Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir, Investigational Hepatitis C Prote

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Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir,

Investigational Hepatitis C Protease Inhibitor

From the PharmaLive.com News Archive - Jan. 23, 2008

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 23, 2008 - Vertex Pharmaceuticals

Incorporated (Nasdaq: VRTX) today announced that it will begin Phase 3

evaluation of telaprevir, Vertex's lead investigational hepatitis C protease

inhibitor. The primary focus will be a global, 3-arm pivotal controlled trial

that will evaluate two 24-week telaprevir-based regimens in approximately 1050

treatment-naive genotype 1 HCV patients. In this study, rapid viral response

(RVR) criteria will be used to determine which telaprevir patients can stop all

treatment at 24 weeks. A second study of approximately 400-500 HCV patients is

planned to evaluate a 48-week telaprevir-based regimen, to confirm the results

from Phase 2 studies and provide additional evidence that supports the 24-week

regimen that is being evaluated in the primary Phase 3 trial. The Company

expects that both studies will run concurrently and that the first trial will

begin enrolling patients in March 2008.

" Data presented in late 2007 from two large Phase 2b studies suggest that

telaprevir, dosed in combination with pegylated interferon and ribavirin, may be

able to meaningfully increase the proportion of treatment-naive genotype 1 HCV

patients who achieve a sustained viral response, and also cut the current

treatment duration in half, to 24 weeks, " said McHutchison, M.D., Principal

Investigator for the primary telaprevir Phase 3 pivotal study and Associate

Director of Duke Clinical Research Institute. " Telaprevir is the most advanced

protease inhibitor in development for hepatitis C, and the initiation of Phase 3

clinical development for this investigational drug will begin the process of

helping to further assess its potential efficacy and the safety in a larger

number of patients. "

Pivotal Trial to Evaluate 24-Week Telaprevir-Based Treatment Regimens

In accordance with the design and protocol Vertex submitted to the FDA, the

primary pivotal trial will focus on evaluation of 24 weeks of telaprevir-based

therapy and will enroll approximately 1050 treatment-naive, genotype 1 HCV

patients, who will be randomized equally across three treatment arms

(approximately 350 patients per arm).

The study will be conducted at approximately 100 centers in the U.S., E.U. and

certain other countries. The study arms will include:

-- 24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h)

for 12 weeks in combination with standard doses of pegylated interferon alfa-2a

(peg-IFN) and ribavirin (RBV) for 12 weeks, then continuing for another 12 weeks

with peg-IFN and RBV alone;

-- 24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h)

for 8 weeks in combination with standard doses of peg-IFN and RBV for 8 weeks,

then continuing for another 16 weeks with peg-IFN and RBV alone; and

-- A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks.

Patients in both telaprevir arms who achieve rapid viral response (RVR), defined

as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who

stay undetectable at week 12 will receive 24 weeks of treatment. Patients in

these treatment arms who do not meet the RVR criteria but are undetectable at

week 24 will continue on peg-IFN and RBV for a total duration of 48 weeks.

Concurrent 48-Week Second Study to Support Registration

Vertex has agreed to conduct a second well-controlled clinical study as part of

the registration program for a treatment-naive indication. The objective of this

second study would be to develop additional sustained viral response (SVR) and

relapse rate data with 48-weeks treatment duration that confirm results from the

Phase 2 studies, thereby providing additional evidence supporting the 24-week

regimen in the Phase 3 trial. The design of this second study is being

finalized, but at this time Vertex expects this study to enroll approximately

400-500 patients, including patients in the control arm.

The primary objective of the two studies will be to assess the proportion of

patients in each study arm who achieve SVR, defined as undetectable (less than

10 IU/mL, as measured by the Roche TaqMan® assay) HCV RNA 24 weeks after the

completion of dosing. Vertex expects to have SVR data from both studies by

mid-2010.

Update on Meeting with FDA

Vertex and the FDA met in mid-January 2008 to discuss telaprevir's Phase 3

development program. This meeting included a review of available data from Phase

2b clinical trials of telaprevir, including newly available post-treatment data

from the 48-week treatment arms in PROVE 1. In the control arm of PROVE 1, on an

ITT basis, 37% of patients had undetectable HCV RNA at 12 weeks post-treatment

follow-up. In the 48-week ( " 12+36 " ) telaprevir-based treatment arm in PROVE 1,

also on an ITT basis, 66% of patients had undetectable HCV RNA at 12 weeks

post-treatment follow-up. The relapse rate in the 48-week telaprevir-based arm

in PROVE 1 was 6%.

