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7/30/2013 7:00:43 AM
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FDA lifts clinical hold on Cangene's hemophilia compound IB1001
WINNIPEG , July 29, 2013 /CNW/ - Cangene Corporation (Cangene) today announces that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on clinical trials evaluating the safety and efficacy of IB1001, a recombinant Factor IX (rFIX) product being developed for the treatment and prevention of bleeding episodes with hemophilia B.
"IB1001 continues to provide an opportunity to address a significant global need for patients with hemophilia B, and we are pleased to be moving forward with our phase 3 studies," said John A. Sedor, President and Chief Executive Officer of Cangene. "Our manufacturing, analytical and clinical expertise has facilitated clinical hold removal and our regulatory interactions continue to shape the pathway to IB1001 licensure. We acquired IB1001 because we are confident in IB1001 and our ability to achieve its licensure, which will benefit hemophilia B patients and build value for our shareholders."
In a letter to the Company, the FDA acknowledged that Cangene had addressed all of the Agency's clinical hold issues and that the clinical hold had been lifted, effective immediately. Cangene will now re-initiate ongoing studies and begin new studies in adult and pediatric patients, which will be used to submit updated licensure applications in the U.S. and Europe . Specific clinical data requirements to support licensure may vary by jurisdiction and discussions are ongoing with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
IB1001 is an intravenous recombinant FIX (rFIX) product being developed for the treatment and prevention of bleeding in individuals with hemophilia B. In February 2013 , Cangene acquired all rights to the development of the investigational hemophilia compound IB1001 from Ipsen and Inspiration Biopharmaceuticals Inc. At the time of the acquisition, the asset was under regulatory review by the FDA and EMA, and IB1001 clinical studies were on clinical hold due to a higher than expected rate of host cell antibody development in people treated with IB1001. Since then, manufacturing process changes have been implemented for the drug substance leading to significant reduction in the levels of HCP and comparability data confirms that the process changes have been successful. With the lifting of the clinical hold, IB1001 clinical studies will be started with the product using the modified process and involve adults and pediatric patients with hemophilia B.
Cangene intends to seek licensure from the FDA and EMA with this updated manufacturing and developmental information.
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 (CNJ.TO), 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 Corporation
Chief Financial Officer
Ph: (204) 275-4267
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