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William Haynes

 
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  • Amarin Must Be Acquired - And There Are Plenty of Potential Suitors [View article]
    Thanks for the insults everyone. I have no skin in this game so I'm not sure why all the hostility. I thought people might be interested in the perspective of a prescriber. I probably shouldn't respond at all but there are some misconceptions and omissions above:

    1. I did not say that AMR101 lowered HDL, I said it lowered non-HDL. That is the exact opposite. And it is important because it is an important contributor to atherosclerosis and a key point differentiating AMR101. But the degree of lowering is pretty small.

    2. There are data showing that Lovaza works in the TG 250-500 population, and that data is in the LOVAZA label, though not as an 'indication'.

    3. There is strong debate about whether triglycerides are dangerous in the 250-500 range in terms of cardiovascular disease. So I would not say that most physicians regard it as an imperative to treat triglycerides between 250 and 500 mg/dl, or would be so worried about it they would recommend a prescription fish oil over a supplement. The new lipid guidelines are coming out this year and I doubt they will be any more aggressive than the current ones are in terms of triglycerides between 250 and 500 mg/dl (and possibly less aggressive).

    4. Triglycerides above 1000 and possibly above 500 confer risk of pancreatitis which is the major reason to treat. And this population is increasing. Lovaza prescriptions are clearly increasing but so is use of supplements for this population. And I am sure that AMR 101 will get used a fair amount in this population. What I am not sure about is how valuable AMR101 will be to another company given the hazards of generic Lovaza and supplements. I'd say $100-300 million, but likely not more. IF Amarin can get the JELIS study added to their label for AMR101 then that would be a huge plus, but I doubt the FDA will allow that (in that trial the dose was restricted to 2 gram, japanese population, high baseline fish oil consumption, all taking small doses of simvastatin). The FDA may have concerns that the benefit would not be seen in US patients, or that the safety of 4 grams EPA has not been demonstrated (it could increase hemorrhagic stroke, GI bleeds through platelet inhibition).

    5. Many patient prefer supplements especially if they are a lot cheaper. Most doctors are comfortable with supplements if they are reputable brands. Coupons and discounts are not allowed for Medicare or Medicaid patients.

    Please avoid ad hominem attacks.
    Jul 24 01:40 PM | 1 Like Like |Link to Comment
  • Amarin Must Be Acquired - And There Are Plenty of Potential Suitors [View article]
    There are several major issues impacting the potential valuation of Amarin. The two most important are:

    1. Generic Lovaza is coming in a couple of years. Even though AMR101 has some advantages over Lovaza these are relatively minor. LDL and non-HDL cholesterol are lower by about 5%. There may be less fish after taste. But if AMR101 costs patients a $30-75 copay and Lovaza has no copay then I think many physicians will prescribe generic Lovaza.

    2. Intellectual property protection. While AMR101 may get FDA protection as a prescription product there is absolutely NOTHING stopping a competitor marketing a nutritional supplement containing EPA alone, and forgoing FDA approval. They won't infringe any patent that Amarin has if they market it without mentioning lipid lowering. Just as many patients take OTC fish oil capsules (or a product like SuperEPA) rather than LOVAZA the same could happen to AMR101.

    So it seems to me (a practicing MD who has an active lipid clinic and does research in this area), that it will be difficult to persuade any company to pay large sums of money for a product that could be sidelined by generics or nutritional supplements. I'd be careful with Amarin.
    Jul 23 02:23 AM | Likes Like |Link to Comment
  • Apple: Possible iPhone Scenarios and Stock Price Implications [View article]
    Thanks for the comment. Actually, you have a point. While the A5 is substantially larger than the A4 in terms of die size (122 versus 53 square mm), package size is only modestly bigger (200 versus 240 square mm). See:

    www.informationweek.co...