Additional HCV Studies

Vertex and Tibotec continue to conduct additional clinical studies to evaluate

the potential role of telaprevir treatment for important HCV sub-populations as

well as different dosing regimens for telaprevir.

-- The companies are conducting PROVE 3, a Phase 2b clinical trial of

telaprevir-based combination therapy in patients with genotype-1 HCV who have

not achieved SVR with a previous pegylated interferon-based treatment. Vertex

plans to discuss with regulatory authorities in mid-2008 the next steps in the

telaprevir development program for treatment-failure HCV patients after the

first interim clinical data are available from the PROVE 3 clinical trial.

-- Tibotec is conducting a Phase 2 clinical study in Europe to evaluate 8-hourly

and 12-hourly dosing of telaprevir in combination with pegylated interferon

(Pegasys® or PegIntron) and ribavirin. Interim 12-week on-treatment data

are expected to be available in the second half of 2008.

-- Tibotec is also conducting a Phase 2 viral kinetics study in Europe to

evaluate telaprevir in patients infected with genotype 2/3 HCV. Interim

on-treatment data are expected to be available in late 2008.

-- In addition, in December, Tibotec initiated a Phase 2 study in Europe to

evaluate telaprevir in patients infected with genotype 4 HCV.

Updates on the status of Vertex and Tibotec's clinical trials of telaprevir are

available at www.clinicaltrials.gov.

About Telaprevir

Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an

enzyme essential for viral replication, and is one of the most advanced

investigational antiviral agents in development that specifically targets HCV.

The types of adverse events that have been commonly observed with Peg-IFN and

RBV were seen across all treatment arms in Phase 2b trials of telaprevir. The

most common adverse events, regardless of treatment assignment, were fatigue,

rash, headache and nausea. Gastrointestinal disorders, skin adverse events

(rash, pruritus) and anemia were more common in the telaprevir arms compared to

the control arm over the dosing period.

About Hepatitis C

Hepatitis C is a liver disease caused by the hepatitis C virus, which is found

in the blood of people with the disease. HCV, a serious public health concern

affecting 3.4 million individuals in the United States, is spread through direct

contact with the blood of infected people. Though many people with hepatitis C

may not experience symptoms, others may have symptoms such as jaundice,

abdominal pain, fatigue and fever. Chronic hepatitis C significantly increases a

person's risk for developing long-term infection, chronic liver disease,

cirrhosis or death. The burden of liver disease associated with HCV infection is

increasing, and current therapies typically provide sustained benefit in less

than half of patients with genotype 1 HCV, the most common strain of the virus.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed

to the discovery and development of breakthrough small molecule drugs for

serious diseases. The Company's strategy is to commercialize its products both

independently and in collaboration with major pharmaceutical companies. Vertex's

product pipeline is focused on viral diseases, inflammation, autoimmune

diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV

protease inhibitor, Lexiva, with GlaxoKline.

Disclosure: Dr. McHutchison receives research support, as does the Duke Clinical

Research Institute, from Vertex, and he has served in an advisory capacity for

the company.

Lexiva is a registered trademark of the GlaxoKline group of companies.

TaqMan® is a registered trademark of Hoffman-La Roche Inc.

Webcast and Conference Call on January 23

Vertex Pharmaceuticals will host a conference call on January 23, 2008 at 8:00

a.m. Eastern Time (ET) to review the Phase 3 trial announcement. This call will

be broadcast via the Internet at www.vrtx.com from the 'Events & Presentations'

page. To listen to the call live on the telephone, dial (800) 374-0296 (U.S. and

Canada) or (706) 634-2224 (International). The call will be available for replay

via telephone commencing January 23, 2008 at 11:00 a.m. ET running through 5:00

p.m. ET on February 6, 2008. The replay phone number for the US and Canada is

(800) 642-1687. The international replay number is (706) 645-9291 and the

conference ID number is 32008293. Following the live webcast, an archived

version will also be available on Vertex's website until 5:00 p.m. ET on

February 6, 2008.

