Cangene Announces Extension of VIGIV Biodefence Contract with U.S. Government
Readers are referred to the cautionary notes regarding Forward-looking Information and non-IFRS Financial Measures at the end of this release. Unless noted otherwise, all dollar amounts are in U.S. dollars.
WINNIPEG, Sept. 3, 2013 /CNW/ - Cangene Corporation (Cangene) announced today that the scope of work under its contract with the Centers for Disease Control and Prevention (CDC) for the supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile has been expanded. The contract, which relates to United States Government biodefence programs, has been extended by 18 months and has also been modified to include three additional option periods that extend through 2017.
Under the terms of the contract extension, Cangene will conduct additional services to support licensure maintenance activities for VIGIV that could generate up to approximately $6.9 million in revenue for Cangene over the next 18 months. In addition, the contract extension includes future optional services to support licensure maintenance activities for the product, as well as options for additional manufacturing and plasma collections. The optional periods, if exercised, could generate an additional $45 million in revenue if the baseline scope of work is implemented or up to an additional $77 million in revenue if the maximum scope is implemented.
John A. Sedor, President and CEO of Cangene, said: "The extension of our VIGIV contract underscores Cangene's leadership in biodefence contracting, which complements our pipeline-focused strategy in the specialty biopharmaceutical space. We look forward to continuing to work together with the U.S. Government and the CDC to ensure preparedness against the threat of smallpox."
VIGIV is a hyperimmune product to be used in treating and preventing certain types of severe complications that may be associated with smallpox vaccination, and is considered an important component of smallpox vaccination programs. The Company originally entered into a 5-year contract for the supply of VIGIV in 2002, which was extended to a 10-year term, before entering into a new contract with the Centers for Disease Control and Prevention in 2012. Cangene's VIGIV product was first accepted into the U.S. Strategic National Stockpile in 2002 and was subsequently licensed in the United States by the U.S. Food and Drug Administration in 2005 and in Canada by Health Canada in 2007.
About Cangene Corporation
Cangene Corporation (TSX: CNJ), headquartered in Winnipeg, Canada, is one of the nation's oldest and largest biopharmaceutical companies. It is focused on the development and commercialization of specialty therapeutics. Cangene's products are sold worldwide and include products that have been accepted into the U.S. Strategic National Stockpile. Cangene has offices in three locations across North America. It operates manufacturing facilities in Winnipeg, Manitoba and Baltimore, Maryland (through its wholly-owned subsidiary, Cangene bioPharma, Inc.) where it produces its own products and undertakes contract manufacturing for a number of customers. Cangene also operates a plasma-collection facility in Winnipeg, Manitoba under the name Cangene Plasma Resources. Its U.S. sales and marketing office is located in Philadelphia, Pennsylvania. For more information about Cangene, visit the Company's website at www.cangene.com.
Cautionary Note regarding Forward-Looking Information
This document contains forward-looking statements about the Corporation, including its business operations, strategy, and expected financial performance and condition. Forward-looking statements include statements that are predictive in nature, depend upon or refer to future events or conditions, or include words such as "expects", "anticipates", "intends", "plans", "will", "believes", "estimates", or negative versions thereof, and similar expressions. In addition, any statement that may be made concerning future financial performance (including revenues, earnings or growth rates), ongoing business strategies or prospects, future use, safety and efficacy of unapproved products or unapproved uses of products, and possible future action by the Corporation are also forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and are inherently subject to, among other things, risks, uncertainties and assumptions about the Corporation, economic factors and the biopharmaceutical industry generally. They are not guarantees of future performance. Actual events and results could differ materially from those expressed or implied by forward-looking statements made by the Corporation due to, but not limited to, important factors such as sales levels; fluctuations in operating results; the Corporation'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; the availability and cost of raw materials, and in particular, the cost, availability and antibody concentration in plasma; progress and cost of clinical trials; 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 costs associated with its defence as well as general economic, political and market factors in North America and internationally; interest and foreign exchange rates; business competition; technological change; changes in government action, policies or regulations; decisions by Health Canada, the United States Food and Drug Administration and other regulatory authorities regarding whether and when to approve drug applications that have been or may be filed, as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of drug candidates; unexpected judicial or regulatory proceedings; catastrophic events; the Corporation's ability to complete strategic transactions; and other factors beyond the control of management.
The reader is cautioned that the foregoing list of important factors is not exhaustive and there may be other factors listed in other filings with securities regulators, including factors set out under "Risk and Uncertainties" in the Corporation's Management Discussion and Analysis, which, along with other filings, is available for review at www.sedar.com. The reader is also cautioned to consider these and other factors carefully and not to place undue reliance on forward-looking statements. Other than as specifically required by applicable law, the Corporation has no intention to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Cautionary Note Regarding Non-IFRS Financial Measures
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