Better Then SOC; Improvements in Viral Cure Rates W-Telaprevir-Based TX Regardless of IL28B Genotype Status
- File Under EASL, IL28B, telaprevir
Data From Phase 3 Studies Showed Substantial Improvements in SVR
(Viral Cure) Rates With Telaprevir-Based Therapy Compared to
Currently Available Medicines in People With Hepatitis C, Regardless
of Their IL28B Genotype Status
BERLIN--(BUSINESS WIRE)--Mar 31, 2011 -90% of people with the ˜CC' variation of IL28B who
were new to treatment and received a telaprevir-based regimen
achieved a viral cure, 78% of them were eligible to stop all
treatment at 24 weeks -
- Nearly three-fold improvement in viral cure rates was
observed among people with the ˜CT' and ˜TT' variations
compared to the control group, regardless of prior treatment
experience -
Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced new data from
retrospective analyses that evaluated the relationship between
variations at the IL28B gene and a patient's response to treatment
with telaprevir in combination with pegylated-interferon and
ribavirin from two of its pivotal Phase 3 studies (ADVANCE and
REALIZE) for a group of people who were tested for IL28B genotype.
These analyses showed that people in these studies had substantial
improvements in sustained viral response (SVR, or viral cure) rates
across all IL28B genotypes (CC, CT or TT) for those treated with
telaprevir-based combination therapy compared to those treated with
pegylated-interferon and ribavirin alone. Telaprevir is a medicine
in development for the treatment of genotype 1 chronic hepatitis C.
Safety and tolerability results were consistent across the Phase 3
studies of telaprevir. Data from these IL28B analyses were
presented today at The International Liver Congress™ 2011,
the 46th annual meeting of the European Association for
the Study of the Liver (EASL) in Berlin, Germany.
retrospective analyses that evaluated the relationship between
variations at the IL28B gene and a patient's response to treatment
with telaprevir in combination with pegylated-interferon and
ribavirin from two of its pivotal Phase 3 studies (ADVANCE and
REALIZE) for a group of people who were tested for IL28B genotype.
These analyses showed that people in these studies had substantial
improvements in sustained viral response (SVR, or viral cure) rates
across all IL28B genotypes (CC, CT or TT) for those treated with
telaprevir-based combination therapy compared to those treated with
pegylated-interferon and ribavirin alone. Telaprevir is a medicine
in development for the treatment of genotype 1 chronic hepatitis C.
Safety and tolerability results were consistent across the Phase 3
studies of telaprevir. Data from these IL28B analyses were
presented today at The International Liver Congress™ 2011,
the 46th annual meeting of the European Association for
the Study of the Liver (EASL) in Berlin, Germany.
A specific genetic region near the IL28B gene is referred to as
an IL28B genotype. The three variations of IL28B genotypes have
been associated with a person's response to hepatitis C treatment
with pegylated-interferon and ribavirin. The CC variation is
associated with better responses to these medicines.
an IL28B genotype. The three variations of IL28B genotypes have
been associated with a person's response to hepatitis C treatment
with pegylated-interferon and ribavirin. The CC variation is
associated with better responses to these medicines.
“Doctors sometimes use IL28B genotype status to decide
which patients should be treated with currently available medicines
because people with the CT and TT variations of IL28B tend to have
substantially lower viral cure rates compared to those with the CC
variation,” said Ira Jacobson, M.D., Chief of the Division of
Gastroenterology and Hepatology at New York-Presbyterian
Hospital/Weill Cornell Medical Center, and the Vincent Astor
Distinguished Professor of Medicine at Weill Cornell Medical
College and principal investigator for the ADVANCE study. “In
this study, telaprevir was associated with a substantial
improvement over currently available medicines, regardless of IL28B
status, and the greatest improvement was observed in patients with
the CT and TT variations.”
which patients should be treated with currently available medicines
because people with the CT and TT variations of IL28B tend to have
substantially lower viral cure rates compared to those with the CC
variation,” said Ira Jacobson, M.D., Chief of the Division of
Gastroenterology and Hepatology at New York-Presbyterian
Hospital/Weill Cornell Medical Center, and the Vincent Astor
Distinguished Professor of Medicine at Weill Cornell Medical
College and principal investigator for the ADVANCE study. “In
this study, telaprevir was associated with a substantial
improvement over currently available medicines, regardless of IL28B
status, and the greatest improvement was observed in patients with
the CT and TT variations.”