Safe Harbor Statement

This press release contains forward-looking statements, including statements

regarding (i) Vertex's plan to begin Phase 3 clinical development of telaprevir;

(ii) the designs and protocols of the planned clinical trials, including the

anticipated number of patients and the description of the anticipated treatment

arms; (iii) Vertex's expectation that the two clinical trials will run

concurrently and that the larger trial will begin enrolling patients in March

2008; (iv) the expectation that the second study will evaluate a 48-week

telaprevir-based regimen, to confirm the results from Phase 2 studies and

provide additional evidence that supports the 24-week regimen that is being

evaluated in the primary Phase 3 trial; (v) Vertex's expectation that it will

have SVR data for both clinical trials of telaprevir by mid-2010; (vi) Vertex's

plan to discuss with regulatory authorities in mid-2008 the next steps in the

telaprevir development program for patients with HCV who have failed to achieve

sustained viral response with previous treatments; and (vii) the dates by which

interim on-treatment data is expected for the Phase 2 clinical trials being

conducted by Tibotec in Europe. While Vertex believes the forward-looking

statements contained in this press release are accurate, there are a number of

factors that could cause actual events or results to differ materially from

those indicated by such forward-looking statements. These risks and

uncertainties include, among other things, that Vertex's ongoing discussions

with regulatory authorities may result in changes to the clinical trials

described in this press release, that the outcomes for each of the planned

clinical trials of telaprevir may not be favorable or may reflect unanticipated

results which could impact the planned development path for telaprevir, that

enrollment in the clinical trials may be more difficult or slower than Vertex

currently anticipates or that the planned clinical trials may not start on the

dates anticipated, and other risks listed under Risk Factors in Vertex's form

10-K filed with the Securities and Exchange Commission on March 1, 2007.

(VRTX-GEN)

Contact

Vertex Pharmaceuticals Incorporated

Partridge, 617-444-6108

Senior Director, Strategic Communications

or

Lora Pike, Manager, 617-444-6755

Investor Relations

or

Farrell, 617-444-6533

Director, Public Relations

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=507900 & contenttyp\

e=newsarchive & channelID=31

_________________________________________________________________

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[Guest guest]

Vertex Pharmaceuticals to Begin Phase 3 Development of Telaprevir,

Investigational Hepatitis C Protease Inhibitor

From the PharmaLive.com News Archive - Jan. 23, 2008

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan 23, 2008 - Vertex Pharmaceuticals

Incorporated (Nasdaq: VRTX) today announced that it will begin Phase 3

evaluation of telaprevir, Vertex's lead investigational hepatitis C protease

inhibitor. The primary focus will be a global, 3-arm pivotal controlled trial

that will evaluate two 24-week telaprevir-based regimens in approximately 1050

treatment-naive genotype 1 HCV patients. In this study, rapid viral response

(RVR) criteria will be used to determine which telaprevir patients can stop all

treatment at 24 weeks. A second study of approximately 400-500 HCV patients is

planned to evaluate a 48-week telaprevir-based regimen, to confirm the results

from Phase 2 studies and provide additional evidence that supports the 24-week

regimen that is being evaluated in the primary Phase 3 trial. The Company

expects that both studies will run concurrently and that the first trial will

begin enrolling patients in March 2008.

" Data presented in late 2007 from two large Phase 2b studies suggest that

telaprevir, dosed in combination with pegylated interferon and ribavirin, may be

able to meaningfully increase the proportion of treatment-naive genotype 1 HCV

patients who achieve a sustained viral response, and also cut the current

treatment duration in half, to 24 weeks, " said McHutchison, M.D., Principal

Investigator for the primary telaprevir Phase 3 pivotal study and Associate

Director of Duke Clinical Research Institute. " Telaprevir is the most advanced

protease inhibitor in development for hepatitis C, and the initiation of Phase 3

clinical development for this investigational drug will begin the process of

helping to further assess its potential efficacy and the safety in a larger

number of patients. "

Pivotal Trial to Evaluate 24-Week Telaprevir-Based Treatment Regimens

In accordance with the design and protocol Vertex submitted to the FDA, the

primary pivotal trial will focus on evaluation of 24 weeks of telaprevir-based

therapy and will enroll approximately 1050 treatment-naive, genotype 1 HCV

patients, who will be randomized equally across three treatment arms

(approximately 350 patients per arm).

The study will be conducted at approximately 100 centers in the U.S., E.U. and

certain other countries. The study arms will include:

-- 24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h)

for 12 weeks in combination with standard doses of pegylated interferon alfa-2a

(peg-IFN) and ribavirin (RBV) for 12 weeks, then continuing for another 12 weeks

with peg-IFN and RBV alone;

-- 24 weeks of therapy, with telaprevir dosed at 750 mg every eight hours (q8h)

for 8 weeks in combination with standard doses of peg-IFN and RBV for 8 weeks,

then continuing for another 16 weeks with peg-IFN and RBV alone; and

-- A control arm with standard doses of peg-IFN and RBV dosed for 48 weeks.

