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HUMAN GENOME SCIENCES ANNOUNCES PHASE 3 CLINICAL DEVELOPMENT PROGRAM FOR ALBUFERON IN CHRONIC HEPATITIS C
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- Phase 3 clinical trials to begin in 2006 -
ROCKVILLE, Maryland - October 4, 2006 - Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced its Phase 3 clinical development program for Albuferon(albumin-interferon alpha 2b) in patients with chronic hepatitis C.
"We believe that Albuferon could become the best-in-class immunomodulator in treatment regimens for chronic hepatitis C, and we are pleased to move this important program forward," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Advancing Albuferon to Phase 3 development is a major step toward the transformation of HGS into a development and commercialization company."
"We have met with U.S. and key European regulatory authorities and have agreement on the design of the Phase 3 program and clinical trials," said David C. Stump, M.D., Executive Vice President, Drug Development, HGS. "HGS designed the program working closely with our collaborator, Novartis, and with leading international experts in the treatment of hepatitis C. We expect to initiate Phase 3 trials before the end of 2006, and we look forward to continuing the evaluation of Albuferon in larger populations to define its appropriate therapeutic role."
"The current standard of care for the treatment of chronic hepatitis C is a combination of pegylated interferon alpha and ribavirin," said John McHutchison, M.D., Professor of Medicine and Director, GI/Hepatology Research, Duke Clinical Research Institute and Duke University Medical Center , Durham , NC . "This combination produces cures in approximately 50 percent of all genotype 1 HCV patients completing therapy. Side effects, many of which are associated with injections of interferon alpha, also continue to be a significant issue. Clearly, chronic hepatitis C represents a significant unmet medical need. In the Phase 3 trials of Albuferon, we hope to build upon preclinical and clinical results to date, which show that Albuferon appears to offer efficacy and safety at least comparable to pegylated interferon with half the frequency of injections."
About the Design of the Albuferon Phase 3 Development Program
The Albuferon Phase 3 clinical development program will include two randomized, open-label, active-controlled, multi-center non-inferiority Phase 3 trials, ACHIEVE 1 and ACHIEVE 2/3, to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus PEGASYS (PEG-IFNƒ¿2a) in combination with ribavirin.
ACHIEVE 1 will be conducted in treatment-naive patients with chronic hepatitis C genotype 1, and will randomize a minimum of 1278 patients into 3 treatment groups, including 2 groups that will receive subcutaneously administered Albuferon once every 2 weeks (900 mcg or 1200 mcg), and an active control group that will receive PEGASYS once every week at a dose of 180 mcg. All patients will receive oral ribavirin concomitantly. The total duration of therapy will be 48 weeks, with 24 weeks of follow-up to document sustained virologic response (SVR). The primary efficacy endpoint will be SVR, defined as undetectable HCV RNA (< 10 IU/mL) at Week 72.
ACHIEVE 2/3 will be conducted in treatment-naive patients with chronic hepatitis C genotype 2 or 3, and will randomize a minimum of 918 patients into 3 treatment groups, including 2 groups that will receive Albuferon once every 2 weeks at doses of 900 mcg or 1200 mcg, and an active control group that will receive PEGASYS once every week at a dose of 180 mcg - with all patients receiving oral ribavirin concomitantly. The total duration of therapy will be 24 weeks, with 24 weeks of follow-up to document SVR. The primary efficacy endpoint will be SVR, defined as undetectable HCV RNA at Week 48.
About Recent Phase 2 Trial Results
Recently released data from ongoing Phase 2 trials of Albuferon in combination with ribavirin demonstrate that Albuferon may offer efficacy and safety at least comparable to the current standard of care, but with less frequent injections - with dosing every two weeks, compared to weekly dosing for the pegylated interferons, which are the current standard of care. In addition, the Phase 2 studies provide a strong scientific basis for the continued exploration of Albuferon at higher doses administered once a month.
In May 2006, HGS reported 12-week interim results from a Phase 2b trial in patients with genotype 1 chronic hepatitis C who are naive to interferon alpha-based treatment regimens. Based on the available data, Albuferon shows a trend for greater antiviral activity at a dose of 1200 mcg every two weeks, versus the leading pegylated interferon with weekly dosing. At doses of 900 mcg every two weeks, Albuferon appears to exhibit efficacy comparable to pegylated interferon administered weekly. Interim data emerging from other Phase 2 studies show that Albuferon doses of 1500 mcg and 1800 mcg are well tolerated and have greater antiviral activity than the lower doses when given every two weeks.
About the Collaboration with Novartis
In June 2006, HGS entered into an exclusive worldwide agreement with Novartis for the development and commercialization of Albuferon. Novartis is a global leader in the pharmaceutical industry and has demonstrated its commitment to leadership in infectious diseases. HGS and Novartis will work closely together to advance Albuferon rapidly to the market. Under the agreement, HGS and Novartis will co-commercialize Albuferon in the United States , and will share U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay HGS a royalty on those sales. HGS and Novartis will share equally in clinical development costs. HGS has received an upfront fee of $45 million. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including $47.5 million when the first patient is dosed in a Phase 3 clinical trial. HGS will have primary responsibility for the bulk manufacture of Albuferon.
About Albuferon
Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using the Company's proprietary albumin fusion technology. This technology enables scientists to improve the pharmacological properties of therapeutic proteins by fusing the gene that expresses human albumin to the gene that expresses the active protein. Albuferon results from the genetic fusion of human albumin and interferon alpha 2b. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.
About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. It is the most common chronic blood-borne infection in the developed world. It is estimated that as many as 170 million people worldwide are infected with hepatitis C virus. This includes nearly four million people in the United States . When detectable levels of the hepatitis C virus in the blood persist for at least six months, a person is diagnosed as having chronic hepatitis C.
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