In ADVANCE, patients were randomized 1:1:1 to receive telaprevir
(eight weeks or 12 weeks) in combination with pegylated-interferon
and ribavirin, followed by pegylated-interferon and ribavirin alone
for a total of either 24 weeks or 48 weeks of treatment.
Eligibility for the shorter treatment duration was based on having
undetectable hepatitis C virus at weeks four and 12. Among patients
in this study tested for their IL28B genotype, 90 percent (45/50)
of CC patients who received a 12-week telaprevir-based combination
regimen, achieved a viral cure and 78 percent (39/50) of them were
eligible to stop all treatment at 24 weeks. These results were
compared to 64 percent (35/55) of patients who achieved a viral
cure with pegylated-interferon and ribavirin alone for 48
weeks.
(eight weeks or 12 weeks) in combination with pegylated-interferon
and ribavirin, followed by pegylated-interferon and ribavirin alone
for a total of either 24 weeks or 48 weeks of treatment.
Eligibility for the shorter treatment duration was based on having
undetectable hepatitis C virus at weeks four and 12. Among patients
in this study tested for their IL28B genotype, 90 percent (45/50)
of CC patients who received a 12-week telaprevir-based combination
regimen, achieved a viral cure and 78 percent (39/50) of them were
eligible to stop all treatment at 24 weeks. These results were
compared to 64 percent (35/55) of patients who achieved a viral
cure with pegylated-interferon and ribavirin alone for 48
weeks.
“The 90 percent viral cure rate among people with the CC
variation of IL28B in this study is significant, but the fact that
nearly 80 percent of them were eligible for the shorter course of
treatment is an equally important finding,” said Robert
Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical
Officer for Vertex. “Vertex plans to conduct a study
evaluating a short-duration, 12-week telaprevir-based regimen in
people who have not been treated for hepatitis C who have the CC
variation of IL28B.”
variation of IL28B in this study is significant, but the fact that
nearly 80 percent of them were eligible for the shorter course of
treatment is an equally important finding,” said Robert
Kauffman, M.D., Ph.D., Senior Vice President and Chief Medical
Officer for Vertex. “Vertex plans to conduct a study
evaluating a short-duration, 12-week telaprevir-based regimen in
people who have not been treated for hepatitis C who have the CC
variation of IL28B.”
Data from the ADVANCE study showed that patients with the CC
variation of IL28B who were new to treatment and received a
telaprevir-based combination regimen had the highest viral cure
rates compared to those with the CT and TT variations. Data from
both ADVANCE and REALIZE showed a nearly three-fold improvement in
viral cure rates among patients with the CT and TT variations of
IL28B who received telaprevir-based combination therapy compared to
those who received pegylated-interferon and ribavirin. These
differences were observed among patients who were new to treatment
as well as those whose prior treatment for hepatitis C was
unsuccessful.
variation of IL28B who were new to treatment and received a
telaprevir-based combination regimen had the highest viral cure
rates compared to those with the CT and TT variations. Data from
both ADVANCE and REALIZE showed a nearly three-fold improvement in
viral cure rates among patients with the CT and TT variations of
IL28B who received telaprevir-based combination therapy compared to
those who received pegylated-interferon and ribavirin. These
differences were observed among patients who were new to treatment
as well as those whose prior treatment for hepatitis C was
unsuccessful.
Retrospective Analysis from ADVANCE
The Phase 3 ADVANCE study evaluated people who were new to
treatment for hepatitis C. The retrospective analysis of IL28B
status presented today includes people tested for IL28B genotype
(454/1088; 42 percent). Of the patients in ADVANCE who were tested
for their IL28B genotype, the distribution of the variations was
consistent with previously published studies in people new to
treatment.1 Data from the subanalysis of IL28B status in
the control and telaprevir treatment arms (12 weeks) of the study
are shown in the table.
treatment for hepatitis C. The retrospective analysis of IL28B
status presented today includes people tested for IL28B genotype
(454/1088; 42 percent). Of the patients in ADVANCE who were tested
for their IL28B genotype, the distribution of the variations was
consistent with previously published studies in people new to
treatment.1 Data from the subanalysis of IL28B status in
the control and telaprevir treatment arms (12 weeks) of the study
are shown in the table.
