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Boceprevir filing

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Anonymous

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Anyone have any info on either the boceprevir or the Vertex telaprevir filing? An colleague of mine said that he believed that some portions for boceprevir have already been submitted to the FDA last week. The target deadline for submission is end of December which only leaves about 6 weeks. And what about Vertex? They were claiming a matter of weeks 4 weeks ago. If this product gets lost or significantly delayed along the way, the consequences will be serious. Already that anti-thrombisis product seems to have become significantly delayed. Clinical trilas have already been finished for months but no filing date seems to be targeted. WTF. Let's get some of that bursting pipeline delivering something more than hot air. No new products means few new sales means grim future.
 

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Boceprevir Not sure when it will hit the street but you should know that vertex brand Teleprevir has significant advantages. Clinical trials of T done with market leading drug cocktail Pegasys. Clinical trial design resulted in shorter length of therapy, potentially 12 weeks based on response curves vs Bo at 24 to 48 weeks. Bo trials also designed to encompass lead therapy with Peg-Intron. This will infer less potency to astute physicians. Wow...a relatively toxic cocktail often given to poorly compliant patients...wonder who will win that one ? No wonder the US marketing lead at Merck defected to Vertex...I heard that many of the SP HCV managers/reps are running to PC, Oncology, Hospital...anywhere but HCV. Projected blood bath...another great reason to acquire SP.
 








In this business, what matters is that something works and it is approved. So what if Vertex gets 75% of a 4 billion market. Merck will still have one more billion-dollar product than it had before approval. And do marginal changes in efficacy really have such an overwhelming impact on prescribing? So this drug will not exactly sell itself but it will sell. The market for these therapies is hyped and there will be all sorts of schemes to push sales. However, for the long term - or the short term if this boceprevir doesn't pan out or the anti-clotting drug doesn't live up to its hype, the toaster is moving to high. Those were actually the major compounds that got Merck to fork over 41 billion to Fast Freddie.
 




Anonymous said:
Boceprevir Not sure when it will hit the street but you should know that vertex brand Teleprevir has significant advantages. Clinical trials of T done with market leading drug cocktail Pegasys. Clinical trial design resulted in shorter length of therapy, potentially 12 weeks based on response curves vs Bo at 24 to 48 weeks. Bo trials also designed to encompass lead therapy with Peg-Intron. This will infer less potency to astute physicians. Wow...a relatively toxic cocktail often given to poorly compliant patients...wonder who will win that one ? No wonder the US marketing lead at Merck defected to Vertex...I heard that many of the SP HCV managers/reps are running to PC, Oncology, Hospital...anywhere but HCV. Projected blood bath...another great reason to acquire SP.
Click to expand...
1st- Boceprevir and Telaprevir have been doing a rolling file with the FDA for their "NDA" which means they've both been filing as they can fulfill certain requirements.
2nd- Telaprevir is on 12 week triple therapy and then 24-48 weeks of double therapy so the total course of treatment for the patient will be the same on Telaprevir or Boceprevir AND Telaprevir will probably only get FDA approval for shortening treatment for NIEVE PATIENTS which means relapsers and non responders will only be 48 weeks of treatment on Telarevir vs. 24 on Boceprevir (plus 4 week lead in)
3rd- look at the assay results they matter which one you used to calculate viral load
4th... resistance matters and
5th- WHO WANTS RASH? it's bad you may have hidden it under cleaver "drop out" rates or dematological problems, but once people start getting it like they did in phase 1 and 2 you will be DOOMED...
6th... we'll see in the end- both of these drugs will be short lived until new regimens come out then people will move on to bigger and better things. Enjoy your 2 years in the HCV world, then be careful of the newbies on the block
Telaprevir and Boceprevir= they both have the same results when you actually look at the studies and pull them apart and compare the populations that are similar- ie nieve populations, retreatment, non responders.

LASTLY___You can't compare Merck's OVERALL SVR to Vertex's NIEVE population and claim you have 10% higher SVR doesn't work that way. Doctors will think you are slimy when they figure out your are manipulating the data incorrectly.
 




It's NAIVE. Jesus. Don't you guys even have to finish high school anymore?
Vertex has completed their filing. Merck is a few weeks behind. Approval could still hapen for both on the same day though. Then it's all about who can hit the streets the fastest,a nd whose drug costs less. Pricing is something no one is talking about. I'd love some thoughts on that one!
 




This org could ___ up a wet dream...I still see my buds in HCV defecting whenever they get the chance. true second generation PI's will take the market when available 2012-13.
BMS has the drug...a few years out...
 




