Healthcare Industry News: Albuferon
News Release - February 27, 2007
Human Genome Sciences Initiates Phase 3 Clinical Trial of Albuferon(R) With Ribavirin in Treatment-Naive Patients With Chronic Hepatitis C Genotypes 2 and 3Enrollment of both Phase 3 trials of Albuferon to be completed in 2007 Global marketing applications planned in 2009
ROCKVILLE, Md., Feb. 27 (HSMN NewsFeed) -- Human Genome Sciences, Inc. (Nasdaq: HGSI ) today announced that it has initiated dosing in ACHIEVE 2/3, a Phase 3 clinical trial of Albuferon® (albinterferon alfa-2b) in combination with ribavirin in treatment-naive patients with chronic hepatitis C genotypes 2 and 3. ACHIEVE 2/3 is the second of two pivotal Phase 3 trials of Albuferon that HGS is conducting, with the goal of filing global marketing applications in 2009. Albuferon is being developed by HGS and Novartis under an exclusive worldwide development and commercialization agreement entered into in June 2006.
"We believe that Albuferon could become the interferon of choice in treatment regimens for chronic hepatitis C, and we are pleased to announce that both Phase 3 trials of this potentially important compound are now underway," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "These trials, assuming that they are successful, will provide the pivotal data to support global marketing applications for Albuferon in 2009."
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. 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.
"Chronic hepatitis C represents a significant unmet medical need," said David Nelson, M.D., lead investigator of the ACHIEVE 2/3 trial, and Associate Professor of Medicine, Medical Director of Liver Transplantation, and Chief of the Hepatobiliary Disease Section, University of Florida. "Albuferon requires half as many injections, and clinical results to date suggest it may offer efficacy at least comparable to pegylated interferon, with the potential for less impairment of health-related quality of life. We look forward to continuing the evaluation of Albuferon in larger populations in Phase 3 trials."
About the Albuferon Phase 3 Development Program
The Albuferon Phase 3 clinical development program includes two randomized, open-label, active-controlled, multi-center, non-inferiority trials to evaluate the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus PEGASYS (peginterferon alfa-2a) in combination with ribavirin. In December 2006, HGS initiated dosing in ACHIEVE 1, a Phase 3 trial of Albuferon in treatment-naive patients with chronic hepatitis C genotype 1. ACHIEVE 2/3 will be conducted in treatment-naive patients with chronic hepatitis C genotype 2 or 3.
"HGS designed ACHIEVE 1 and ACHIEVE 2/3 working closely with our development and commercialization partner, Novartis, and with leading international experts in the field of hepatitis C," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We also reviewed the pivotal trial designs with U.S. and key European regulatory authorities and received their positive feedback. Based on the response we have had from the clinical research community, we fully expect to attain our goal of completing the enrollment of both of our Phase 3 trials of Albuferon by the end of 2007."
Higher doses of Albuferon administered every 4 weeks, in combination with ribavirin, will be explored in a separate Phase 2b trial to be conducted by Novartis, beginning in 2007.
Albuferon is a novel, long-acting form of interferon alpha, which was created by HGS using the Company's proprietary albumin fusion technology. Albuferon results from the genetic fusion of human albumin and interferon alpha. Human albumin is the most prevalent naturally occurring blood protein in the human circulatory system, persisting in circulation in the body for over twenty days. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the proteins. Recombinant interferon alpha is approved for the treatment of hepatitis C, hepatitis B and a broad range of cancers.
About the Collaboration with Novartis
Under an exclusive worldwide development and commercialization agreement entered into in June 2006, HGS and Novartis will co-commercialize Albuferon in the United States, and will share clinical development costs, 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. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million, including a $45 million upfront payment and $47.5 million received in January 2007 following dosing of the first patient in a Phase 3 trial.
HGS management will hold a conference call to discuss this announcement, as well as the Company's fourth quarter and full-year 2006 results, today at 5:00 PM Eastern time. Investors may listen to the call by dialing 800-263-8506 or 719-457-2681, passcode 1549825, five to ten minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 1549825. Today's conference call also will be webcast and can be accessed at http://www.hgsi.com. Investors interested in listening to the live webcast should log on before the conference call begins in order to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
The HGS clinical development pipeline includes novel 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® for hepatitis C, and LymphoStat-B® for lupus. Phase 3 clinical trials of both compounds are now underway.
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 drugs 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 clinical trials of Albuferon or other studies involving HGS products may 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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