| ADVANCE | ||||||||
| CC (n=150) | CT (n=224) | TT (n=80) | Overall Study | |||||
TVR+ | Control++ | TVR+ | Control++ | TVR+ | Control++ | TVR+ | Control++ | |
RVR* | 84% (42/50) | 16% (9/55) | 60% (41/68) | 2% (2/80) | 59% (13/22) | 0% (0/26) | 68% (246/363) | 9% (34/361) |
eRVR** | 78% (39/50) | 16% (9/55) | 57% (39/68) | 2% (2/80) | 45% (10/22) | 0% (0/26) | 58% (212/363) | 8% (29/361) |
SVR*** | 90% (45/50) | 64% (35/55) | 71% (48/68) | 25% (20/80) | 73% (16/22) | 23% (6/26) | 75% (271/363) | 44% (158/361) |
Due to the de-identification procedure, only samples from Caucasian patients were included in this analysis. *RVR: rapid viral response; undetectable (less then 25 IU/mL undetectable by Roche COBAS Taqman HCV test) at week 4. **eRVR: extended rapid viral response; undetectable (less then 25 IU/mL undetectable by Roche COBAS Taqman HCV test) at weeks 4 and 12. ***SVR: defined as the proportion of people who had undetectable hepatitis C virus 24 weeks after the end of all treatment; less then 25 IU/mL, undetectable by Roche COBAS Taqman HCV test. TVR+: 12 weeks of telaprevir (TVR, 750 mg, q8h), Pegasys(R) (PEG, pegylated-interferon alfa-2a) and Copegus(R) (RBV, ribavirin) followed by 12 weeks or 36 weeks of only PEG & RBV, based on response to treatment at week 4 and week 12. Control++: 12 weeks of placebo, PEG & RBV, followed by 36 weeks of PEG & RBV alone. | ||||||||
Retrospective Analysis from REALIZE
The Phase 3 REALIZE study evaluated people whose prior treatment
with pegylated-interferon and ribavirin was unsuccessful (prior
relapsers, prior partial responders and prior null responders). Of
the patients in REALIZE who were tested for their IL28B genotype
(527/662; 80 percent), the distribution of patients with the CT
variation was over-represented and the distribution of those with
the CC variation was under-represented. This is consistent with
expectations for a population that has not responded to a prior
course of treatment.
with pegylated-interferon and ribavirin was unsuccessful (prior
relapsers, prior partial responders and prior null responders). Of
the patients in REALIZE who were tested for their IL28B genotype
(527/662; 80 percent), the distribution of patients with the CT
variation was over-represented and the distribution of those with
the CC variation was under-represented. This is consistent with
expectations for a population that has not responded to a prior
course of treatment.
| REALIZE | ||||||
| SVR | CC | CT | TT | |||
TVR+ | Control++ | TVR+ | Control++ | TVR+ | Control++ | |
| Prior Relapsers | 88% (51/58) | 33% (4/12) | 85% (100/117) | 20% (6/30) | 85% (29/34) | 30% (3/10) |
| Prior Partial Responders | 63% (5/8) | 20% (1/5) | 58% (33/57) | 20% (2/10) | 71% (10/14) | 0% (0/5) |
| Prior Null Responders | 40% (4/10) | n/a (0/0) | 29% (27/92) | 6% (1/18) | 31% (10/32) | 7% (1/15) |
Overall | 79% (60/76) | 29% (5/17) | 60% (160/266) | 16% (9/58) | 61% (49/80) | 13% (4/30) |
TVR+: Since there was no difference between the two telaprevir groups studied, SVR rates reflect the combined telaprevir-based treatment groups. (a) 12 weeks of telaprevir (750 mg, q8h), PEG, pegylated-interferon alfa-2a) and Copegus (RBV, ribavirin), followed by 36 weeks of PEG & RBV alone and (b) 4 weeks of PEG and RBV alone followed by 12 weeks of telaprevir (750 mg, q8h), PEG and RBV, followed by 32 weeks of PEG and RBV alone. Control++: 12 weeks of placebo, PEG and RBV, followed by 36 weeks of PEG and RBV alone. Relapser: Defined as a person whose hepatitis C virus was undetectable at the completion of at least 42 weeks of a prior course of therapy but whose virus became detectable during the follow-up period. Partial Responder: Defined as a person who achieved at least a 2 log10 reduction in HCV RNA at week 12, but whose hepatitis C virus never became undetectable by week 24 of a prior course of therapy. Null Responder: Defined as a person who achieved a less than 2 log10 reduction in HCV RNA at week 12 of a prior course of therapy. | ||||||
Safety and Tolerability Information from Phase 3 Studies of
Telaprevir
Telaprevir
The safety and tolerability results of the telaprevir-based
combination regimens were consistent across the Phase 3 studies.
