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Notes from Vertex conference June 3, 2010 by Chairman & CEO
Hopefully some people will find some interesting info here.
Event Title:
Sanford C. Bernstein Strategic Decisions 2010 Conference
Thursday, June 3, 2010 at 9:00 a.m. EDT
Notes made from listening to conference audio: Hectorsf
Talk given by Vertex Chairman & CEO Matthew Emmens.
Background:
The ADVANCE study - Phase 3 telaprevir Clinical Development: In October 2008, Vertex completed enrollment in ADVANCE, the first Phase 3 clinical trial of telaprevir. ADVANCE is an international 3-arm pivotal trial evaluating two 24-week telaprevir-based treatment regimens in approximately 1,050 treatment-naïve genotype 1 HCV patients.
Completed at end of May 2010. Data will be available. In 4 weeks, 90% chance knowing if patient will achieve SRV. 75% SVR for 6 months duration.
The ILLUMINATE study - Phase 3 telaprevir Clinical Development: In January 2009, Vertex completed enrollment in the global 2-arm ILLUMINATE trial that will include evaluation of 24-week and 48-week telaprevir-based regimens in genotype 1 treatment-naïve HCV patients. The ILLUMINATE trial enrolled approximately 500 patients.
The REALIZE study - Phase 3 telaprevir Clinical Development: In February 2009, Vertex and its collaborator, Tibotec, completed enrollment of REALIZE, a pivotal Phase 3 clinical trial of telaprevir–based treatment regimens for patients with genotype 1 HCV infection who failed to achieve SVR with prior therapy with pegylated-interferon and ribavirin. The REALIZE trial enrolleded approximately 650 patients.
3rd quarter 2010 results will be available.
HCV info and potential Telaprevir market
4 million HCV infected in EU
3.3 million HCV infected in US
1 million diagnosed
2.3 undiagnosed
Most people with HCV don’t know they have HCV
300,000 treatment failure patients
40,000-55,000 undergo treatment each year. Vertex Telaprevir production and sales force can treat to 3 times number of patients being treated now, yearly.
Vertex is hiring sales force of 100 now for 2011 release. Vertex will focus on major city specialists.
Cost/pricing of Telaprevir:
$70,000 cost for current SOC treatment
Product Advantage: Double cure rate in half the time
Chairman & CEO of Vertex said price of Telaprevir “comforting and significant”. Could be Blockbuster drug – a drug with annual sales of at least $1 billion
Breakthrough medicines in Europe can be priced more than U.S.
Healthcare Reform will help Telaprevir due to focus on preventative medicine and need to cut costs. HCV treatment vs. advanced liver disease.
Vertex working on Bill in Congress to have routine HCV screening for people over 50 years old. Vertex working with Black Caucus on the issue of undiagnosed HCV. Working with local officials, churches to have more awareness of HCV in 25 major cities and minority communities. This will take 2-3 years to implement. Will not be an advantage when Telaprevir is released.
Next treatment major step: 2015-2016 STAT-C combos available (no more peg-INF & Ribavirin)
Event Title:
Sanford C. Bernstein Strategic Decisions 2010 Conference
Thursday, June 3, 2010 at 9:00 a.m. EDT
Notes made from listening to conference audio: Hectorsf
Talk given by Vertex Chairman & CEO Matthew Emmens.
Background:
The ADVANCE study - Phase 3 telaprevir Clinical Development: In October 2008, Vertex completed enrollment in ADVANCE, the first Phase 3 clinical trial of telaprevir. ADVANCE is an international 3-arm pivotal trial evaluating two 24-week telaprevir-based treatment regimens in approximately 1,050 treatment-naïve genotype 1 HCV patients.
Completed at end of May 2010. Data will be available. In 4 weeks, 90% chance knowing if patient will achieve SRV. 75% SVR for 6 months duration.
The ILLUMINATE study - Phase 3 telaprevir Clinical Development: In January 2009, Vertex completed enrollment in the global 2-arm ILLUMINATE trial that will include evaluation of 24-week and 48-week telaprevir-based regimens in genotype 1 treatment-naïve HCV patients. The ILLUMINATE trial enrolled approximately 500 patients.
The REALIZE study - Phase 3 telaprevir Clinical Development: In February 2009, Vertex and its collaborator, Tibotec, completed enrollment of REALIZE, a pivotal Phase 3 clinical trial of telaprevir–based treatment regimens for patients with genotype 1 HCV infection who failed to achieve SVR with prior therapy with pegylated-interferon and ribavirin. The REALIZE trial enrolleded approximately 650 patients.
3rd quarter 2010 results will be available.
HCV info and potential Telaprevir market
4 million HCV infected in EU
3.3 million HCV infected in US
1 million diagnosed
2.3 undiagnosed
Most people with HCV don’t know they have HCV
300,000 treatment failure patients
40,000-55,000 undergo treatment each year. Vertex Telaprevir production and sales force can treat to 3 times number of patients being treated now, yearly.
Vertex is hiring sales force of 100 now for 2011 release. Vertex will focus on major city specialists.
Cost/pricing of Telaprevir:
$70,000 cost for current SOC treatment
Product Advantage: Double cure rate in half the time
Chairman & CEO of Vertex said price of Telaprevir “comforting and significant”. Could be Blockbuster drug – a drug with annual sales of at least $1 billion
Breakthrough medicines in Europe can be priced more than U.S.
