to patients so I will try lomitapide first but monitor carefully for liver fat accumulation. And if there are abnormal LFTs at baseline then I will go straight to mipo. I think about a 60:40 split between lomitapide and mipomersen is reasonable as a short term estimate. Longer term it may end up being 50:50. The market size estimates are overblown. There are 300 patients with homozygous FH in the US. There are many more with heterozygous FH and/or severe hypercholesterolemia, but these are not the indication voted on. And remember that insurance companies will be exceedingly tough on prior approvals, probably more so than for LDL apheresis which is cheaper (~$150k) and has other obstacles to widespread adoption. And neither treatment is likely going to be able to lower LDL as much as LDL apheresis so the insurance companies may well restrict it further. So I would redo your math based on a smaller market size.
    Oct 24 05:21 PM | 1 Like Like |Link to Comment
  • Report Raising Vivus Qsymia Patent Infringement Concerns Was Not Competent [View article]
    topiramate lowers BP A LOT. Phentermine increases BP modestly. Qsymia lowers BP modestly (because the big benefit of topiramate is offset by the deleterious effect of phentermine). Why would anyone want to give a patient a drug like Qsymia that contains a BP-increasing component when they can give topiramate alone (which is generic and cheap/free). I have extensively reviewed all these drugs. I have prescribed them for years. I have done research and published on obesity, weight loss and blood pressure. The issue with these drugs (Qsymia and Belviq) is not that doctors do not know the information. It is that investors uncritically accept the company propaganda.
    Aug 2 10:01 AM | Likes Like |Link to Comment
  • Report Raising Vivus Qsymia Patent Infringement Concerns Was Not Competent [View article]
    Doctors can get sued for prescribing any drug, whether it is on or off label. I speak as a physician. I for one will for sure prescribe topiramate and lorcaserin, though not Qsymia. The phentermine component is potentially addictive and increases blood pressure.
    Aug 1 12:35 AM | Likes Like |Link to Comment
  • 5 Potential Financial Catalysts For Apple [View article]
    My apologies. I meant to say $76B exceeds $62B.
    Sep 14 11:21 AM | Likes Like |Link to Comment
  • Is Arena's Lorcaserin On Track For Approval In 2012? [View article]
    Your point about mammary cancer is not quite correct. You said:

    'The PWG was able to decisively demonstrate that there is no increased cancer risk to humans and that the risk is actually lower than Arena originally estimated in their first New Drug Application.'

    That misses some subtle points, like there IS an increase at the highest dose.

    Here is the press release from Arena:

    'The PWG consisted of five pathologists contracted by Arena. Arena consulted the US Food and Drug Administration (FDA) in selecting these pathologists. According to the PWG's re-adjudication, the incidence of adenocarcinomas was numerically lower than the control group in both the lorcaserin low (10 mg/kg/day) and mid (30 mg/kg/day) dose groups and was statistically higher than the control group in the lorcaserin high (100/kg/day) dose group, and the incidence of fibroadenomas was statistically higher than the control group for all three lorcaserin dose groups.'

    AND

    'It is important to note that the FDA may have a different interpretation of the re-adjudication and subsequent conclusions of the PWG. There may be other factors in addition to incidence that may contribute to the FDA's assessment of human risk for the finding of mammary tumors in female rats. The information reported in this press release summarizes a report containing voluminous and detailed data that will be reviewed by the FDA. The FDA may analyze or weigh the importance of data from the report differently than the PWG or Arena.'
    Sep 12 05:23 PM | Likes Like |Link to Comment
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