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Doug Miller

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  • Bristol Myers' HCV Cocktail Has Gilead, AbbVie In Its Crosshairs [View article]
    If the BMY solution requires Sovaldi, wouldn't that have to be purchased from Gilead? Or, at least licensed from Gilead?
    Mar 2, 2015. 10:39 AM | 17 Likes Like |Link to Comment
  • The Power Of Fear: Is Gilead A Buy Or Sell In 2015 After 1st Quarter Guidance? [View article]
    In a bit of breaking news, the FDA has withdrawn Merck's breakthrough therapy designation for their new HCV treatment.
    Feb 4, 2015. 10:24 AM | 6 Likes Like |Link to Comment
  • Some Pre-Earnings Release Observations About Gilead Sciences [View article]
    You may have noticed the announcement that Gilead has expanded its agreement with certain India based generic drug manufacturers to include a license to manufacture the pan genotype single pill treatment (not yet approved). Along with the announcement were quotes from a number of authorities on third world medicine that this would be the actual practical treatment that would be used in developing countries. (Advanced testing for specific genotypes is either not available or too expensive).
    I don't know if this is related to the India patent problem, but it does seem that Sovaldi, by itself, is not really that useful in treating large populations under third world conditions.
    Feb 2, 2015. 11:35 AM | 2 Likes Like |Link to Comment
  • What Lessons Has Express Scripts Taught Us? The Future For The Pharmaceutical Industry [View article]
    One interesting development in the area of oncology drugs is the emergence of companion diagnostic guided treatment. Some of the new drugs might be really expensive, but the diagnostic tools approved along with the drug will help limit the use of the drugs to those who are likely to actually benefit. This is good for both the insurance company and the patient. One new class of drug I am somewhat familiar with are the PARP inhibitors. There is an FDA approved companion diagnostic for these, with additional tests to guide their use likely to be approved in the near future.

    Another interesting development is a recent deal J&J cut with the NHS in England concerning the use of Olysio. The NHS will only pay for Olysio if the patient is actually cured. In addition, Jansen will pay for some upfront testing to determine which patients are likely to see success using Olysio.

    So, we might begin to see the emergence of results based payment. The drugs may be expensive, but will have a high chance of success in the selected patient population. That would be an all round good.

    Jan 23, 2015. 10:25 AM | 5 Likes Like |Link to Comment
  • How To Play Gilead In 2015: It's Going To Be A Bumpy Ride [View article]
    Cameron, your photo must have been taken on a bad day. It does make you look at least 25 or 26.
    Jan 16, 2015. 03:02 PM | 7 Likes Like |Link to Comment
  • Gilead Strikes Hep-C Deal With Anthem. Stock Remains Strong Buy [View article]
    A barely reported (but possibly significant) press release was issued by Cigna a little while back:

    Credit for this info goes to one of the primary bio tech analyst at The Motley Fool. It was reported within one of their subscription services.

    Jan 12, 2015. 11:43 AM | 2 Likes Like |Link to Comment
  • Gilead Sciences' New Contract Exclusivity Helps The Shares Advance [View article]
    I am going to offer up a bit of pure speculation here (obviously, I have no way of knowing what might really be going on behind the scenes).

    It seems to me that all along, Express Scripts has been engaging in some very unseemly chest thumping and posturing in their effort to intimidate Gilead into lowering the price of their drug. I believe they may have gotten caught up in all the bravado, and made a very bad strategic move. The idea of the preferred formulary is that it will contain medically equivalent or even medically superior drugs that can be prescribed instead of those on the non-preferred list. This was done to combat the efforts of drug companies to introduce new drugs that had little or no benefit over existing drugs, but were higher priced. (The drug companies would often market these heavily to the consumer so that patients would ask their doctors for the new drug).

    However, Express Scripts seems to have gotten so caught up in their desire to "start a price war", that they turned this common sense use of a preferred formulary on it's head. AbbV's treatment appears to be inferior to Gilead's in a number of important ways, and yet Express Scripts has insisted it is just as good, only a bit less convenient.

    Express Scripts is now in a position where they may have been successful in helping their competitors (CVS) in negotiating a lower price, but Express Scripts won't be able to get as good a price as CVS, and yet, despite their agreement with AbbV, may end up needing to purchase a lot more Harvoni than they had hoped. As you mention in your article, it is hard to imagine a Dr. prescribing a regimen requiring ribavirin when a better, safer alternative is available. (I don't know how often AbbV's treatment would require the addition of Ribavirin, but I have seen analyst estimates as high as 75% of the time when treating genotype 1a).

    I own both Express and Gilead, so I hope both companies do well. But, as an Express Scripts shareholder, their high profile position on this has been worrisome.

