Healthcare Industry News:  hepatitis B virus 

Biopharmaceuticals FDA

 News Release - April 9, 2007

FDA approves Cangene's HepaGam B(TM) for a second indication; for use in hepatitis B-positive liver transplant recipients

TORONTO and WINNIPEG, April 9 (Healthcare Sales & Marketing Network) - Cangene Corporation today reports that the United States Food and Drug Administration ("FDA") has approved HepaGam B(TM) for use to prevent hepatitis B recurrence following liver transplantation in hepatitis B surface antigen ("HBsAg")-positive liver transplant patients. HepaGam B(TM) is Cangene's Hepatitis B Immune Globulin Intravenous (Human), which is a purified antibody or hyperimmune that is specific for the hepatitis B virus. Patients who undergo hepatitis B-related liver transplantation require long-term post-transplant therapy with hepatitis B immune globulin. Clinical trial data showed HepaGam B(TM) was highly effective at preventing hepatitis B recurrence and the dosing regimen used consistently yielded anti-HBsAg levels that exceeded target therapeutic levels. HepaGam B(TM) is distributed in the U.S. by Apotex Corp., which recently expanded its distribution by successfully placing the drug within Novation, LLC's product line-up, making HepaGam B(TM) directly available to Novation's nearly 2,500 member healthcare organizations in the United States.

"This is a very important approval and addresses a significant medical need," said Dr. John Langstaff, Cangene's president and chief executive officer. "And with the recent agreement for distribution of this product with Novation, the timing could not be better," he said.

HepaGam B(TM) was approved last year 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, and was approved earlier this year by Health Canada for prevention of Hepatitis B recurrence following liver transplantation in adult patients.

Hepatitis B is a highly infectious virus that can be spread through contact with blood and other bodily fluids and it can recur 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 had remained in circulation.

Cangene manufactures HepaGam B(TM) in its Winnipeg facility using a process similar to that of WinRho(R) SDF, Vaccinia Immune Globulin and VariZIG(TM), the Company's other hyperimmune products that have been approved in Canada and/or the United States.

A vaccine for hepatitis B is available, yet the virus continues to cause significant disease worldwide and pose a significant public health problem. Hyperimmune products can be used in situations where a vaccine is not applicable. Approximately 60,000 new infections are seen annually. There are an estimated 1.25 million chronically infected Americans, 20-30% of whom were infected as children. Severe liver disease is seen in 15-25% of chronically infected people.

Important Safety Information

HepaGam B(TM) is Hepatitis B Immune Globulin Intravenous (Human), a purified gamma globulin fraction of human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g. viruses and, theoretically, the Creutzfeldt-Jakob disease ("CJD") agent. Individuals known to have severe, potentially life-threatening reactions to human globulin should not receive HepaGam B(TM) or any other immune globulin (Human). Individuals who are deficient in IgA may have the potential for developing IgA antibodies and have severe, potentially life-threatening allergic reactions. The maltose contained in HepaGam B(TM) can interfere with some types of blood glucose monitoring systems. Only testing systems that are glucose-specific should be used in patients receiving HepaGam B(TM). This interference can result in falsely elevated glucose readings that can lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia.

The most common expected adverse drug reactions for immune globulins like HepaGam B(TM) are chills, fever, headaches, vomiting, allergic reactions, nausea, arthralgia and moderate low back pain.

For prevention of hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients, HepaGam B(TM) should be administered intravenously.

For post-exposure prophylaxis, HepaGam B(TM) must be administered only intramuscularly. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B(TM), should be given only if the expected benefits outweigh the potential risks.

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 carries out research and development in Mississauga, Ontario and in Winnipeg. It uses patented manufacturing processes to produce plasma-derived and recombinant therapeutic proteins. Cangene has three FDA-approved products and a fourth that has been approved in Canada. One of its recombinant protein products has received an approvable letter from the FDA and another has been submitted for regulatory review in Canada. In addition, the Company has several more products in development at various stages. 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.

Forward-looking information

The reader should be aware that Cangene's businesses are subject to risks and uncertainties that cannot be predicted or quantified; consequently, actual results may differ materially from past results and those expressed or implied by any forward-looking statements. Factors that could cause or contribute to such risks or uncertainties include, but are not limited to: the regulatory environment including the difficulty of predicting regulatory outcomes; changes in the value of the Canadian dollar; the Company's reliance on a small number of customers including government organizations; the demand for new products and the impact of competitive products, service and pricing; availability and cost of raw materials, especially the cost, availability and antibody concentration in plasma; fluctuations in operating results; government policies or actions; progress and cost of clinical trials; reliance on key strategic relationships; costs and possible development delays resulting from use of legal, regulatory or legislative strategies by the Company's competitors; uncertainty related to intellectual property protection and potential cost associated with its defence; the Company's exposure to lawsuits, and other matters beyond control of management.

Risks and uncertainties are discussed more extensively in the MD&A section of the Company's most recent annual report and annual information form, which are available on the Company's website or on SEDAR at www.sedar.com. Scientific information that relates to unapproved products or unapproved uses of products is preliminary and investigative. No conclusions can or should be drawn regarding the safety or efficacy of such products. Only regulatory authorities can determine whether products are safe and effective for the uses being investigated. Healthcare professionals are directed to refer to approved labelling for products and not rely on information presented in news releases.

The cautionary statements referred to above should be considered in connection with all written or oral statements, especially forward-looking statements, that are made by the Company or by persons acting on its behalf and in conjunction with its periodic filings with Securities Commissions, including those contained in the Company's news releases and most recently filed annual information form. Forward-looking statements can be identified by the use of words such as "expects", "plans", "will", "believes", "estimates", "intends", "may", "bodes" and other words of similar meaning (including negative and grammatical variations). Should known or unknown risks or uncertainties materialize, or should management's assumptions prove inaccurate, actual results could vary materially from those anticipated. The Company undertakes no obligation to publicly make or update any forward-looking statements, except as required by applicable law.


Source: Cangene

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