The most common adverse events were fatigue, pruritus, nausea,
headache, rash, anemia, flu-like symptoms, insomnia and diarrhea
with the majority being mild to moderate. Rash and anemia occurred
more frequently in the telaprevir-based treatment arms compared to
the control groups.
combination regimens were consistent across the Phase 3 studies.
The most common adverse events were fatigue, pruritus, nausea,
headache, rash, anemia, flu-like symptoms, insomnia and diarrhea
with the majority being mild to moderate. Rash and anemia occurred
more frequently in the telaprevir-based treatment arms compared to
the control groups.
Rash was primarily characterized as eczema-like, manageable and
resolved upon stopping telaprevir. More than 90 percent of rash was
mild to moderate and was primarily managed with the use of topical
corticosteroids and/or antihistamines. Anemia was primarily managed
by reducing the dose of ribavirin.
resolved upon stopping telaprevir. More than 90 percent of rash was
mild to moderate and was primarily managed with the use of topical
corticosteroids and/or antihistamines. Anemia was primarily managed
by reducing the dose of ribavirin.
To optimize each patient's opportunity to achieve viral cure in
the Phase 3 studies, sequential discontinuation of the medicines
was recommended as a strategy to manage certain adverse events.
This strategy allowed patients to continue on pegylated-interferon
and ribavirin after stopping telaprevir. Discontinuation of all
medicines due to either rash or anemia during the
telaprevir/placebo treatment phase was 1 percent to 3 percent in
the telaprevir treatment arms.
the Phase 3 studies, sequential discontinuation of the medicines
was recommended as a strategy to manage certain adverse events.
This strategy allowed patients to continue on pegylated-interferon
and ribavirin after stopping telaprevir. Discontinuation of all
medicines due to either rash or anemia during the
telaprevir/placebo treatment phase was 1 percent to 3 percent in
the telaprevir treatment arms.
About IL28B
IL28B is a gene related to the interferon system. A genetic
region near the IL28B gene is referred to as an IL28B genotype.
There are three variations of IL28B genotypes: CC, CT or TT. These
variations have been associated with a person's response to
treatment for hepatitis C with pegylated-interferon and ribavirin.
Studies have shown that people with the CC variation respond better
to treatment with pegylated-interferon and ribavirin than those
with the CT or TT variations. The CC variation is more frequent in
Caucasians compared to African Americans (39 percent versus 16
percent), which may partially explain the lower response to
treatment observed among African Americans in most clinical trials
of pegylated-interferon and ribavirin.1
region near the IL28B gene is referred to as an IL28B genotype.
There are three variations of IL28B genotypes: CC, CT or TT. These
variations have been associated with a person's response to
treatment for hepatitis C with pegylated-interferon and ribavirin.
Studies have shown that people with the CC variation respond better
to treatment with pegylated-interferon and ribavirin than those
with the CT or TT variations. The CC variation is more frequent in
Caucasians compared to African Americans (39 percent versus 16
percent), which may partially explain the lower response to
treatment observed among African Americans in most clinical trials
of pegylated-interferon and ribavirin.1
About the Phase 3 ADVANCE and REALIZE Studies
ADVANCE was a pivotal Phase 3, randomized, double-blind,
placebo-controlled, global study of 1,088 people who were new to
hepatitis C treatment. The primary endpoint of ADVANCE was SVR
(defined as the proportion of people who had undetectable hepatitis
C virus 24 weeks after the end of all treatment; <25 IU/mL,
undetectable by Roche COBAS Taqman HCV test). The secondary
endpoint evaluated the safety of telaprevir when dosed in
combination with pegylated-interferon and ribavirin.
placebo-controlled, global study of 1,088 people who were new to
hepatitis C treatment. The primary endpoint of ADVANCE was SVR
(defined as the proportion of people who had undetectable hepatitis
C virus 24 weeks after the end of all treatment; <25 IU/mL,
undetectable by Roche COBAS Taqman HCV test). The secondary
endpoint evaluated the safety of telaprevir when dosed in
combination with pegylated-interferon and ribavirin.