    Jan 7, 2015. 09:20 AM | 17 Likes Like |Link to Comment
  • Buffalo Wild Wings Is Morphing Into A Sports Franchise [View article]
    One reason the growth has been so strong, is that they have focused very, very heavily on increasing same store sales and profitability. Many restaurant chains grow by building more stores, but tend to lose focus on increasing (or at least maintaining) the profitability of each store. B-dubs has not made that mistake. I own a small handful of companies that have been 10 baggers for me. There just aren't that many stocks that have been 10 baggers over a 10 year period. This could not have happened if the stores weren't popular.
    Jan 2, 2015. 11:30 AM | 1 Like Like |Link to Comment
  • Buffalo Wild Wings Is Morphing Into A Sports Franchise [View article]
    John, I've been a shareholder for over ten years, and their relentless innovation continues to surprise me. Back then, this was a recommendation in The Motley Fool Hidden Gems newsletter. My cost basis was about $15. Sally Smith, the CEO, has done an amazing job. I've seen her interviewed a number of times, and she comes across as confident, but modest. Just when I start to wonder what more they can do to continue to grow, they surprise me. In fact, at an investor presentation this year analyst were asking if they were reaching a plateau, but Sally reiterated that they remain a very growth oriented company. Thanks for the article ... I always enjoy reading about my favorite investments.
    Dec 31, 2014. 10:44 AM | 2 Likes Like |Link to Comment
  • Update: Myriad Genetics Won FDA Approval For BRACAnalysis CDx [View article]
    The approval of BracAnalysis CDx is a bit more significant than it may appear to those who haven't been following this closely. Even though Myriad has been doing this basic test for close to 20 years, the test has never received any sort of FDA approval. It is what is called an LDT, or Laboratory Developed Test. Sometimes, referred to as "home brew" (obviously that has a derogatory conatation). These tests are governed by the CLIA provisions. That does not carry near the weight of FDA approval. Payers are all over the map concerning reimbursement on these types of tests. There has been a move afoot (both within the FDA and supported by test developers) to provide a better path to FDA approval for these tests.
    This FDA approval of BracAnalysis CDx is actually a first. Here is a quote from the FDA press release:

    “The approval of safe and effective companion diagnostic tests and drugs continue to be important developments in oncology,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “We are very excited that the BRACAnalysis CDx is the FDA’s first approval of an LDT under a premarket approval application and is the first approval of an LDT companion diagnostic. The use of companion diagnostics helps bring to market safe and effective treatments specific to a patient’s needs.”

    Even though Myriad has been doing these test for almost 20 years, they actually had to build out a separate FDA approved laboratory to do these tests. Both the FDA and the lab industry view this as a first time event. A first step towards official FDA approved tests (for the test maker, the advantage is much easier payer acceptance).

    So, if the drug is used without this test being done, the drug is being used off label. Doctors may choose to use a drug off label, but with all the wild and crazy things insurance companies tend to do, they will not be able to decide that it is fine to use this drug without the FDA approved diagnostic test. In fact, even if the patient has already had the regular BracAnalysis test, using those results to guide treatment with this drug would be an off label use of the drug. (I suppose a doctor could choose to do this, but would have little incentive to do so).

    So, the BracAnalysis test is the germline test. And that's where the drug companies are starting. However, Myriad has another test called HRD which measures a specific tumor tissue (perhaps multiple times over the course of treatment) to gauge how effective PARP inhibiting drugs would be in treating that particular tumor. This may apply to folks who don't have the BRCA germline defects. They are working with all five companies developing PARP inhibitors with both of their tests. Their goal is to have both FDA approved as companion diagnostics.

    So, to repeat, if PARP inhibitors are successfull, this will be a really big deal for Myriad. Myriad will have the companion diagnostics for all PARP inhibitors manufactured by five different companies. If PARP inhibitors prove to be duds, there will be five disappointed drug companies and one disappointed lab test company.

    Dec 29, 2014. 11:25 AM | Likes Like |Link to Comment
  • Update: Myriad Genetics Won FDA Approval For BRACAnalysis CDx [View article]
    "Only approved for a very specific indication. Have to have failed chemo three times for ovarian cancer."

