Large Scale Biology Corporation (LSBC), incorporated in 1987, is a product-focused biotechnology company using technologies to develop and manufacture recombinant biologics. The biomanufacturing opportunities include vaccines, complex proteins and follow-on, off-patent therapeutics. The Company is focusing its efforts on products: Recombinant Aprotinin, a protease inhibitor used in medical, research and manufacturing applications; Vaccines for human and animal healthcare, including anti-viral and anti-cancer applications, and Certain follow-on, off-patent biologics and products, including Interferon alpha 2a and 2b, Alpha-galactosidase A for treatment of Fabry disease, and Lysosomal acid lipase for the treatment of Wolman disease, cholesterol ester storage disorder (CESD) and reduction of plaque in arteries. During the year ended December 31, 2004, the Company entered into a commercial distribution agreement with Sigma-Aldrich Fine Chemicals, a division of Sigma-Aldrich Corporation, for its first plant-produced recombinant product, and shipped APRONEXIN NP, the research-grade Aprotinin to them. Aprotinin is a protease inhibitor used for medical, research and biomanufacturing applications. The Company initiated a biomanufacturing agreement to extract and purify Planet Biotechnology Inc.'s lead product, CaroRx, a plant-made antibody to control dental caries in 2004. During 2004, the Company also entered new collaborative agreements. It entered into the initial research phase with Cincinnati Children's Hospital Medical Center to develop lysosomal acid lipase as a treatment for Wolman disease and CESD and as an atherosclerosis therapeutic. Predictive Diagnostics, Inc. (PDI), a wholly owned subsidiary of the Company entered into a co-marketing relationship with PerkinElmer Inc., under which PerkinElmer will provide access to PDI's BAMF technology along with its prOTOF 2000 MALDI O-TOF mass spectrometer. In 2004, the Company also initiated a collaborative program to jointly develop and evaluate new therapeutics to prevent and treat diseases caused by human papillomaviruses with the University of Louisville. The Company's Germantown, Maryland facility was closed and the machinery and equipment was re-deployed, sold or scrapped during 2004. On January 31, 2005, the Company extended its research collaboration agreement with Schering-Plough Animal Health Corporation (Schering-Plough) that will fund additional product development of animal health vaccines. Vaccines for three animal health targets were delivered by the Company to Schering-Plough for animal clinical evaluation. It developed and produced trial quantities of the vaccines using its GENEWARE biomanufacturing platform. The GENEWARE biomanufacturing technology provides a method for producing animal health vaccines using non-transgenic, non-food/fodder plants as production hosts. The Company has achieved proof of principle with its own human and animal healthcare therapeutics. While biomanufacturing and some early stages of regulatory and clinical development have been internally financed, the Company plans to achieve advanced clinical trials, final regulatory approvals and commercialization in collaboration with pharmaceutical and biotechnology companies. Its cat parvovirus vaccine has successfully completed early stage pre-clinical trials, demonstrating safety and initial efficacy, and is moving forward into advanced development. It has completed manufacturing process development of Aprotinin and Alpha-galactosidase A, and has received Orphan Drug designation from the Food and Drug Administration (FDA) for Alpha-galactosidase A. The Company is improving its manufacturing process for human lysosomal acid lipase, and is conducting research on its potential use as a therapeutic to treat Wolman disease and CESD and to reduce atherosclerotic plaque. It is developing biomanufacturing capability for proteins and peptides to capitalize on the capacity constraints of the biotechnology industry. It has built a manufacturing facility in Owensboro, Kentucky, which is rea