    Having said that, 2-3 mm larger in even one dimension could make it harder to fit in the iphone chassis. More likely reasons for a delay this year in introducing new iphone model(s) would be cheaper components for an economy model, and 4G/LTE chipsets for a 'luxe' version.
    May 3 03:06 PM | Likes Like |Link to Comment
  • In Streaming Movie Market, Will Apple Come Out on Top? [View article]
    Netflix is dead on iphone, ipod, appleTV and ipad witht the new app store rules. That may slow them down a little.
    Feb 16 11:19 PM | Likes Like |Link to Comment
  • Amarin's Potential Blockbuster in the Making [View article]
    I would not get your hopes too high. It is not going to be difficult for GSK/Lovaza to expand their label to include patients with TG 200-500. In fact, GSK already have published data with Lovaza in patients with TG 200-500:

    www.ncbi.nlm.nih.gov/p...

    Non-HDL cholesterol was reduced by 7% and triglycerides by 23% (both placebo-adjusted) in this study. The only advantage for Amarin would be if they can demonstrate better reductions in lipids (unlikely given my review of the literature on omega-3 fatty acid subtypes), or can demonstrate better adverse event profile. Showing superiority on AEs may be difficult too. Lovaza is pretty well tolerated. From the paper cited above:

    'Adverse events (AEs) reported by > or= 1% of patients in the P-OM3 group that occurred with a higher frequency than in the group that received simvastatin alone were nasopharyngitis (4 [3.3%]), upper respiratory tract infection (4 [3.3%]), diarrhea (3 [2.5%]), and dyspepsia (3 [2.5%]). There was no significant difference in the frequency of AEs between groups. No serious AEs were considered treatment related.'

    To be able to market directly against Lovaza, Amarin would need a claim of superiority for AEs in its label. To persuade the FDA they would have to do a head to head study (likely 2 such studies), and show statistically significantly fewer GI AE's. With a GI AE rate of only 5% with Lovaza, the number of subjects that would be needed to demonstrate such an effect would likely be over 1000 in each study.

    Finally more and more physicians are using non-prescription fish oil to save patient's money.
    Oct 26 03:48 PM | Likes Like |Link to Comment
  • 9 Questions on Apple's 'iTunes for News' Store [View article]
    One other thing Apple provides is payment processing. I suspect that they will let companies that already have a subscriber relationship continue to get all the money (i.e. someone has already paid or will pay for the service outside of an ipad app). This would cover the Knidle app too (where payments are made through a link to the browser). If newspapers and magazines want Apple to handle payments then I think they will have to pay the 30%.

    One other thing. It would not surprise me if Apple cut the 30% to 20% or less for a subscription model. They make their money from hardware and want to merely breakeven for the app store.
    Sep 22 02:18 PM | 1 Like Like |Link to Comment
  • Arena Pharmaceutical's Lorqess: A Briefing Document Analysis [View article]
    Given the Meridia vote a few minutes ago was split 8 to 8 on whether to withdraw the drug (for an agent that has been PROVEN to increase CV events), I think the panel on 9/16 is likely to vote in a majority for lorcaserin. I agree completely that the FDA can require further animal toxicology studies and also post marketing surveillance for cancer. They did that for liraglutide (Victoza; NVO) where there was thyroid cancer in BOTH mice and rats at low doses. Interestingly, for that drug the FDA wrote an editorial in the NEJM that said the approval was given despite the possible cancer signal because of the need for a new treatment option and the weight loss associated with liraglutide. The same argument could apply to lorcaserin.