REALIZE was a pivotal Phase 3, randomized, double-blind,
placebo-controlled study conducted globally with the majority of
clinical trial sites in Europe and North America. The study was
designed to evaluate the efficacy, safety and tolerability of
telaprevir-based combination regimens in people infected with
genotype 1 chronic hepatitis C who did not achieve a viral cure
after at least one course of prior treatment with interferon-based
therapy.
placebo-controlled study conducted globally with the majority of
clinical trial sites in Europe and North America. The study was
designed to evaluate the efficacy, safety and tolerability of
telaprevir-based combination regimens in people infected with
genotype 1 chronic hepatitis C who did not achieve a viral cure
after at least one course of prior treatment with interferon-based
therapy.
Patients were randomized 2:2:1 to two telaprevir-based treatment
arms (simultaneous start and lead-in) and a control arm of
pegylated-interferon and ribavirin alone. The primary endpoint of
the REALIZE study was SVR in each of the two telaprevir treatment
arms compared to the control arm and for the three groups of people
included in the study.
arms (simultaneous start and lead-in) and a control arm of
pegylated-interferon and ribavirin alone. The primary endpoint of
the REALIZE study was SVR in each of the two telaprevir treatment
arms compared to the control arm and for the three groups of people
included in the study.
Status of Telaprevir Regulatory Applications
The regulatory applications for the approval of telaprevir have
been granted Priority Review by the U.S. Food and Drug
Administration (FDA) and Health Canada and accelerated assessment
by the European Medicines Agency for the treatment of people with
genotype 1 chronic hepatitis C. The FDA has scheduled its Antiviral
Drugs Advisory Committee to discuss the New Drug Application for
telaprevir on April 28, 2011. A target response date of May 23,
2011 is set under the Prescription Drug User Fee Act (PDUFA). The
applications include data from three registration studies, ADVANCE,
ILLUMINATE and REALIZE, which evaluated telaprevir in combination
with pegylated-interferon and ribavirin in people with hepatitis C
who were new to treatment as well as those who did not achieve a
viral cure after treatment with currently available medicines. For
complete information on the telaprevir clinical trials or a fact
sheet on the trial designs visit:
www.vrtx.com/press.cfm.
been granted Priority Review by the U.S. Food and Drug
Administration (FDA) and Health Canada and accelerated assessment
by the European Medicines Agency for the treatment of people with
genotype 1 chronic hepatitis C. The FDA has scheduled its Antiviral
Drugs Advisory Committee to discuss the New Drug Application for
telaprevir on April 28, 2011. A target response date of May 23,
2011 is set under the Prescription Drug User Fee Act (PDUFA). The
applications include data from three registration studies, ADVANCE,
ILLUMINATE and REALIZE, which evaluated telaprevir in combination
with pegylated-interferon and ribavirin in people with hepatitis C
who were new to treatment as well as those who did not achieve a
viral cure after treatment with currently available medicines. For
complete information on the telaprevir clinical trials or a fact
sheet on the trial designs visit:
www.vrtx.com/press.cfm.
About the Telaprevir Development Program
Telaprevir is an investigational, oral inhibitor that acts
directly on the HCV protease, an enzyme essential for viral
replication. To date, more than 2,500 people with hepatitis C have
received telaprevir-based therapy as part of Phase 2 studies and
the Phase 3 ADVANCE, ILLUMINATE and REALIZE studies. Together,
these studies enrolled people with genotype 1 chronic hepatitis C
who had not been treated for their disease previously as well as
people who had been treated before but did not achieve a viral
cure.
directly on the HCV protease, an enzyme essential for viral
replication. To date, more than 2,500 people with hepatitis C have
received telaprevir-based therapy as part of Phase 2 studies and
the Phase 3 ADVANCE, ILLUMINATE and REALIZE studies. Together,
these studies enrolled people with genotype 1 chronic hepatitis C
who had not been treated for their disease previously as well as
people who had been treated before but did not achieve a viral
cure.
