ROCKVILLE, Md., Aug. 28 /PRNewswire-FirstCall/ -- Human Genome Sciences, Inc., today announced that it will receive a $40 million payment from Novartis in September 2007 for the previously reported successful completion of a Phase 2b trial of Albuferon(R) (albinterferon alfa-2b) in treatment-naive patients with chronic hepatitis C.
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"This $40 million payment will bring the total milestone payments received from Novartis under our Albuferon co-development and commercialization agreement to $132.5 million," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Novartis and HGS are also sharing clinical development costs equally. From a strategic perspective, our collaboration with Novartis is proceeding very well. Our companies are jointly committed to the highest quality of clinical development, and we are working closely together to bring Albuferon to market as rapidly as possible."
HGS also reported in a separate press release issued earlier today that it has completed enrollment ahead of schedule in the first of two pivotal Phase 3 trials of Albuferon in chronic hepatitis C, and now expects to have Phase 3 data available by the spring of 2009, with filing of global marketing authorization applications anticipated by the fall of 2009.
Under a 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 the $40 million payment expected in September 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.
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 in a significant proportion of people who are infected, 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 www.hgsi.com. For more information about Albuferon, please visit 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, 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.
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