is an excerpt from a press release issued by the 2 companies
describing their forthcoming joint work.
Squibb and Pharmasset Enter into a Clinical Collaboration Agreement
for Proof of Concept Combination Study in Patients Chronically
Infected with Hepatitis C
is the first cross-company collaboration combining two
oral, direct-acting antivirals
to evaluate the combination with and without ribavirin
in treatment-naive patients
York, N.Y. and Princeton, N.J. -- January 10, 2011 -- Bristol-Myers
Squibb Company (NYSE:BMY) and Pharmasset (NASDAQ: VRUS) announced
today that the companies have entered into a clinical collaboration
agreement to evaluate the utility of BMS-790052, Bristol-Myers
Squibb's NS5A replication complex inhibitor, in combination
with PSI-7977, Pharmasset's nucleotide polymerase inhibitor,
for the treatment of chronic hepatitis C virus (HCV).
This proof of concept study will evaluate the potential to achieve
sustained viral response 24 weeks post treatment with an oral,
once-daily treatment regimen in patients across HCV genotypes.
Specifically, the study will assess the safety, pharmacokinetics
and pharmacodynamics of BMS-790052 in combination with PSI-7977,
with and without ribavirin, in treatment-naive patients chronically
infected with HCV genotypes 1, 2, and 3. The study is planned
to start in the first half of 2011. This collaboration represents
the first cross-company collaboration combining two oral agents
to address a significant unmet medical need in the treatment
"Bristol-Myers Squibb is committed to the goal of helping
patients prevail over hepatitis C by investigating multiple
therapeutic platforms," said Brian Daniels, senior vice
president, Development. "We are pleased to partner with
Pharmasset on this important study to advance the scientific
understanding of the potential for an all-oral regimen to treat
hepatitis C. Conducting this study highlights Bristol-Myers
Squibb's ability to collaborate with other companies to develop
innovative combination therapies in areas of high unmet need."
are excited to be working with Bristol-Myers Squibb and to be
investigating PSI-7977 with a different class of direct acting
antivirals," stated Michelle Berrey, MD, MPH, Chief Medical
Officer. "This collaboration represents one of many approaches
we are pursuing with our portfolio of nucleoside/tide analogs
that include both interferon free and interferon-sparing regimens.
We believe the development of an all oral treatment regimen
represents an important evolution in the treatment of HCV."
BMS-790052 is an investigational oral hepatitis C NS5A replication
complex inhibitor. NS5A is one of the essential components for
HCV replication. BMS-790052 is one of several molecules Bristol-Myers
Squibb is studying for the potential treatment of chronic hepatitis
C. The portfolio of investigational compounds, which also includes
a novel pegylated interferon lambda, fits into the company's
overall R&D focus on diseases where there is major unmet
PSI-7977 is a uracil nucleotide analog inhibitor of the NS5B
polymerase being developed for the treatment of chronic HCV
infection. Nucleotide analog polymerase inhibitors work by acting
as alternative substrates that block the synthesis of HCV RNA,
which is essential for the virus to replicate. PSI-7977 has
been studied in combination with peginterferon and ribavirin
for up to 12 weeks in genotype 1, 2 or 3 patients and is currently
in two Phase 2b studies, one of which is investigating an interferon
sparing regimen in genotype 2 or 3 patients. PSI-7977 is also
being investigated in a 14-day combination study with PSI-938,
a guanine nucleotide analog.
About Bristol-Myers Squibb
Squibb is a global biopharmaceutical company whose mission is
to discover, develop and deliver innovative medicines that help
patients prevail over serious diseases. For more information,
please visit http://www.bms.com
or follow us on Twitter at http://twitter.com/bmsnews.
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
C virus (HCV). Our research and development efforts focus on
nucleoside/tide analogs, a class of compounds which act as alternative
substrates for the viral polymerase, thus inhibiting viral replication.
We currently have four clinical-stage product candidates. RG7128,
a cytosine nucleoside analog for chronic HCV infection, is in
two Phase 2b clinical studies in combination with Pegasys plus
Copegus and is also in the INFORM studies, the first series
of studies designed to assess the potential of combinations
of small molecules without Pegasys and Copegus to treat chronic
HCV. These clinical studies are being conducted through a strategic
collaboration with Roche. Our other clinical stage HCV candidates
include PSI-7977, an unpartnered uracil nucleotide analog that
is in two Phase 2b studies in patients with HCV genotypes 1,
2, or 3, and PSI-938, an unpartnered guanine nucleotide analog
which recently completed a 14-day monotherapy study and has
recently initiated a 14-day combination study with PSI-7977.
We also have in our pipeline an additional purine nucleotide
analog, PSI-661, in advanced preclinical development. For more
information visit www.pharmasset.com.
Squibb and Pharmasset. Bristol-Myers Squibb and Pharmasset Enter
into a Clinical Collaboration Agreement for Proof of Concept
Combination Study in Patients Chronically Infected with Hepatitis
C. Press release. January 10, 2011.