Salmon Rises -- Legacy Schering-Plough's Boceprevir "Back-Burnered" -- By New Merck?

[spectda]

http://shearlingsplowed.blogspot.com/2010/03/salmon-rises-legacy-schering-ploughs.html

THURSDAY, MARCH 11, 2010

Salmon Rises -- Legacy Schering-Plough's Boceprevir "Back-Burnered" -- By New Merck?

Is this simply a case of the NIH Syndrome (as in "Not Invented Here"), or is it (even more) simply true that Vertex's Telaprevir will win this coming generation of Hep C treatment candidates, and New Merck is now retooling for the next generation, beyond that?

I dunno -- but Salmon gives us the scoop, from Boston.com -- do go read it all:

. . . .[Merck's Peter] Kim said top prospects among the drugs acquired from Schering-Plough include two that would each be the first in a new class, an anticlotting drug referred to as TRA and a hepatitis C drug called boceprevir. . . .

The two companies' pipelines overlapped only in hepatitis C and cancer. In those two cases, each company had a lead compound out of multiple candidates. The combined company decided to put the Schering-Plough compounds on the back burner and move forward on testing of the Merck compounds. . .

More generally, Salmon writes: Merck doesn't give MK numbers until after proof of concept studies have been positive. This implies that MK-7009 is in late phase II whereas boceprivir was much further along in development in phase III.

For Merck to have placed boceprivir on hold and instead move forward a compound in the same class that is much further behind suggests that they don't think much of boceprivir. In fact it may even have major toxicity issues that they don't like. Otherwise you continue with getting it to market as number two for market share and hope a later compound is better than Vertex's compound and will eventually take market share.

As I once heard someone from Merck say they either want to be first to market or best to market.

Of course this is speculation based on news articles and we don't know how reliable the reports are.

-- Salmon

I'm a little confused by this information or whether it is good info or not. This is the first info I"ve seen about boceprevir development be replaced with mk-7009 developement? If so why do they continue the trials for boceprevir? I'm especially wondering since I am about to being treatment with Boceprevir
Thanks to anyone who knows more about it.
Dave

[spectda]

From what I understand, if you were resistant to telaprevir you will be resisant to boceprevir, but other PIs are being developed that will target different parts of the virus. If Merck doesn't continue with boceprevir it because they see more promise with mk-7009 which may be better for your situation, although a longer time for approval unfortunately. it would seem odd to me that they would be putting so much money into the boceprevir trial if they weren't going to seek FDa approval.

[susan400]

I certainly hope that this is just rumor and speculation and not true!  I can't do Telaprevir again..., I just WON'T DO IT, let's put it that way!  It was an awful drug for me, I've already been exposed to it, so I have resistance issues and the worst part was I got the AWFUL rash 2 wks into the trial. And for those of you who don't know, it was definitely Telaprevir causing it because I was randomized into the 'NO RIBA' group.  I've treated many other times w/Riba and NEVER-EVER had a rash this horrendous.  I NEED to have Boceprevir developed.

Susan400

[spectda]

I've had several friends that have been through tx, although not with the any PIs. It sounds like most people experience similar side effects to interferon and riba. It's true that tx is a double edged sword, I don't expect it to be a picnic.

I agree being in a trial gets you the best health care possible. The drug companies have a lot invested in your success, and a lot to lose if something serious happens, so you get much more attention then when you're paying a doctor to put you through tx. I'm not too worried, more hopeful that I am one of the lucky ones who svr, and I don't put my wife through too much!!  From what I understand the people that become anemic have a higher percentage of svr. Thanks for your help and sharing your experience.

[WriteItDown]

Yes, that was very good luck. And it also means you may well not even become anemic, so you'll just be getting the free ride.

Still, even though you *know* you're fortunate to be on the trial, I'm guessing you also know it ain't gonna be a picnic... so it's a weird place to be.

Before my husband started his trial I was very nervous and worried, but he ended up tolerating it much better than I'd feared. It wasn't fun, but he was able to manage. He had an 80% chance of getting the trial drug, and our biggest worry was that he'd end up on the placebo arm.  He lucked out and got the trial drug.  You won't even have to worry about that, which is great. And another good thing about being on a trial is that they see you often and monitor you closely, and help you to manage the sides. This is a big plus I came to appreciate more as the tx went on. It was very comforting to my husband to be able to talk to the trial nurses whenever anything concerned him. They were very responsive.

Also, as you probably know, when you start there are quite a number of people on here who did Boceprevir and can help you to manage your sides. Hope you can relax a little and not worry too much about it between now and then. I can't believe I said that. Relax, great advice, right? I know.

[spectda]

Thank you for the encouragement. I am feeling guardedly optimistic about the trial. I know I am lucky to have been accepted. Luckily once out of many tries my hemoglobin was slightly under 15, the main requirement for the study.

[WriteItDown]

This is a great trial you're in.  You have an excellent chance of clearing, and they've done so many trials by now with Boceprevir that they have the dose and duration down, so you're not a "guinea pig."

But I understand the worry -- it's hard not to worry pre-tx!  Hope you clear early and have mild sides.

[spectda]

Thanks for the comments, The article looked a bit unusual and speculative. I suppose it really shouldn't matter to me as I am glad to be accepted into a trial with no placebo arm. This will be my first tx. Although I've had the disease and known about it for a long time the docs kept saying all looks good and this will probably never effect you. Since last biopsy this year, progression of liver damage and other complications I have been advised to treat asap.

[WriteItDown]

Isn't this article written by someone who is an investor?  I've found that many of them really know little about the actual drugs, they're just trying to figure out who's going to be to market first and whose stock is going to go up the most.

Boceprevir has a great track record, and many people on here have cleared with it.  Don't worry, it's currently one of the two best treatment options.

[newleaf09]

The article is from an opinion column.  I was in a boceprevir trial and the rumor from the medical people in the trial is that boceprevir will come out but Merke has back-burnered narleprevir (Schering's second PI that was just about to finish it's phase 2).  Merke feels like their phase 2 PI is better so they dropped the narleprevir.  All is just rumor and conjecture, as is any certainty about which will get to market first, Boceprevir or Telaprevir.