© 2008 The Associated Press
NEW YORK — Vertex Pharmaceutical Inc.'s hepatitis C drug telaprevir will likely dominate the market and its rival, Schering-Plough Corp.'s boceprevir, according to several analysts.
The companies presented dueling data on each of their developing hepatitis C drugs at the 43rd annual meeting of the European Association for the Study of the Liver last week. Analysts said telaprevir showed the most promise.
"We maintain that boceprevir should eventually be approved but its potential to garner significant market share is unclear due to an inferior profile and uncertainties about the timing of Phase III (clinical trial) initiation," Cowen and Co. analyst Steve Scala said in a note to Schering-Plough investors.
On Saturday, Schering-Plough said an interim analysis of midstage study results showed the drug candidate prompted an immune response in patients. But, earlier in the week, Vertex showed that telaprevir prompted a higher response rate.
"Following underwhelming competitor clinical data we believe Vertex's telaprevir will play a dominant role in the treatment of hepatitis C," Wachovia Capital Markets analyst George Farmer said in a note to Vertex investors.
Hepatitis C is a blood infection that can cause liver inflammation and possibly liver cancer. Both companies plan to move their respective drug candidates into late-stage development, where effectiveness will be tested on larger groups of patients. Though Wall Street is leaning toward telaprevir as the market leader, it is the Phase III, or late-stage, study that will really prove a drug's effectiveness.
Though telaprevir's recent results set it up as the likely top drug, said Oppenheimer & Co, analyst Dr. Brian Abrahams, boceprevir could still pose a threat.
"We believe boceprevir's clear activity and reasonable safety do warrant further development," he said, adding that the Schering-Plough data substantially reduce, but do not completely eliminate, a long-term competitive overhang on Vertex.
Telaprevir has never passed the pregnancy test and there is no information on it's pregnancy category. There is a BOX WARNING on Pegsys and COPEGUS for birth defect, and they both were labeled as Pregnancy category X.
Telaprevir showed impairment of fertility in animal study, but VRTX had never tried to test and obtained the human data. If these 3 drugs are used in combination, it would cause more severe damage to human fertility, and it would be a very important safety issue.
The FDA is under pressure on safety issue from the Congress because the "Pro-Business" from the Bush administration, and ignored the safety issue in many aspect.
The tide will be changed when democrat take control of the Whitehouse next year.
the last post is from me, willow. I'm on my dad's computer, so my screen name didn't come up. I just wanted you to know that I was so very glad to hear from you!! I gotta remember to sign on as myself when I do maintenance on my dad's computer!!!
maybe I will try with you. Being over 50 and just barely under 60, I feel the need to try again most acutely. To put it bluntly, it sucks. I hate the idea of interferon again, but I hate the ides of doing nothing even more. My greatest fear is that I will end up with the worst profile for treating...over 60, stage 3, a woman and geno one. And yet, I'm cruising to that profile so very quickly.
You are a brave soul. I need to think about exactly what you are...if telaprevir is close by the end of next year, I can wait. If not, well, hello interferon.
You gotta live in Hep C land to understand what the hell it is like. to know the virus is taking your liver bit by bit and there is not really anything effective to treat it is so very AWFUL and can even make 10% seem okay. Good luck, jren, perhaps we will be in the same boat soon.
as for rah, i really have to learn to control my enthusiasm better and to not be so cross. You are EXACTLY right about the financial versus medication perspective, I need to remember to be kinder.
I agree with you entirely. I've tried to find a journal article I read recently that stated that the biggest predictor of rapid progression was age. Can't find it, though. It found, I believe, that regardless of age at infection, gender, genotype, etc. the patient age of about 65 years was when the progression to cirrhosis occurs. That is the age that most of us are rapidly approaching.
More people in this country died from HCV than HIV/AIDS last year,yet it is still under most people's radar.
On the other hand, if someone doesn't get their facts straight, like Rah, we need to remember that this is a purely financial situation for them. I don't think that they are trying to be insensitive; they are just uninformed.
On a side note, I'm in the same situation as you, but may try to re-treat this summer even though there is only a 10-15% chance of it succeeding. My doctor feels that he'll know in May whether telaprevir is likely to be approved early. If not, I think I'll give it another try for the summer (I don't work in the summer)and see if there is an EVR.
Wishing the best for both of us. I so look forward to posts from you, Emserm,DD and JustRPaul. Thanks. S.
rah pissed me off. And I have to repost when I MEANT to say...instead of what I posted in my "riled up" condition....
I'd say you might be right, but the perspective that the "protracted history" of Hep C does not indicate quick consideration by the FDA is total bull. There is no minimizing the absolute explosion in Hep C related deaths and liver transplants, and consider that liver transplants are the number one transplant in our country, with the need growing.
Hep C was finally ferreted out because doctors and hospitals began to see this horrific increase in liver related deaths...in people with no history of drug use or drinking. The virus was finally identified and your sentiment that Hep C is "not a big enough deal" to warrant the FDA's quick scrutiny is crap. The numbers are there...