Pharmasset, Inc.
(Nasdaq: VRUS), Roche (SWX: ROG) and InterMune, Inc. (Nasdaq: ITMN)
announced that the first patients have been dosed in an innovative clinical
trial in patients chronically infected with the hepatitis C virus (HCV).
The trial (run in centers in Australia and New Zealand) is the first to
investigate the combination of two oral antiviral molecules in the absence
of interferon.
The initial study will evaluate the safety and combined antiviral
activity of R7227 (ITMN-191), a protease inhibitor, and R7128, a polymerase
inhibitor, in 14 days of combination therapy in treatment-naive patients
infected with HCV genotype 1.
This direct antiviral combination study represents an important first
step in evaluating the therapeutic potential of an all-oral,
interferon-free combination treatment for HCV. Roche is uniquely positioned
to develop all-oral combination studies in HCV through its collaborations
with InterMune and Pharmasset, which provide access to both protease and
polymerase inhibitors, respectively.
With InterMune, Roche is developing R7227, an HCV protease inhibitor
compound to be used in combination with PEGASYS(R) (peginterferon alfa-2a)
and COPEGUS(R) (ribavirin), the current standard of care (SOC).
Concurrently with Pharmasset, Roche is developing R7128, an HCV RNA
polymerase inhibitor, also for therapy in combination with PEGASYS(R) and
COPEGUS(R). Both of these molecules have successfully completed Phase 1
monotherapy studies, have been dosed in combination with PEGASYS(R) and
COPEGUS(R) and both have individually demonstrated their efficacy against
HCV.
Current standard of care for HCV comprises pegylated interferon plus
ribavirin, for a duration that is dependent upon factors such as genotype
of the virus. For the most difficult to treat genotype 1 virus, a 48-week
treatment course generally results in sustained viral response in about 50%
of patients. PEGASYS(R) and COPEGUS(R) are the current foundation of HCV
treatment and the preferred pegylated interferon therapy of choice for most
HCV antiviral agents in development.
Nick Cammack, Leader of the Virology Disease Biology Leadership Team at
Roche stated: "It is exciting to be at the forefront of designing
innovative clinical approaches in fighting this chronic disease together
with our partners, InterMune and Pharmasset. Our approach demonstrates our
strong interest in combining molecules in development and investigating all
possibilities that may enable us to deliver a new standard of care for
patients with HCV."
Dan Welch, Chairman, Chief Executive Officer and President of
InterMune, said, "The goal is to develop a treatment regimen that is better
tolerated, shorter in duration and delivers higher sustained viral response
rates. We are pleased to participate in the first clinical exploration of
an all-oral, direct antiviral regimen towards that goal."
"The combination of oral antiviral therapies for HCV represents an
exciting step in the evolution of HCV treatment," stated Patrick Higgins,
Executive Vice President of Marketing and Sales at Pharmasset. "We believe
the development of an all oral treatment regimen may help attract many more
patients into therapy that are currently not on treatment."
About R7128
R7128, being developed for the treatment of chronic HCV infection, is a
pro-drug of PSI-6130, a cytidine nucleoside analog inhibitor of HCV RNA
polymerase. A pro-drug is a chemically modified form of a molecule designed
to enhance the absorption, distribution and metabolic properties of that
molecule. R7128 has shown in vitro activity against all of the most common
HCV genotypes (1, 2, 3 and 4).
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed to
discovering, developing and commercializing novel drugs to treat viral
infections. Pharmasset's primary focus is on the development of oral
therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C
virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates. Clevudine,
for the treatment of chronic HBV infection, is enrolling Phase 3 clinical
trials for registration in North, Central and South America and Europe.
Clevudine is already approved for HBV in South Korea and marketed by
Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128,
an oral treatment for chronic HCV infection, is in a 4-week Phase 1
clinical trial in combination with PEGASYS(R) plus COPEGUS(R). Racivir,
which is being developed for the treatment of HIV in combination with other
approved HIV drugs, has completed a Phase 2 clinical trial.
About R7227 (ITMN-191)
R7227 is an inhibitor of HCV NS3/4A protease activity, and has produced
multi-log10 reductions in circulating HCV RNA in chronic HCV patients when
administered for 14 days as monotherapy. In support of clinical studies
that will combine R7227 with R7128, including the INFORM-1 study,
InterMune, Roche and Pharmasset have investigated in vitro the combined
antiviral effect of these compounds.
About InterMune
InterMune is a biotechnology company focused on the research,
development and commercialization of innovative therapies in pulmonology
and hepatology. InterMune has a pipeline portfolio addressing idiopathic
pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The
pulmonology portfolio includes the Phase 3 program, CAPACITY, which is
evaluating pirfenidone as a possible therapeutic candidate for the
treatment of patients with IPF and a research program focused on small
molecules for pulmonary disease. The hepatology portfolio includes HCV
protease inhibitor ITMN-191 (R7227) in Phase 1b, a second-generation HCV
protease inhibitor research program, and a research program evaluating a
new target in hepatology. For additional information about InterMune and
its R&D pipeline, please visit intermune
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of pharmaceuticals
and diagnostics. As the world's biggest biotech company and an innovator of
products and services for the early detection, prevention, diagnosis and
treatment of diseases, the Group contributes on a broad range of fronts to
improving people's health and quality of life. Roche is the world leader in
in-vitro diagnostics and drugs for cancer and transplantation, and is a
market leader in virology. It is also active in other major therapeutic
areas such as autoimmune diseases, inflammatory and metabolic disorders and
diseases of the central nervous system. In 2007 sales by the
Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the
Diagnostics Division posted sales of 9.3 billion Swiss francs. Roche has
R&D agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai, and invested over 8
billion Swiss francs in R&D in 2007. Worldwide, the Group employs about
80,000 people. Additional information is available on the Internet at
roche.
Forward Looking Statements
Pharmasset "Safe Harbor" Statement under the Private Securities
Litigation Reform Act of 1995: Statements in this press release regarding
our business that are not historical facts are "forward-looking statements"
that involve risks and uncertainties, including without limitation, the
risk that adverse events could cause the cessation or delay of any of the
ongoing or planned clinical trials and/or our development of our product
candidates, the risk that the results of previously conducted studies
involving our product candidates will not be repeated or observed in
ongoing or future studies involving our product candidates, the risk that
our collaboration with Roche will not continue or will not be successful
and the risk that any one or more of our product candidates will not be
successfully developed and commercialized. For a discussion of these risks
and uncertainties, any of which could cause our actual results to differ
from those contained in the forward-looking statements, see the section of
our Annual Report on Form 10-K for the fiscal year ended September 30, 2007
filed with the Securities and Exchange Commission entitled "Risk Factors"
and discussions of potential risks and uncertainties in our subsequent
filings with the Securities and Exchange Commission.
Pharmasset, Inc.
pharmasset