- On track to have Phase 3 data available by the spring of 2009 - - Filing of global marketing authorization applications expected by the
fall of 2009 -
ROCKVILLE, Md., Aug. 28 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that it has completed enrollment and initial dosing ahead of schedule in ACHIEVE 1, the first of two pivotal Phase 3 trials of Albuferon(R) (albinterferon alfa-2b) in combination with ribavirin in treatment-naive patients with chronic hepatitis C. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006.
"We have completed enrollment in the ACHIEVE 1 trial ahead of schedule and now expect to have Phase 3 data available for Albuferon by the spring of 2009, with global marketing applications anticipated in the fall of 2009," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Assuming success in Phase 3 trials, we believe that Albuferon could become the interferon of choice in treatment regimens for hepatitis C."
HGS previously projected enrollment of both Phase 3 trials by the end of 2007. A total of 1331 patients at 150 clinical sites in 12 countries have been enrolled and randomized in ACHIEVE 1, which is being conducted in treatment-naive patients with genotype 1 chronic hepatitis C. ACHIEVE 2/3 was initiated in February 2007, and will enroll and randomize a minimum of 918 treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. Enrollment in ACHIEVE 2/3 is also progressing well, and will be completed later in 2007.
"At the doses we are evaluating in Phase 3, Albuferon requires half as many injections as the pegylated interferons, and Phase 2 results suggest that it may offer efficacy at least comparable to peginterferon alfa-2a, with comparable safety and possibly less impairment of quality of life," said John McHutchison, M.D., Coordinating Center Principal Investigator for both Phase 3 trials, Professor of Medicine, Duke University Medical Center, and Associate Director, Duke Clinical Research Institute, Durham, N.C. "We are pleased with both the quality and the rapid progress of enrollment, and we look forward to continuing the evaluation of Albuferon 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 -- 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 (peginterferon alfa-2a) in combination with ribavirin.
"The rapid pace of ACHIEVE 1 enrollment demonstrates a high level of interest in Albuferon among clinical investigators, as well as the significant need for improved treatment options for patients with chronic hepatitis C," said Mani Subramanian, M.D., Ph.D., Senior Director of Clinical Research, Infectious Diseases, HGS.
Higher doses of Albuferon administered monthly, in combination with ribavirin, will be explored in a separate Phase 2b trial conducted by Novartis, which is expected to begin later in 2007.
Albuferon is a novel long-acting form of interferon alpha created by HGS using its 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 more than 20 days. Research shows 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 number of cancers.
Under the worldwide co- 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 $92.5 million received to date and a $40 million payment expected in September 2007.
About Hepatitis C
Hepatitis C is an inflammation of the liver caused by the hepatitis C virus. An estimated 170 million people worldwide are infected with the virus, including nearly 4 million people in the United States. When detectable levels of the hepatitis C virus persist in the blood for at least six months, a person is diagnosed as having chronic hepatitis C. The hepatitis C virus can cause serious liver disease, leading to cirrhosis, primary liver cancer and even death.
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 and other immune-mediated diseases. The Company's primary focus is rapid progress toward the commercialization of its two key lead drugs, Albuferon for hepatitis C and LymphoStat-B(R) (belimumab) for lupus. Phase 3 clinical trials of both drugs are under way.
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) (raxibacumab) for the treatment of anthrax disease. Other HGS drugs in clinical development include two TRAIL receptor antibodies for the treatment of hematologic and solid malignancies.
For more information about HGS, please visit the Company's web site at http://www.hgsi.com. For more information about Albuferon, please visit http://www.hgsi.com/products/albuferon.html. Health professionals or patients interested in Albuferon clinical trials 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 (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 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, Inc.|
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