Human Genome Sciences, Inc. (HGSI) announced an exclusive worldwide licensing agreement with Novartis for the development and commercialization of Albuferon (albumin-interferon alpha 2b) for chronic hepatitis C and all other uses.
Under the agreement, HGS and Novartis will co-commercialize Albuferon in the United States, and will share US commercialization costs and US profits equally. Novartis will be responsible for commercialization outside the US and will pay HGS a royalty on those sales. HGS and Novartis will share equally in clinical development costs. HGS will receive 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.
"This agreement brings the strengths of a global leader in the pharmaceutical industry to the development and commercialization of Albuferon, a product that could become the best-in-class immunomodulator in treatment regimens for chronic hepatitis C," said H. Thomas Watkins, President and Chief Executive Officer of Human Genome Sciences. "Novartis has demonstrated its commitment to leadership in infectious diseases, and we look forward to working closely together to advance Albuferon rapidly to the market. This collaboration is a significant step forward in our company's progress toward commercialization."
HGS expects to initiate Phase 3 clinical development of Albuferon by the end of 2006.
Clinical studies to date indicate that Albuferon could offer improved dosing in the treatment of chronic hepatitis C, with efficacy and safety at least comparable to the current standard of care, pegylated interferons. These results demonstrate that Albuferon is well tolerated, remains in the blood substantially longer than is reported for recombinant interferon alpha and pegylated interferon alpha, and exhibits robust antiviral activity.
Albuferon is a novel, long-acting form of interferon alpha. It is a Human Genome Sciences drug created 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.
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. The hepatitis C virus is transmitted primarily through significant or repeated exposures to infected blood. Intravenous drug use and sexual contact with infected persons account for the majority of new hepatitis C infections. 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.