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value investor12

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  • Cocrystal Pharma - Overhyped Biotech Or The Next Pharmasset? [View article]
    What you need to remember is entrenched markets can be overcome if there is a true differentiating factor in the new product. Look how Tenofovir became the clear market leader when Abacavir was the clear market leader based on the (D:A:D: safety data, ACTG 5202 showing the tenofovir seems to be more potent, etc). 12 weeks to 8 weeks isn't a big differentiating factor. 12 weeks to 6 weeks I can see people starting to use the 6 week regimen. But if you are able to come up with a 2~4 week regimen I do think most people will use the shorter regimen. So the question is how do we get there. The studies all suggest it is through combining regimens that have a different mechanism of action and a potent NUC seems to be the back bone of these treatment options. That is why ABBV can never win. The value of $cocp lies in the fact that it is the only company that has the potential to achieve such a short duration.

    There were two companies in early 2014 that had a NUC in development after the Inhibitex mess. They were ACHN and IDIX. ACHN did not pay attention to there NUC back then and was really touting the PI and NS5A inhibitor that they had in their presentations. IDIX was putting a lot of effort into their NUC. ABBV was focusing on a non-NUC single table regimen. Many in the HCV community knew the importance of a NUC backbone when the PSI-7977 (sofosbuvir) data kept on coming out. The SVR rates and side effect profile were consistently equal or superior to other regimens. It made much sense to own an NUC company and I thought IDIX was the way to go because their strategy made sense.

    COCP makes sense to me because if you want to win in the HCV market you have to be better than GILD. Not equal but better. Because it is difficult to gain market share in an entrenched market if you are equal but if you are better it is very doable. And I think COCP is the only company that has the potential to be the winner and companies will start to realize that.

    The big risk here is that it is too early. But if you looked at their presentation their NUC seems very promising. It is very potent and it does not seem to have much effect on gamma DNA polymerase in the mitochondria. As you know, the dreaded side effect of a NUC is mitochondria side effect which can lead to various bad outcomes and the preclinical data looks very good. The helicase inhibitor is a new class and we will have to see how it plays out. Experience in drug development is also very important and I do think the people involved in the development of these drugs is the best there is out there.

    You need to remember that drug COCP will likely be bought before they are ready for filing approval. Also remember that these HCV studies have very fast enrollments and that they are short. So once you enter into phase 1, it rapidly transitions to phase 2a/b and then it gets noticed and bought. Phase 3s and regulatory filing takes much more time but I do not think $COCP will be doing that job. Just my opinion.

    I am $COCP long.
    Apr 10, 2015. 10:35 AM | 1 Like Like |Link to Comment
  • Cocrystal Pharma - Overhyped Biotech Or The Next Pharmasset? [View article]
    Yes. Many things can happen and that is why I am not all in $cocp and I always tell myself "I could be wrong". But the upside to $cocp is too big for me not to be in it. Just my humble opinion. And obviously you know much more about finance then I do and I am aware that is my weak spot as an investor. Still learning.
    Apr 8, 2015. 02:05 PM | Likes Like |Link to Comment
  • Cocrystal Pharma - Overhyped Biotech Or The Next Pharmasset? [View article]
    I agree about your thesis that it does seem over valued at current prices. Just one comment regarding $achn. Before $IDIX got acquired (I was a IDIX share holder) $ACHN's strategy seemed to be targeting the genotype 1b patient population when the market clearly wanted a pangenotypic regimen. After $IDIX got acquired they started touting their NUC. The fact that management was suggesting a genotype 1b strategy made me concerned about how competent they were. I still think $ACHN adds little value to the current HCV market and they are way overvalued.

    The value $COCP brings is this. To differentiate yourself from $GILD you basically need a shorter regimen while achieving similar SVR rates. That is what $MRK is trying to do and the way they are trying to do it is by adding 3 potent regimens and seeing what happens. $COCP is the only company to my knowledge that has the potential to combine 4 direct acting antivirals (because they are the only ones that are developing a helicase inhibitor to my knowledge). They could be the ultimate winner if they are able to get away with making the treatment to 4 weeks with high SVR rates.

    On top of that, they are targeting influenza and norovirus. If you listen to any of Dr. Kornberg's lectures (a whole bunch are on youtube), you will know that his main hypothesis is that the polymerase's are very similar in structure across different viruses and if you are able to engineer a drug in such a way that is fits into the common structure that many viruses share, you will be able to target various types of viruses with the same NUC. See how tenofovir is active against HIV and HBV. The structure that is binds to is very similar in these two very different viruses.

    It is still too early, I agree. But the science and technology is amazing and the potential is huge and I think that is why all these smart people are on board. Because it could be potentially game changing. Or of course it could be a flop. But you have to agree, the people involved in this company is just amazing.

    I am $COCP long mainly because of the science and people involved. I don't think the shareholders really are looking at market cap and I am not either.
    Apr 8, 2015. 11:38 AM | 1 Like Like |Link to Comment
  • Why Big Pharma Has No Interest In Achillion's 'Me Too' Hepatitis C Drug [View article]
    Mercitabine failed because of potency, BMS 986094 failed because of safety, psi 938 failed because of safety reasons. In theory you are right but in reality there are more failures than successes despite favorable preclinical data. I don't think it is easy to develop and nuc that is not already on patent that is potent and effective.
    Jun 12, 2014. 01:38 PM | Likes Like |Link to Comment
  • Why Big Pharma Has No Interest In Achillion's 'Me Too' Hepatitis C Drug [View article]
    SOF is approved with IFN mainly because of regulatory reasons. The market is using it with simeprevir because it makes sense.

