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value investor12

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  • 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 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 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 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 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 04:27 PM | 2 Likes Like |Link to Comment