-- 900-mcg Albuferon (albinterferon alfa-2b) dosed every two weeks met the primary efficacy endpoint of sustained virologic response comparable to peginterferon alfa-2a dosed weekly in patients with genotype 1 chronic hepatitis C -- Patients receiving 900-mcg Albuferon had comparable rates of serious and/or severe adverse events versus peginterferon alfa-2a -- Filing of global marketing applications planned in fall 2009Human Genome Sciences, Inc. (
Human Genome Sciences Announces Positive Results in Second of Two Phase 3 Trials of Albuferon(R) in Chronic Hepatitis C
| Quelle: Human Genome Sciences, Inc.
ROCKVILLE, MD--(Marketwire - March 9, 2009) -
NASDAQ : HGSI ) today announced that Albuferon® (albinterferon
alfa-2b) met its primary endpoint of non-inferiority to peginterferon
alfa-2a (Pegasys) in ACHIEVE 1, a Phase 3 clinical trial of Albuferon in
combination with ribavirin in treatment-naive patients with genotype 1
chronic hepatitis C (p=0.0008). Albinterferon
alfa-2b is being developed by HGS and Novartis under an exclusive worldwide
co-development and commercialization agreement entered into in June 2006.
"These Phase 3 data show that, with half the injections, the efficacy of
Albuferon was comparable to Pegasys," said H. Thomas Watkins, President and
Chief Executive Officer, HGS. "We are pleased that Albuferon met its
primary endpoint in the ACHIEVE 1 trial as it also did in ACHIEVE 2/3. We
look forward to the filing of global marketing applications in fall 2009,
following discussions with regulatory authorities. Assuming licensure, we
believe Albuferon could become a market-leading treatment for chronic
hepatitis C."
Stefan Zeuzem, M.D., Professor of Medicine and Chief, Department of
Medicine, J.W. Goethe University Hospital, Frankfurt, Germany, said, "These
Phase 3 results in patients infected with the genotype 1 virus, evaluated
together with the previously reported Phase 3 results in patients infected
with the genotypes 2 and 3 viruses, suggest that albinterferon alfa-2b has
the potential to become an important new treatment option for chronic
hepatitis C."
"We are encouraged that albinterferon alfa-2b met the primary efficacy
endpoint of non-inferiority to peginterferon alfa-2a in both of our pivotal
Phase 3 studies," said David C. Stump, M.D., Executive Vice President,
Research and Development, HGS. "As we found with the earlier results from
ACHIEVE 2/3, the ACHIEVE 1 data show that the rate of sustained virologic
response was comparable for the treatment group receiving the 900-mcg dose
of albinterferon alfa-2b every two weeks, versus the treatment group
receiving the standard dose of peginterferon alfa-2a once weekly.
Importantly, the rate of serious and/or severe adverse events was also
comparable for these treatment groups. We were pleased to see that serious
pulmonary adverse events in the 900-mcg group were infrequent and all
resolved with cessation of treatment."
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