Dragon is developing an engineered version of the naturally occurring granulocyte-colony stimulating factor, G-CSF. This human protein stimulates the bone marrow to produce neutrophils, a type of white blood cell or leukocyte. White blood cells help the body fight infection and disease and, when these cells are reduced in number (leukopenia), susceptibility to infection increases dramatically. Cancer radiation and chemotherapy often destroy leukocytes, as does advanced HIV infection. White blood cell counts are also low in patients with acute myelogenous leukemia and in people receiving bone marrow transplants.
The introduction of G-CSF products has minimized the potential for infection in patients with leukopenia, by rapidly increasing the white blood cell count and reestablishing their protective function. This lucrative market, currently worth over $1.3 billion a year, has been developed by the world’s largest biotechnology company, Amgen, and its multinational partners: Hoffmann La-Roche and Kirin. Furthermore, we believe the market has potential for further development as US physician surveys of clinical practice in oncology suggest that G-CSFs are currently used relatively sparingly.
Dragon G-CSF is being produced by a fundamentally different production technology to that presently used in G-CSF manufacture. Because of its high yields, we believe that this proprietary Pichia yeast cell culturing technology will be capable of producing G-CSF at a fraction of the cost of currently available product. We intend to begin preclinical studies with our engineered protein during the second half of 2001, and clinical investigations are scheduled for the end of 2002. We anticipate first regulatory approvals for this product in 2004.