    I certainly don't want to get into an argument with a doc (since I'm not one). Olaparib was granted accelerated approval by the FDA. The FDA does this for certain drugs (particularly cancer drugs) that show promise, but are short on the normal amount of clinical data required. That often means patients in the trials are doing well ... but we would have to wait additional years to see if endpoints are met. For these accelerated approvals, the indications are often as a last line of defense, until additional clinical data is complete. So, we really don't know how good these drugs are yet. As I mentioned in my comment, Myriad's success with the companion diagnostics for these drugs (both the BRCA and HRD test) are tied to the success of the class of drugs itself.
    By the way, Biomarin is in Phase 3 trials of a PARP inhibitor which independent researchers at the NIH believe will be about 100x as effective as the other four drugs in the class. This is because PARP inhibitors do their job via two different mechanisms. The other 4 drugs mostly act through one of the mechanisms. But BioMarin's drugs acts very robustly through both mechanisms.
    Once again, this class of drugs holds a lot of unproven potential. If they are very effective, MYGN will do very well. If not, then this won't help MYGN all that much.
    Dec 26, 2014. 11:48 AM | 1 Like Like |Link to Comment
  • Update: Myriad Genetics Won FDA Approval For BRACAnalysis CDx [View article]
    Andy, I am a long time MYGN shareholder and follow them pretty closely. Olaparib is one of five PARP inhibitors currently in some stage of development. MYGN is working with all drug companies developing these drugs, and will likely receive approval as a companion diagnostic for all five. (Assuming all five reach the market). Their success in this area will, of course, be linked to the success of PARP inhibitors as a drug class. They also have developed a proprietary test called HRD, which measures a particular tumor's susceptibility to PARP drugs. This is really starting to get into advanced personalized medicine (well beyond the germline test). The drug makers are hoping the HRD test may allow some label expansion beyond patients with particular BRCA variants. Myriad has a lot of other things going on, such as their prostate cancer test, Crescendo, RBM (rules based medicine) and other efforts. And, they have very strong cash flow which they are using to buy back shares. The profitability of these ventures is still uncertain, so despite the large potential, the market is taking a wait and see attitude. I will continue to hold my shares. Not many articles on SA about MYGN, so thanks for the effort.
    Dec 25, 2014. 12:13 PM | Likes Like |Link to Comment
  • What Happened To Gilead Is Health Reform In Action [View article]
    I'm confused by your reply. What ESRX is doing is not different than what is going on in Europe. That's why we are heading that way. The general drift of the author's article is that, since Obamacare, cost cutting and control is the name of the game. In order to craft Obamacare, the government has climbed so deeply into bed with the insurance companies, and is giving them so much power, that they are dictating what treatments you are allowed to have. (Insurance company profits are growing nicely, by the way.)

    In the US the CDC tells us IV drug use is the #1 way HCV is currently transmitted. However, before the advent of AIDS in the 1980's we were unaware of the precautions necessary to prevent the spread of blood borne disease. The CDC believes there are quite a number of baby boomers infected who don't know it yet. Worldwide HCV is a huge scourge and has been spread by various other means. For example, in Egypt back in the 1980's a country vaccine program that reused needles ended up giving HCV to a huge percentage of the population.

    Your callous attitude towards HCV sufferers, regardless of how they got it, seems characteristic of the 1%-ers attitude towards us.
    Dec 24, 2014. 04:39 PM | 3 Likes Like |Link to Comment
  • What Happened To Gilead Is Health Reform In Action [View article]
    For the most part, health insurance is not really a free market (unless, of course, you are buying your own policy from the insurance company). For most people, your employer decides what your health care coverage will be, and how much they will subsidize it.

    If someone had HepC, could use Veikira Pak with adding ribavirin into the mix, and didn't use any of the drugs that are listed on the label as posing a drug interaction problem, Veikira Pak would probably work fine (although it would be a lot less convenient and take longer)

    If the insurance company was insisting on Veikira Pak, even though you had to use ribavirin (nasty, nasty side effects) with it, you might have some recourse. All insurance is governed at the state level. So, you might be able to appeal through the state regulation appeal process. You might be able to appeal through your employer. Your doctor might be able to pressure them.

    And, you would need to get the details on what "preferred formulary" means. I am currently insured through Express Scripts. Generics are always preferred, when available. However, my doctor could write a prescription that did not allow generic substitution. ESRX would fill it, but I would pay the brand name price. In my case, that is 20% of the actual price, capped at $50. So, the most I ever pay for a prescription is $50. (My doctor would probably get a call from them asking for a justification. I don't know if the doc is obligated to provide a justification, or can just tell them to buzz off).

    I'm not suggesting that you could use Harvoni instead, and just pay $50. But there might be some option like that to use drugs not on the preferred list.

    If the only option ESRX provides is for folks to have to use ribavirin, there will be some ugly blowback for them. This gets into the whole question of who is making medical decisions on your behalf ... the doctor, the insurance company, the government? In Europe, you get what the government says you get. We are certainly headed in that direction here in the US.
    Dec 24, 2014. 12:47 PM | 1 Like Like |Link to Comment
  • What Happened To Gilead Is Health Reform In Action [View article]
    Of course, as the biotech discovery companies go away, so does the biotech discovery. If you want to see a future in which the stuff we already have is cheaper, this will be great. If you would like a future with amazing advances in cancer and Alzheimer's treatments, then this will be not so great.
    Dec 24, 2014. 11:52 AM | 4 Likes Like |Link to Comment