Cangene receives marketing authorization approval for WinRho 1500 LQ in Portugal
Readers are referred to the cautionary note regarding Forward-looking Information.
WINNIPEG, Sept. 11, 2013 /CNW/ - Cangene Corporation (Cangene) announced today that the company's wholly owned subsidiary, Cangene Europe Limited, received marketing authorization approval for WinRho® 1500 LQ in Portugal from the National Authority of Medicines and Health Products, IP (INFARMED).
The Company has received a national license to market the product in Portugal for two indications: to prevent Rho(D) immunization women that are in Rho(D) negative, and to treat Rho(D) negative patients after incompatible Rho(D) positive blood transfusions or other products containing erythrocytes antigens.
John A. Sedor, President and CEO of Cangene, said: "Today's approval is a milestone for Cangene and significant news for expectant mothers and other Rh-negative patients in Portugal. By bringing WinRho to Portugal, we have reestablished a foothold in Europe as we drive the growth of Cangene's flagship product in markets outside of North America."
The product will be distributed nationally in Portugal by a third party distributor on behalf of Cangene.
WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)] is a purified human immunoglobulin used for two distinct indications: to treat immune thrombocytopenic purpura (ITP) and to suppress red blood cell antibody development in pregnant mothers' following Rh-positive blood cells that have entered the maternal blood stream from the fetus or Rh-negative patients after incompatible Rh-positive blood transfusions. WinRho® SDF was developed in 1968 by renowned pediatric researchers, Drs. Bruce Chown and John (Jack) Bowman. These physicians gained global recognition as pioneers for treating hemolytic disease of the newborn. In appreciation of their achievements, both physicians were made Officers of the Order of Canada.
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.
SOURCE Cangene CorporationFor further information:
Chief Financial Officer
Ph: (204) 275-4267