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Alexander J. Poulos  

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  • Capturing The Growth Of The Diabetic Epidemic Via Shares Of Novo Nordisk [View article]
    To all,

    NVO continues to outperform this year. I can across this report from fierce biotech detailing the potential for Victoza as a treatment for NASH. The unmet need here is huge, any sort of movement is not reflected in the share price of NVO.

    Novo's liraglutide works in diabetes and obesity. How about NASH?

    By Damian Garde Comment | Forward | Twitter | Facebook | LinkedIn


    Novo Nordisk Chief Science Officer Mads Krogsgaard
    The commercial potential of NASH, a common liver disease with no approved treatments, has seemingly launched a thousand R&D ships around the industry. And Novo Nordisk ($NVO), emboldened by an investigator-sponsored study, might be sitting on an effective therapy for the pervasive ailment with liraglutide, a blockbuster already approved for diabetes and obesity.

    In a small Phase II study presented at last month's International Liver Congress, liraglutide beat out placebo in treating NASH, or nonalcoholic steatohepatitis, after 48 weeks of treatment, using liver biopsy to confirm the results. The study, sponsored by the U.K.'s University of Birmingham, concluded that one daily dose of Novo's drug has the potential to ward off NASH's characteristic liver scarring, and researchers strongly recommended advancing the subcutaneous treatment into Phase III to see if the provise pans out.

    And Novo is listening. The company told Reuters that the Birmingham data were "very interesting" and that its in-house researchers are looking into starting a NASH program of their own but are yet to make a final decision.

    The prevalence of NASH and other fatty liver diseases in the developed world has galvanized a growing horde of drugmakers to pursue projects in the field. Leading the way is Intercept Pharmaceuticals ($ICPT), whose breakthrough-designated obeticholic acid is on its way into Phase III after posting some promising mid-stage efficacy data. French biotech Genfit is pressing into Phase III with its NASH drug despite a mid-stage failure, while Gilead Sciences ($GILD), Shire ($SHPG), Enanta Pharmaceuticals ($ENTA) and a host of other advance therapies of their own.

    As for Novo, if liraglutide can come through in NASH, the Danish drugmaker could burnish what is already a blockbuster product. The drug, which mimics the protein GLP-1, is approved as Victoza to treat Type 2 diabetes and brings in more than $2 billion a year from that indication. In 2014, Novo won approval for a higher dose liraglutide to treat obesity, launching that drug under the name Saxenda earlier this year.

    But the company isn't getting ahead of itself. The Birmingham study involved only 52 patients, and, as investigators noted, it's unclear how much of liraglutide's observed benefits in NASH is direct and how much is a result of the drug's effect on weight loss. As Reuters notes, Chief Science Officer Mads Krogsgaard Thomsen told a Danish newspaper that the study involved "a very small patient group, but I believe it is fair to say that we have been discussing this in management."


    May 21, 2015. 12:14 PM | Likes Like |Link to Comment
  • Why I Bought The Dips In Both Gilead And Achillion Today [View article]
    Doc,

    Thanks for the timely article. JNJ made a smart partnership here as they attempt to repair their HCV franchise. What has me intrigued is the possibility the HCV marketplace will exhibit real staying power instead of a sudden drop off as many expect. If GILD is able to generate sales north of 25 billion over the next three years, the shares are an absolute steal, akin to AAPL a few years ago when they were trading at $58 per share.
    May 20, 2015. 05:19 PM | 11 Likes Like |Link to Comment
  • Cinemark Shares On Sale With Blockbuster Year, International Growth, And Concession Growth [View article]
    Chris,

    It seems the momentum investors have fled the movie exhibition plays. The are leaving way too early in my opinion, as the summer and fall slate (Star Wars reboot) will drive record attendance. I am long AMC, as it is a pure play in the US market. I am watching the increase in concession per attendee to gauge demand. Interestingly, DIS negotiated a higher revenue split for Avengers due to the huge draw (60/40 vs traditional 50/50), yet the exhibitors will more than offset with IMAX and concession sales. AMC has the largest IMAX exposure which bodes well for them. Thanks for the article, I enjoyed it.
    May 20, 2015. 08:14 AM | 2 Likes Like |Link to Comment
  • Illustrating Johnson & Johnson's Fair Value [View article]
    Qniform,

