WINNIPEG , Canada I July 29, 2013 I 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).
About IB1001
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.
SOURCE: Cangene
Post Views: 160
WINNIPEG , Canada I July 29, 2013 I 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).
About IB1001
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.
SOURCE: Cangene
Post Views: 160
