Telaprevir 2nd half 2010 "likely"

[HectorSF]

A new Phase III study looking at 24 vs 48 weeks and starting with Peg and Riba before introducing telaprevir to market...

"Vertex announces new trial of telaprevir in non responders
Last updated:26June2008
A speedier-than-expected regulatory filing for Vertex Pharmaceuticals' hepatitis C drug appears less likely after the company disclosed plans on Monday for a new phase III study of the drug.

Investors have been hoping that Vertex and partner Johnson & Johnson could seek regulatory approval for telaprevir in 2009 based on data from existing clinical trials in treatment-resistant patients. However, the companies posted details of a new phase III study of telaprevir in treatment-resistant hepatitis C patients on the ClinicalTrials.gov Web site on Monday. The disclosure dampened investor outlook for a quick telaprevir filing.

If Vertex cannot file telaprevir with the U.S. Food and Drug Administration in 2009, the filing will likely come in the second half of 2010 after studies of the drug in treatment-naïve hepatitis C patients are completed.

"We have learned that telaprevir's phase III study in treatment experienced hepatitis C patients is different from PROVE 3 and study 107, which in our view decreases the chances of an early filing," wrote Citibank analyst Yaron Werber in a note to clients Monday evening. PROVE 3 and study 107 refer to the existing telaprevir studies in treatment-resistant patients.

Werber has a hold rating on Vertex, and perhaps echoing the sentiment of his momentum and catalyst-driven hedge fund clients, he added that, "We are no longer warming up to the stock and believe the momentum has cooled off as we believe that the chances for an early approval on PROVE 3 and 107 are low."

Vertex spokesman Michael Partridge says Monday's disclosure of a new phase III telaprevir study is in line with the company's previous guidance and "not closely connected to a possible [FDA] filing based on PROVE 3 results."
Partridge added that Vertex and the FDA are still discussing the previously disclosed PROVE 3 data, but that "initiation of a new phase III study is a natural extension of the PROVE 3 results which we would have started no matter the path to a filing."

The new phase III study disclosed on Monday will test two different regimens of telaprevir in patients who previously did not respond to conventional hepatitis C treatment with pegylated interferon and ribavirin.

The study differs from previous studies in that patients will be treated with two regimens of telaprevir for a full 48 weeks instead of the accelerated 24-week treatment cycle used for treatment-naïve patients.

In addition, one of the arms of the new study will see whether a "lead-in" treatment with interferon and ribavirin alone before dosing of telaprevir may improve overall cure rates.

The design of the new study is sufficiently different from the previous PROVE 3 and study 107 trials to suggest that regulators want more and different data on telaprevir's effect on treatment-resistant patients before considering the drug for approval.

Cowen & Co. analyst Rachel McMinn views Monday's selloff as an overreaction to expected news. She reiterated her outperform raring on Vertex.
"We believe that yesterday's [Vertex] sell off was driven by an over-reaction to two-week old information. Timelines for commercial launch of telaprevir (late 2010/early 2010) are unchanged, and we see 50% upside relative to the market on the basis of this timeframe. While probability of an early 2009 FDA approval is low, we see 100% upside relative to the market under this scenario over the next 6-12 months."


Hector

[willows]

Boy, let me second Andiamo's assessment of "analysts"....I too agree that very few of them know what they are talking about.   What I have read since this statement was released made me feel a bit better...the design of phase III does not have much to do with early approval of Telaprevir for non responders, even tho the analyst would have you believe it does.  There are remarks from Vertex that say they are getting ready to at least "try" for early approval for non-responders...so it is between Vertex and the FDA.  What analysts think has so very little to do with it...thank the gods for that.

Willow

cross your fingers...

[Marcia2202]

Eric, thanks for the info... so it's actually no news at all. I thought Vertex had come with this statement. I guess one should always read the bottom of a statement like that, too. I tend to skip that part. :-)

You definitely are a walking, running, kicking and sailing example of why they should approve it ASAP.

Marcia

[Andiamo1]

I think this is not bad news or good news; it is just another analyst blowing hot air in return for gobs of money.  My personal experience with analysts is that many of them have very little knowledge of the subject they are talking about.

Many companies perform studies after the drug is approved; they want to see if another dose regimen will be more effective.  I think there is a good chance that there will be early approval for Telaprevir for SOC failures.  I am a prime example of why that might get approval.  Lives can be saved when there is no other reasonable alternative - that is a powerful reason to grant approval.

Eric

[Marcia2202]

Thanks for posting this. It is bad news, that it will take so long to be approved.

The good news is to hear how they will be conducting the trials. That is actually quite interesting. It would be great tif they were ti improve overall cure rates with the lead -in treatment.

Marcia