Winnipeg, MB
Cangene Corporation is an export driven Canadian company focusing on the development, manufacture, and marketing of blood- based and biotechnology-derived pharmaceutical products. Publicly-traded on the Toronto Stock Exchange (TSX: CNJ), Cangene has facilities in Winnipeg, Toronto, California, Maryland and Florida, as well as a network of partners that span the globe.
In less than ten years, Cangene has achieved dramatic sales growth in export markets, with export sales increasing from CD$2.1 million in 1994 to more than CD$46 million in 2001. This success has been driven by Cangene's international sales strategy which is to develop a stable base of long-term customers through a commitment to personal service and the delivery of superior products. In the last five years, Cangene has established partnerships with many types of organizations including commercial distributors, governmental organizations and national Ministries of Health, and has successfully undertaken product registration in a number of countries including Ireland, the United States, Poland, Australia and the United Kingdom.
Early in fiscal 1998, Cangene began marketing its manufacturing capability. Cangene has ample capacity to make its expertise available to others due to its recent expansion of the FDA-licensed Winnipeg manufacturing facility, a new 71, 000 sq. ft. Biotech Facility as well as its acquisition of Chesapeake Biological Laboratories Inc., a 70A licensed manufacturing facility in Baltimore, Maryland.
Cangene operates under cGMP (current good manufacturing practices) and is licensed by the U. S. Food and Drug Administration, the Canadian Health Protection Branch, and the U. K. Medicines and Control Agency. As part of continuous improvement efforts, in 1998 Cangene undertook and was awarded the ISO 9001 designation. The ISO 9001 designation is considered a key tool for managing Cangene's quality systems and assisting in Cangene's future export growth.
155 Innovation Dr.
Winnipeg, MB R3T 5Y3
CA
155 Innovation Dr.
Winnipeg, MB R3T 5Y3
CA
Legal Name: Cangene Corporation
Number of Employees: 600
CA
HYPERIMMUNES: Selected antibodies that have been highly purified from specialty human plasma for therapeutic use. Cangene specializes in high-quality, small batch production.
BIOPHARMACEUTICAL: Recombinant protein products purified from host cell production systems for therapeutic use. Cangene uses a strategy similar to that of the generic drug industry and focuses on developing its own version of established products using its own host systems.
INNOVATIVE PRODUCTS: Cangene develops innovative technologies or products, through collaborations and in-house research, that may become the platforms for its next generation of products.
Early in fiscal 1998, Cangene began marketing its manufacturing capabilities. With the recent expansion of the FDA-licensed, ISO 9001-registered, cGMP manufacturing facility in Winnipeg, Cangene. The new 71, 000 sq. ft. Biotech facility is currently being validated and is capable of Recombinant Protein Manufacturing, Microbial Fermentation and Downstream Processing which includes Solvent Purification.
Cangene's Human Growth Hormone (hGH); Cangene completed Phase III clinical trials with Human Growth Hormone (hGH). These trials were designed to support regulatory submission in Canada, the U. S., Europe and other jurisdictions. These studies follow a comparative bioavailability study which compared Cangene's hGH with an approved product.
Cangene performed two separate studies, assessing their hGH drug's ability to combat short stature in children with growth hormone deficiency and girls with Turner's Syndrome. A deficiency of human growth hormone during childhood results in abnormally small stature. While Turner's Syndrome is an X- chromosome linked genetic disorder that occurs in about 1 in 3000 girls resulting in short stature and infertility.
Hepatitis B Immune Globulin: Cangene's own version of this product has been submitted for regulatory review in the United States and Canada. Hepatitis B Immune Globulin is a blood-based product that may be used to prevent Hepatitis B infection in exposed persons.
LEUCOTROPIN is Cangene's Recombinant Human Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF), was successfully used to complete Phase III trials and found to be an effective and safe treatment in myeloid reconstitution in subjects with Hodgkins and non-Hodgkins lymphoma. GM-CSF is a protein that stimulates the production of certain infection fighting white blood cells. These white blood cells are depleted by cancer chemotherapy and certain AIDS treatments, putting the patient at risk.
Varicella zoster Immune Globulin VariZIG is a blood-based product that has been approved in Canada to prevent chickenpox in pregnant women.
325410
ISO 9001
6515-Medical and Surgical Instruments, Equipment, and Supplies
Algeria, Australia, Brazil, Iran, Japan, United Kingdom, United States