Novavax co-invented hepatitis E vaccine technology licensed to SmithKline Beecham.

Novavax, Inc. (Columbia, MD; 301-854-3900) announced that the National Institutes of Health recently licensed the rights to the NIH and Novavax recombinant Hepatitis E virus clones and antigen production technology to SmithKline Beecham plc (Brentford, England; 44-20-8-975-2000) for the development of a human vaccine. The recombinant Hepatitis E virus DNA clones were co-developed by NIH and Novavax, while the Hepatitis E virus capsid protein purification process was developed by Novavax. Presently, there is no vaccine or antiviral therapy available for Hepatitis E virus, which is an acute form of viral hepatitis with epidemics in Asia, Africa and Mexico and has high mortality among pregnant women. The vaccine was invented by Drs. Robert Purcell, Sergei Tsarev and Suzanne Emerson of the NIH/National Institute for Allergy and Infectious Diseases (Bethesda, MD) and Dr. Robin Robinson, associate director of Novavax's Biomedical Services Division (Rockville, MD). Under the terms of the agreement, SmithKline Beecham was granted a non-exclusive license to the recombinant Hepatitis E virus ORF2 capsid genes cloned into baculoviruses for commercial development, manufacturing, and marketing of Hepatitis E virus vaccines. NIH and Novavax will receive upfront licensing fees and benchmark payments, as well as royalties on future product sales from SmithKline Beecham. Novavax's Biomedical Services Division, through contracts with the NIH and SmithKline Beecham, has collaborated with SmithKline Beecham since 1995, while National Institute for Allergy and Infectious Diseases has collaborated with SmithKline Beecham for over ten years.

As previously announced, National Institute for Allergy and Infectious Diseases and Novavax have collaborated to develop a recombinant protein expression system in insect cells for production of recombinant Hepatitis E virus capsid antigens and a novel proprietary downstream process for purifying the viral antigen used as a vaccine. The latter was published in the peer reviewed journal, Protein Expression and Purification (1998; 12: 75-84) and was issued a patent recently (United States Patent 6,054,567 -- April 25, 2000).

"Results from Phase I human clinical studies in the United States indicated that low doses of the Hepatitis E virus vaccine were immunogenic and caused no significant adverse effects. The Hepatitis E virus vaccine, which is intended for residents of Hepatitis E virus endemic areas worldwide and for travelers to these areas, is currently being evaluated in a Phase II clinical trial in Nepal, designed to demonstrate the efficacy of this recombinant vaccine," stated Dr. Robinson. These clinical trials are being conducted and paid for by NIH, SmithKline Beecham Biologicals and Walter Reed Army Institute of Research.

John A. Spears, president and CEO of Novavax, stated, "We are very pleased to be working with SmithKline Beecham and the Walter Reed Army Institute of Research on this important project. Currently, we are participating in the ongoing worldwide Phase II clinical trials of the Hepatitis E virus vaccine, as well as developing further its commercial production process."

"From a corporate standpoint, this is the first license of a Novavax vaccine technology to a major pharmaceutical company, and is yet another example of the value that is inherent in Novavax's Biomedical Services Division. We continue to believe that the extensive proprietary research being developed at the Novavax's Biomedical Services Division, either internally or through collaboration, has substantial licensing potential. We certainly look forward to pursuing these valuable opportunities for our many promising products."

Novavax is a biopharmaceutical drug delivery company engaged in the research and development of differentiated drug products focused on women's health, infectious diseases and cancer. The company is applying its proprietary lipid vesicle encapsulation technologies including Novasome lipid vesicles and micellar nanoparticles to develop product candidates for the topical and oral delivery of generic and non-generic drugs, peptides, proteins and oligonucleotides. The company's Novasome technology is also being developed as an adjuvant delivery system for enhanced vaccine efficacy. Novavax has several product candidates in pre-clinical and human clinical trials, including ESTRASORB, a topical cream for estrogen replacement therapy which has entered Phase III clinical testing. Novavax's Biomedical Services Division is engaged in contract research and development and Phase I/II vaccine manufacturing of human vaccines for government laboratories and other vaccine companies.