Microbix Biosystems Inc. develops biological products and technologies. The Company was founded in 1988 as a producer of Infectious Disease Antigens, primarily for the diagnostics market. The Company invests in the virology business to build capacity and develop new products to address emerging market opportunities, while enhancing manufacturing and laboratory capabilities and technologies. Building on expertise in virology and protein biochemistry, the Company developed a pipeline of selected biological technologies including VIRUSMAX (Influenza Virus Yield Enhancement Technology), LumiSort™ (Semen Sexing Technology) and the thrombolytic drug, Kinlytic® (Urokinase). Funded by income from the antigen business, the pipeline products take aim at large market opportunities. With Microbix’ core competencies in the Infectious Disease Antigen business, including cell culture, molecular biology, and a GMP quality system, the pipeline products build on Microbix’ strength.
LumiSort™ is next generation instrument based (cytometric) technology that will improve the yield and quality of sexed semen while increasing the speed of sex-sorting by an order of magnitude over methods used in the livestock industry today. It incorporates a novel and innovative instrument design to address fundamental problems with the existing commercial sex selection technology, while providing Microbix with a strong and well differentiated intellectual property advantage in the industry.
LumiSort™ technology emerged from Microbix’ research focus in semen sexing initiated in 2005, a program founded to establish a deeper understanding of the biomolecular composition of sperm cells, and focused on the question of delivering high quality sexed semen.
Urokinase (previously marketed under the trade names Kinlytic®, and Abbokinase™) is a natural human protein that stimulates the human body’s blood clot-dissolving processes. Urokinase is an injectable drug and is approved in Canada and the U.S. for clinical use as a thrombolytic agent for the treatment of pulmonary embolism and coronary occlusion. The drug’s originator, Abbott Laboratories, also received approval to market Urokinase in Canada for treatment of pulmonary embolism and the clearance of blocked biomedical catheters.
In September 2008, Microbix acquired all of the assets relating to the approval and sale of Urokinase in the United States, including the New Drug Application (NDA 21-846) filed by Abbott Laboratories with the U.S. Food and Drug Administration (FDA). Microbix originally identified Urokinase as a product for the Company to develop in order to become established in the biological drug business in the U.S. The product, a protein derived from large scale tissue culture, is a good fit with Microbix core competencies in cell culture, process scale-up, and protein biochemistry.
Microbix intends to serve the Urokinase market through existing FDA and more recently Health Canada approvals, leveraging opinion leader relationships, and formulary listings US hospitals. The Company plans to utilize our established, approved raw materials banks and Microbix’ expertise in cell culture production to proceed with the validation of Microbix’ Urokinase production facility, which will serve existing and new markets. The company will pursue intellectual property for new indications, particularly in ophthalmology and oncology.
Microbix intends to re-introduce Urokinase together with a partner bringing the financial and market resources to complement Microbix’ technical and infrastructure capabilities for Urokinase manufacture.
The Virology business develops, manufactures and distributes infectious disease antigens for the medical diagnostic and vaccine research industries. The Company has commercialized over 60 products derived from infectious pathogens cultured and processed at its facilities.
VIRUSMAX technology is a proprietary process for recovery of more virus from influenza virus-infected chick embryos (eggs) to enhance influenza vaccine production. Virus associated with granular and fibrous debris in the allantoic fluid can be disassociated from the debris and recovered, thereby increasing yield. These increases enhance the productivity of the influenza vaccine manufacturing processes and decrease the time required to produce vaccine in response to emergent viral strains.
Patents have been granted in the U.S., Canada, Europe, India, Italy, Australia, China, Argentina, Mexico and Japan.
Microbix signed its first agreement to establish a manufacturing joint venture agreement in China to build and manage a new flu vaccine manufacturing facility.