Patients in both telaprevir arms who achieve rapid viral response (RVR), defined

as undetectable (less than 10 IU/mL) viral levels by the end of week 4, and who

stay undetectable at week 12 will receive 24 weeks of treatment. Patients in

these treatment arms who do not meet the RVR criteria but are undetectable at

week 24 will continue on peg-IFN and RBV for a total duration of 48 weeks.

Concurrent 48-Week Second Study to Support Registration

Vertex has agreed to conduct a second well-controlled clinical study as part of

the registration program for a treatment-naive indication. The objective of this

second study would be to develop additional sustained viral response (SVR) and

relapse rate data with 48-weeks treatment duration that confirm results from the

Phase 2 studies, thereby providing additional evidence supporting the 24-week

regimen in the Phase 3 trial. The design of this second study is being

finalized, but at this time Vertex expects this study to enroll approximately

400-500 patients, including patients in the control arm.

The primary objective of the two studies will be to assess the proportion of

patients in each study arm who achieve SVR, defined as undetectable (less than

10 IU/mL, as measured by the Roche TaqMan® assay) HCV RNA 24 weeks after the

completion of dosing. Vertex expects to have SVR data from both studies by

mid-2010.

Update on Meeting with FDA

Vertex and the FDA met in mid-January 2008 to discuss telaprevir's Phase 3

development program. This meeting included a review of available data from Phase

2b clinical trials of telaprevir, including newly available post-treatment data

from the 48-week treatment arms in PROVE 1. In the control arm of PROVE 1, on an

ITT basis, 37% of patients had undetectable HCV RNA at 12 weeks post-treatment

follow-up. In the 48-week ( " 12+36 " ) telaprevir-based treatment arm in PROVE 1,

also on an ITT basis, 66% of patients had undetectable HCV RNA at 12 weeks

post-treatment follow-up. The relapse rate in the 48-week telaprevir-based arm

in PROVE 1 was 6%.

Additional HCV Studies

Vertex and Tibotec continue to conduct additional clinical studies to evaluate

the potential role of telaprevir treatment for important HCV sub-populations as

well as different dosing regimens for telaprevir.

-- The companies are conducting PROVE 3, a Phase 2b clinical trial of

telaprevir-based combination therapy in patients with genotype-1 HCV who have

not achieved SVR with a previous pegylated interferon-based treatment. Vertex

plans to discuss with regulatory authorities in mid-2008 the next steps in the

telaprevir development program for treatment-failure HCV patients after the

first interim clinical data are available from the PROVE 3 clinical trial.

-- Tibotec is conducting a Phase 2 clinical study in Europe to evaluate 8-hourly

and 12-hourly dosing of telaprevir in combination with pegylated interferon

(Pegasys® or PegIntron) and ribavirin. Interim 12-week on-treatment data

are expected to be available in the second half of 2008.

-- Tibotec is also conducting a Phase 2 viral kinetics study in Europe to

evaluate telaprevir in patients infected with genotype 2/3 HCV. Interim

on-treatment data are expected to be available in late 2008.

-- In addition, in December, Tibotec initiated a Phase 2 study in Europe to

evaluate telaprevir in patients infected with genotype 4 HCV.

Updates on the status of Vertex and Tibotec's clinical trials of telaprevir are

available at www.clinicaltrials.gov.

About Telaprevir

Telaprevir (VX-950) is an investigational oral inhibitor of HCV protease, an

enzyme essential for viral replication, and is one of the most advanced

investigational antiviral agents in development that specifically targets HCV.

The types of adverse events that have been commonly observed with Peg-IFN and

RBV were seen across all treatment arms in Phase 2b trials of telaprevir. The

most common adverse events, regardless of treatment assignment, were fatigue,

rash, headache and nausea. Gastrointestinal disorders, skin adverse events

(rash, pruritus) and anemia were more common in the telaprevir arms compared to

the control arm over the dosing period.