    I am very long on GILD as it is one of my top 5 holdings. An astute collaboration by JNJ, lets see what will come of it.
    May 20, 2015. 08:09 AM | Likes Like |Link to Comment
  • Illustrating Johnson & Johnson's Fair Value [View article]
    Chuck,

    Actually your comment provides a nice little segue into market timing. The old adage of sell in May needs to be changed to sell in July and buy in Oct. The last few years we seem to get some type of "worry" that causes an excellent buying opportunity during the August-Oct time frame. Perhaps I will get my entry price on JNJ then. Thanks for reading and commenting, I enjoyed the comment.
    May 18, 2015. 09:05 PM | 2 Likes Like |Link to Comment
  • Illustrating Johnson & Johnson's Fair Value [View article]
    Qniform,

    Exactly, it is too expensive for a new purchase yet a compelling reason to sell does not exist either.
    May 18, 2015. 09:02 PM | 1 Like Like |Link to Comment
  • Illustrating Johnson & Johnson's Fair Value [View article]
    brazo,

    You are welcome.
    May 18, 2015. 09:00 PM | Likes Like |Link to Comment
  • Illustrating Johnson & Johnson's Fair Value [View article]
    Doc,

    Thank you, you neatly summed up my conclusion.
    May 18, 2015. 09:00 PM | Likes Like |Link to Comment
  • Gilead Sciences Is Poised To Break Out [View article]
    ptatty,

    Yes, however GILD continues to test additional combos to improve on its current position. Additional quote from recent conference.

    Harvoni access is progressing at a faster rate than we saw with [Harvoni]. Harvoni reimbursement is already in place in few of the smaller countries of the EU, and we expect reimbursement in Italy and Spain to be in place imminently. Despite our successes already in hepatitis C, we think there's an opportunity for innovation and we're exploring two different courses of action. The first is to take Sovaldi and combine it with GS-5816, which is a pan-genotypic NS5A inhibitor. The pan-genotypic regimen of GS-5816 in sofosbuvir is currently being evaluated in four separate Phase 3 studies, all of which have a 12 week duration.

    Based on the data to-date and the success of Harvoni, we believe the best medical use of sofosbuvir plus GS-5816 will be in non-genotype 1 infected patients, where the unmet medical need is the greatest. We should be in a position to share the topline results with you in the third quarter and hope to file a marketing authorization towards the end of the year. We're also exploring a three drug combination with a drug called GS-9857, which is a pan-genotypic protease inhibitor that when combined with Sovaldi and GS-5816, can potentially reduce the treatment duration below eight weeks. The triple combination of sofosbuvir, GS-5816 and GS-9857 is currently being evaluated in two Phase 2 studies with treatment durations of six, eight and 12 weeks.

    As for the PBM's the consolidation wave has descended on the payers. As with any therapy your label determines what you can charge.
    May 17, 2015. 08:08 PM | Likes Like |Link to Comment
  • Gilead Sciences Is Poised To Break Out [View article]
    ptatty,

    There is the potential here for the HCV franchise to follow the traditional annuity like revenue stream of branded pharmaceuticals. The fear of a sudden drop in revenues (peak sales) is the primary reason why GILD is priced as if it is a declining asset. I am monitoring this very closely, if the franchise does indeed have significant staying power, GILD is grossly undervalued.
    May 17, 2015. 03:50 PM | Likes Like |Link to Comment
  • Gilead Sciences' Rumored Takeover Of Vertex Pharmaceuticals Has Merit [View article]
    Confirmation that GILD will not acquire VRTX.

    Ying Huang, Bank of America Merrill Lynch - Analyst [8]

    So Paul, maybe I'll throw a soft ball question now there. You told me that you are going to stay in the therapeutic areas where you already have a presence today. Would you consider cystic fibrosis, a therapeutic area you already have established presence today, and would be interested in getting into orphan drug space?

    Paul Carter, Gilead Sciences, Inc. - EVP, Commercial Operations [9]

    Well, I'll quote our Chief Scientific Officer, Norbert Bischofberger, he said that we think a lot about a lot of companies but we don't think very often about the Vertex, if you want to be very specific.

    Ying Huang, Bank of America Merrill Lynch - Analyst [10]

    I didn't say that.
    May 17, 2015. 10:14 AM | Likes Like |Link to Comment
  • Gilead Sciences Is Poised To Break Out [View article]
    To all,

    The Q&A concerning the tail of the HCV franchise is the most salient question of all. If the market evolves as GILD anticipates, Sovalidi/Harvoni will become the best selling med of all time.
    May 17, 2015. 10:12 AM | 2 Likes Like |Link to Comment
  • Gilead Sciences Is Poised To Break Out [View article]
    Confirmation GILD does not want to acquire VRTX.

