On March 26, Canadian biotechnology company Cangene announced that its hepatitis B intravenous immune globulin, HepaGam B, was granted exclusive orphan drug approval by the U.S. Food and Drug Administration (FDA) for use in preventing recurrence of HBV following liver transplantation.

Below is an edited excerpt from a Cangene press release announcing the approval:

Cangene's anti-hepatitis B product granted orphan-drug exclusive approval by the U.S. Food and Drug Administration

TORONTO and WINNIPEG, March 26 -- Cangene Corporation today announces that its HepaGam B (Hepatitis B Immune Globulin Intravenous (Human)), has received orphan-drug exclusive approval from the United States Food and Drug Administration ("FDA") for the prevention of hepatitis B recurrence following liver transplantation in hepatitis B surface antigen (HBsAg)-positive liver transplant patients. This approval gives HepaGam B seven years of market exclusivity and could facilitate the recovery of certain regulatory filing fees.

"This approval is a significant achievement for Cangene, providing seven years of market exclusivity in the United States. This exclusivity further solidifies HepaGam B)'s position in the U.S. market as the only hepatitis B immune globulin approved for the prevention of hepatitis B recurrence following liver transplantation," said Dr. John Langstaff, Cangene's president and chief executive officer.

Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids. Hepatitis B recurrence can occur after liver transplantation in patients who are HBsAg-positive at the time of transplant. Recurrence results from the infection of the liver graft with hepatitis B virus that has remained in the patient's body. The hepatitis B virus continues to pose a significant public health problem. Of the estimated 6,500 liver transplants performed annually in the United States, approximately 5% are a result of hepatitis B infection. The U.S. market is estimated at $40 to $50 million annually.

About HepaGam B

HepaGam B is Cangene's Hepatitis B Immune Globulin (human) Injection, which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. It is the only intravenous product licensed in Canada or the U.S. for prevention of Hepatitis B recurrence following liver transplantation in adult patients with Hepatitis B who have no or low levels of hepatitis B virus replication. It is also approved by the FDA for treatment following acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAG-positive persons and household exposure to persons with acute hepatitis B virus infection. Cangene manufactures HepaGam B in its Winnipeg, Manitoba facility. The company has four FDA-approved hyperimmunes that it manufactures using similar processes.

HepaGam B is distributed in the U.S. by Apotex Corp., which has placed the drug within Novation LLC's product line-up, making HepaGam B directly available to Novation's nearly 2,500 member healthcare organizations in the United States.

About Orphan-Drug Exclusive Approval

A drug can be granted orphan-drug designation if the disease or condition the drug is intended to treat affects fewer than 200,000 people in the United States or, if the drug is a vaccine, diagnostic drug or preventative drug; will be administered to fewer than 200,000 people per year in the United States. Once a product receives orphan-drug exclusive approval for use in the disease or condition, FDA will not approve another sponsor's product for that use for seven years.

About Cangene Corporation

Cangene is one of Canada's largest and earliest biopharmaceutical companies. It was founded in 1984 and is headquartered in Winnipeg, Manitoba. Cangene has approximately 650 employees in eight locations across North America. It operates three large manufacturing facilities-two in Winnipeg, Manitoba and one in Baltimore, Maryland-where it produces its own products and undertakes contract manufacturing for a number of companies. Cangene operates three U.S. and one Canadian plasma-collection facilities. In addition, it has a regulatory affairs, sales and investor relations office in Toronto, Ontario (NOTE: this office moved effective January 2008, the new address is 180 Attwell Drive, Suite 360, Toronto, ON, M9W 6A9; phone 416-675-8300; fax 416-675-8301).

The Company uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Cangene has four FDA and Health Canada-approved products and a fifth that has been approved in Canada only. In addition, the Company has several more products in development at various stages. Three of Cangene's products have been accepted into the U.S. Strategic National Stockpile-botulism antitoxin, anthrax immune globulin and vaccinia immune globulin, a product used to counteract certain complications arising from smallpox vaccination.

Capitalizing on its drug manufacturing expertise, Cangene also operates a significant contract research and manufacturing business using its Winnipeg facilities and the resources of Baltimore, Maryland-based Chesapeake Biological Laboratories, Inc. (a wholly owned subsidiary). An expansion in 2006 at the Winnipeg location increased the Company's capacity to fractionate plasma to accommodate the growing manufacturing requirements. Cangene's website, www.cangene.com, includes product and investor information, including past news releases. Chesapeake's website is www.cblinc.com.

4/04/08

Source
Cangene Corporation. Cangene's anti-hepatitis B product granted orphan-drug exclusive approval by the U.S. Food and Drug Administration. Press release. March 26, 2008.