About Hepatitis C

Hepatitis C is a liver disease caused by the hepatitis C virus, which is found

in the blood of people with the disease. HCV, a serious public health concern

affecting 3.4 million individuals in the United States, is spread through direct

contact with the blood of infected people. Though many people with hepatitis C

may not experience symptoms, others may have symptoms such as jaundice,

abdominal pain, fatigue and fever. Chronic hepatitis C significantly increases a

person's risk for developing long-term infection, chronic liver disease,

cirrhosis or death. The burden of liver disease associated with HCV infection is

increasing, and current therapies typically provide sustained benefit in less

than half of patients with genotype 1 HCV, the most common strain of the virus.

About Vertex

Vertex Pharmaceuticals Incorporated is a global biotechnology company committed

to the discovery and development of breakthrough small molecule drugs for

serious diseases. The Company's strategy is to commercialize its products both

independently and in collaboration with major pharmaceutical companies. Vertex's

product pipeline is focused on viral diseases, inflammation, autoimmune

diseases, cancer, pain and bacterial infection. Vertex co-discovered the HIV

protease inhibitor, Lexiva, with GlaxoKline.

Disclosure: Dr. McHutchison receives research support, as does the Duke Clinical

Research Institute, from Vertex, and he has served in an advisory capacity for

the company.

Lexiva is a registered trademark of the GlaxoKline group of companies.

TaqMan® is a registered trademark of Hoffman-La Roche Inc.

Webcast and Conference Call on January 23

Vertex Pharmaceuticals will host a conference call on January 23, 2008 at 8:00

a.m. Eastern Time (ET) to review the Phase 3 trial announcement. This call will

be broadcast via the Internet at www.vrtx.com from the 'Events & Presentations'

page. To listen to the call live on the telephone, dial (800) 374-0296 (U.S. and

Canada) or (706) 634-2224 (International). The call will be available for replay

via telephone commencing January 23, 2008 at 11:00 a.m. ET running through 5:00

p.m. ET on February 6, 2008. The replay phone number for the US and Canada is

(800) 642-1687. The international replay number is (706) 645-9291 and the

conference ID number is 32008293. Following the live webcast, an archived

version will also be available on Vertex's website until 5:00 p.m. ET on

February 6, 2008.

Safe Harbor Statement

This press release contains forward-looking statements, including statements

regarding (i) Vertex's plan to begin Phase 3 clinical development of telaprevir;

(ii) the designs and protocols of the planned clinical trials, including the

anticipated number of patients and the description of the anticipated treatment

arms; (iii) Vertex's expectation that the two clinical trials will run

concurrently and that the larger trial will begin enrolling patients in March

2008; (iv) the expectation that the second study will evaluate a 48-week

telaprevir-based regimen, to confirm the results from Phase 2 studies and

provide additional evidence that supports the 24-week regimen that is being

evaluated in the primary Phase 3 trial; (v) Vertex's expectation that it will

have SVR data for both clinical trials of telaprevir by mid-2010; (vi) Vertex's

plan to discuss with regulatory authorities in mid-2008 the next steps in the

telaprevir development program for patients with HCV who have failed to achieve

sustained viral response with previous treatments; and (vii) the dates by which

interim on-treatment data is expected for the Phase 2 clinical trials being

conducted by Tibotec in Europe. While Vertex believes the forward-looking

statements contained in this press release are accurate, there are a number of

factors that could cause actual events or results to differ materially from

those indicated by such forward-looking statements. These risks and

uncertainties include, among other things, that Vertex's ongoing discussions

with regulatory authorities may result in changes to the clinical trials

described in this press release, that the outcomes for each of the planned

clinical trials of telaprevir may not be favorable or may reflect unanticipated

results which could impact the planned development path for telaprevir, that

enrollment in the clinical trials may be more difficult or slower than Vertex

currently anticipates or that the planned clinical trials may not start on the

dates anticipated, and other risks listed under Risk Factors in Vertex's form

10-K filed with the Securities and Exchange Commission on March 1, 2007.

(VRTX-GEN)

Contact

Vertex Pharmaceuticals Incorporated

Partridge, 617-444-6108

Senior Director, Strategic Communications

or

Lora Pike, Manager, 617-444-6755

Investor Relations

or

Farrell, 617-444-6533

Director, Public Relations

http://www.therapeuticsdaily.com/news/article.cfm?contentvalue=507900 & contenttyp\

e=newsarchive & channelID=31

_________________________________________________________________

Climb to the top of the charts! Play the word scramble challenge with star

power.

http://club.live.com/star_shuffle.aspx?icid=starshuffle_wlmailtextlink_jan