Human Genome Sciences, Inc. (NASDAQ: HGSI) announced that
Albuferon(R) (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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View drug information on Pegasys.