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.
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.
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)
I agree with you.
There are no lab tests where they may take a patient's blood and add interferon to it in a test tube and voila-- come up with anything that says they can or can not tolerate INF. So the only way to establish intolerance is if they have already taken INF and had to discontinue because they were not able to put up with the side effects. Also keep in mind that many of those who dropped out of experimental trials were in blinded trials where they did not know if they were getting the new drugs such as Incivek, Victrelis, etc. Had they known they were taking the new drug many would not have dropped out.
Getting back to VRUS and based on the above I do not see how VRUS can say 7977 is for TREATMENT NAIVE yet INF INTOLERENT PATIENTS unless the FDA allows patients or their doctors to decide the criteria based on guessing. I doubt it that the FDA would allow that.
I think what will happen is that the FDA would establish a minimum number of weeks of INF use before one could be considered intolerent. VRUS would then try to comply with that requirement by administering INF for the required specified weeks and talk all the patients quietly into saying they have a hard time with its side effects (or at the least give patients a choice to discontinue INF). They then report data on those who stopped taking INF. This sounds like a conspiracy, but with some of these biotech companies it would not surprise me if it happens.
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.
"treatment naïve individuals who are not eligible for interferon"
according to the info on pegasys
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!
I think the Pharmasset strategy is to get the FDA to approve their PSI-7977/RBV oral regimen for interferon intolerant HCV patients, regardless of genotype, and then market the combo to every HCV patient even if it has a low cure rate for GT1. Using the vague designation "interferon intolerant," you can include any patient that might not want to experience influenza-like side effects. And wouldn't that include everyone?
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.
<<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