Mon, Mar 2, 2015, 1:23 AM EST - U.S. Markets open in 8 hrs 7 mins

Recent

% | $
Quotes you view appear here for quick access.

Vertex Pharmaceuticals Incorporated Message Board

  • mbr041076 mbr041076 Dec 6, 2011 12:15 PM Flag

    If you are right

    Vertex stock will go up dramatically and Vertex will own the HepC world.Soon we will know for sure but I dont trust the FDA as for as I can throw them.Many strange things have come from them like,BRIBES,PAYOFF,FAVORS,ECT...ya know,so anything is possible!When big money is involved funny things happen and more money here than the Federal Gov. plans on saving in the next 10 yrs. this goes past medicine and into politics(science)of making money for people in high places!WATCH AND SEE!!!!!hope Iam wrong.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • I think a better way to put it is Vertex will continue to dominate the HCV market when it becomes clear that the PSI-7977/RBV cure rate for HCV GT1 is inferior to Incivek/interferon/RBV. It will be difficult to justify using an oral regimen with an inferior cure rate in these patients when the cost of treatment failure is so high. The 79 percent vs. 66 percent cure rate for Incivek vs. Victrelis has resulted in a 70 percent market share for Incivek. This occurred despite an earlier approval for Victrelis and the marketing power and political power of Merck. Without an effective PSI-7977 oral regimen for HCV GT1 patients, Pharmasset is no better off than so many other pharma companies with as yet unproven oral regimens for HCV GT1 in early stages of clinical trials. In fact, one of the most promising oral regimens for this patient population is the phase II study by Vertex of Incivek/VX222/RBV with data expected early in 2012.

      • 1 Reply to swhitemd50
      • still dont trust FDA/politicans meaning your very own congress,senators who have privy to what will pass and what wont.These people are in contact with FDA.Get it FEDERAL,this is how they make their millions and its not against the law! for us like Martha Stewart we go to prison.Do you think for one moment this part of the Goverment is honest?I dont think so,sorry but its as crooked as my dogs back leg!!!! Too much money involved it will pass regardless of soc or anything else that why wall street has made VRUS its golden boy.

    • I think there may be a good possiblity that VRUS's data for geno 1 will not be very good. If that is the case, the question then is, will GILD still go through with its offer or just decide to pay the $330M penalty and not go through with it.

      They may still go through with the buy out even with bad trial results because these guys who are managing GILD would not want to admit they may have made a big mistake.

    • If 70-75% are chronic then my personal opinion is we are in the better position.That high of % being chronic means that these people are sick!They and their doctors are looking for the best treatment possible so changing to a new drug that has a question mark is going to take time.Vertex worst case is,even if VRUS is pasted we will still have 1/2 the sales until they prove to be a better drug.That just my opinion.

    • Thats my point about FDA dispute' will they just allow this dodging,headfakes,be be all they need? There is no headon comparison with SOC,I dont get it how they wound even entertain such a study. Can some one enlighten me because I thing this all is about (SHOW ME THE MONEY)

    • <<The first example is obvious, the second not as obvious - but I'm sure there is a SMALL subset population of people who show signs that taking interferon will lead to complications, and that risk puts them into a group where the doctor is unwilling to give it to them. Because there is no HCV treatment on the market without interferon. This is defined as an unmet need. VRUS's strategy is to run the Ph3 targeted at this population which will give them priority review (6 months) due to the unmet need…>>

      For a SMALL subset population!

      <<…thus faster to market. Once on market they are depending on off-label use…>>>
      This is a very risky proposition to bet $11B on. Off-label use will not ensure rapid market penetration – especially with hepatologists who have become accustomed to using Incivek successfully. Further, if you perused the PubMed link I provided earlier relating to the use of leukocyte IFN alpha (multiferonTM) instead of pegylated IFN, you’ll notice that there already is an alternative in Europe. Multiferon is currently being investigated in the U.S. in a PII trial for melanoma. See http://www.clinicaltrials.gov/ct2/show/NCT01341158?term=multiferon&rank=1

    • "treatment naïve individuals who are not eligible for interferon"
      according to the info on pegasys

      http://www.pegasys.com/patient/about-chronic-hepc/treatment/index.html

      these are the conditions for "intolerance":

      >>Who should not take PEGASYS?

      Do not take PEGASYS if you:

      have certain other liver problems
      have certain types of hepatitis caused by your immune system attacking your liver (autoimmune hepatitis)
      have had a serious allergic reaction to another alpha interferon medicine or to any of the ingredients in PEGASYS. Symptoms of a serious allergic reaction to alpha interferon may include: itching, swelling of your face, tongue, throat, trouble breathing, feeling dizzy or faint, and chest pain
      Do not take PEGASYS in combination with COPEGUS (ribavirin) if you:

      are pregnant, or planning to get pregnant during treatment or during the 6 months after treatment
      are a male patient with a female sexual partner who is pregnant or plans to become pregnant at any time while you are being treated with COPEGUS (ribavirin) or during the 6 months after your treatment has ended
      have certain blood disorders such as thalassemia major or sickle-cell anemia
      take didanosine (Videx® or Videx® EC)
      Do not give PEGASYS to a baby under 1 year of age. PEGASYS contains benzyl alcohol, which can cause nervous system problems and other problems that can lead to death.<<

      so obviously not many treatment naive patients have to avoid peg-inf. VRUS certainly wants to expand that group, don't think that FDA will follow. One thing is for sure, Hoffmann-La Roche will fight these attempts!

    • Does anyone know if the oral treatment has (mental) side effects,such as anger,depression, suicide,ect.Not one medical expert has mentioned any mental side effects.This is one of the biggest,badest of all side effects!

    • Good post papa alien. At least that will serve as a good guide until the FDA refines it. It does represent a much smaller population than I thought.

      It seems to me if those INF intolerence criteria are upheld by the FDA, VRUS may find it somewhat difficult to recruit enough patients in a timely basis.

    • FYI - here is how VRUS is thinking about interferon intolerance (from a recent cc):

      "So patients who cannot take interferon could include a broad population including those who have demonstrated intolerance to interferon with previous exposure as well as those treatment naïve individuals who are not eligible for interferon, the specific requirements are under discussing with the health authorities..."

      The first example is obvious, the second not as obvious - but I'm sure there is a small subset population of people who show signs that taking interferon will lead to complications, and that risk puts them into a group where the doctor is unwilling to give it to them. Because there is no HCV treatment on the market without interferon. This is defined as an unmet need.

      VRUS's strategy is to run the Ph3 targeted at this population which will give them priority review (6 months) due to the unmet need, thus faster to market. Once on market they are depending on off-label use (very likely given it's all oral and if the side effects prove to be low) or hoping the FDA will be very very lenient with it's labeling.

    • Agree. Most hepotologist would think twice before they prescribe an INF free regimen off label. Keep in mind that once you remove INF, you have less efficacy and also if a person does not achieve SVR, the patient could have mutant HCV virus which then may be very resistant to any subsequent regimen even if it includes INF.

      If that happened to me you can your last dollar that I would sue that doctor all the way to the bank for my family (since I may eventually end up with liver problems including cancer).

    • View More Messages
 
VRTX
119.43-0.54(-0.45%)Feb 27 4:00 PMEST

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.