Healthcare Industry News: antiviral
News Release - October 4, 2006
Human Genome Sciences Announces Phase 3 Clinical Development Program for Albuferon(TM) in Chronic Hepatitis CPhase 3 Clinical Trials to Begin in 2006
ROCKVILLE, Md., Oct. 4 (HSMN NewsFeed) -- Human Genome Sciences, Inc. (Nasdaq: HGSI ) today announced its Phase 3 clinical development program for Albuferon(TM) (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-IFN alpha 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.
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.
HGS Analyst Day Webcast
The HGS senior management team will provide an overview of the Company at its Analyst and Investor Meeting today in New York, starting at 12 noon Eastern time. The presentations will be webcast and may be accessed at http://www.hgsi.com. Investors interested in listening to the live webcast should log on before the presentations begin in order to download any software required. The archive of the presentations will be available for several days following the meeting.
About Human Genome Sciences
The mission of Human Genome Sciences is to discover, develop, manufacture and market innovative drugs that serve patients with unmet medical needs, with a primary focus on protein and antibody drugs.
The HGS clinical development pipeline includes drugs to treat hepatitis C, lupus, anthrax disease, cancer, rheumatoid arthritis and HIV/AIDS. The Company's primary focus is rapid progress toward the commercialization of its two lead compounds, Albuferon(TM) for hepatitis C, and LymphoStat-B(TM) for lupus. Both compounds are expected to advance to Phase 3 clinical trials in 2006.
In June 2006, HGS announced that the U.S. Government exercised its option under an existing contract to purchase 20,000 doses of ABthrax(TM) for the treatment of anthrax disease. Other HGS compounds in clinical development include three TRAIL receptor antibodies for the treatment of hematopoietic and solid malignancies, in addition to an antibody to the CCR5 receptor for the treatment of HIV/AIDS.
For more information about HGS, please visit the Company's web site at http://www.hgsi.com. For more information about Albuferon, visit http://www.hgsi.com/products/albuferon.html. Health professionals or patients interested in inquiring about Albuferon clinical trials or any other study involving HGS products in development are encouraged to inquire via the Contact Us section of the company's web site, http://www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550.
HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the Company will continue to face risks related to animal and human testing, to the manufacture of ABthrax and to FDA concurrence that ABthrax meets the requirements of the ABthrax contract. If the Company is unable to meet the product requirements associated with the ABthrax contract, the U.S. Government will not be required to reimburse the Company for the costs incurred or to purchase any ABthrax doses. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Source: Human Genome Sciences
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