Healthcare Reform will help Telaprevir due to focus on preventative medicine and need to cut costs. HCV treatment vs. advanced liver disease.
Vertex working on Bill in Congress to have routine HCV screening for people over 50 years old. Vertex working with Black Caucus on the issue of undiagnosed HCV. Working with local officials, churches to have more awareness of HCV in 25 major cities and minority communities. This will take 2-3 years to implement. Will not be an advantage when Telaprevir is released.
Next treatment major step: 2015-2016 STAT-C combos available (no more peg-INF & Ribavirin)
http://www.medhelp.org/posts/Hepatitis-C/Think-you-could-add-pis-later-in-treatment/show/1241485?personal_page_id=909269#post_5757160
Have you read this thread? Willing is going to start tx in October with Alina and then add Ribavirin for 2 weeks and then do SOC and add the PIs assuming they become available while he is one treatment. Maybe this would work for you. It is a very good thread.
frijole
Have you read this thread? Willing is going to start tx in October with Alina and then add Ribavirin for 2 weeks and then do SOC and add the PIs assuming they become available while he is one treatment. Maybe this would work for you. It is a very good thread.
frijole
Yes, the screening would be for HCV RNA levels .
So-called "liver panels" can not diagnose HCV or the extent of liver disease.
Hectorsf
So-called "liver panels" can not diagnose HCV or the extent of liver disease.
Hectorsf
I think it is a great idea to have everybody over 50 screened as long as they are doing an antibody test at least. None of my previous doctors were the least bit concerned about my liver since my liver panels came back normal. If that is what they are going to do for patients over 50, they are still going to miss a lot of people who have hep c. I really think they need to educate the doctors about this disease.
Waiting and waiting along with many. The rep at Vertex said that it is a public right to write the FDA to try and "fast track" Telaprevir as they did the AIDS medicines. Certainly couldn't hurt...
Mag
Mag
Hector - thanks for posting this. I had read that Vertex was going to market the drug unlike all the other R&D companies. Hiring a sales force now - a year in advance - sounds risky. I wonder if that means early 2011. I hope to be treating this time next year.
Magnum -- you crack me up. You are quite astute! Doesn't look like the shareholders are going wild yet -- no big rise in the value of VTX. BUt it is intersting that they are putting up an all out push to get testing done to all over 50. Good idea to me even if they have an ulterior motive. How are you doing? How is QOL? Can you wait that long?
frijole
Magnum -- you crack me up. You are quite astute! Doesn't look like the shareholders are going wild yet -- no big rise in the value of VTX. BUt it is intersting that they are putting up an all out push to get testing done to all over 50. Good idea to me even if they have an ulterior motive. How are you doing? How is QOL? Can you wait that long?
frijole
Magnum -
Yep, the conference was for investors. But I didn't learn some interesting things about their business model. I used to work in pharma, so it was interesting to learn about their business, how they will focus their sales staff and the possible impact the PIs will have on the HCV community. I think Telaprevir and all the other pipeline STAT-C meds will be a C change for this disease. Hope I can hang on long enough to get to try it.
"Free meds and two weeks all expenses paid vacation in the Bahamas... "
As "Hurley" might say "Sign me up, dude!!!"
Hectorsf ;-)
Yep, the conference was for investors. But I didn't learn some interesting things about their business model. I used to work in pharma, so it was interesting to learn about their business, how they will focus their sales staff and the possible impact the PIs will have on the HCV community. I think Telaprevir and all the other pipeline STAT-C meds will be a C change for this disease. Hope I can hang on long enough to get to try it.
"Free meds and two weeks all expenses paid vacation in the Bahamas... "
As "Hurley" might say "Sign me up, dude!!!"
Hectorsf ;-)
Wouldn't be a bad idea and a good publicity promo if they had a Telaprevir Sweepstakes monthly. The winner .... free meds... Or even better... Free meds and two weeks all expenses paid vacation in the Bahamas...
Magnum
Magnum
If you read between the lines, this sounds like a commercial for potential stock investors. They mention “$70,000 treatment”, “working on a bill on Congress for a routine check of Hep C (so there will be more and more customers?)”, "Could be Blockbuster drug – a drug with annual sales of at least $1 billion", oh wow! "Vertex Telaprevir production and sales force can treat to 3 times number of patients being treated now, yearly"... Alert the media!
Then they mildly try to redeem themselves with this statement...
"Caucus on the issue of undiagnosed HCV. Working with local officials, churches to have more awareness of HCV in 25 major cities and minority communities. This will take 2-3 years to implement. Will not be an advantage when Telaprevir is released".
It's a shame that it will not be an advantage when Telaprevir will be released, otherwise a massive amount more customers. I don't know... what do you read into this?
Magnum
Then they mildly try to redeem themselves with this statement...
"Caucus on the issue of undiagnosed HCV. Working with local officials, churches to have more awareness of HCV in 25 major cities and minority communities. This will take 2-3 years to implement. Will not be an advantage when Telaprevir is released".
It's a shame that it will not be an advantage when Telaprevir will be released, otherwise a massive amount more customers. I don't know... what do you read into this?
Magnum
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