PRINCETON, N.J., Nov. 10 /PRNewswire-FirstCall/ -- Pharmasset,
Inc. (NASDAQ:VRUS) , Roche and InterMune, Inc. (NASDAQ:ITMN)
today 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
www.intermune.com
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 www.roche.com.
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.
Source: Pharmasset, Inc.
CONTACT: Richard E. T. Smith, Ph.D., VP, Investor Relations and
Corporate Communications, +1-609-613-4181,
richard.smith@pharmasset.com, of Pharmasset, Inc.
Web site: http://www.pharmasset.com/
http://www.roche.com/
http://www.intermune.com/
www.aegis.org