    The high SVR rate for sovaprevir is in genotype 1b. They designed it that way most likely because they were not confident enough in including genotype 1a which is the more difficult genotype to treat. The market standard is pangeotype and not a regimen that covers just one genotype or sub genotype.
    Jun 12, 2014. 11:07 AM | Likes Like |Link to Comment
  • Why Big Pharma Has No Interest In Achillion's 'Me Too' Hepatitis C Drug [View article]
    It is very clear that the current surge is based on hype, rumors and emotions and less on facts. ACHN could have a blockbuster nuc in their pipeline but the chances are low, since they really have no known experience in prior development of nucleot(s)ides. This is important since often times, successful drugs are the result of many failures. You learn from those failures and the chances of coming up with the right chemistry with no previous human experience is also very low.

    Their preclinical data suggests that it could be safe and potent but it is preclinical. If you understand drug development, preclinical data often is not replicated once you go clinical.

    People who are long could be right and ACH-3422 could be the next blockbuster nuc but the chances again are very low.

    IDIX was a company of many failures and I believed that they learned from them. They have experience of developing a nucleotide to market (telbivudine). Their NUC had more robust efficacy and safety data. They had a viable plan to come up with a pangenotypic one pill once a day regimen. They were the only ones in the market that could come up with a single tablet regimen with pangenotypic activity other than Gilead. I did not invest in ACHN because they had a mediocre protease inhibitor (which pretty much everyone has) and if you listened to their presentations it seemed as if their plan was a genotype 1b strategy, at least a few months ago. This I thought was a flawed strategy because who would use such a regimen when you have better options. The reason they came up with that plan is that their protease inhibitor and NS5A inhibitor combination was not potent enough combined together. They did mention their nuc but it was lab data. It looked promising and potent but the problem with potency is safety. If you potently inhibit the NS5B polymerase inside the virus, you should also be concerned that you maybe inhibiting the mitochondrial DNA polymerase. The trick is to bind tightly to the virus enzyme but not the human enzyme, and that is the trick in developing a successful nuc. So it really is too early to say anything regarding Achillion.

    I was IDIX long. Currently holds no other positions.
    Jun 12, 2014. 10:25 AM | 1 Like Like |Link to Comment
  • CA panel deems Sovaldi a "low value" treatment [View news story]
    Previous standard of care usually included IFN + ribavirin + a 1st generation protease inhibitor. It caused a lot of side effects leading to many follow ups, possible admissions, management of the side effects with certain drugs, etc which leads to extra costs other than the drug itself. If you consider all this I do not think that SOF's price is unreasonable, although I do agree with the moral argument that it is wrong for people who do not have money to not be offered this life saving drug. Pricing is always tricky for this reason.
    Mar 12, 2014. 11:27 PM | Likes Like |Link to Comment
  • Revisiting Idenix: Continues To Have Big Potential With Low Risk/High Reward [View article]
    The bar for HCV is high. It will likely be one pill (single tablet regimens), once a day, pangenotypic coverage. NS5B polymerase inhibitors will be a backbone and NS5A inhibitors seem like a good combination. Protease inihibitors are good except it has more drug-drug interactions compared to the NS5B polymerase inhibitors and NS5A inhibitors. Idenix has a good NS5A inhibitor. The question is do they have a good NS5B inhibitor. There previous attempts failed because FDA stopped the development of there(IDIX) NS5B inhibitors based on BMS's Inhibitex NS5B polymerase inhibitor SNAFU. We will see. This is the biggest risk that IDIX has in my opinion.

    Pan-genotype is important. It means you diagnose HCV and don't need to further check genotypes, and possibly viral loads, especially if your SVR12 rate is greater than 95%. This is important in more developing countries where the bulk of HCV is, and where these more sophisticated tests may not be available. Achillion is another company that has a potentially potent NS5B polymerase inhibitor but they don't have a pangenotypic companion to develop a single tablet regimen. There's(Achillion) is suboptimal in genotype 1a which is the more difficult genotype to treat, and if you have a pangenotypic drug in the market, why spend the extra money and time to confirm genotype

    Idenix and Gilead, to my knowledge are the only companies that have the potential to develop a single tablet regimen with a pangenotypic NS5B polymerase inhibitor and NS5A inhibitor which seems to be the best combination so far in terms of SVR12 rate, side effect profile, drug-drug interactions, price matters. Abbvies will include a protease inhibitor and also ritonovir which will lead to a significant drug drug interaction. The size of the pill will likely be bigger.

    Duration of 8 weeks vs 12 weeks may not be that important. 4 weeks vs 12 weeks might matter.

    HCV market looks a lot like HIV. Single tablet regimens, once it comes out will dominate. Pill size matters, daily dosing matters, pangenotypic coverage matters, side effect matters, drug drug interaction matters. NS5B polymerase inhibitor + NS5A inhibitors seem to be the best that please all these factors.

    Gilead will be the market leader, Idenix is the only company that has the potential to match Gilead, in terms of science regarding the above. In my honest opinion, IDIX is undervalued. A good buy. I am IDIX long.
    Mar 11, 2014. 04:27 PM | 2 Likes Like |Link to Comment