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208Pb

208Pb
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  • Celgene: Do The Revlimid Polymorph And Use Patents Matter? [View article]
    I do not disagree with anything written by the author.

    But I would like to augment it.


    Polymorph are often less stable that crystals:

    1- Chemically, these form sometime decompose to produce impurities, some of these could be toxic or, more often, reduce potency because there is less drug


    2- As indicated polymorph are more soluble, some polymorph, over time, transform to crystals that are less soluble.


    Solubility is very important:


    1- Bioavailability relates to the proportion absorbed in the blood


    2- The rate of dissolution indicates the speed at which the drug gets in the blood. Too fast or too slow may be a problem even if the bioavailability is the same. This leads to toxicities (if too fast) or less efficacy (too slow)


    In general none of the above is a killer. Definitely a core competency of generic manufacturer is formulation of drug product.
    May 5 04:01 PM | 1 Like Like |Link to Comment
  • Proof of Olysio + Sovaldi? [View news story]
    Combo SOF/SIM most cost effective against HepC G1

    http://1.usa.gov/RmNTgN
    Apr 15 04:29 PM | Likes Like |Link to Comment
  • Intercept Pharmaceuticals: 6 Different Insiders Have Sold Shares This Year [View article]
    Dr Karmaswimswami, you seem to suggest overvaluation here.
    You are a medical doctor with a PhD and familiar with hepatic conditions, would you care to suggest the number of NASH patients that could benefit from OCA? And perhaps could you shed some light on the current cost for NASH patient support (since there are no current treatments)?
    Jan 21 02:17 PM | 1 Like Like |Link to Comment
  • Summer Street not giving up on Ariad's Iclusig despite suspension [View news story]
    Here is a quote from the USFDA statement on the issue:

    “Patients who are currently taking Iclusig and responding to the drug and whose health care professionals determine that the potential benefits outweigh the risks should be treated under a single-patient Investigational New Drug (IND) application or expanded access registry program while FDA’s safety investigation continues. FDA will work with the manufacturer on a plan to quickly transition these patients to a program that will allow access under an IND or expanded access registry program”
    So from a patient perspective not all is lost.

    Also from the same USFDA statement we learn that in a Ph1 with patient median duration of 2.7 years, 48% of patient had “experienced serious adverse vascular events”, there are more details in the statement.

    It seems fair to say that in general the toxicity appear to be proportional to duration and dose.

    From a shareholder perspective, this is bleak.
    I was long Ariad.
    Nov 1 11:29 AM | Likes Like |Link to Comment
  • Summer Street not giving up on Ariad's Iclusig despite suspension [View news story]
    Some readers may remember the TYSABRI story; following news of patient deaths the drug distribution was suspended. The story may be a good comparator for timing purpose.

    Here is the TYSABRI time line

    February 28th 2005, the drug commercial distribution was suspended

    July 24th 2006, the drug became available again but with a substantial risk management plan and new label

    So, 17 months.
    TYSABRI is a Biogen drug for MS
    Oct 31 04:02 PM | Likes Like |Link to Comment
  • Ariad slides again as FDA details adverse event reports [View news story]
    Well, I am not sure as to the meaning of the word “principle”.

    The patent (5,521,184) expired on 28may13 and was extended for 586 days under 35 USC 156. The patent is a composition of matter patent or, more plainly said, on the molecular structure and synthesis of the drug active.

    So, no new molecule need to be invented here.

    Other patents have been awarded on formulations and crystal polymorphs. These types of patents are usually recognised as “weak”: Not only difficult to defend in court but can also be formulated around. Generic manufacturer have a lot of expertise here.
    Oct 11 09:59 PM | 1 Like Like |Link to Comment
  • Ariad slides again as FDA details adverse event reports [View news story]
    David, this is all true.

    But the competitive context is on safety.

    There are other drug in the space, in particular Gleevec (Novartis) that will be generic 4jan15 to be precise. Thus if the tox is somewhat comparable it will be difficult to ask for a premium price.

    I was long ARIA
    Oct 11 12:24 PM | Likes Like |Link to Comment
  • Insiders Are Selling Biogen Idec [View article]
    These sales originate from option awards.
    All options have an expiry date.
    Have you checked the expiry date?

    Also note that the main value driver for BIIB at this time is Tecfidera, what is your view on the sales growth of this drug? Why?
    Sep 25 11:01 AM | Likes Like |Link to Comment
  • Onyx Pharmaceuticals 5-Year Revenue Projection - Part 2 [View article]
    I am curious, how did you model Kyprolis sales?
    Did you use Velcade data?

    Regards
    Jul 2 11:09 AM | Likes Like |Link to Comment
  • This Stock Deserved Its Sudden Upswing [View article]
    US government bonds offer a lot more certainty. There are no if, but and when...

    Insurance companies do pay, at this time, for catastrophic disease like CF.

    BMRN is a good case study in this regard.
    May 13 03:11 PM | Likes Like |Link to Comment
  • Vertex Spikes On Phase II Data, Then The CFO Sells His Shares [View article]
    Look at this from a fundamental perspective.

    There are about 70 000 CF patients worldwide (30 000 in the US).
    The proposed therapy target about half of these (the homozygous del F508 mutation carriers).

    About 4% of the CF population is currently treated with a Vertex drug, Kalydeco, at an annual cost of about 300 000$. Kalydeco is part of the proposed drug combination.

    Historically, positives result in Phase II for deadly genetic diseases generally lead to an FDA approval (in fact as I write this, I cannot think on one negative example). The reason is easy to understand; unfortunately CF patients have a very challenging quality of life even with best current therapies. Every improvement is welcomed; here the expected improvement is significant.

    Do the math.
    Apr 28 02:14 PM | Likes Like |Link to Comment
  • Vertex Spikes On Phase II Data, Then The CFO Sells His Shares [View article]
    Here is a short seller that prefers not to tell the whole story.

    So please before taking action go and read the F4 entirely, in particular the note that reads in part:
    "Transaction made pursuant to Mr. Smith's company approved trading plan under Rule 10b5-1."

    In other words this is an automatic transaction that follows a set of trading rules that are part of the 10b5-1.
    Apr 24 09:56 AM | Likes Like |Link to Comment
  • Ariad Pharmaceuticals (ARIA -4.8%) is having a rough day after an analyst at Favus Institutional Research said survey data shows the company's leukemia drug Iclusig (Ariad's first product to reach market) may be producing "a much larger-than-expected number of serious side effects" such as pancreatitis, stroke, and non-reversable liver toxicity. When the drug received early approval in December some analysts were surprised to see "liver toxicity" as a possible side effect on the drug's label. [View news story]
    This does not represent much new news.

    In particular the product label is clear and read in part in the black box:
    “Hepatotoxicity, liver failure and death have occurred in Iclusig treated patients. Monitor hepatic function prior to and during treatment”
    I would suggest to read the label before taking action:
    http://bit.ly/Z2wdUr

    The label of competing products approved for these indications harbor similar warnings.
    Apr 3 05:03 PM | Likes Like |Link to Comment
  • 3 High-Growth Biotech Stocks Positively Correlated With Volatility [View article]
    Be Careful with conclusions based only on correlation.

    To illustrate consider the declining stork population in Europe and the lowering of birthrates. The correlation is excellent. Should we then conclude that stork bring babies in Europe to joyful families?

    For a correlation to be useful there has to be a mechanism that links the 2 data set.

    Regards
    Jun 11 02:32 AM | Likes Like |Link to Comment
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