Seeking Alpha

Big Jake 1

Big Jake 1
Send Message
View as an RSS Feed
View Big Jake 1's Comments BY TICKER:
Latest  |  Highest rated
  • Why You Should Be Bullish On Keryx Biopharmaceuticals [View article]
    @Logical Thought...
    From the company
    Thank you for your email. Our CEO has discussed the intellectual property position for Zerenex on several investor conference calls over the past few months, however, mis-information on our patents, and a purposeful focus on the importance of NCE, still circulates on the Internet from sources outside Keryx. First, we have always maintained that NCE designation is a nice to have, not a need to have, for Zerenex. We believe our IP position is very strong, and our portfolio includes issued patents with composition claims on our Zerenex active pharmaceutical ingredient (API), extending to 2024, which we believe will protect Zerenex from generic competition through such date. We also have patent applications which, if issued, could extend our IP protection beyond 2030. Moreover, the bioequivalence path for any generic will be extremely lengthy, costly, and difficult. In addition, on top of our patents, Zerenex will automatically qualify for 10 years of exclusivity in Europe just because it’s the first NDA for ferric citrate in the EU. If you look at our current institutional shareholder list, you’ll find several sophisticated healthcare funds that have done significant due diligence on our patents.
    Oh,by the way ,I am LONG......
    Jake
    Dec 10 12:29 PM | 11 Likes Like |Link to Comment
  • Why Doctors, Dialysis Providers And Investors Are Excited About Zerenex [View article]
    @Airkills

    Mudshark ox's reply to AF's bash job on Kerx from comments to his article...enjoy!

    Your point regarding IP is conclusory. You have no expertise that I am aware of and are repeating the points made by self-interested individuals whom I presume you rely on for content. Actually, that's no longer a presumption, given the article you pastiched using the voice of your source.

    The PropThink interview with Scott Chambers should effectively settle the myriad points surrounding the exclusivity argument. NCE, PTE, and multiple patents, all would have to fail in order for your "prove a negative" perspective to have value. It is effective in discouraging individuals who don't have access to an IP lawyer - who clerked for the Chief Judge of the Circuit Court of Appeals and was an assistant solicitor at the PTO - from investing in a stock with a 17% short position. Patents extend to 2030, potentially. I actually think that the IP protection is great. BTW - AMRN didn't fail because of IP, it failed because of lack of traction selling in a largely primary care
    setting. And their effort to get approved on a surrogate bio-marker seems to have failed. By the way, I agreed with you that it would. Nice call.

    Moving on to PA 21. It's a chewable. You might have mentioned that. Also, why is PA21 different than Fresenius' interest in Phos-Lo? Are you telling me that none of their patients take Renagel or other generic phosphate binders? Fresenius doesn't prescribe phosphate binders as I understand it - but even if they did, I think that their economic savings under the - now soon to be reduced - bundle would trump any interest they have in pushing their chewable, if the savings are greater. Big if - but then that has been demonstrated with a strong level of statistical significance in the long-term Phase III. The simple fact is that ESA is expensive. IV iron is not as expensive but is associated with serious adverse events and is expensive to administer. Dealing with the associated AE's is even more expensive. Margins at the dialysis providers are under extreme pressure. This isn't going to happen, but I did a back of the envelope calculation that if all of of DVA's patients were on Zerenex in Q4 2012, their adjusted EPS would have been up 25%. Again, 100% is certainly not going to happen, but ponder that for a second.
    Also, weren't you struck by the fact that patients on Zerenex in the long-term trial had fewer deaths, SAE's, infections, vascular disorders, and cardiovascular disorders than patients on standard of care? That isn't a coincidence.

    It was also striking to see, in the Phase II trial in CKD, that patients on Zerenex had fewer AE's than placebo! When was the last time you saw that? The reason is because Iron Deficiency Anemia is such a pernicious, and unfortunately relatively undertreated / untreated medical need. I won't even go in to the FGF-23 correlation with cardiovascular outcomes but that is important, too. FGF-23 may still be considered a bio-marker. I personally think it has a mediator role but that is still being determined.

    What is beyond doubt is that anemia is decidedly not a surrogate endpoint. You should, I think, know better.

    To sum up:

    1) Your IP remarks are conclusory and un-substantiated. But just as impossible to disprove as it is for me to prove that the sun will rise tomorrow.

    2) The pharmaco-economic benefits of Zerenex are compelling in and of themselves with respect to ESA sparing and IV iron sparing and even more so when one calculates the attendant cost savings in terms of additional care that arises primarily through the over-use of IV iron in the current system.

    3) Anemia is a large unmet medical need in and of itself. It is also associated with disease progression Treating anemia with oral iron simply doesn't work as well as it should. Achieving comparable amelioration of hemoglobin versus IV iron without the attendant inflammation and other issues that a bolus of iron cause is a big, big deal.
    Nov 18 09:01 AM | 1 Like Like |Link to Comment
  • 3 Insurance Companies For Growth And Income In The New Year [View article]
    uh, Met has never raised the dividend due to Bank status.

    Am I missing something here?
    Jan 3 03:08 PM | Likes Like |Link to Comment
  • Is This What A Three-Bagger Portfolio Looks Like? [View article]
    Rocco,

    I'm missing something here. If your total p&l is +$1356 ,shouldn't your total portfolio value be $11,356? Is the math wrong or am I missing something here?

    Jake
    Nov 4 08:42 PM | 1 Like Like |Link to Comment
  • World Wrestling Entertainment, Frontline: High Yield Dividend Payers [View article]


    There is no current split.....yet.

    The 5-1 split was authorized by shareholder vote at the last shareholder meeting. Management can now split the stock when such action is necessary.


    Nov 14 06:23 AM | Likes Like |Link to Comment
COMMENTS STATS
5 Comments
13 Likes