    Ying Huang, Bank of America Merrill Lynch - Analyst [8]

    So Paul, maybe I'll throw a soft ball question now there. You told me that you are going to stay in the therapeutic areas where you already have a presence today. Would you consider cystic fibrosis, a therapeutic area you already have established presence today, and would be interested in getting into orphan drug space?

    Paul Carter, Gilead Sciences, Inc. - EVP, Commercial Operations [9]

    Well, I'll quote our Chief Scientific Officer, Norbert Bischofberger, he said that we think a lot about a lot of companies but we don't think very often about the Vertex, if you want to be very specific.

    Ying Huang, Bank of America Merrill Lynch - Analyst [10]

    I didn't say that.
    May 17, 2015. 10:10 AM | 2 Likes Like |Link to Comment
  • Gilead Sciences Is Poised To Break Out [View article]
    Commentary from recent BOFA conference.

    Lastly, within liver disease, I'd just like to say a few things about NASH. NASH or Non-Alcoholic Steatohepatitis is advancing in the US and is likely to become the leading cause for liver transplantations. It's projected to surpass even hepatitis C in the next decade with an estimated 12 million people in the US. Needless to say, this disease represents a significant unmet medical need.

    NASH, however, is a complex disease and one that might require multiple approaches. Simtuzumab is the furthest along for Gilead with two Phase 2 studies that are fully enrolled. At the end of Q3 or early Q4, we'll hit the 48-week point whether the Data and Safety Monitoring Board or DSMB will look into this blinded study. If those data are determined to be robust enough, we could file for approval at that time.

    In addition to simtuzumab, two other mechanisms of action are being explored. The first, GS-4997, an ASK-1 inhibitor, will be evaluated in a Phase 2 study by itself and in combination with simtuzumab. The second mechanism is GS-9674, an FXR agonist, which we hope to have in the clinic before the end of the year.
    May 17, 2015. 10:08 AM | 1 Like Like |Link to Comment
  • Gilead Sciences Is Poised To Break Out [View article]
    Unidentified Audience Member [11]

    Hi. So an important part of I think the debate around Gilead as the business goes forward is the tail of HCV, can you talk about the degree to and your sense of where the disconnect is between what the market is perceiving and what you are perceiving?

    Paul Carter, Gilead Sciences, Inc. - EVP, Commercial Operations [12]

    Yes, I mean, there's a fairly funny dynamic here that the more -- obviously the more patients you treat sooner the less patients you treat later. And we had a situation in the US where, and I think most of you see the same data as we do in terms of weekly scripts, there is no doubt there is a flattening of weekly scripts in the US. And we believe that the reason for that is that the capacity, not physicians to treat nor payers actually to open up for treatment. But the capacity constraint is literally the back offices of physicians to process patients through the system and it's, in exact science, where we are at. But we believe that this year, the US capacity limits will be challenged and we think that capacity limit is around 300,000 patients per year. That nevertheless implies, still many, many years of patients to be treated in the US.

    And certainly, when I talk to doctors, they say they have a lot of patients that they would like to treat, but for various reasons they are unable to treat, at this point. Europe is slightly different. Actually, in a macro sense, Europe has more patients than the US. The capacity constraint in Europe to treat isn't physician capability or capacity it's budget capacity country by country and we've certainly been working with all of the major governments to establish what budgets realistically they can get to. And combine that with the level of prevalence and so on and the GDP to capital to come up with, what we believe is a kind of fair and reasonable approach to pricing and -- but the objective is to treat as many patients as possible, recognizing that budgets are extremely limited especially in some of the economically stressed countries.

    So the picture in Europe is a different one, the less patients are going to be treated each year we think probably around half the US would be the capacity limit of Europe to treat right now, but the longevity of that treatment is likely to be significantly longer than the US, that's the way we're thinking about it. And then of course there's other countries like I just mentioned Japan, who, for genotype 2 there are 200,000 patients, many of those have been diagnosed already. They have no interferon-free options today. And that's a high unmet medical need and it'll be very interesting to see the kind of whether or what the constraints are on the number of patients that get treated each year. So that's the sort of picture how we see it.
    May 17, 2015. 10:07 AM | 2 Likes Like |Link to Comment
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