Vertex is developing telaprevir in collaboration with Tibotec
BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to
commercialize telaprevir in North America. Through its affiliate,
Janssen, Tibotec has rights to commercialize telaprevir in Europe,
South America, Australia, the Middle East and certain other
countries. Mitsubishi Tanabe Pharma has rights to commercialize
telaprevir in Japan and certain Far East countries.
BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to
commercialize telaprevir in North America. Through its affiliate,
Janssen, Tibotec has rights to commercialize telaprevir in Europe,
South America, Australia, the Middle East and certain other
countries. Mitsubishi Tanabe Pharma has rights to commercialize
telaprevir in Japan and certain Far East countries.
About Hepatitis C
Hepatitis C is a serious liver disease caused by the hepatitis C
virus, which is spread through direct contact with the blood of
infected people and ultimately affects the liver.2
Chronic hepatitis C can lead to serious and life-threatening liver
problems, including liver damage, cirrhosis, liver failure or liver
cancer.2 Though many people with hepatitis C may not
experience symptoms, others may have symptoms such as fatigue,
fever, jaundice and abdominal pain.2 Approximately 60
percent of people who undergo treatment with an initial 48-week
regimen of pegylated-interferon and ribavirin, the currently
approved medicines for genotype 1 hepatitis C, do not achieve
SVR,3,4,5 or viral cure.6 If treatment is not
successful and a person does not achieve a viral cure, they remain
at an increased risk for progressive liver
disease.7,8
virus, which is spread through direct contact with the blood of
infected people and ultimately affects the liver.2
Chronic hepatitis C can lead to serious and life-threatening liver
problems, including liver damage, cirrhosis, liver failure or liver
cancer.2 Though many people with hepatitis C may not
experience symptoms, others may have symptoms such as fatigue,
fever, jaundice and abdominal pain.2 Approximately 60
percent of people who undergo treatment with an initial 48-week
regimen of pegylated-interferon and ribavirin, the currently
approved medicines for genotype 1 hepatitis C, do not achieve
SVR,3,4,5 or viral cure.6 If treatment is not
successful and a person does not achieve a viral cure, they remain
at an increased risk for progressive liver
disease.7,8
More than 170 million people worldwide are chronically infected
with hepatitis C.6 In the United States, nearly 4
million people have chronic hepatitis C and 75 percent of them are
unaware of their infection.9 The majority of people with
hepatitis C in the United States were born between 1946 and 1964,
accounting for two of every three people with chronic hepatitis
C.10 Hepatitis C is the leading cause of liver
transplantations in the United States and is reported to contribute
to 4,600 to 12,000 deaths annually.11,12 By 2029, total
annual medical costs in the United States for people with hepatitis
C are expected to more than double, from $30 billion in 2009 to
approximately $85 billion.10
with hepatitis C.6 In the United States, nearly 4
million people have chronic hepatitis C and 75 percent of them are
unaware of their infection.9 The majority of people with
hepatitis C in the United States were born between 1946 and 1964,
accounting for two of every three people with chronic hepatitis
C.10 Hepatitis C is the leading cause of liver
transplantations in the United States and is reported to contribute
to 4,600 to 12,000 deaths annually.11,12 By 2029, total
annual medical costs in the United States for people with hepatitis
C are expected to more than double, from $30 billion in 2009 to
approximately $85 billion.10
PEGASYS® and COPEGUS® are
registered trademarks of Hoffmann-La Roche.
registered trademarks of Hoffmann-La Roche.
