Cangene Corporation

Cangene Corporation

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.

Company Details

Year Established: 1984

Total Sales ($CDN): $25,000,000 - $50,000,000

Number of Employees: 600

Products

Winrho Sdf [rho(d) Immune Globulin]

Varicella Zoster Immune Globulin Varizig
Varicella zoster Immune Globulin VariZIG is a blood-based product that has been approved in Canada to prevent chickenpox in pregnant women.

Hepagamb (hpatitis B Immune Globulin)
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.

Accretropin (hgh)
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.

Leucotropin (gm-csf)
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.

Winrhosdf (rho(d) Immune Globulin)

Vaccinia Immune Globulin (vig)

Anthrax Immune Globulin

Botulism Antitoxin

Services

Contract Manufacturing 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.

Biopharmaceuticals

Biodefense

Hyperimmunes