    Also, the human cancer data actually showed only 4 cases of breast cancer versus 7 with lorcaserin in the placebo group. Tiny numbers, but not of a concern at all. And weight loss should reduce cancer rates in the long term, which would likely outweigh a remote risk from the drug itself. Hopefully, the panelists or FDA will mention that.
    Sep 15 04:26 PM | 2 Likes Like |Link to Comment
  • The Importance of Arena's BLOOM-DM Study [View instapost]
    I think lorcaserin will get approved for obesity. Diabetes may be a more difficult indication. The FDA has tighter criteria for diabetes drugs, including proof that the effect on glucose in INDEPENDENT from that on weight (this is both weird and tough). This requirement tripped up orlistat (Xenical), which showed improved HBA1c and prevention of diabetes but was unable to get a suppl NDA approved for either indication. SInce then, the FDA has tightened up on diabetes drugs and now demands CV safety data. I think the best lorcaserin will be able to achieve is an indication for WEIGHT LOSS in type 2 diabetes, with coincidental improvement in HBA1c. This is subtly but importantly different from a full diabetes indication and may limit its uptake somewhat in this population.
    Sep 6 12:53 PM | 2 Likes Like |Link to Comment
  • Arena Pharma: Understanding the Market for Anti-Obesity Drugs [View article]
    Wow - I think this is the best article I have read on seekingalpha. Carefully argued, impeccably researched, novel concepts, meticulously referenced. I'm a physician treating and researching obesity and I really appreciate your teasing out the relationship between treatment persistence and efficacy.

    I'll add a couple of caveats. First, lorcaserin used with orlistat and metformin and/or topiramate could cause 15-20% weight loss. That won't happen quickly but will help in the long run. Second, the thing that really helped statin sales was the demonstration of cardiovascular protection from MI and stroke. Meridia has failed that test but orlistat may pass it (in the LOOK AHEAD trial). Lorcaserin will likely have to do such a study. So it seems possible that $1B in sales could be achieved in the first 3 years that them take another bump upwards in years 4-8 from combination use and proof of CV protection - perhaps to $3B.

    Some minor points:
    1. Reimbursement is critical - no insurance company I deal with covers obesity treatments now.
    2. I think there is a strong possibility that the FDA will put stronger warnings on or even withdraw phentermine after the Meridia discussions on 9/15. Sorry if I disappoint those commenters who think phen/lor will be prescribed to tens of millions of patients.
    3. On current trends there is no way lorcaserin will be competitive in a stand alone diabetes indication. Orlistat was unable to get that indication and had a larger effect on fasting glucose in non-diabetics than lorcaserin does. Also, almost every obesity drug tested has a smaller weight loss effect in diabetes than in non-diabetes.
    Sep 4 12:53 AM | 2 Likes Like |Link to Comment
  • Good News for Generex: Positive Data on Oral Insulin Coming in September [View article]
    This could be good. But another reason for an absence of antibodies and insulin resistance, no weight gain, and less hypoglycemia could simply be that the oral insulin is less bioavailable (i.e. less ibulin is getting into the body). That would not be good. So the critical question is what are the changes in HBA1c with oral insulin and how do they compare with the control group?
    Aug 16 06:50 PM | 3 Likes Like |Link to Comment
  • Dendreon and Provenge: What if We Lived in England? [View article]
    I'm not going to even get into the QALY issue. But I am disturbed by the umber of people touting 'median' as being a reason why this analysis is incorrect. Sure, we all know that 'median' is different from 'mean'. But if using mean versus median survival has minimal impact on on QALY. It does not matter if some patients life years longer - median of 4 months means half of them live less than that, and half more! If one is to do a QALY calculation you have to assume that everyone gets the medicine, INCLUDING those who lives less than the median! Now for a medicine that is given in cycles over many months, one can adjust the cost down as non-responders die or drop out. But my understanding is that this would not apply to Provenge. I thought this was a very reasoned analysis. After all, WE pay for Medicare. I'm a cardiologist and am very concerned about what happens when we have a safe and effective implantable artificial heart that costs $1M that could save the life of the 30% plus people who ultimately die of heart disease. The company that makes it will get FDA approval. The company (and it's investors) will insist Medicare pays for it. How can medicare afford to implant millions of such devices a year - just 1 million artiicial hearts per year would 1 trillion dollars per year. Someone needs to think about how we make this work. Control prices? Ration care? Exclude from Medicare?
    Jul 7 04:06 PM | 2 Likes Like |Link to Comment
  • How Apple Keeps Screwing It Up [View article]
    The reasons for switching all seem to be techy ones, with the possible exception of ATT (though I have excellent ATT service - far faster than I used to get with Verizon - and I can get data at the same time as voice). As a consumer, I don't really care about 'intermediate software layers' or app store approval times (there are 185k apps despite supposedly draconian approval steps). What i care about is user experience, user experience, user experience. I am a physician, not a techy. I want a phone that I never never ever need to look at a manual for. That I turn on and use. That does email, web, epocrates, stock tracking, a few games without me even thinking about it. That is fast, and doesn't crash. Multitasking would be nice (and I think that's coming in a couple of weeks). I tried using a palm pre phone and gave up - I couldn't figure out how to navigate. I tried the Nexus One and an app froze the first day!!!! Unbelievable. I don't believe that google will be able to maintain a pristine user experience on Android with an open source OS PLUS no curation of apps PLUS multiple handset manufacturers. And what's wrong with a 'Walled Garden' if it maintains quality. Everyone goes on and on about this 'walled garden' without realizing that while it may have it disadvantages (to tech types who want to switch out their 'dialer'), for me it only has advantages (seamless consistent interface, trustworthy apps, fast, no crashes, can easily transfer music, vids, photos etc). I have no doubt that Android will take a significant market share, but I never thought Apple would get 100%. However, I suspect that the Android market share may not continue to rise quite as fast when Verizon stop giving away free smartphones.
    May 26 07:08 PM | 6 Likes Like |Link to Comment
  • Gilead: A Step in the Right Direction [View article]
    There are a couple of other upsides for Gilead:

