Intends to Re-File with Additional Clinical Data
Readers are referred to the cautionary notes regarding Forward-looking Information at the end of this release.
WINNIPEG, June 13, 2013 /CNW/ - Cangene Corporation (Cangene) today announces its withdrawal of the Marketing Authorization Application (MAA) for hemophilia compound IB1001 in Europe and intention to re-file the MAA with the additional clinical data requested by the European Medicines Agency (EMA).
In February 2013, Cangene acquired all rights to the development of the investigational hemophilia compound IB1001 from Ipsen and Inspiration Biopharmaceuticals Inc. IB1001 is a recombinant Factor IX (rFIX) product being developed for the treatment and prevention of bleeding episodes with hemophilia B. At the time of the acquisition, the asset was under regulatory review by the U.S. Food and Drug Administration (FDA) and in the latter stages of review by the EMA.
In May 2013, Cangene presented an Oral Explanation of IB1001 at the Committee for Medicinal Products for Human Use (CHMP). The EMA subsequently requested additional clinical data for IB1001 as part of the Marketing Authorization Application's Centralised Procedure. Given the results of the clinical study producing the data requested will not be available within the timeframe allowed in the Centralised Procedure, Cangene has notified the EMA of its withdrawal of the application at this time. Cangene intends to re-file the MAA for European Union licensure of this important product for hemophilia B patients when the additional clinical data is available.
Cangene continues to address the FDA issued Complete Response Letter (CRL) with a clearly defined path to approval in connection with the Biologics License Application (BLA).
IB1001 is an intravenous recombinant FIX (rFIX) product being developed for the treatment and prevention of bleeding in individuals with hemophilia B. A Biologics License Application (BLA) was submitted to the United States Food and Drug Administration in April 2012, while in August 2011, a Marketing Authorization Application (MAA) was submitted to the European Medicines Agency. In July 2012, IB1001 was put on a clinical hold by the FDA due to a higher than expected rate of host cell antibody development in people treated with IB1001. Manufacturing process changes have been implemented for the drug substance leading to significant reduction in the levels of HCP. Comparability data on drug substance manufactured using the former and the modified processes confirm that the process changes have been successful. Work is ongoing to remove the clinical hold. The FDA issued a Complete Response Letter (CRL) in February 2013 in connection with the BLA for IB1001 and additional manufacturing and development information will be required for the BLA. No additional clinical data was requested under the CRL.
About Hemophilia B
Hemophilia B, previously known as "Christmas disease," is a rare, inherited disorder occurring in about one in 25,000 male births annually. Approximately 25,000 people worldwide, including more than 4,000 in the U.S., have been diagnosed with hemophilia B. Hemophilia B patients have an impaired ability of their blood to clot, which is caused by having substantially reduced or no FIX activity. People with hemophilia B need FIX injections to restore normal blood coagulation and prevent frequent bleeding that could otherwise result in pain, irreversible joint damage and life-threatening hemorrhages. Currently, prophylaxis in hemophilia B typically requires multiple injections of FIX to maintain adequate levels of clotting factor in the blood.
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.
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SOURCE: Cangene Corporation
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