It is December 18th and Boceprevir still has not received a completion notice on their NDA from the FDA. Telaprevir will be first to market with cure rates of 75% for treatment naive, up to 88% for relapsers and 31% for null responders. Boceprevir did not even bother to try to include null responders based on prior negative experience. It is clear who will be first in class and first to market. As for new drug cocktails it took Vertex 3 years to go from Phase III study approval to complete NDA filing followed by another 6 months for approval. Following this logic any new drug combination will take 3.5 years+ to come to market. Finally, Vertex is already in advanced phase II with Telaprevir dosed with polymerase Inhibitor VX222. Vertex did its homework and found that VX222 is active against the wild viruses created by Telaprevir and vice versa. Only time will tell which new cocktail will win but what we do know is that we are looking at at least 4 years for these new drug cocktails to replace Telaprevir and Boceprevir.
 




Managed care is going to play a big part and it makes me nervous. NEVER with my SP years or my Merck years has managed care even cared about PegIntron. We've been at the bottom of all the drugs in their bag. Now, Putz is going to tell us that Bo is #1 and a priority? Managed care has burned so many bridges there is no respect anymore. The thought is Vertex can't do anything but they're hiring experienced reps who have relationships AND 1 drug to concentrate on. I'm concerned that there is not enough concern over what Vertex is capable of. I know there are several managers with the same concern but Merck doesn't care to hear about it. The arrogance is going to spank us...and it won't be a happy spanking! Not only do I not have confidence in managed care, but upper management has to wake up and smell the reality of the morale and do something POSITIVE and be PROACTIVE for once!!!!
 




Anonymous said:
Managed care is going to play a big part and it makes me nervous. NEVER with my SP years or my Merck years has managed care even cared about PegIntron. We've been at the bottom of all the drugs in their bag. Now, Putz is going to tell us that Bo is #1 and a priority? Managed care has burned so many bridges there is no respect anymore. The thought is Vertex can't do anything but they're hiring experienced reps who have relationships AND 1 drug to concentrate on. I'm concerned that there is not enough concern over what Vertex is capable of. I know there are several managers with the same concern but Merck doesn't care to hear about it. The arrogance is going to spank us...and it won't be a happy spanking! Not only do I not have confidence in managed care, but upper management has to wake up and smell the reality of the morale and do something POSITIVE and be PROACTIVE for once!!!!
Click to expand...

I agree with your mgd care argument except bocep is completely different. PegIntron is a $100+ million drug. bocep is potentially $2+ billion. Managed care will be busting their hind ends on this one.
 




Anonymous said:
Managed care is going to play a big part and it makes me nervous. NEVER with my SP years or my Merck years has managed care even cared about PegIntron. We've been at the bottom of all the drugs in their bag. Now, Putz is going to tell us that Bo is #1 and a priority? Managed care has burned so many bridges there is no respect anymore. The thought is Vertex can't do anything but they're hiring experienced reps who have relationships AND 1 drug to concentrate on. I'm concerned that there is not enough concern over what Vertex is capable of. I know there are several managers with the same concern but Merck doesn't care to hear about it. The arrogance is going to spank us...and it won't be a happy spanking! Not only do I not have confidence in managed care, but upper management has to wake up and smell the reality of the morale and do something POSITIVE and be PROACTIVE for once!!!!
Click to expand...

If you've been with SP then you know how angry the liver community is at SP. It was an eye opener for Merck how people said they used Pegasys, not because it was better, but because it wasn't SP. The SP model never supported the professionals, Genentec does! Sure SP engaged a few select individuals but not the broader constituencies in American or European associations for study of liver disease. That message was heard loud and clear and changes are being made to address the weaknesses. Unfortunately it's late. Managed care is a piece and hopefully Merck will take what it's learned HIV and transfer that to Hep C.
 




I heard from colleagues in manufacturing that the US filing is complete. But I have seen nothing in the form of a press release. What's the real deal? Anyone have any confirming info? Has this filing target deadline of 2011 been met or not? Vertex has had announcements for EU and FDA already. If the filing is still not complete that places telaprevir more than 5 weeks ahead and counting. Problem?
 




Anonymous said:
I heard from colleagues in manufacturing that the US filing is complete. But I have seen nothing in the form of a press release. What's the real deal? Anyone have any confirming info? Has this filing target deadline of 2011 been met or not? Vertex has had announcements for EU and FDA already. If the filing is still not complete that places telaprevir more than 5 weeks ahead and counting. Problem?
Click to expand...


Troll post. Maufacturing is not the authority on whether or not a filing is complete. Ever hear of Regulatory? Yeah, that's the ticket. Regulatory decides when something's ready to be because Regulatory sends it in to FDA. And when was the last time Mother Merck put out a press release on sending in an NDA to FDA? We don't play that game, remember?
 




Well, Mother or no Mother, the FDA NDA site does provide a response in the form of their NDA number list to a search on telaprevir and does not provide a similar response to a search on boceprevir. In any case, if it isn't already filed, REGULATORY will have it filed before the company discusses 4th quarter results next month. Ken's coming and Dick's going just about demands that.
 












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