    1. Ranexa has benefits on blood sugar, and Gilead could easily apply to the FDA for specific labeling for diabetes. Ranolazine already has shown CV safety in the MERLIN-TIMI36 study, which would help any FDA review for a diabetes indication. It appears to lower glucose in patients with T2DM about as much as Onglyza and Januvia. Ranolazine also reduces the incidence of impaired fasting glucose in non-diabetics by about one third. (see: circ.ahajournals.org/c...).

    2. CV Therapeutics published intriguing preclinical data on an adenosine A1 receptor partial agonist (CVT-3619) with both anti-diabetes and lipid lowering efficacy. (see: www.ncbi.nlm.nih.gov/p...)
    Feb 25 01:19 AM | 1 Like Like |Link to Comment
  • Arena, The Aftermath [View article]
    One other thing. Someone mentioned adding phentermine to Qnexa. Qnexa already contains phentermine (in combination with topiramate).
    Feb 6 07:12 PM | Likes Like |Link to Comment
  • Arena, The Aftermath [View article]
    Ruthanne - was that snide comment about degrees aimed at me? I didn't even mention my degree. I was trying to be helpful not destructive. In any case, obesity is a only a part part of my practice and I welcome any new effective drug. To imply otherwise is insulting. Obesity is such a huge problem that even the approval of 6 new drugs would not appreciably reduce our referrals (and would probably increase them because of the extra choices). Just as the PAH, CHF, diabetes or hypertension specialists - treatment choices have exploded but the need for specialist advice is growing even faster.

    The bigger picture is depressing though. The very recent Meridia outcome trial data showing increased death and CV events in obese patients treated with Meridia is going to make the FDA even tougher on obesity drugs.

    It is entirely possible that they will now apply the same criteria for approval to obesity drugs that they now demand for diabetes drugs (sufficient CV events to exclude an increase CV risk. Some companies developing in the diabetes field thought they would be grandfathered in because they 'agreed' plans with the FDA prior to the change. That did not work well - ask Takeda about alogliptin. Patients were young in the lorcaserin trials and it is likely there were not enough CV events to meet the FDA diabetes criteria. Not saying it will happen, but it's a risk. As is the reimbursement. And the reason I mentioned that is that I NEVER see that issue mentioned in any of these discussions. Everyone talks about FDA approval but nobody seems to think about who is going to pay. If we are meant to be discussing stock valuations surely who pays is critical.
    Feb 6 07:10 PM | 1 Like Like |Link to Comment
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