Special Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995,
including statements regarding (i) Vertex's plan to conduct a study
evaluating a short-duration, 12-week telaprevir-based regimen in
people how have not been treated for hepatitis C who have the CC
variation of IL28B, (ii) the date of the scheduled meeting of the
FDA's Antivirial Advisory Committee and (iii) the FDA's target
review date for the telaprevir NDA. While the company 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. Those risks and uncertainties include,
among other things, that Vertex could experience unforeseen delays
in obtaining approval to market telaprevir; that there may be
varying interpretations of the data from the telaprevir clinical
trials; that future outcomes from clinical trials of telaprevir may
not be favorable; that future scientific, clinical, competitive or
other market factors may adversely affect the potential for
telaprevir-based therapy and the other risks listed under Risk
Factors in Vertex's annual report and quarterly reports filed with
the Securities and Exchange Commission and available through
defined in the Private Securities Litigation Reform Act of 1995,
including statements regarding (i) Vertex's plan to conduct a study
evaluating a short-duration, 12-week telaprevir-based regimen in
people how have not been treated for hepatitis C who have the CC
variation of IL28B, (ii) the date of the scheduled meeting of the
FDA's Antivirial Advisory Committee and (iii) the FDA's target
review date for the telaprevir NDA. While the company 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. Those risks and uncertainties include,
among other things, that Vertex could experience unforeseen delays
in obtaining approval to market telaprevir; that there may be
varying interpretations of the data from the telaprevir clinical
trials; that future outcomes from clinical trials of telaprevir may
not be favorable; that future scientific, clinical, competitive or
other market factors may adversely affect the potential for
telaprevir-based therapy and the other risks listed under Risk
Factors in Vertex's annual report and quarterly reports filed with
the Securities and Exchange Commission and available through
Vertex's website at
www.vrtx.com. Vertex disclaims any obligation to update the
information contained in this press release as new information
becomes available.
www.vrtx.com. Vertex disclaims any obligation to update the
information contained in this press release as new information
becomes available.
About Vertex
Vertex creates new possibilities in medicine. Our team aims to
discover, develop and commercialize innovative therapies so people
with serious diseases can lead better lives.
discover, develop and commercialize innovative therapies so people
with serious diseases can lead better lives.
Vertex scientists and our collaborators are working on new
medicines to cure or significantly advance the treatment of
hepatitis C, cystic fibrosis, epilepsy and other life-threatening
diseases.
medicines to cure or significantly advance the treatment of
hepatitis C, cystic fibrosis, epilepsy and other life-threatening
diseases.
Founded more than 20 years ago in Cambridge, MA, we now have
ongoing worldwide research programs and sites in the U.S., U.K. and
Canada.
ongoing worldwide research programs and sites in the U.S., U.K. and
Canada.
For more information and to view Vertex's press releases, please
visit
www.vrtx.com.
visit
www.vrtx.com.
(VRTX - GEN)
1 Ge D, Fellay J, Thomspon AH, et al. Genetic
variation in IL28B predicts hepatitis C treatment-induced viral
clearance. Nature. 2009; 461:399-401
variation in IL28B predicts hepatitis C treatment-induced viral
clearance. Nature. 2009; 461:399-401
2 Centers for Disease Control and Prevention.
Hepatitis C Fact Sheet: CDC Viral Hepatitis. Available at:
http://www.cdc.gov/hepatitis/HCV/PDFs/HepCGeneralFactSheet.pdf.
Accessed March 21, 2011.
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3 Manns MP, McHutchison JG, Gordon SC, et al.
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C: a randomised trial. Lancet. 2001;358:958-965.
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4 Fried MW, Shiffman ML, Reddy KR, et al.
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infection. N Engl J Med. 2002;347:975-982.
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5 McHutchison JG, Lawitz EJ, Shiffman ML, et al;
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for treatment of hepatitis C infection. N Engl J Med.
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for treatment of hepatitis C infection. N Engl J Med.
2009;361:580-593.
6 Ghany MG, Strader DB, Thomas DL, Seeff, LB.
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Hepatology. 2009;49 (4):1-40.
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7 Morgan TR, Ghany MG, Kim HY, Snow KK, Lindsay K,
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Against Cirrhosis (HALT-C) trial. Hepatology. 2008;50(Suppl
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Updated January 11, 2010. Accessed March 21, 2011.
10 Pyenson B, Fitch K, Iwasaki K. Consequences of
hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver
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Pharmaceuticals, Inc.
hepatitis C virus (HCV): Costs of a baby boomer epidemic of liver
disease. Available at:
http://www.natap.org/2009/HCV/051809_01.htm. Updated May 2009.
Accessed March 21, 2011. This report was commissioned by Vertex
Pharmaceuticals, Inc.
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or
Investors:
Michael Partridge, 617-444-6108
or
Lora Pike, 617-444-6755
or
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